drug regulatory authority of pakistan

7/25/2019 Drug Regulatory Authority of Pakistan

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Government of PakistanDrug Regulatory Authority of Pakistan

Ministry of National Health Services Regulations and Coordination********

Islamabad, the 27thMay 2014

N!"#"CA!"N

S$R$$ %&' (")'+&%$, In exercise of the powers conferred by section 23of the Dru !eulatory "uthority of #a$istan "ct, 2012 %&&I of 2012', the Dru!eulatory "uthority of #a$istan, with prior appro(al of the )ederal *o(ernment, ispleased to ma$e the followin rules, namely+

&- Short title and commencement- %1'- .hese rules may be called the"lternati(e Medicines and /ealth #roducts %nlistment' !ules, 2014-

%2' .hey shall come into force at once-

'- Definitions- %1' In these rules, unless there is anythin repunant inthe subect or the context-

(i) "cceptance riteriameans numerical limits, ranes, or other suitablemeasures for acceptance of the herbal substance, preparation,medicines and health products based on the results of analyticalprocedures5

(ii) "ct means the Drus "ct, 1675

(iii) "d(ertisementmeans the publication, dissemination, con(eyance ofinformation for the purpose of promotin, whether directly or indirectly,the sale or use of any product by any means or in any form includinthe followin namely+

%a' publication in a news paper, maa8ine, ournal or periodical5%b' display of poster or notices-%c' letters addressed to indi(iduals, bodies corporate or unicorporate5%d' photoraphs or documentary or cinematoraphs films5

%e' sound broadcastin throuh tele(ision or any other media5 and%f' public demonstration for use of the product offer of trial of theproduct to the member of the public5

(iv) "dulterated alternati(e medicine or health product means alternati(emedicine or health product shall be deemed to be adulterated if,

%a' it consists, in whole or in part, of any filthy, putrid or decomposedsubstance5 or

%b' it has been prepared, pac$ed or stored under insanitary conditionswhereby it may ha(e been contaminated with filth or whereby it

may ha(e been rendered inurious to health5 or%c' its container is composed in whole or in part, of any poisonous or

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deleterious substance which may render the contents inurious tohealth5 or

%d' it bears or contains, for purposes of colourin only, a colour otherthan one which is prescribed5 or

%e' it contains any harmful or toxic substance which may render it

inurious to health5 or%f' any substance has been mixed therewith so as to reduce its

9uality or strenth5

(v) "d(erse !eaction means a noxious and unintended response to aproduct that occurs at any dose used to test for the dianosis,treatment or pre(ention of a disease or for modifyin an oranicfunction5

(vi) "llersode means homeopathic preparations of antiens, %substanceswhich, under suitable conditions, can induce the formation of

antibodies'- "ntiens include toxins, ferments, precipitinoens,alutinoens, opsonoens, lysoens, (enins, alutinins,complements, opsonins, amboceptors, precipitins and most nati(eproteins5

(vii) "llopathic Inredients means inredients used in allopathic orwestern system which are chemically defined inredients andsynthetically manufactured, excludin naturally occurrin inredientsobtained from natural sources5

(viii) :"lternati(e Medicine: means medicinal products which include,indienous or unani medicine, imported medicinal product,homeopathic medicines ,new medicines ,herbal preparation, herbalsubstance ,proprietary medicines, herbal medicinal product , phytomedicines or any other product meant for therapeutic or pre(enti(e usewhich ha(e been deri(ed from plant, animal or mineral inredientsalone or their combinations but does not contain chemically definedsynthetic inredients5

(ix) "uthori8ed #erson means person reconi8ed by the authority as

9ualified technical person ha(in deree in pharmacy or

pharmaceutical sciences and necessary basic scientific and technicalbac$round and experience5

(x) :baby mil$ and foods: means infant formula as a breastmil$ substitutespecially manufactured to satisfy, by itself, the nutritional re9uirementsof infants durin the first months of life up to the introduction ofappropriate complementary feedin and includes infant or babyformulae, follow up formulae, formulae for special medical purposes orcomplementary foods intended for infants and youn children5

(xi) calibration means the set of operations which establish, under

specified conditions, the relationship between (alues indicated by ameasurin instrument or measurin system, or (alues represented by a

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material measure, and the correspondin $nown (alues of a referencestandard5

(xii) clinical trial means an in(estiation with respect to a product thatin(ol(es human subects and is intended to disco(er or (erify its

clinical, pharmacoloical or pharmacodynamic effects, to identify anyad(erse e(ents that are related to its use, to study its absorption,distribution, metabolism and excretion, or to ascertain its safety orefficacy5

