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PHARMACEUTICS AND HEALTHCARE:regulatory framework in Ukraine

Kyiv 2010



Kyiv 2010

PHARMACEUTICS AND HEALTHCARE:regulatory framework in Ukraine



4 Arzinger. «Pharmaceutics and Healthcare».



1

Contents

INTRODUCTION......................................................................................................... 3

SECTION IREGULATORY ASPECTS OF COMPANY'S ACTIVITY IN PHARMACEUTICAL FIELD

1. Legislation in pharmaceutical eld ………………………..........………………............………42. State administration in the eld o creation, manuacturing, quality control

and sale o medicinal products………………………………..............................................…43. Intellectual property……………..........................………………........…..................................54. Pre-clinical trials…………....................................................……………………………............75. Clinical trials………………............................................................……………………….......…86. State registration (authorization) o medicinal products………………………........97. Drug manuacturing ……………………...............................................................................12

7.1. Licensing …………………………………….......…………………………………...….127.2. Certication………………...……………………………………………………....……137.3. Labeling ……………........……………………………………………………………...… 147.4. Quality control…………………....……………………………………………...…...…15

8. Import o drugs to Ukraine………………..............................................……................…158.1. State registration……………………..........……………………………………….…...15

8.2. Customs procedures……………………………………………………………………168.3. Quality control …………..…………………………………………………………...…179. Drug sale in Ukraine.....…….............................................................................……………18

9.1. Drug wholesale………….....................................................................….........…189.1.1. Licensing ………………........…………………………………...............….189.1.2. Sale conditions………..............………….....…………………………......18

9.2. Drug retail.................................................................................................………199.2.1. Licensing ……………………......…………………………………….....… 199.2.2. Sale conditions…………..………………………………………………..…19

9.3. General provisions on drug wholesale and retail……...............……….......209.3.1. Trade patenting ………...............................................…………..........209.3.2. Incoming control …………………....…………………………………..….209.3.3. Storage and transportation……………................……………………..219.3.4. Public procurement ……………......................................................…219.3.5. Pricing ………………….............…………………………….............….. 239.3.6. Taxation…………….............………………………………….…............. 239.3.7. Advertising …………………..………………………………...............……24

10. Utilization and disposal o drugs……….....……………..................………………..........…24

Contents




SECTION ІІ

REGULATORY ASPECTS OF COMPANY’S ACTIVITIESIN THE MEDICAL FIELD

1. Legislation in the medical eld………………......………………………………….................26

2. State administration in the medical eld……………....................................................263. Business activities in the medical eld…………...........…………………………….........…273.1. Licensing o medical activities…………...........…………………………………...273.2. State accreditation o health-care institutions……………..............………….283.3. Obtaining a permit or medical activities in the sphere

o olk medicine and alternative medicine……………….................…………304. Attestation o medical ocers…………….........……………………………………………….31

4.1. Attestation o medical specialists……………………………………………….…314.2. Attestation o junior medical specialists……………...........………………..…32

Annex 1

PROCEDURE FOR CLASSIFICATION OF FOOD AS FOOD AND DIETARY SUPPLEMENTS, FUNCTIONAL FOOD AND FOOD PRODUCTS FOR SPECIAL DIETARY CONSUMPTION, AND THEIR STATE REGISTRATION ..................................................................…33

Annex 2

PROCEDURE OF STATE (RE-)REGISTRATION OF MEDICALIMMUNOBIOLOGICAL DRUGS .........................................................................……35

Annex 3

PROCEDURE FOR STATE REGISTRATION OF MEDICALEQUIPMENT AND MEDICAL PRODUCTS………………….........………………..…39

Annex 4

GOVERNMENT INSTITUTIONS IN THE FIELD

OF HEALTHCARE...........................................................................................................…41

Annex 5

LEGISLATIVE REGULATIONIN HEALTHCARE FIELED …………..........……………….................................................53



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INTRODUCTION

Te pharmaceutical market o Ukraine with the annual total sales volume reaching 2.2 billionEUR is the second large one in the CIS territory. Due to strategically advantageous geographiclocation o Ukraine and its big population (about 46 million people) this market is extremely

attractive and promising rom investment point o view.

Introduction o obligatory GMP standardization and harmonization o Ukrainian pharma-ceutical legislation with EU requirements is a positive signal or coming o oreign and devel-opment o local pharmaceutical companies.

Introduction o obligatory medical insurance and Ukraine’s joining to PIC/S expected in thenearest uture will surely contribute to rush development o national healthcare sphere.

Signicant investment potential o the healthcare eld shall be outlined in particular. Despite

the act that development rate o private healthcare in Ukraine cannot be compared to devel-oped countries, more experts consider this direction as very perspective and orecast coming o big investors in the nearest uture.

Te importance o the pharmaceutical market or the economy o Ukraine as well as consti-tutional obligation o the state to create conditions or eective and accessible or all citizenshealthcare system explain the constant close control o state regulatory authorities.

Te legal regulation o healthcare in Ukraine is dened by a large number o legal acts andtheir quick changes; thereore a reliable legal partner is highly important and necessary on all

stages o business conduction in Ukraine.

Arzinger is the leading independent law rm on the legal services market in Ukraine. Te rm was ounded in 2002 and has now about 80 employees working in 3 oces o the rm – Kyiv,Lviv and Odesa.

Healthcare and pharmaceutics is one o Arzinger’s priority industries. In order to providequality legal assistance our lawyers collaborate with other practices o the rm, in particular,corporate, employment, intellectual property, litigation etc. which allows us to provide ourclients with integrated and exhaustive advice on all Ukraine-related business issues.

Te Arzinger’s attorneys provide a solution driven legal advice to leading international anddomestic companies on all legal issues in the healthcare eld.

Tis edition intends to provide general idea about legal ramework o the healthcare sectorin Ukraine as o 01.10.2010. Inormation contained herein does not represent a complex re-search or practical guideline. Beore taking any actions based on inormation contained in thisedition we would recommend you to get legal advice.

For urther inormation please contact: Timur Bondaryev , Senior partner. [email protected]

el.: +38 (044) 390 55 33; Assistant: +38 (044) 390 55 39

Introduction




SECTION I

REGULATORY ASPECTS OF COMPANY'S

ACTIVITY IN PHARMACEUTICAL FIELD

1. LEGISLAIONIN PHARMACEUICAL FIELD

Business in pharmaceutical eld in Ukraine is regulated by a number o legal acts basic provisions o which are directed at supply o sae, quality and eective drugs to the

population. Te undamental legal act in the pharmaceutical legislation o Ukraine isthe Law o Ukraine «On Medicinal Products» dd. 04.04.1996 #123/96-VR whichregulates legal relations connected to creation, registration, manuacturing, qualitycontrol and sale o medicinal products (hereinaer – medicinal products or drugs),determines rights and obligations o companies, institutions, organization and citizensas well as o state authorities and their ocials in this sphere.

2. SAE ADMINISRAION IN HE FIELDOF CREAION, MANUFACURING,QUALIY CONROL AND SALEOF MEDICINAL PRODUCS

Te Parliament o Ukraine determines state policy and regulates on legislative level therelations in the sphere o creation, manuacturing, quality control and sale o drugs.

Te Cabinet o Ministers o Ukraine (hereinaer – the CMU) implements the state policy as to creation, manuacturing, quality control and sale o drugs through a systemo state executive authorities, ensures development and implementation o respectivenationwide and other programs within limits o their powers, ensures control over ad-herence to the legislation on drugs.

Te Ministry o Healthcare o Ukraine (hereinaer – the MHC o Ukraine), the StatePharmacological Centre o the MHC o Ukraine (hereinaer – the State Pharmaco-logical Centre or the Centre), the State Inspectorate or Quality Control o Drugs o

the MHC o Ukraine (hereinaer – the State Drugs Inspectorate) and other specially




5 years, according to the Instruction approved by the Ministry o Education and Science o Ukraine dd 13.05.2002 # 298. Te issue o patent extension shall be considered by the StateDepartment o Intellectual Property on the request o the interested person.

Packaging and external shape o medicinal products may be objects o industrial design’s

rights, protection o which is held in accordance with the Law «On Protection o Rightsto Industrial Designs» dd. 15.12.1993 # 3688-XII. Te ownership title to an industrialdesign is certied by a patent. Te period o validity o a patent is 10 years rom the date o ling to the State Enterprise «Ukrainian Institute o Industrial Property» (hereinaer –Ukrpatent) and may be extended on the owner’s request, but not more than or5 years.

A medicinal product enters the civil circulation under the trade mark which is protectedunder the Law «On Protection o Rights to rademarks or Goods and Services" dd15.12.1993 # 3689-XII. Te trademark’s protection can be granted only to original, spe-cially invented names o drugs. Te protection is established by the way o the registrationo property rights to the trademark under the application, submitted to the Ukrpatent inaccordance with the provisions o the Law. Based on the examination’s results the trade-mark’s registration is held, and a certicate o ownership is issued. Te certicate is validor 10 years, its validity can be extended every time or another 10 years at the request o the holder, the number o extensions is not limited. Upon termination o the certicateonly the holder is entitled to register this mark again during the next 3 years.

While considering application the Ukrpatent shall be governed by the list o Inter-

national non-proprietary names (INN) o World Healthcare Organization regard-ing medicinal products which may not be registered as trademarks. Te mentioned iscaused by the act that INNs are directly connected with structural ormulas o activesubstances o medicinal products and correspond to respective simplied substitu-tions o their chemical names. Te so called «common» names o medicinal products which have been used since USSR times and are well known among some generationsare not subject to a separate legal protection. In such cases a trademark may include thename o manuacturer as well as inormation on its ormulation or indication.

Te inormation which is contained in the application or state registration and its at-

tachments is subject to state protection rom disclosure and unair commercial use.I a medicinal product is registered in Ukraine, it is prohibited or ve years rom thedate o registration (regardless o the validity o any patent that is related to the drug)to use registration inormation or applying or state registration o another product,except when the right to reer or use such inormation obtained in due course.

For disclosure, improper use o the registration inormation guilty persons are broughtto disciplinary, administrative, civil and/or criminal liability in accordance with thelaws o Ukraine.



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4. PRE-CLINICAL RIALS

Pre-clinical study o drugs envisages a complex o chemical, physical, biological, mi-crobiological, toxicological and other science researches o drugs which are carried out

beore the the beginning o clinical trials.Procedure or pre-clinical drugs studies, requirements to conditions o single research-es as well as procedure or expert examination o materials or pre-clinical trials o me-dicinal products is determined by the Decree o MHC o Ukraine dd. 14.12.2009#944 «On approval o procedure or conduction o pre-clinical drug trials and expertexamination o pre-clinical drug trial’s materials».

Te pre-clinical trial is conducted in ollowing directions: establishment o pharmaco-logical ecacy o medicinal products, study o their pharmacokinetics and toxicologi-

cal researches.

Te pre-clinical trial shall be conducted by research institutions irrespectively theirownership orm and departmental subordination which are able to provide respectivemethodical and scientic level o pre-clinical study o saety and ecacy o drugs as well as duly adherence according to the current legislation to principles o humanetreatment o laboratory animals, i any.

Customer o pre-clinical trial is a legal entity irrespectively o its ownership orm or an

individual which/who initiates conduction o pre-clinical trial, determines its scope,approves and provides nancing or pre-clinical drug trial.