(xiii) ommon ;ame means name for any medicinal or nonmedicinalinredient contained in a product, the name by which it is commonly$nown and is desinated in a scientific or technical references5

(xiv) :omplementary foods for infants and youn children means foodsthat are intended for infants six months of ae and older, and for

proressi(e adaptation of infants and children to ordinary food-#roducts may be ready to eat or in powder form to be reconstitutedwith water, mil$, or other suitable li9uid- .hese foods exclude infantformulae, follow up formulae, and formulae for special medicalpurposes li$e+ cereal, fruit (eetable and meat based baby foods forinfants, toddler foods, and unior foods5 for children5

(xv) ontract "cceptor means a manufacturer who manufacturers thefinished product under the label and brand of contract i(er- /e isresponsible for the followin, namely+

%a' he must ha(e ade9uate premises and e9uipment, $nowlede and

experience, and competent personnel to carry out satisfactorily thewor$ ordered by the ontract *i(er- ontract manufacture may beunderta$en only by a manufacturer who is the holder of amanufacturin authori8ation5

%b' he should ensure that all products or materials deli(ered to him aresuitable for their intended purpose5

%c' he should not pass to a third party any of the wor$ entrusted to himunder the contract without the ontract *i(er


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%a' technical aspects of the contract should be drawn up bycompetent persons suitably $nowledeable in pharmaceuticaltechnoloy, analysis and *ood Manufacturin #ractice %*M#'5

%b' all arranements for manufacture and analysis must be inaccordance with the mar$etin authori8ation and areed by both

parties5%c' the ontract should specify the way in which the =ualified #erson

releasin the batch for sale ensures that each batch has beenmanufactured and chec$ed for compliance with the re9uirementsof Mar$etin "uthori8ation5

%d' the contract should describe clearly who is responsible forpurchasin materials, testin and releasin materials, underta$inproduction and 9uality controls, includin inprocess controls, andwho has responsibility for samplin and analysis5

%e' in the case of contract analysis, the contract should state whetheror not the ontract "cceptor should ta$e samples at the premises

of the manufacturer5%f' manufacturin, analytical and distribution records, and reference

samples should be $ept by, or be a(ailable to, the ontract *i(er-"ny records rele(ant to assessin the 9uality of a product in thee(ent of complaints or a suspected defect must be accessible andspecified in the defect or recall procedures of the ontract *i(er5and

%' the ontract should permit the ontract *i(er to (isit the facilitiesof the ontract "cceptor- In the case of contract analysis, theontract "cceptor should understand that he is subect toInspection by the competent "uthorities5

(xvii) ontract *i(er means the person who awards the contract ofparticular products under his brand -ontract *i(er is responsible,

%a' for assessin the competence of the ontract "cceptor to carryout successfully the wor$ re9uired and for ensurin by means ofthe ontract that the principles and uidelines of *M# arefollowed5

%b' the ontract *i(er should pro(ide the ontract "cceptor with allthe information necessary to carry out the contracted operations

correctly in accordance with the mar$etin authori8ation and anyother leal re9uirements5%c' the ontract *i(er should ensure that the ontract "cceptor is

fully aware of any problems associated with the product or thewor$ which miht pose a ha8ard to his premises, e9uipment,personnel, other materials or other products5 and

%d' the ontract *i(er should ensure that all processed products andmaterials deli(ered to him by the ontract "cceptor comply withtheir specifications or that the products ha(e been released by a=ualified #erson5

(xviii) counterfeit medicine or health products means an alternati(emedicine or health product is an imitation of, or a substitute for,

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another dru or medicine or health product or resembles another drumedicine or health product, in a manner li$ely to decei(e or bears uponit or upon its label or container the name of another dru, medicine orhealth product unless it is plainly and conspicuously mar$ed so as tore(eal its true character and its lac$ of identity with such other dru,

medicine or health product5

(xix) :dietetic foods intended for special medical purposes means foods forspecial dietary use that are specially processed or formulated andpresented for the dietary manaement of patients and may be usedonly under medical super(ision- .hey are intended for the exclusi(e orpartial feedin of patients with limited or impaired capacity to ta$e,diest, absorb or metaboli8e ordinary foods or certain nutrientscontained therein, or who ha(e other special medically determinednutrient re9uirement, whose dietary manaement cannot be achie(edonly by modification of the normal diet5

(xx) Disinfectant means a health product or inredient used for destroyinor inhibitin microoranisms that may be harmful to humans oranimals- Disinfectants also include inredients or products ha(inadditional antiseptic acti(ity or use5

(xxi) D!"# "ct means the Dru !eulatory "uthority of #a$istan "ct, 2012%&&I of 2012'-

(xxii) Dru extract ratio %D!' means the ratio between the 9uantity ofherbal substance used in the manufacture of a herbal preparation andthe 9uantity of the herbal preparation obtained- .he number %i(en asthe actual rane' written before the colon is the relati(e 9uantity of theherbal substance5 the number written after the colon is the relati(e9uantity of the herbal preparation obtained5

(xxiii) nlistment means pro(isional allocation or entry of proper number tothe firm or the product in the enlistment reister for the purpose oftemporary manufacturin and mar$etin authori8ation till theprocedure for manufacturin %authori8ation' license and productreistration % mar$etin authori8ation ' is finali8ed and enacted 5

(xxiv) nlistment "pplication means an application in the prescribed form asspecified in the >chedule ", accompanied with re9uired information,attachments, data ,e(idence to support the claims made in theapplication and proper fee submitted under the rules to the Di(ision of/ealth and ?. #roducts%non drus' by the manufacturer or importeror another eliible person5

(xxv) nlistment ertificate means a certificate on the form prescribed in>chedule " to the applicant containin an identification numberallocated to the firm or product formulation in the enlistment reister

which enables its holders for temporary manufacturin and mar$etin

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authori8ations subect to compliance to the rules and conditions forenlistment5

(xxvi) nlistment holder means proprietor or owner of the company or firmto whom nlistment of company or product has been ranted5

(xxvii) xpiry date+ means earlier of-

%a' the date, expressed at minimum as a year and month, up to andincludin which a medicine or a health products maintains itspurity and physical characteristics and its medicinal inredientsmaintain their 9uantity per dosae unit and their potency5 and

%b' the date, expressed at minimum as a year and month, after whichthe manufacturer recommends that the medicine and healthproducts should not be used5

(xxviii) extract means substances prepared by treatin a plant or a plantmaterial, an ala, a bacterium, a funus, or nonhuman animal materialwith sol(ents or pressure to remo(e any constituents5

(xxix) )inished #roduct means alternati(e medicine or health product whichis ready for use after release certificate based on conformance tospecifications by the 9uality control department5

(xxx) )ollow up formulae means food intended for use as a li9uid part ofthe complementary feedin of infants %aed at least months' and foryoun children %aed 13 years'-.hey may be ready to eat or in apowdered form to be reconstituted with water- #roducts may be soybased hydroly8ed protein or amino acid based, or mil$ base nutritional(itamins and minerals5

(xxxi) )ood supplements or dietary supplement or health supplement or:;utraceuticals: means products containin (itamins, pro(itamins,multi(itamins, minerals includin a mineral salt, a naturally occurrinmineral , metals and their salts, a lipid, includin an essential fatty acidor phospholipids liproteins,aminoacids, proteins, fatty acids,carbohydrates, a mucopolysaccharide, plant or herbal material %or a

synthetic duplicate of that $ind', includin plant fibers, en8ymes, alae,funi, cellulose and deri(ati(es of cellulose and chlorophyll, herbalpreparation, resins ,balsams, (olatile oils, nonhuman animal material%or a synthetic duplicate of that $ind' includin dried material, bone andcartilae, fats and oils and other extracts or concentrates, amicrooranism, whole or extracted, except a (accine expressed uices,exudates etc-, alone or their combinations and are presented inpharmaceutical dosae forms intended for health related purpose5

(xxxii) healthcare professional means professionals who render theirser(ices for betterment of human healthcare and are reistered with

their respecti(e ouncil under the law as medical doctor, dentist,pharmacist, homeopathic doctor, ha$im or nurse5

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(xxxiii) health products means health and ?. products %nondrus' asdefined in the D!"# "ct and include probiotic, prebiotic, disinfectants,food supplements, nutritional products, baby mil$ and foods, medicatedcosmetics, medicated soaps, medicated shampoos, medicated plasters

and dermacare products or any other product which may be notified inofficial a8ette by D!"# as /ealth and ?. #roducts5

(xxxiv) health related purpose means a therapeutic, curati(e, pre(enti(e,palliati(e, or cosmetic purpose or for promotion and well bein ofhumans and animal health5

(xxxv) herbal medicinal products means any medicinal product, exclusi(elycontainin as acti(e substances one or more herbal substances or oneor more herbal preparations, or one or more such herbal substances incombination with one or more such herbal preparations5

(xxxvi) herbal preparations means preparation obtained by subectin herbalsubstances to treatment such as extraction, distillation, extraction,fractionation, purification, concentration or fermentation, includincomminuted or powdered herbal substances, tinctures, extracts,isolates, essential oil, expressed uices and processed exudates5