Tere are ollowing types o pre-clinical trials: study o the test-sample’s toxicity, repro-ductive toxicity, embryo-toxicity and teratogenicity, mutagenicity and cancerogenic potential, pharmacodynamics, pharmacokinetics, and local eect o the test-sample.

est-sample or pre-clinical trial shall be provided by the ordering customer together with a quality certicate or each series signed by an authorized person o the manu-acturer. Tere are two types o trials: short-term o 2-4 weeks and long-term o 3-6

months.

Te actual pre-clinical trial shall be preceded by an evaluation o ethical, moral andlegal aspects o the trial as well as by an approval o a written protocol (plan) o the pre-clinical trial. Te protocol shall correspond with requirements o GLP and shall beagreed upon with the head o the research institution and the customer. Results o the pre-clinical trial shall be set out in a report signed by the trial director and approved bythe head o the research institution and the customer.

In case inormation in the provided materials revokes any doubts as to its authenticity

Regulatory aspects of company's activity in pharmaceutical field




or i there is no documented evidence regarding adherence to GLP requirements dur-ing toxicity and saety studies, an audit o the pre-clinical can be carried out during theexpert examination o pre-clinical drug trial’s materials. Te results o the audit shall bestated in a respective report.

All materials o a pre-clinical trial, including the report copy, shall be kept in the ar-chives o the research institution or at least 5 years.

5. CLINICAL RIALS

Clinical trials o medicinal products shall be conducted according to the Decree o theMHC o Ukraine dd. 23.09.2009 #690 «On approval o the Procedure or conduc-tion o clinical trials o medicinal products and expert examination o clinical trials’materials and the Standard provision on Ethics Commission».

All clinical trials shall be conducted according to international ethical principles en-suring protection o rights, saety and well-being o participants. Clinical trial can beconducted only i the expected advantage justies possible risks.

Clinical trials shall be conducted in medico-prophylactic institutions having a medicallicense and accreditation certicate issued by the MHC o Ukraine or any other body

authorized by it.

Te choice o investigators as well as medico-prophylactic institutions is the unctiono the sponsor (a legal entity or an individual responsible or initiation and organiza-tion o the clinical trial and its nancing).

Conclusion on conduction o the clinical trial is provided by the Centre. Upon resultso the expert examination o materials the Centre provides a positive conclusion orgives a reasonable reusal as to conduction o the clinical trial. Te conclusion o theCentre shall be approved by the MHC o Ukraine.

Approval o the clinical drug trial is granted by the Central Ethics Commission. Lo-cal ethics commissions shall ensure adherence to ethical norms during clinical trials inmedico-prophylactic institutions.

It shall be noted that the Procedure or conduction o clinical trials approves main require-ments as to protection o study subjects, in particular as to provision o inormation on theclinical trial to patients (healthy volunteers) and obtaining o an inormed contest; detailedregulation o the process o the clinical trials with participation o minors and under-aged

patients, disabled persons who are not capable to give inormed consent on their own.



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Besides, the Procedure stipulates requirements to investigators and medico-prophylac-tic institutions as well as main requirements as to marking o study drugs.

Study drugs not used during the clinical trial shall be utilized according to require-

ments o the current legislation or returned to the sponsor.

6. SAE REGISRAION (AUHORIZAION)OF MEDICINAL PRODUCS

Medicinal products can be used in Ukraine only aer their state registration.

Medicinal products which are prepared in pharmacies o active and supplementarysubstances upon doctors’ prescriptions (mainline ormulas) and upon order o medi-co-prophylactic institutions (ocinal ormulas) are not subject to state registration.

Te procedure or the state drug registration (re-registration) and (re-)registration eeis approved by the Resolution o the CMU dd. 26.05.2005 #376.

Te MHC o Ukraine registers and re-registers medicinal products upon results o an expert examination o registration materials (registration le) on such drug and its

quality control carried out by the Centre.

Te ee or the state medicinal product (re-)registration shall be paid to the state bud-get by the applicant in ollowing amounts:

1) For the state (re-)registration o medicinal products, except or radioactive drugs,diagnostic agents, simple or complex (galenical) drugs made rom crude drugs – inthe amount equivalent to 100 EUR or each drug orm, 10 EUR or each next dose,10 EUR or each next drug package;

2) For the state (re-)registration o radioactive medicinal products, diagnostic agents,simple or complex (galenical) medicinal products, active medicinal products withrestricted use and such produced pursuant to ormulations approved by the MHCo Ukraine (inormation o composition, manuacture (preparation) technology,quality control and medicinal product application), preparation made rom donorblood or plasma – in the amount equivalent to 25 EUR or one name, 5 EUR oreach next dose, 5 EUR or each next drug package.

Additionally, the applicant pays a ee or expert examination under a contract on ex-

pert examination concluded between the Centre and the applicant. Te ee amount





depends on application type and is the same or all business entities (residents andnon-residents).

Only aer payment o the ee or the drug (re-)registration and expert examinationregistration materials will be accepted by the Centre or consideration.

I the Centre has examined pre-clinical or clinical materials pursuant to the established procedure, the applicant shall pay only or expert examination or additional materials,i any.

Te procedure or expert examination o the drug registration le submitted to thestate (re-)registration as well as expert examination o materials on amendments to reg-istration le within validity term o the registration certicate is approved by the De-cree o the MHC o Ukraine dd. 26.08.2005 #426. Tis procedure shall be applied toactive substances (active pharmaceutical ingredients), ocinal dugs (except or medi-cal immunobiological drugs) as well as preparations registered upon denition o theMHC o Ukraine as medicinal products, in particular: curative cosmetics, disinectorsand diagnostic agents.

Expert examination o the medicinal product registration le submitted or the state(re-) registration has ollowing stages:

— Initial expert examination o the application in order to determine that the medici-nal product does not belong to drugs prohibited or use in Ukraine and can be (re-)

registered and that the application type has been specied correctly.

— Preliminary expert examination the goal o which is to determine the origin o themedicinal product oered by the applicant, drug manuacturing process (ull tech-nological cycle or its packing in bulk or carrying out o a certain stage as well as thelevel o infuence o the manuacturing on the medicinal product characteristicsetc.), compliance o the submitted registration le, participation level in the drug manuacturing, accuracy o inormation sources identication or provision o bib-liographical inormation as to qualities o the drug i the applicant is responsibleor nal stages o the drug production with proos that its activity cannot infuence

the medicinal product characteristics as to its quality, saety and ecacy.

Te preliminary expert examination also determines the completeness o the registra-tion le as to evidence or saety, ecacy and quality o the medicinal product, orderand procedure o the specialized expert examination.Te specialized expert examination o the registration le and results o additional ex-aminations (trials) o the medicinal product is conducted in order to reach a motivatedconclusion on the ecacy, saety and quality o the drug.



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Expert examination terms:

— Not more than 210 calendar days beginning with the date o ocial acceptance o a state registration application: or registration les on medicinal products submittedor state registration based on ull and independent/autonomous application;

— Not more than 90 calendar days beginning with the date o ocial acceptance o a respective application as to:• medicinalproducts submitted for state registrationunder other application

types;• activesubstances;• medicinalproductssubmittedforstatere-registration.

— Not more than 60 calendar days aer receipt by the Centre o the respective appli-cation: or les on introduction o changes to registration le type I or II (changesto registration le not subject to new medicinal product registration).

Te expert examination term does not include period when the registration le has beenmodied by the applicant and period o conduction o additional examinations (trials).

Upon results o the expert examination the Centre shall prepare a motivated conclu-sion as to ecacy, saety and quality o the medicinal product and its recommenda-tions as to approval o or reuse in state (re-)registration o such drug.

Based on conclusion and recommendations o the Centre the MHC o Ukraine shalldecide within one month on registration o or reusal in registration o the drug.

Te Decree o the MHC o Ukraine on drug state registration approves a pharmaco- peial item or methods or control o its quality, instruction on medical application, package insert or patients, technological regulation or manuacturing technology as well as assigns a registration number which shall be entered to the State drug registerand interdepartmental data bases on drugs registered in Ukraine.

Te registration certicate with indication o the term during which the drug may be

used in Ukraine shall be issued by the Centre within 10 days term aer drug registra-tion.

Te drug can be administered in Ukraine within 5 years as o its state registration, i the MHC o Ukraine does not decide on complete or temporary prohibition o itsadministration due to discovery o previously unknown dangerous qualities.

Aer end o the administration term its urther application is possible subject to re-registration.





A re-registration application o the drug shall be submitted to the Centre not earlierthan one year but not later than 90 calendar days beore the end o the certicate valid-ity term. I application on re-registration is submitted aer such term, the re-registra-tion shall be carried out under procedure o a new registration.

Inormation contained in application on drug state registration and annexes to it issubject to state protection against disclosure and unair commercial use. Te MHC o Ukraine and the Centre are obliged to protect such inormation against disclosure and prevent its unair commercial use.

It is prohibited within 5 years as o drug state registration (irrespectively validity o any drug related patent) to use registration inormation contained in the applicationand annexes to it regarding saety and eciency o the registered drug, except or cases when the right to reer to or use such inormation has been obtained rom a person orinstitution which provided such inormation according to procedure established bylegislation or inormation has been prepared by or or the applicant.

Persons responsible or disclosure or illegal use o registration inormation shall bebrought to disciplinary, administrative, civil and/or criminal liability according to thelaws o Ukraine.

For purposes o the state registration o drugs which are based or connected to intel-lectual property objects having respective patent in Ukraine pursuant to the legislationthe applicant shall submit a copy o the patent or a license allowing manuacturing and

sale o registered drug and a letter with indication that rights o a third party protectedby the patent are not violated in connection with the drug registration.

7. DRUG MANUFACURING

7.1. Licensing

Pursuant to Article 10 o the Law o Ukraine «On Medicinal Products» dd.04.04.1996 #123/96-VR medicinal products shall be manuactured by business enti-ties under a license.

License is a document which permits economic activity on drug manuacturing on the whole territory o Ukraine. Licensing conditions or exercise o economic activity ondrug manuacturing, wholesale, retail are approved by the Decree o the State Com-mittee o Ukraine on Regulatory Policy and Entrepreneurship, the State Drug Inspec-torate dd. 03.03.2009 #44/27 (hereinaer – the Licensing conditions).



13

Pursuant to the Resolution o the CMU "On approval o list o documents whichshall be attached to a license application on a specic economic activity type» dd.04.07.2001 #756 in order to obtain a license or drug manuacturing the applicantsubmits in orm approved by the MHC o Ukraine inormation on availability andconormity o material and technical resources and sta qualication to Licensing

conditions signed by the head o the business entity or attested by it certicates o thegood manuacturing practice or all manuacture sites issued according to procedurestipulated by the MHC o Ukraine.

Te license or drug manuacturing is issued i there are respective material and techni-cal resources, qualied personnel (qualication o a single person in case o individualmanuacturing) as well as conditions as to drug quality control.

Te State Drug Inspectorate (licensing authority) shall decide within 10 business daysas o receipt o the license application and accompanying documents on issuance o orreusal in issuance o the license.

Notication on decision as to issuance o or reusal in issuance o the license shall besent (provided) to the applicant in writing within 3 business days aer respective deci-sion making.

Te license shall be handed over personally to the applicant or its authorized person with-in 3 business days aer receipt o a document conrming payment o the license ee.

I within 30 calendar days as o receipt o the notication on decision making as tolicense issuance the applicant ails to submit a document conrming payment o thelicense ee or to come to the State Drug Inspectorate to receive the license, the StateDrug Inspectorate which has issued the license is entitled to withdraw its decision onlicense issuance or to declare such license as void.

7.2. Certifcation

Certication o drug manuacturing (hereinaer – certication) as to compliance withrequirements o good manuacturing practice (hereinaer – GMP), including accep-tance o GMP certicates, shall be introduced in order to create conditions or exporto domestic drugs, improve and guarantee drug quality according to world standards, prevent circulation o poor quality drugs in Ukraine by means o conrmation o compliance o drug manuacturing with GMP requirements valid in Ukraine. Certication,including acceptance o GMP certicates, shall be carried out on voluntary basis.

Te certication shall be carried out by the State Drug Inspectorate; expert examination canbe carried out under participation o specialists o enterprises, institutions and organizations.





Te certication procedure shall be determined pursuant to the Decree o the MHCo Ukraine dd. 30.10.2002 #391 «On approval o Drug manuacturing certication procedure».

According to the Procedure certication is carried out in respect to the whole produc-

tion and single manuacturing sites. In order to certiy «in bulk» ocinal drug manu-acturing production o all «in bulk» products used or manuacturing o such drugsshall have GMP certicate issued or accepted pursuant to the Procedure.

Certicates can be accepted (the State Drug Inspectorate conrms the compliance o certied oreign drug production with GMP requirements eective in Ukraine) with-out inspection in ollowing cases:

— i certied manuacturing is located in country – party to the international Phar-maceutical Inspection Co-operation Scheme (PIC/S), in USA or Japan or i man-uacturing site is own oreign subdivision o a company with main manuacturing located in said countries (provided document conrming compliance o this site with GMP requirements issued by respective authority o the state where the mainmanuacturing is located and a report on last inspection o such site carried out bythis authority);

— i there is condition on mutual recognition o GMP requirements and inspection procedures between the State Drug Inspectorate and a respective authority o thestate where manuacturing subject o the application is located.

Te validity term o certicate is not more than 2 years as o decision making on itsissuance (or productions certied pursuant to the Procedure or the rst time) or 5 years (or productions certied not or the rst time) and cannot exceed the validityterm o the drug manuacturing license. Te decision on acceptance o the GMP cer-ticate is valid or not more than 5 years and cannot remain valid aer expiration o the validity term o the certicate being accepted.

Manuacturing veried pursuant to this Procedure is subject to scheduled and un-scheduled inspections as to adherence to GMP requirements within the certicate

validity term.

7.3. Labeling

Marking o the label, external and internal package o drugs shall contain ollowing inormation: drug’s name, name and address o the manuacturer, registration number,series number, administration, active substance dose in each unit and their quantity in package, shel lie, storage conditions, and precautions.



15

Te external package o drugs shall contain name o the drug, active substance doseand pharmaceutical orm stated in Braille letters. Te MHC o Ukraine shall deter-mine a list o drugs package o which is not subject to marking with Braille letters oronly name o which shall be stated in Braille letters.

During state (re-)registration additional requirements as to labeling and package canbe determined in connection with special drug administration mode.

Drugs intended or use during clinical trials shall have the marking «or clinical trials».

Package o each drug to be sold shall have a package insert with ollowing content:drug’s name, general characteristics (chemical name, main physiochemical qualities,composition), inormation on pharmacological qualities, indications, contraindica-tions, interaction with other medications, mode o administration and dosage, side e-ects, precautions, presentation, shel lie term and storage conditions, sale conditions.

7.4. Quality control

Te State Pharmacological Centre is authorized to control side eects o drugs permit-ted to medical use and to ollow up cases o drug ineciency by their medical applica-tion according to provisions o the Decree o the MHC o Ukraine dd. 27.12.2006#898. Doctors, healthcare acilities and manuacturers are obliged to provide inorma-tion on drug side eects or ineciency to the Centre.

Te procedure o prohibition (suspension), removal rom circulation in Ukraine o drugsnot complying with requirements established by regulatory technical documentation andregulatory legal acts or which showed previously unknown dangerous qualities is deter-mined by the Decree o the MHC o Ukraine dd. 12.12.2001 #497 «On approval o Pro-cedure or prohibition (suspension) and removal rom circulation o drugs in Ukraine».

8. IMPOR OF DRUGS O UKRAINE

8.1. State registration

Drugs registered in Ukraine can be imported to Ukraine subject to availability o a manuacturer quality certicate.

Te State Drug Inspectorate controls the import o drugs to the customs territory o Ukraine.





Unregistered drugs can be imported to the customs territory o Ukraine or:

— Pre-clinical and clinical trials;— Registration o drugs in Ukraine (drug samples in pharmaceutical orm);— Exhibits at exhibitions, airs, conerences etc. without the right to sell;

— Individual use by citizens.

Te procedure o import o unregistered drugs to the customs territory o Ukraine inorder to carry out pre-clinical and clinical trials and state registration is approved bythe Decree o the MHC o Ukraine dd. 17.01.2002 #13 according to which importo such drugs to the customs territory o Ukraine through state border entry points isnot subject to sanitary control. For purposes o customs clearance or ree circulationo products imported to the customs territory o Ukraine a drug quality certicate anda letter o the Centre authorized or this purposes by the MHC o Ukraine shall besubmitted to customs authority carrying out such clearance.

In order to obtain such letter a business entity or a person authorized by it shall submitan application to the Centre indicating the purpose o import o an unregistered drug,its quantity, trade name (international unpatented name, i any), composition, phar-maceutical orm, origin as well as an original and a copy o the quality certicate. Tecopy o the certicate is kept by the Centre and the original shall be returned to thebusiness entity. Te Centre examines inormation stated in the application and provides a letter to the customs authority conrming the purpose o import o an unregis-tered drug, its quantity, trade name (international unpatented name, i any), composi-

tion, pharmaceutical orm, origin etc. For import into Ukraine o unregistered drugs which according to the legislation are dened as narcotics, psychotropic substancesor precursors additionally to the letter o the Centre a permit (certicate) o the StateNarcotics Control Committee o Ukraine or their import shall be obtained.

For a one-time import o unregistered drugs or exhibition or individual use purposesand in cases o acts o God, catastrophes or epidemics the permit is granted according to provisions o the Decree o the MHC o Ukraine dd. 15.05.1997 #143. Te permitis issued by the MHC o Ukraine based on a letter to the name o the Deputy Minister with submission o documents determined or each case by the Decree.

Sending o narcotics, psychotropic substances or precursors and drugs having limitedshel lie term and requiring special storage such as vaccines, serums, immunobiologi-cal preparations etc. or individual use purposes is prohibited.

8.2. Customs procedures

By joint Decree o the MHC o Ukraine and the State Customs Service o Ukraine dd.

08.06.2001 #224/387 «On approval o Procedure or keeping and use o interdepart-



17

mental data base o drugs registered in Ukraine» the interdepartmental data base ondrugs registered in Ukraine has been implemented. Tis data base contains inorma-tion o the State Drug Register and is submitted by the MHC o Ukraine in digitaland printed orm with a cover letter rom the State Customs Service. Te data base isused by ocials o the State Customs Service within limits o their powers as inorma-

tion source or purposes o customs clearance o reights at the destination customs.Pursuant to the Decree o the State Customs Service dd. 22.06.2006 #514 preerentialconditions or a drug can be applied only provided registration o such drug in theinterdepartmental data base o drugs registered in Ukraine or provided submission o an original or a copy o the registration certicate, or conrmation o the state drug registration issued by the MHC o Ukraine, conrmation o the drug manuactureraccording to the registration certicate (shipping documentation, labeling).

8.3. Quality control Te state quality control is carried out by the State Drug Inspectorate with directly sub-ordinated to it state drug inspectorate in the Autonomous Republic o Crimea, regions,Kyiv and Sevastopol pursuant to the Procedure or the state control over drugs importedinto Ukraine as approved by the Resolution o the CMU dd. 14.09.2005 #902.

Drugs registered in Ukraine can be imported to Ukraine provided availability o a quality certi-cate issued by the manuacturer which conrms their compliance to the quality specications.

All drugs imported to the customs territory o Ukraine or purposes o their urthersale or use in manuacturing ocinal drugs, are subject to state quality control.

Within 3 business days aer customs clearance o the drugs a business entity shall sub-mit to the state control authority at the place o its business conduction an applicationon issue o a quality report on imported drug in the orm approved by the State Drug Inspectorate. Additionally, the applicant shall submit a copy o its license, copies o the drug quality and registration certicates, a copy o the document conrming thatthe manuacturer has drug manuacturing license or a copy o the GMP certicate,

a list o drugs to be imported, copies o the customs declaration and invoice as wellas a sample o the original package. Inormation on submitted documents is subjectto expert examination; the reight shall be inspected and, i necessary, is subject tolaboratory analysis. Te results o the control shall be stated in a report. I the report is positive, the circulation o imported drug is allowed in Ukraine.

During the state control a business entity is obliged to place the reight with the drugs ina special zone (premises) in the warehouse at the place o its business apart rom other products, to make inscription «quarantine» and to provide duly conditions or its stor-age. Until receipt o a positive report the circulation o drugs in Ukraine is not allowed.





9. DRUG SALE IN UKRAINE

9.1. Drug wholesale

9.1.1. Licensing

Pursuant to par. 9 Article 9 o the Law o Ukraine «On Licensing o Certain Econom-ic Activity ypes» dd. 01.06.2000 #1775-3, Article 19 o the Law o Ukraine «OnMedicinal Products» dd. 04.04.1996 #123/96-VR medicinal product wholesale canbe exercised by legal entities and individuals – private entrepreneurs having respectivelicense. Detailed description o the procedure and conditions or license obtaining iscontained in the Licensing conditions or medicinal product manuacturing, whole-sale and retail approved by the joint decree o the State Committee o Ukraine on Reg-

ulatory Policy and Entrepreneurship and the State Drug Inspectorate dd. 03.03.2009#44/27.

Te wholesale license is issued based on an application submitted personally or throughan authorized person and documents provided in the Licensing conditions. Te StateDrug Inspectorate shall decide on issue or reusal in issue o license within 10 businessdays as o receipt o the license application and attached documents.

I there are any reasons or re-execution o the license (change o legal entity's or privateentrepreneur’s name, change o address etc) the licensee is obliged to submit a licensere-execution application and respective documents to the State Drug Inspectorate within 10 business days.

9.1.2. Sale conditions

Drug wholesale is permitted only through pharmacy depots. Tere are legislative re-quirements as to area o production acilities, minimal number o locker and auxil-iary rooms. Te licensing conditions determine necessary standards or drug storagein pharmacy depots. In every pharmacy depot there shall be a designated authorized

person responsible or creation, implementation and unctioning o the quality system.Such authorized person shall personally perorm its duties, shall have degree in phar-maceutics and at least 2 years work experience in same occupation.

Te licensee shall have an immediate plan o action in order to stop sale o poor qualityand alsied drugs, remove drugs rom circulation, i necessary, and take measures orreturn o such drugs to manuacturer or or their utilization.



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9.2. Drug retail

9.2.1. Licensing

Pursuant to par. 9 Article 9 o the Law o Ukraine «On Licensing o Certain Eco-nomic Activity ypes» dd. 01.06.2000 #1775-3, Article 19 o the Law o Ukraine«On Medicinal Products» dd. 04.04.1996 #123/96-VR medicinal products retail canbe exercised by legal entities and individuals – private entrepreneurs having respectivelicense. Detailed description o the procedure and conditions or license obtaining iscontained in the Licensing conditions or medicinal product manuacturing, whole-sale and retail approved by the joint decree o the State Committee o Ukraine on Reg-ulatory Policy and Entrepreneurship and the State Drug Inspectorate dd. 03.03.2009#44/27.