(xxxvii) herbal substances means all mainly whole, framented or cut plants,plant parts, alae, funi, lichen in an unprocessed, usually dried formbut sometimes fresh- ertain exudates that ha(e not been subected toa specific treatment are also considered to be herbal substances-/erbal substances are precisely defined by the plant part used and thebotanical name accordin to the binomial system %enus, species,(ariety'5

(xxxviii) herbal teas means teas which consist exclusi(ely of one or moreherbal substance intended for oral a9ueous preparations by means ofdecoction, infusion or maceration- .he preparation is preparedimmediately before use- /erbal teas are usually supplied in bul$ formor in sachets5

(xxxix) imported medicinal product


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the first months of life up to the introduction of appropriatecomplementary feedin- #roduct is in a li9uid form, either as a ready toeat product, or is reconstituted from a powder- #roducts, may be,hydroly8ed protein or amino acid based, or mil$ based nutritional(itamins and minerals5

(xli) inprocess control or tests inprocess control or tests are tests, whichmay be performed durin the manufacture of either the herbalpreparation or herbal medicinal product or any other finished productrather than as part of the formal battery of tests which are conductedprior to product release- Inprocess tests, which are used for thepurpose of adustin process parameters durin manufacturin processwithin control or an operatin rane, e--, hardness and friability oftablet cores, weiht (ariation, disinteration test -etc5

(xlii) isode means homeopathic preparations of botanical, 8ooloical or

chemical substances, includin drus, excipients or binders, whichha(e been inested or otherwise absorbed by the body and arebelie(ed to ha(e produced a disease or disorder which interferes withhomeostasis- .hey are sometimes referred to as Detoxodes as well5

(xliii) homeopathic excipient means substance needed for manufacturin adosae form %used after potentisation' such as wheat starch andmanesium stearate for tablets- It may also represent the substance ofthe dosae form5

(xliv) /omeopathic medicine include any medicine which is recorded in/omoeopathic pro(in or therapeutic efficacy of which has beenestablished throuh lon clinical experience as recorded inauthoritati(e /omoeopathic literature and which is prepared accordinto the techni9ues of /omoeopathic pharmacy and co(ers combinationof inredients of such /omoeopathic medicines but does not include amedicine which is administered by parenteral route5 and ahomeopathic product must meet two criteria, that is manufactured from,or contain as medicinal inredients, only substances referenced in ahomeopathic monoraph in one of the followin homeopathicpharmacopoeias, as they are amended from time to time5

%a' /omeopathic #harmacopoeia of the @nited >tates %/#@>'5%b' /omAopathische "r8neibuch %/"B' or *erman /omeopathic

#harmacopoeia5%c' #harmacopCe franaise or )rench #harmacopoeia %#h)'5%d' British /omeopathic #harmacopoeia %B/#'5%e' Indian /oeopatic #harmacopoeia %I/#'5%f' uropean #harmacopoeia %#h-ur'5%' ncyclopedia of /omeopathic #harmacopoeia %/#'5 and

is prepared in accordance with the methods outlined in one of the

homeopathic pharmacopoeias listed abo(e, as they are amended fromtime to time5

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(xlv) /omeopathic source material means the oriinal raw material usedfor the production of /omeopathic medicines- .his material is obtainedfrom natural sources, e-- of botanical, 8ooloical, microbioloical,mineral, chemical, animal and human oriin, or synthetic procedures-

>ource materials may undero preliminary treatment in order to befurther processed5

(xlvi) Indienous or @nani Medicine means5%a' any substance or mixture of substances, product, or preparations

intended for external or internal use in human beins or animalsfor the treatment, mitiation, or pre(ention of disease, anabnormal physical state, or the symptoms thereof, or forrestoration, correction or modification of oranic functions ofhuman beins or animals, which contains as acti(e substancesany combination of inredients, or is in accordance to a formula,

prescribed in the authoritati(e boo$s of .ibbe@nani and asprescribed under the rules5 and

%b' any substance or material or mixtures thereof as may beprescribed by the "uthority in the ?fficial a8ette5

(xlvii) intended purpose means use for which alternati(e medicine orhealth product is intended accordin to the claim of manufacturer orimporter as per recommended conditions for use and stated on any orall of the followin, namely5

%a' label of the product5%b' instruction for use of the product5 and%c' promotional material in relation to the product5

(xlviii) isolate means a purified constituent of a defined molecular structureobtained from a plant or a plant material, an ala, a bacterium, afunus or a nonhuman animal material5