Te retail license is issued based on an application and documents submitted person-ally or through an authorized person provided in the Licensing conditions. Te StateDrug Inspectorate shall decide on issuance or reusal in issuance o license within 10business days as o receipt o the license application and attached documents.

9.2.2. Sale conditions

Drug retail is permitted only through pharmacies and their structural subdivisions(pharmacy points o sale and pharmacy kiosks). Tere are legislative requirements as to

type, area, sanitary condition and other requirements as to premises, including lockerand production area. Te retailer shall have necessary number o personnel comply-ing with qualication requirements stipulated by the Licensing conditions, adhere torespective conditions o drug storage and to ensure minimal drug assortment as de-termined by the MHC o Ukraine etc. Te list o internal pharmacy stocks shall beapproved by the territorial drug quality inspactorate.

Te decree o the MHC o Ukraine dd. 26.11.2004 # 577 determines a list o goodssubject to purchase and sale by pharmacy institutions.

Such goods are purchased and sold by pharmacy institutions and their structuralsubdivisions only provided Ukrainian state registration certicate or such goods orsanitary and hygienic report o the MHC o Ukraine issued in accordance with theestablished procedure.

Te minimal drug assortment or pharmacies is stipulated by the Decree o the MHCo Ukraine dd. 25.11.2004 #569.

Pharmacies and their structural subdivisions sale OC drugs pursuant to the list o

OC drugs permitted or use in Ukraine as approved by the Decree o the MHC o





Ukraine dd. 02.11.2009 #793. Pharmacy kiosks sell only ocinal OC drugs. Proce-dure or sale o drugs and medicinal products in pharmacies and their structural sub-divisions is determined by the Decree o the MHC o Ukraine dd. 19.07.2005 #360.Te sale o Rx drugs without a prescription is orbidden.

In order to supply village population with drugs and medicinal products there isa Minimal obligatory assortment o drugs and medicinal products to be sold to popu-lation in nurse practitioners’ (eldsher’s) and rural medical and obstetrical station asapproved by the MHC o Ukraine dd. 27.09.2005 # 495.

Drugs shall be prepared in pharmacies according to the Decree o the MHC o Ukrainedd. 15.12.2004 #626 «On Approval o Rules or Preparation o Drugs in Pharma-cies» according to which such preparation o drugs shall be carried out in pharmaciesupon prescription and order o prevention and treatment acilities provided they havea license or drug preparation. It shall be noted that drugs prepared in pharmacies are

not subject to state registration and their sale to other business entities selling drugs,except prevention and treatment acilities, is prohibited.

Substances and additives (each series, batch) used in drug preparation in pharmaciesshall be accompanied with a report on their quality issued by a laboratory attestedand/or accredited in accordance with the Procedure on attestation and accreditationo drug quality and saety control laboratories as approved by the MHC o Ukrainedd. 14.01.2004 #10.

9.3. General provisions on drug wholesale and retail

9.3.1. Trade patenting

Cash trade as well as trade or other payment types and credit cards exercised by busi-ness entities is subject to patenting pursuant to provisions o the Law o Ukraine «OnPatenting o Certain Economic Activity ypes» dd. 23.03.1996 #98/96-VR. rade patent is issued or a ee by the state tax authorities at the residence place o such enti-

ties or their structural subdivisions. A single patent shall be obtained or each struc-tural subdivision. Te patent is valid or 12 months. rade activity o pharmacies incommunal or state ownership is not subject to patenting.

9.3.2. Incoming control

Incoming control o drugs means drug quality control at their delivery to the businessentity by visual means or through a drug analysis. Incoming control procedure is regu-lated by the Instruction on drug quality control in wholesale and retail as approved bythe Decree o the MHC o Ukraine dd. 30.10.2001 #436. A person authorized by the



21

company shall carry out the incoming control o drugs delivered to the pharmacy andits structural subdivisions. Main responsibilities o such authorized person are verica-tion o delivered drugs and accompanying documents – invoices, quality certicatesissued by the manuacturer, verication o inormation on drug state control, drawing up a report on drug quality incoming control, keeping records on drugs delivered to

the company and reporting poor quality and alsied drugs or drugs o questionablequality to the territorial inspection.

In case o positive results o the drug incoming control the authorized person shallorward the delivered drug batches or sale. In case o negative results the authorized person shall prepare a protocol on revealed deects being basis or return o the batchto the supplier. Te copy o the protocol shall be submitted to the territorial inspection which aer additional inspection and sampling analysis shall inorm other pharmacieson revealed poor quality or alsied drugs and control the supplier by utilization orreturn to manuacturer o such drugs (in case o low quality series).

9.3.3. Storage and transportation

Storage o drugs and medicinal products in pharmacies shall be organized pursuant to provisions o the Instruction on storage o dierent types o drugs and medicinal prod-ucts in pharmacies as approved by the Decree o the MHC o Ukraine dd. 16.03.1993#44. Te sanitary regime or pharmacies is determined by the Instruction on sanitaryand anti-epidemic regime or pharmacies as approved by the Decree o the MHC o Ukraine dd. 15.05.2006 #275.

Drugs shall be transported in accordance with provisions o the Decree o the Ministryo ransport o Ukraine dd. 14.10.1997 #363, par. 24.2 Procedure or transportationor chemical-pharmaceutical and perume-pharmaceutical products and the state stan-dard #17768-90 «Drugs. Package, labeling , transportation and storage».

9.3.4. Public procurement

Public procurement o goods, works and services purchased partially or completely or

state unds, provided the purchase price o goods or services amounts to 100 thousandsUAH (1 EUR = 10,8 UAH as o 01.10.2010) or more, and o works – 300 thousandUAH or more, shall be carried out pursuant to provisions o the Law o Ukraine «OnPublic Procurement» dd. 01.06.2010 #2289-IV. Te public procurement is madeaccording to the annual plan. Te Law stipulates that national and oreign compa-nies participate in public procurement on equal terms. Te Ministry o Economy o Ukraine and other authorities within their powers control and regulate the sphere o the public procurement.

Te ordering customer (administrator o state unds responsible or procurement ac-





cording to the procedure established by the Law) shall publish under the procedureestablished by the Law the inormation on public procurement ree o charge on the web-portal o the Ministry o Economy o Ukraine. Additionally, announcement o the public procurement, inormation o acceptance o the oer or quotation, inorma-tion on decision o the Ministry o Economy o Ukraine on approval o or reusal in

approval o the procurement procedure (in case o purchase procedure by one participant), announcement o results o the public procurement procedure shall be obligato-rily published in the state ocial printed issue on public procurement.

I expected value o the procurement exceeds amounts in equivalent o or goods — 200 thousand EUR;or services — 300 thousand EUR;or works — 500 thousand EUR

inormation on public procurement and results o the procedure shall be obligatorily published in international inormation issue on public procurement o the authorizedbody and on the web-portal in English.

For purposes o organization and conduction o public procurement the MHC o Ukraine with its Decree dd. 06.08.2010 #650 established the ender committee o the MHC o Ukraine which pursuant to the legislation o Ukraine:

• makesannualplans forpublicprocurementpursuant totheapprovedcostesti-mate, nancial plan (assignation plan, budget (state) unds allocation plan);

• makesandapprovesannualpublicprocurementplans;• decidesonpublicprocurementprocedure;• carriesoutpublicprocurement,priorqualicationofparticipants;• ensuresequalconditionsforallparticipants,objectiveandfairselectionofthewin-

ner;• ensuresdrawingup,approvalandstorageofrespectivedocumentsonpublicpro-

curement as stipulated by the Law.

Te public procurement can be carried out with application o one o the ollowing procedures: public tender, two-stage tender, quotation, prior qualication o partici-

pants or purchase by one participant.

In order to participate in public procurement procedure the participants shall comply with ollowing qualication requirements:• equipmentandmaterialaswellastechnicalresources;• personnelwithrespectivequalications,knowledgeandworkexperience;• experienceinfulllmentofsimilarcontractsconrmedwithdocuments;• solvency(balancesheet,nancialreport,circulationreport,informationfromthe

bank on lack o overdue credits).



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9.3.5. Pricing

According to the resolution o the CMU # 955 dd 17.10.2008 «On measures regard-ing stabilization prices or drugs and medical products» or drugs and medical prod-ucts included in the National List o Essential Drugs and Medical Products (with the

exception o narcotics, psychoactive drugs, precursors and medical gases), there havebeen established mandatory supply and sales markups which shall not exceed 12 per-cent o wholesale price and boundary trade (retail) markups which shall not exceed 25 percent o the purchase price.

Te National List o Essential Drugs and Medical Products has been approved by theResolution o CMU # 333 dd 25.03.2009.

For exhaustive drugs and medical products (with the exception o drugs, psychoactive

drugs, precursors and medical gases) which are ully or partially purchased with stateunding, there have been established boundary supply and sales markups which shallnot exceed 10 percent o wholesale price and boundary trade (retail) markups whichshall not exceed 10 percent o the procurement price. Te list o drugs o domestic and oreign manuacture, which can be purchased byhealth care institutions and establishments ully or partially nanced out o state andlocal budgets, has been established by the Resolution o CMU # 1071 dd 05.09.1996.

Prices or drugs and medical products o domestic manuacture, with the wholesale

price not exceeding 12 UAH per package, are not subject to state regulation, except orthose purchased with state unding.

9.3.6. VAT-Taxation

According to Subclause 5.1.7 Clause 5.1 Article 5 o the Law o Ukraine «On ValueAdded ax» # 168/97-ВР dd 03.04.1997, delivery transactions (including those by pharmacies) with drugs and medical products registered and permitted or applicationin Ukraine under the list, determined annually by the CMU prior to 1 September o

the year preceding the reporting year, are VA-.exempted.

Te Resolution o the CMU # 1949 «On the List o Drugs and Medical Products, Salesransactions Exempted rom Value Added ax» dd 17.12.2003 states that the list o drugs,sales transactions wherewith are exempt rom value added tax, is the State Registry o Drugs.

Recently an issue o introducing VA or drugs has been widely discussed with stateauthorities, mass media as well as the proessional community. At the same time, repre-sentatives o authorities believe that introduction o VA or drugs would only be rea-

sonable aer the reimbursement procedure o outpatient drugs has been introduced.





9.3.7. Advertising

Te main regulatory legal acts regulating the procedure o advertising drugs in Ukraineare the Law o Ukraine «On Medicinal Products», the Law o Ukraine «On Adver-tising» # 270/06-ВР dd 03.07.1996, Resolution o the Ministry o Health Care o

Ukraine # 177 d/d 10.06.1997 «On the Approval Procedure or Regulatory Acts onIssues o Drugs Advertising». On the legislative level the criteria have been establishedregarding drugs which can be subject to advertising. Advertising is only allowed orthe drugs permitted or application in the territory o Ukraine (registered), which areavailable without a doctor’s prescription (OC drugs) and the use o which does notrequire any special knowledge or training. Advertisement o Rx drugs is prohibited.

Te Law species the inormation which should obligatory be contained in advertise-ments or drugs, as well as data prohibited or positioning. Advertisements or drugs

shall not include participation o doctors, other medical proessionals, persons whoseappearance imitates the appearance o doctors. It is also prohibited to use images ormention names o popular persons, heroes o movies, V and animation lms, autho-rized organizations. Advertisements cannot include reerences to therapeutic eects o drugs with respect to diseases which are unresponsive to treatment or hardly respondto treatment.

Inormation contained in advertisements o drugs or children and teenagers is subjectto endorsement with the MHU o Ukraine, which issues a permit on the basis o anexpert opinion o the Center.

Drugs advertisements designated or medical institutions and doctors are distributedexclusively via specialty printed media meant or medical and pharmacy experts. Un-air advertising o drugs is legally prohibited.

10. UILIZAION AND DISPOSAL OF DRUGS

Drugs o poor quality shall be recalled rom circulation pursuant to the Procedureor prohibition (termination) and recalling rom circulation o drugs in the territoryo Ukraine, approved by Decree o the MHU o Ukraine # 497dd 12.12.2001. Suchdrugs are not subject to urther use or sale and shall be utilized or destroyed.

Utilization and disposal o drugs proceeds according to the Rules or utilization anddisposal o sub-quality drugs (hereinaer – Rules), approved by Decree o the MHUo Ukraine # 349 dd 08.07.2004 and by other provisions o laws. Te rules cover sub-quality and alsied domestic or imported drugs recalled rom circulation (hereinaer –



25

drug waste products) and are mandatory or all business entities exercising activitiesconnected with circulation o drugs.

Drug waste products are recalled rom circulation via returning them to the respective busi-ness entity (supplier or manuacturer) notied in the decision or the order o state drugs

control bodies on recalling a drug product circulation. A business entity, which according to a decision on recalling a drug product rom circulation receives drug waste products, perorms operations regarding utilization or disposal thereo at its own expense.

Drugs reerred to poisonous substances, including biotechnology products and otherbiological agents (vaccines, serums), antibiotics, shall be destroyed in specially intended places (reuse dumps) or within objects o waste disposal on condition o compliance with sanitary norms and under availability o a permit rom state sanitary-hygienic services, as well as with a permission o specially authorized executive authorities accord-ing to the Resolution o the CMU # 440 dated 20.06.1995 «On approval o the pro-cedure or obtaining a permit or production, storage, transportation, usage, landll,disposal and utilization o poisonous substances, including biotechnology productsand other biological agents» and in compliance with the Rules.

For disposal o sub-quality drugs the ollowing methods shall be applied:

— Encapsulation— Inertization— Termal methods (high-temperature burning, pyrolysis)

— Chemical neutralization— Autoclaving (or medicines containing living cells and spores o microorganisms)— Method o diluting waste with water and discharge thereo into a municipal sewer

(can be applied to low-toxic liquid drugs waste).

Te act o drug waste disposal is documented by a statement drawn up according tothe sample provided in the Annex to the Rules. Within a two weeks’ term a copy o thestatement shall be directed to the drugs state control body which made a decision onrecalling the drug product rom circulation.





SECTION ІІ

REGULATORY ASPECTS OF COMPANY’S

ACTIVITIES IN THE MEDICAL FIELD

1. LEGISLAION IN HE MEDICAL FIELD

Legislation o Ukraine in the medical eld is based on the Constitution o Ukraineand is comprised o the Principles o Ukrainian Legislation on Healthcare #2801-ХІІdd 19.11.1992 (hereinaer Principles) and other legislative acts which are approved in

compliance with the Principles and regulate social relationships in the eld o health-care.

2. SAE ADMINISRAIONIN HE MEDICAL FIELD

Te basis or the state policy regarding healthcare is ormed by the Verkhovna Radao Ukraine via providing constitutional and legislative base or healthcare, setting thegoal and main tasks, determining sectors, principles and priorities, setting standardsand amounts o budget nancing, creating a system o respective nancial, tax, cus-toms and other regulators, approval o national healthcare programs.

Implementation o the state healthcare policy is imposed on state executive bodies.Te annual report o the President o Ukraine to the Verkhovna Rada o Ukraine in-cludes a statement on the implementation condition o the state policy in the eld o

healthcare.Te specially authorized governmental body in the eld o healthcare is the MHC o Ukraine, with powers determined by the provisions approved by the CMU.

Te unctions o specially authorized state executive bodies in administrative-territori-al units o Ukraine are imposed on the healthcare department o the Council o Minis-ters o the Republic o the Crimea and on local state administration bodies.

According to the Principles, the state exercises control and supervision via specially




— A certicate rom the MHC o Ukraine or its authorized institution on the state o the physical inrastructure o a business entity, availability o the respective regulatorydocuments, including those on standardization which are required or implementa-tion o a respective type o economic activities;

— Copies o documents certied in due order, which conrm the compliance o per-sonnel’s competence with medical practice standards (a state standard diploma onmedical education or a medical specialist certicate, issued by a higher educationmedical institution with accreditation levels III – IV , or by an institution or advanced studies);

— A certicate on conerment (approval) o a respective prociency category;

— A certicate on advanced training and retraining or paramedical personnel and junior pharmacy ocers, issued by a higher education medical institution, or bya medical institution with accreditation levels III – IV;

— A document conrming the continuity o proessional employment as o the applica-tion date (a copy o work record certied in due order with inormation on the lastve years or an excerpt thererom, other document).

3.2. State accreditationo health-care institutions

State accreditation o a health-care institution consists in the ocial recognition o thestatus o a healthcare institution, conditions available therein or providing a certainlevel o medical assistance, conrmation o its compliance with the established criteriaand a guarantee o high quality proessional activities.

According to the current legislation o Ukraine all healthcare agencies shall be subject toaccreditation. Accreditation shall be perormed once in three years. Te term or the rstaccreditation shall be not later than two years aer commencement o the activities. Ac-

creditation committees shall be set up at the MHC o Ukraine to perorm accreditationo healthcare institutions: the Main Accreditation Committee o the MHU o Ukraine,as well as accreditation committees to be set up at the MHC o the Autonomous Repub-lic o the Crimea, at regional, Kyiv and Sevastopol city state healthcare administrations.

It is worth mentioning that the Main Accreditation Committee perorms accredita-tion o public and private healthcare institutions (including those reerring to the ad-ministration sphere o regional state administrations), while accreditation committeesonly perorm accreditation o municipally owned institutions (except or those reer-ring to the administration sphere o regional state administrations).



29

Te list o documents to be submitted by a healthcare institution subject to accredi-tation is specied in Annex 1 o the «Accreditation Procedure or State HealthcareInstitutions» approved by the Decree o the CMU # 765 dd 15.07.1997.

Te respective accreditation committee passes a decision regarding accreditation and

reerring the institution to the appropriate category (second, rst, highest) or on reus-al thereo on the basis o an application and documents submitted by the institution,as well as o expert opinions.

Decisions o territorial accreditation committees shall be approved by the Main Accredi-tation Committee o which the institution shall be notied within a 10 days’ term.

In the course o accreditation an expert committee estimates the healthcare institu-tion’s compliance with the state accreditation criteria, approved by the Decree o theMHC o Ukraine # 92 dd 24.02.2007 via ranking.

Te criteria subject to estimation are those complying with the agency’s specializationand with the level o medical and preventive assistance it has provided. Te results o the perormed estimation procedure regarding the institution’s activities shall be inserted inthe expert opinion on compliance o the activities with the state accreditation criteria.

I the accreditation committee makes a decision on reerring the agency to a certaincategory, the latter obtains a respective accreditation certicate.

Te validity term o the accreditation certicate is determined by the Main Accredita-tion Committee and shall not exceed three years.

Accredited institutions are entered in the State Register kept by the Main Accredita-tion Committee.

Extraordinary accreditation can be perormed upon an initiative o improving the cat-egory, but not prior to one year aer the preceding accreditation. Te same procedureis applied to accreditation o an institution which obtained reusal thereo.

Te accreditation certicate orm is a strictly accountable document having a serialnumber and a code. Te accreditation certicate contains the name o the issuing ac-creditation committee, the institution’s ull address, registration number, date o issue, validity term and category. Upon termination o the validity term the accreditationcerticate is considered null and void.

Te institution is obliged to return the certicate to the issuing committee within 10days as o the approval date o the decision on revocation o the certicate or down-grading o the category.

Regulatory aspects of company’s activities in the medical field



31

4. AESAION OF MEDICAL OFFICERS

4.1. Attestation o medical specialists

Attestation o medical specialists is perormed or the purpose o raising their responsibil-ity or eectiveness and quality o work, more rational deployment o qualied personnel with respect to proessional skills, experience and complexity o the work perormed. At-testation aimed at improvement o operational improvement o healthcare institutionsregarding urther improvement o medical assistance provided to individuals.

Tus, the ollowing types o attestation are established: — Attestation or estimating knowledge and practical skills with conerment o

a «medical specialist» degree;

— Attestation or conerment o a qualication category;

— Attestation or approval o a qualication category.

Attestation or estimating o knowledge and practical skills with conerment (approv-al) o a «medical specialist» degree is perormed by committees which shall be setup at higher education medical institutions with accreditation levels III - IV and at

institutions or advanced studies.Attestation or conerment (approval) o qualication categories shall be perormed bycommittees set up at the MHC o Ukraine, the MHC the Autonomous Republic o the Crimea, healthcare administrations at regional, Kyiv and Sevastopol city state ad-ministrations, sanitary and anti-epidemic stations o the Autonomous Republic o theCrimea, regions, Kyiv and Sevastopol cities, the Central Sanitary and Anti-epidemicStation on Water ransport, the Central Sanitary and Anti-epidemic Station on Rail- way ransport.

Attestation committees at the MHC o the Autonomous Republic o the Crimea,healthcare administrations at regional, Kyiv and Sevastopol city state administrations,sanitary and anti-epidemic stations o the Autonomous Republic o the Crimea, re-gions, Kyiv and Sevastopol cities perorm qualication o medical specialists employedby directly subordinated healthcare institutions or individual entrepreneurs who ob-tained a license to economic activities in medical practice, execution o disinection,disinsection, disinestations work (except or work on veterinary control objects), processing o donor blood and its components, manuacturing o drugs thererom, as well as o medical specialists employed by business entities duly incorporated as legal

persons.

Regulatory aspects of company’s activities in the medical field




4.2. Attestation o junior medical specialists

Attestation o junior specialists with medical education is perormed or the purposeo raising their expertise and proessional level, being aimed at urther improvement o medical assistance provided to individuals.

Te right to be attested is conerred to:

— junior specialists with medical education o all specialties who obtained educa-tional qualication degree «junior specialist» or «bachelor» at higher educationinstitutions o levels I – IV;

— persons with an incomplete higher education duly admitted to medical practice inthe positions they hold;

— persons without a respective special education, who are admitted by the MHCo Ukraine or by the MHC o the ormer USSR to work in positions o juniorspecialists with medical education (medium medical ocers). Such persons aresubject to qualication under specialties to which these positions reer.

Attestation o junior specialists with medical education is perormed by an attestationcommittee under three qualication categories: second, rst and highest.

Te law sets orth two types o attestation or junior specialists with medical educa-

tion:

• Attestationforconfermentofaqualicationcategory;

• Attestationforapprovalofaqualicationcategory.

Attestation is perormed according to the specialties provided or by the List o Spe-cialties or junior specialists with medical education with respect to qualication re-quirements or junior specialists with medical education once in 5 years.

Upon a specialist’s will, provided that he has got necessary work experience, attestationor approval o a qualication category can be perormed earlier, but not prior to one year aer the preceding attestation. In case o extraordinary attestation the term or thenext attestation shall be determined in 5 years.




In order to classiy oodstu as special products expert institution examines documents,conducts respective researches, evaluates special properties o the product, analyses rec-ommendations o the manuacturer as to its consumption and prepares a report classi-cation o the product as special to be signed by the head o the expert institution. Basedon such report a conclusion dra o sanitary and epidemiological expert examination is

executed. Te State chie sanitary ocer o Ukraine (his/her deputy) shall make a deci-sion within 5 days and approve the conclusion provided by the expert institution.

Aer approval such conclusion receives a respective number and the special oodstu shall be included to the state register.

Fee or classication o oodstu as special products is paid according to the taris approved by the Resolution o the CMU # 1351 dd. 27.08.2003 «On approval o taris(price lists) or works and services executed and provided by institutions and agencieso the sanitary and epidemiological service o Ukraine».

It is prohibited to advertise dietary supplements, unctional ood and ood productsor special dietary consumption unless prior approval o advertisement text has beenobtained by the central body o executive power in the healthcare eld.

It is prohibited to use or advertisement o dietary supplements, unctional ood andood products or special dietary consumption:

— expressions as to therapeutic and pain relie properties;

— letters o gratitude i connected with illness treatment or acilitary action as well asreerences to such inormation;

— expressions leading to or causing eeling o negative mental condition.



35

ANNEX 2

PROCEDURE OF STATE (RE-)

REGISTRATION OF MEDICALIMMUNOBIOLOGICAL DRUGS

Te current legislation o Ukraine denes medical immunobiological drugs (here-inaer MIBD) as vaccines, detoxied bacterial products, immunoglobulin, serums,bacteriophages, intereron, bacterial preparation and other medicinal products usedin medical praxis or specic prevention and diagnostics o inectious, parasitical ill-nesses and allergic conditions and made by means o organisms strain’s and eukaryotecells’ cultivation, extraction o substances rom biological tissue and blood, including human, animal and plan tissue and blood (allergens), use o recombinant DNA tech-nology, monoclonal antibody technolog y, reproduction o living agents in animal em-bryos or organisms, and species as MIBD manuacturer a company carrying out atleast one o MIBD manuacturing stages, including packing.

Only such MIBD which comply with requirements o state and international stan-dards and are registered in Ukraine, included to the state register and have passed qual-ity control according to procedure stipulated by the MHC o Ukraine can be used inmedical practice in Ukraine.

Te state (re-)registration o MIBD is conducted by the MHC o Ukraine.

Expert examination o MIBD submitted or state (re-)registration has ollowing stages:

— primary expert examination o registration materials and state (re-)registration application or MIBD with respect to motivated conclusion o the possibility o state(re-)registration o the medicinal product rom the point o view o its belonging to medical immunobiological drugs, execution o materials;

— preliminary expert examination as to complexity o registration materials on MIBDanalysis o which allows to decide on possibility o acceptation o documents or(re-) registration or reuse in case o lack (non-compliance) o documents and reg-istration materials;

— specialized expert examination o the registration le, results o MIBD qualitycontrol conducted in order to give motivated conclusion as to ecacy and saetyo MIBD.

Procedure of state (re-)registration of medical immunobiological drugs




Initial expert examination o registration materials is carried out by the MHC o Ukraine. Preliminary and specialized expert examination o registration materials andlaboratory analysis o samples is carried out by the State Enterprise «Centre o Immu-nobiological Drugs» upon submission o the MHC o Ukraine.

Upon results o expert examinations, researches and MIBD quality control the Centreshall execute a motivated conclusion on ecacy, saety and quality o MIBD according to which it recommends MIBD or state (re-)registration.

Decision on state registration, re-registration, amendments to registration materialsand/or Certicate on state registration o MIBD or on reusal in such shall be madeby the MHC o Ukraine on the basis o a motivated conclusion on ecacy, saety andquality o MIBD.

In case o decision making on registration, re-registration, amendments to registra-tion materials and/or Certicate on state registration o MIBD the MHC o Ukraineshall approve a package insert or MIBD, package graphic design, analytical-normativedocumentation and approves the normative-technical documentation.

Te validity period o the state registration o MIBD is up to 5 years. Aer expirationo this term MIBD are subject to re-registration.

Within period o validity o the state registration certicate the applicant shall be li-able or quality o the registered MIBD and shall provide inormation on any changes

and amendments regarding manuacturing and quality control o MIBD.

Te expert examination o changes shall be carried out in the same procedure as theexpert examination o registration materials during the (re-)registration o MIBD.Each single change is subject to expert examination, even i there are several simultane-ous changes.

Te term o state (re-)registration o MIBD and expert examination o materials whichhave been amended within the validity term o the state registration certicate andrequire new registration o MIBD shall not exceed 210 calendar days.

Expert examination o changes in order to carry out state registration o a patentedMIBD which is licensed (registered) in the European Economic Community undercentralized procedure, MIBD generics, materials or state re-registration o MIBD, expert examination o materials on amendments o ype I and II occurring within the validity term o the state registration certicate shall not exceed 90 calendar days.

It shall be noted that aorementioned time o expert works does not include time whendocuments have been amended by the application and the time or quality control and

research.



37

Certicate on state registration o MIBD in Ukraine which pursuant to the legislationconrms state registration o medical immunobiological drug in Ukraine is issued tothe applicant aer payment o the registration ee.

Fee or issuance o the certicate conrming MIBD state registration shall be paid by

the applicant in UAH in the amount equivalent to 1000 EUR or each pharmaceuticalorm, 100 EUR or each next dose and 100 EUR or each next package.

Fee or issuance o the certicate conrming state registration o MIBD used in medical practice or diagnostic purposes shall be paid by the applicant in UAH in the amountequivalent to 500 EUR or each pharmaceutical orm, 50 EUR or each next dose and50 EUR or each next package o MIBD.Fee or re-registration o MIBD shall be paid by the applicant in the amount o 50% o the certicate issuance ee.

For issuance o the certicate conrming state registration o MIBD included to thelist o diagnostic MIBD used or medical purposes or diagnostics o inectious dis-eases (hereinaer – the List) as determined by the MHC o Ukraine, volume o import(customs value) and sale o which does not exceed amounts stated in the List or eachdrug under single nosological units o human inectious diseases, the applicant shall pay a ee in UAH in the amount equivalent to 100 EUR or each pharmaceutical orm.Te state registration certicate on MIBD included to the list o diagnostic MIBDused or diagnostics o inectious diseases (hereinaer – the List) as determined by theMHC o Ukraine is valid 1 year. One month prior to the end o the validity period o

the state registration certicate the applicant shall submit an application on prolonga-tion o the state registration to the MHC o Ukraine. I the volume o import (customs value) and sale o MIBD registered according to the List is not exceeded, the validityterm o the state registration certicate shall be prolonged ree o charge, and i the volume o import (customs value) and sale o MIBD registered according to the Listis exceeded, the validity term o the certicate shall be prolonged provided payment o the dierence between the actual amount and amount o the certicate issuance ee orMIBD not included to the List.

For issuance o the certicate conrming the state registration o MIBD packed «in

bulk» the applicant shall pay a ee in UAH in the amount equivalent to 25 EUR oreach pharmaceutical orm and 25 EUR or each next package.

Within the validity term o the MIBD state registration certicate the applicant shallbe obliged to provide to the MHC o Ukraine inormation on side and nonspeciceects o the drug:

• Oncein6monthswithinrst2yearsaerMIBDregistration;• thereaer–annually.

Procedure of state (re-)registration of medical immunobiological drugs




otal and selective quality control o immunobiological drugs manuactured inUkraine and incoming quality control o imported immunobiological drugs is carriedout by the MHC o Ukraine.



39

ANNEX 3

PROCEDURE FOR STATE REGISTRATION

OF MEDICAL EQUIPMENT AND MEDICALPRODUCTS

Pursuant to the current legislation medical products are devices, systems, equipment,appliances, instruments, applications, implants, tools, materials or other products, in-cluding invasive medicinal products; medicinal products or diagnostics in vitro; me-dicinal products not reaching anticipated goals in human organism or on it with helpo pharmacological, immunobiological or metabolic drugs but contributing to unc-tions thereo; medical products used separately or in combination, including sowaretools necessary or their unctioning in order to provide:

— prevention, diagnostics, treatment, observation or relie or patients’ condition incase o disease, trauma, disablement or their compensation;

— research, replacement or change o structure (anatomy) o organs, tissue or physi-ological processes;

— control o ertilization processes.

State registration o medical products is carried out on basis o application and respec-tive document package submitted to the State Drug Inspectorate by the applicant li-able or manuacturing, saety and ecacy o medical products. Te list o documentto be attached to the application is specied by the Procedure or state registration o medical equipment and medical products as approved by the Resolution o the CMUdd. 09.11.2004 # 1497. Te State Drug Inspectorate shall examine submitted docu-ments within max. 90 days.

In order to conduct necessary expert examinations and testing o medical productsthe State Drug Inspectorate shall engage expert institutions and give the applicant re-spective reerrals. Te applicant shall choose expert institutions taking into account prole o the expert institution and the list comprised and approved by the State Drug Inspectorate. Results o the expert examination conducted by the expert institutionshall be stated in a protocol (report, conclusion) which shall be sent to the State Drug Inspectorate or handed over directly to the applicant. Based on motivated conclusiono expert institutions the State Drug Inspectorate shall accept testing o the medical product. It shall be noted that time o such testing shall not be included to the term o expert examination conduction.

Procedure for state registration of medical equipment and medical products




Based on consideration o expert examination (testing) report and recommendationo the advisory body in the sphere o state registration the State Drug Inspectorateshall make a decision on registration o or reusal in registration, i conclusion on sae-ty, quality and ecacy o the product is not conrmed. Within 10 days the State Drug Inspectorate shall inorm the applicant in writing.

Based on decision on state registration medical products shall be included to the StateRegister o Medical Equipment and Medical Products kept by the State Drug Inspec-torate, and the applicant shall receive a certicate on state registration o a medical product. Te certicate can be accompanied annexes with inormation on modica-tion o medical products and component products.

Te certicate is valid or up to 5 years, aer expiration o its term import to Ukraine,sale and use o medicinal products is possible only aer its re-registration. Applicationor re-registration o medical products shall be submitted to the State Drug Inspectorate

not earlier than 120 and not later than 90 calendar days beore the expiration o the cer-ticate validity term. Te legislation stipulates that re-registration o medical products iscarried out in accordance with the procedure stipulated or state registration.

Te re-registration o medical products shall be carried out in case o:

— change o name and location o the owner (manuacturer, developer), medical products’ presentation;

— transer o rights or manuacturing o medical products to other manuacturer;— changes in manuals or medical products;

— changes in requirements o normative documentation as to medical products;

— revealing o contra indications and restrictions in use o medical products;

— use o new materials contacting with human body during manuacturing o medi-cal products.



41

ANNEX 4

GOVERNMENT INSTITUTIONS

IN THE FIELD OF HEALTHCAREName Competence

Regulatory documents

Cabinetof Ministersof Ukraine

Organizes development and implementa-tion o state target programs, creates eco-nomic, legal and organizational mecha-nisms or stimulation o eective work inthe sphere o healthcare, ensures develop-ment o the healthcare acilities network,concludes intergovernmental agreementsand coordinates international collabora-tion on healthcare issues, and in the limitso its competence exercises other powers,entrusted with state executive authoritiesin the sphere o healthcare

FundamentalPrinciples o

Legislation o Ukraine onHealthcare dd.19.11.1992# 2801-ХІІ

determines Procedure o state (re-)regis-

tration o drugs and amount o state (re-)registration ee

Law o Ukraine«On MedicinalProducts» dd.

04.04.1996# 123/96-ВР

upon recommendation o the Ministero Healthcare o Ukraine appoints anddismisses the Chie State Inspectorate o Ukraine on drug quality control

approves Provisions on State drug qual-ity control inspection o the MHC o Ukraine

determines Procedure or selection o drug samples or laboratory analysis bystate quality control o such drugs

determines Regulations on minimal provision o population with state health-care acilities selling drugs

Government Institutions in the Field of Healthcare




Cabinetof Ministersof Ukraine

approves unied license orm to be usedby licensing authorities in Ukraine

Law o Ukraine«On Licensing o Certain EconomicActivity ypes»

dd. 01.06.2000# 1775-ІІІ

stipulates amount o licensing ee and

order o its transer to the State budgeto Ukraine

approves provisions according to whichcentral executive bodies in the sphere o healthcare controls compliance o im-munobiological drugs used in medical practice with requirements o state andinternational standards and their supply

to healthcare acilities

Law o Ukraine

«On Sanitary andEpidemiologicalSecurity o Population» dd.24.02.1994# 4004-ХІІ

approves provisions on state sanitary andepidemiological control in Ukraine and provisions on the state sanitary and epi-demiological service o Ukraine

appoints and dismisses the Chie sani-

tary ocer o Ukraine

upon recommendation o specially au-thorized executive body in the sphere o healthcare determines limits or quantityo narcotics, psychotropic substances and precursors to be contained in medicinal products Law o Ukraine

«On Narcotics,

PsychotropicSubstances andPrecursors» dd.15.02.1995# 60/95-ВР

annually determines quotes or narcoticsand psychotropic substances within limitso which cultivation o plants containing narcotics or psychotropic substances in-cluded to the List is carried out, as wellas manuacturing, storage, import toUkraine, export rom Ukraine o narcot-ics, psychotropic substances included tothe List



43

Ministry of Healthcareof Ukraine

Coordinates activity o healthcare acili-ties, authorities, institutions and estab-lishments o state sanitary and epide-miological service, science and researchinstitutions irrespectively their subordi-nation and ownership orm as to issues o diagnostics, treatment and prevention o diseases, ormation o healthy liestyle

Resolutiono the CMU«On Approvalo Provisionson Ministry o Healthcare o Ukraine» dd.02.11.2006# 1542

takes measures or development o entrepreneurship in the sphere o healthcare

controls and supervises adherence to normso sanitary legislation, state standards, cri-

teria and requirements directed at securing sanitary and epidemiological well-being o population

approves according to legislation statesanitary norms, rules, hygienic norms; de-termines within limits o its powers statequality standards or drugs, immunobio-logical drugs, drink water, medical equip-

ment and medical products; participatesin development and implementation o ecological and radiation saety norms

approves according to procedure estab-lished by legislation all state standards,technical conditions, industrial samples,other normative and technical documen-tation or objects having harmul eecton human health

ensures according to legislation conductiono state registration and control over manu-acturing, storage and sale, quality o drugs,immunobiological drugs, medical equip-ment and medical products, maintains theirassortment, including necessary quantity orcases o Acts o God, catastrophes, epidemicdiseases





Ministry of Healthcareof Ukraine

ensures provision o drugs to popula-tion, inorms employees o healthcareacilities and population on drugs andimmunobiological drugs permitted or

use; ensures adherence to stipulated or-der on ree or preerential provision o drugs and immunobiological drugs to population

stipulates unied qualiying require-ments or persons exercising medical or pharmaceutical activity

approves rules or utilization and de-struction o drugs

Law o Ukraine«On MedicinalProducts»dd.04.04.1996# 123/96-ВР

approves rules or drug prescription as well as list o OC drugs

ensures provision o inormation on reg-istered drugs and drugs excluded romthe State drug register o Ukraine

conducts state (re-)registration o drugsupon results o expert examination o registration materials (registration le)o such drug and its quality control car-

ried out by the State PharmacologicalCentre o MHC o Ukraine

Resolution o the CMU «On

Approval o Pro-cedure or StateDrug (re-)registra-tion and State(re-) RegistrationFee Amount" dd.26.05.2005 # 376

protects inormation contained in theapplication on state drug registrationand annexes thereto against disclosureand prevents unair commercial use o such inormation



45

State Pharmaco-logical Centreof the MHCof Ukraine

Carries out expert examination o clini-cal trial research materials and conductsclinical audit o clinical trials

Decree o theMHC o Ukraine«On Approvalo the Procedureor Conductiono Drug Clinicalrials and ExpertExamination o Clinical rials’Materials and

Standard Provi-sion on EthicsCommissions»dd. 23.09.2009# 690

has direct access to inormation o pri-mary medical documentation o test persons in order to examine proceduresand/or inormation o the clinical trial without violation o anonymity o test persons

examines procedure o inormation provision on clinical trials to patients

(healthy volunteer) and receipt o in-ormed consent rom him/her

gives conclusions on conduction o clini-cal trials

gives conclusion on essential amend-ments on basis o their expert examina-tion

carries out primary expert examinationo drug registration materials

Decree o theMHC o Ukraine«On Approval o the Procedure orExpert Examina-tion o Drug Reg-istration MaterialsSubmitted orState (re-)registra-

tion and ExpertExaminationo Materials onAmendments toRegistration Mate-rials within Regis-tration Certicate Validity erm» dd.26.08.2005 # 426

upon results o drug expert examinationgives motivated conclusion on drug e-

ciency, saety and quality and recom-mends or does not recommend the drug or state (re-)registration, recommendsor approval package insert, packagegraphic design, drug quality controlmethods and manuacturing technology




47

State Drug Quality ControlInspectorate of theMHC of Ukraine

Stipulates within limits o its powers the procedure or inspection o economicentities

Provisions on StateDrug QualityControl Inspec-torate o the Min-istry o Healthcareo Ukraine asapproved by the

Cabinet o Minis-ters o Ukraine dd.20.12.2008 #1121

has ree access to any manuacturing, storageand trading premises o economic entities orinspection purposes with observation o busi-ness hours provided decision on conductiono inspection

sums up results o inspections as to adher-ence by economic entities to regulatorylegal acts and normative documents onensuring duly quality o drugs and me-dicinal products, analyses reasons or vio-lations o standards, technical conditions, pharmacopeian items, technical regula-tions applied during manuacturing o drugs and medicinal products and takesactions to their elimination

transers to law enorcement authori-ties according to procedure establishedby legislation materials o inspectionsresults o which present elements o o-ence

issues licenses or drug manuacturing, wholesale and retail to economic enti-ties, develops and approves according to

procedure established by legislation li-censing conditions or economic activityon drug manuacturing, wholesale andretail and other regulatory documentson licensing issues

decides on annulment o licenses ordrug manuacturing, wholesale and re-tail, respective permits and certicates





State Drug Quality ControlInspection of theMHC of Ukraine

decides on removal rom circulation and prohibition o manuacturing and sale o drugs and medicinal products not complying with requirements o regulatorylegal acts and regulatory documents ando such imported to or exported romUkraine with violation o establishedorder

Provisions on StateDrug QualityControl Inspec-tion o the Minis-try o Healthcareo Ukraine asapproved by the

Cabinet o Minis-ters o Ukraine dd.20.12.2008 #1121

examines letters, applications and com- plaints o citizens as to violation o legis-lative requirements on quality and saetyo drugs and medicinal products, takes inaccordance with legislation respective ac-

tions or elimination o such violationselaborates rules or utilization and de-struction o poor quality drugs and me-dicinal products, controls adherence tothem

monitors prices or drugs and medicinal products and prepares suggestions orimprovement o their state regulation,

organizes keeping o respective state priceregisters

attests in established order accreditedlaboratories in order to entitle them todo researches on quality and saety o drugs and medicinal products

organizes and ensures according to proce-dure established by legislation selection o

samples o drugs and medicinal productsor purposes o state quality control

organizes within limits o its powershearing o cases on administrative o-ences and imposes administrative sanc-tions

attests pharmacists according to proce-dure established by legislation



49

certies manuacturing o drugs and me-dicinal products regarding their compliance with international standards

determines general requirements to ma-terial and technical resources o compa-nies manuacturing drugs and medicinal products, ensures production qualitycontrol

Head

accreditationcommission of theMHC of Ukraine

Accredits state (including acilities subordi-

nated to region state administrations) and private healthcare acilities

Resolutiono the CMU«On Approvalo Procedure

or StateAccreditationo HealthcareFacilities» dd.15.07.1997 # 765

Committeeon Folk and

AlternativeMedicine

Interviews persons intending to exercisemedical activity in the eld o olk and al-ternative medicine and provided positiveresults o such interviews issues reerral orattestation and expert examination o heal-ing sills

Charter o theCommittee onFolk and Alter-native medicineat the MHCo Ukraine asapproved by the

Decree o theMHC o Ukrainedd. 31.10.2000# 278

participates in work o the licensing com-mission o the MHC o Ukraine and con-trols according to established procedure at-testation and expert examination o personsintending to exercise medical activity in theeld o olk and alternative medicine

organizes and carries out certication andgranting permit or using methods (means)o olk and alternative medicine

provides scientic and methodical as-sistance or legal entities and individualsexercising medical activity in the eld o olk and alternative medicine





Tender Committee

of the MHCof Ukraine

Comprises and approves annual public procurement plan Provision on

ender Committeeo the MHCo Ukraine as

approved by theDecree o theMHC o Ukrainedd. 06.08.2010# 650

selects type o procurement

carries out procurement, preliminaryqualication o participants

ensures equal conditions or all participants, objective and air selection o a winner

State NarcoticsControlCommitteeof Ukraine

Controls activity o economic entitiesin the sphere o circulation o narcotics, psychotropic substances and precursors

Resolution o the CMU dd.28.07.2010 #676«On approval o Provision on StateNarcitics ControlCommitteeo Ukraine»

comprises and submits to the Cabinet o Ministers o Ukraine list o narcotics, psy-chotropic substances and precursors and propositions on introduction o amend-ments thereto

issues licenses to economic entities, con-trols adherence by economic entities tolicensing conditions or exercise o eco-

nomic activity in the sphere o circula-tion o narcotics, psychotropic substanc-es and precursors and decides on theirannulment

provides law enorcement authorities with inormation on revealed violationsin the sphere o circulation o narcotics, psychotropic substances and precursors

issues upon agreement with the SecurityService o Ukraine permits or import(export) and transit o narcotics, psy-chotropic substances and precursors toeconomic entities

controls adherence by economic enti-ties to the procedure o destruction o narcotics, psychotropic substances and precursors



51

conducts inspections within limits o its powers and issues upon their resultsbinding notices as to elimination o vio-lation o the legislation in the sphere o

circulation o narcotics, psychotropicsubstances and precursors

State PriceControlInspection

Inspects accounting books, reports, costestimates, declarations, indexes displayedin settlement documents irrespectivelyinormation provision type connected toestablishment, stipulation and applica-tion o prices (taris);

Resolution o the CMU dd.13.12.2000# 1819 «Issueso the State PriceControl Inspec-tion»

examines accuracy o inormation con-tained in documents as to establishment,stipulation and application o state andregulated prices

decides on administrative and economicsanctions or violation o procedure o establishment, stipulation and applica-tion o prices (taris)

inspects correctness o computation o prices (taris) subject to state regulation

monitors prices (taris) and researches prices on consumer and commoditymarkets

Antimonopoly Committeeof Ukraine

Considers applications and cases on viola-

tion o legislation on protection o economiccompetition and carries out investigationsunder such applications and cases, during which is entitled to require provision o inor-mation, including with restricted access, romeconomic entities, unions, state and localsel-government authorities, administrativecontrol and management authorities, theirocers and employees, other individuals andlegal entities

Law o Ukraine«On Antipo-nopoly Commit-tee o Ukraine»dd. 26.11.1993#3659-ХІІ





Antimonopoly Committeeof Ukraine

monitors economic entities, unions,state and local sel-government authori-ties, administrative control and manage-ment authorities regarding adherence to

legislative requirements on protectiono economic competition and during in- vestigations on applications and cases on violation o legislation on protection o economic competition

Law o Ukraine«On Antipo-nopoly Commit-

tee o Ukraine»dd. 26.11.1993#3659-ХІІ

makes binding decision on unair competition cases about:

— admission o unair competition;

— suspension o unair competition;

— ocial rebut o untrue, inaccurate orincomplete inormation at the expense o the guilty party;

— imposing o penalties

Law o Ukraine«On ProtectionAgainst UnairCompetition"dd.07.06.1996# 236/96- ВР



53

ANNEX 5

LEGISLATIVE REGULATION

IN HEALTHCARE FIELED1. Constitution o Ukraine dd. 28.06.1996 #254к/96-ВР;

2. Code o laws on labour o Ukraine dd. 10.12.71 #322-VIII;

3. Economic code o Ukraine dd. 16.01.2003 #436-ІV;

4. Civil code o Ukraine dd. 16.01.2003 #435-IV;

5. Customs code o Ukraine dd. 11.07.2002 #92-IV;6. Fundamental principles o legislation o Ukraine on healthcare dd. 19.11.1992

#2801-ХІІ;

7. Law o Ukraine «On sanitary and epidemiological security o population»dd. 24.02.94 # 4004-XII;

8. Law o Ukraine «On licensing o certain economic activity types»dd. 01.06.2000 # 1775-III;

9. Law o Ukraine «On medicinal products» dd. 04.04.1996 #123/96 – ВР;

10. Law o Ukraine «On narcotics, psychotropic substances and precursors»dd. 15.02.1995 #60/95-ВР;

11. Law o Ukraine "On oodstu saety and quality» dd. 23.12.1997 #771/97 – ВР;

12. Law o Ukraine «On patenting o certain economic activity types»dd. 23.03.1996 #98/96 – ВР;

13. Law o Ukraine «On advertisement» dd. 03.07.1996 #270/06-ВР;14. Law o Ukraine «On value added tax» dd. 03.04.1997 #168/97-ВР;

15. Law o Ukraine «On protection o rights to inventions and useul models»dd. 15.12.1993 #3687 – ХІІ;

16. Law o Ukraine «On protection o rights to industrial samples»dd. 15.12.1993 #3688 – ХІІ;

Legislative Regulation in Healthcare Fieled




17. Law o Ukraine «On protection o rights to trade marks or goods and services»dd. 15.12.1993 #3689 – ХІІ;

18. Law o Ukraine «On customs tari» dd. 05.04.2001 #2371-ІІІ;

19. Resolution o the Cabinet o Ministers o Ukraine dd. 26.05.2005 #376«On approval o Procedure or state (re-)registration o drugs and state (re-)registration ee amount";

20. Resolution o the Cabinet o Ministers o Ukraine dd. 04.07.2001 #756«On approval o list o documents to be attached to license application oncertain economic activity type»;

21. Resolution o the Cabinet o Ministers o Ukraine dd. 14.09.2005 #902«On approval o Procedure or state quality control o drugs importedto Ukraine»;

22. Resolution o the Cabinet o Ministers o Ukraine dd. 03.02.2010 #259«Certain issues o activity connected to drug sale»;

23. Resolution o the Cabinet o Ministers o Ukraine dd. 17.10.2008 #955«On measures or stabilization o drug and medicinal product prices»;

24. Resolution o the Cabinet o Ministers o Ukraine dd. 15.07.1997 #765«On approval o Procedure or state accreditation o healthcare acilities»;

25. Resolution o the Cabinet o Ministers o Ukraine dd. 25.03.2009 #333«Certain issues o state regulation o drug and medicinal product prices»;

26. Resolution o the Cabinet o Ministers o Ukraine dd. 05.09.1996 #1071«On procedure o purchase o drugs by healthcare acilities and institutionsor state unds»;

27. Resolution o the Cabinet o Ministers o Ukraine dd. 02.11.2006 #1542«On approval o Provisions on Ministry o Healthcare o Ukraine»;

28. Resolution o the Cabinet o Ministers o Ukraine dd. 28.08.2010 #676«On approval o Procedure on State drug control committee»;

29. Resolution o the Cabinet o Ministers o Ukraine dd. 20.12.2008 #1121«Certain issues o state drug quality control regulation»;

30. Resolution o the Cabinet o Ministers o Ukraine dd. 15.01.1996 #73«On approval o Provisions on control over compliance o immunobiologicaldrugs used in medical practice with requirements o state and internationalstandards»;



55

31. Resolution o the Cabinet o Ministers o Ukraine dd. 09.11.2004 #1497«On approval o Procedure or state registration o medical equipmentand medical products»;

32. Decree o the State committee o Ukraine on regulatory policy and

entrepreneurship, State Inspectorate or Quality Control o the Ministry o Healthcare o Ukraine dd. 03.03.2009 #44/27 «On approval o licensing conditions or exercise o drug manuacturing, wholesale, and retail;

33. Decree o the Ministry o Healthcare o Ukraine, State Customs Service o Ukraine dd. 8.06.2001 # 224/387 «On approval o Procedure or keeping anduse o interdepartmental data base on drugs registered in Ukraine»;

34. Decree o the Ministry o Healthcare o Ukraine dd. 14.12.2009 #944«On approval o Procedure or pre-clinical drug trials and expert examination

o pre-clinical drug trials’ materials»;35. Decree o the Ministry o Healthcare o Ukraine dd. 23.09.2009 #690

«On approval o Procedure or clinical trials and expert examination o clinicaltrials’ materials and Standard provisions on ethics committee»;

36. Decree o the Ministry o Healthcare o Ukraine dd. 26.08.2005 #426«On approval o Procedure or expert examination o drug registrationmaterials submitted or state (re-) registration and expert examinationo materials on amendments to registration materials within registration

certicate validity term»;37. Decree o the Ministry o Healthcare o Ukraine dd. 30.10.2002 #391

«On approval o drug manuacturing certication procedure»;

38. Decree o the Ministry o Healthcare o Ukraine dd. 27.12.2006 #898«On approval o Procedure or monitoring o side eects o drugs permittedor medical use»;

39. Decree o the Ministry o Healthcare o Ukraine dd. 12.12.2001 #497«On approval o Procedure or prohibition (suspension) and removal romcirculation o drugs in Ukraine;

40. Decree o the Ministry o Healthcare o Ukraine dd. 17.01.2002 #13«On Procedure or import o unregistered drugs to Ukraine or purposeso pre-clinical, clinical trials and state registration»;

41. Decree o the Ministry o Healthcare o Ukraine dd. 15.05.1997 #143«On Procedure or import to Ukraine o unregistered drugs»;

42. Decree o the Ministry o Healthcare o Ukraine dd. 07.08.2009 #577





«On state (re-) registration o drugs and amendments to registration materials»;

43. Decree o the Ministry o Healthcare o Ukraine dd. 15.12.2004 #626«On approval o Rules or manuacturing (preparation) o drugs in pharmacies»;

44. Decree o the Ministry o Healthcare o Ukraine dd. 02.11.2009 #793«On approval o the List o OC drugs permitted or use in Ukraine soldin pharmacies and their structural subdivisions»;

45. Decree o the Ministry o Healthcare o Ukraine dd. 19.07.2005 #360«On approval o Rules or issuance o prescriptions and order requirements ordrugs and medicinal products, Procedure or sale o drugs and medicinal productsin pharmacies and their structural subdivisions, Instruction on storage, recordskeeping and destruction o prescription orms and order requirements»;

46. Decree o the Ministry o Healthcare o Ukraine dd. 25.11.2004 #569«On approval o obligatory minimal drugs assortment in pharmacies»;

47. Decree o the Ministry o Healthcare o Ukraine dd. 27.09.2005 #495«On approval o minimal drug and medical products assortment in nurse practitioners’ (eldsher’s) and rural health posts;

48. Decree o the Ministry o Healthcare o Ukraine dd. 30.10.2001 #436«On approval o Instruction on drug quality control in wholesale and retail»;


«On storage o dierent groups o drugs and medical products in pharmacies»;

50. Decree o the Ministry o Healthcare o Ukraine dd. 15.05.2006 #275«On approval o Instruction or sanitary and epidemiological regime in pharmacies»;

51. Decree o the Ministry o Healthcare o Ukraine dd. 10.06.1997 #177«On approval o normative acts on drug advertisement»;


«On approval o Rules or utilization and destruction o poor quality drugs»;

53. Decree o the State committee o Ukraine or regulatory policy andentrepreneurship and the Ministry o Healthcare dd. 16.02.2001 #38/63«On approval o Licensing conditions or economic activity on processing o donor blood and its components, preparation manuacturing thereo, economicactivity on medical practice and disinection, umigation, deratization works(except or works on veterinary control objects)»;



57

54. Decree o the Ministry o Healthcare o Ukraine dd. 05.06.1997 #174«On approval o Provisions on clinical prevention and treatmenthealthcare acilities»;

55. Decree o the Ministry o Healthcare o Ukraine dd. 19.12.1997 #359«On urther improvement o doctors’ attestation»;

56. Decree o the Ministry o Healthcare o Ukraine dd. 28.10.2002 #385«On approval o list o healthcare acilities, doctor, pharmacist and junior position and positions or specialists with pharmaceutical educationin healthcare acilities»;

57. Decree o the Ministry o Healthcare o Ukraine dd. 24.02.2007 #92«On approval o Criteria (conditions) or state accreditation o preventionand treatment acilities»;

58. Decree o the Ministry o Healthcare o Ukraine dd. 23.11.2007 #742«On attestation o junior specialist with medical education»;

59. Decree o the Ministry o Healthcare o Ukraine dd. 10.08.2000 #195«On issuance o special permits or medical activity in olkand alternative medicine»;

60. Decree o the Ministry o Healthcare o Ukraine dd. 07.09.1993 #198«On continuous medical education o junior specialists with medicaland pharmaceutical education»;

61. Decree o the Ministry o Healthcare o Ukraine dd. 06.08.2010 #650«On approval o Provisions on tender committee o the Ministryo Healthcare o Ukraine»;

62. Decree o the Ministry o Healthcare o Ukraine dd. 06.12.2001 #486«On approval o regulatory legal acts on quality control o medicalimmunobiological drugs»;

63. Decree o the State customs service o Ukraine dd. 22.06.2006 #514

«On approval o Procedure or submission o documents conrming rightso economic entities to tax incentives as determined by the legislation during customs clearance o goods imported to or exported rom Ukraine».




Head Office

Business Centre Eurasia75, Zhylyanska str., 5th floor, 01032, Kyiv, Ukrainetel: +38 044 390 55 33; fax: +38 044 390 55 40

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6 Generala Chuprynky str office 1 79013 Lviv Ukraine

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