(xlix) label means any written, printed or raphic presentation that appearson or is attached to the container of the product or acti(e inredient orherbal preparation or any part of the pac$ain and includesinformational sheet or leaflets that accompanies when finished product

or acti(e inredient or preparation is bein supplied5

(l) label claim means any representation made on a product in relationto its indication, benefits or actions- laims could be stated directly orinferred indirectly but not limited to the followin+

%a' raphic or loos on the product pac$ain5%b' product or brandin5%c' media ad(ertisement %print, sound, liht and sound'5%d' point of sales materials5%e' product broachers or information sheets distributed with or

separately from the product5

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(li) lot or batch means a 9uantity of any product in dosae form, a rawmaterial or a pac$ain material, homoeneous within specified limits,constitutin all or part of a sinle batch and identified by a distincti(e lotnumber which appears on the label of the finished product5

(lii) manufacture means all operations of productions in(ol(ed in theproduction of medicines and health products or any part of the processof brinin the products to their final state, includin enain in theprocessin, assemblin, pac$ain, labellin, storae, sterili8in,testin or releasin for supply of the products or of any component orinredient of the product as part of the process but does not includedispensin or compoundin of products on the ad(ice of healthcareprofessionals- >inle step of manufacture also re9uires manufacturinauthori8ation or license by the "uthority- )or example one of thefollowin processes li$e tablet coatin5 capsule fillin from bul$5aerosol fillin from bul$5 storae other than for sale5 pac$ain

includin labellin5 sterili8ation5 testin includin analysis or testin ofbatch of medicines and health products and releasin for sale %by aperson not in(ol(ed with actually preparin the finished products'5

(liii) mar$ers are chemically defined constituents or roups of constituentsof a herbal substance, a herbal preparation or a herbal medicinalproduct which are of interest for control purposes independent ofwhether they ha(e any therapeutic acti(ity- Mar$ers ser(e to calculatethe 9uantity of herbal substance or herbal preparation in the /erbalMedicinal #roduct if the mar$er has been 9uantitati(ely determined inthe herbal substance or herbal preparations- .here are two cateoriesof mar$ers+

%a' acti(e mar$er which are constituents or roups of constituentswhich are enerally accepted to contribute to the therapeuticacti(ity-

%b' analytical mar$er which are constituents or roups of constituentsthat ser(e for analytical purposes5

(liv) master formula a document or set of documents specifyin thestartin materials with their 9uantities and the pac$ain materials,

toether with a description of the procedures and precautions re9uiredto produce a specified 9uantity of a finished product as well as theprocessin instructions, includin the inprocesscontrols5

(lv) medicated cosmetics means health product used for cleansin,frarencin, deodori8in, beautifyin, preser(in, impro(in, alterin orrestorin complexion of s$in, hair, nail or teeth of human containininredients of natural oriin5

(lvi) medicated oil and balm means any external medicated embrocation,medicated cream, ointment, lotion or inhalant used for soothin

purposes containin followin inredients+

%a' ssential oils5

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%b' )ixed oils deri(ed from natural source5%c' Methyl salicylate5and%d' Menthol camphor and peppermint5

(lvii) misbranded alternati(e medicine or health products means an

alternati(e medicine or health product which is5

%a' so coloured, coated, powdered or polished that damae isconcealed or if it is made to appear of better or reater therapeutic(alue than it really is5 or

%b' not labelled in the prescribed manner5 or%c' label or container or anythin accompanyin it bears any

statement, desin or de(ice which ma$es any false claim for theproduct or which is false or misleadin in any particular5

(lviii) mother tincture or tincture means the initial homeopathic preparation

made from source material that can be further potentised or sometimesused as homeopathic medicines, is rearded as the most concentratedform of a finished homeopathic medicine- Mother tinctures are obtainedclassically by maceration or percolation %sometimes also by diestion,infusion, decoction or fermentation' techni9ues from source materialsaccordin to a procedure prescribed by a reconi8ed /omeopathicpharmacopoeia5

(lix) nati(e extract means the material consistin only of componentspresent in the oriinal plant or formed durin the extraction process,excludin any excipients or other added substances- .his term mayrefer to li9uid extracts or semisolid extracts from which the addedsol(ent has been remo(ed, or may refer to a dry extract or that portionof a finished extract that is comprised solely of plant components5

(lx) nati(e extract ratio means the ratio of the mass of herbal material tothe mass of the resultin nati(e herbal preparation %E nati(e extract'5

(lxi) new formulation or new medicine means5

%a' a formulation, includin bul$ substance, which has not been

e(aluated for 9uality, safety and efficacy nor sufficient standardsof e(idence ha(e been defined reardin the recommendedconditions for use -

%b' a formulation of already appro(ed product for a modified or newclaims namely, indications, dosae, dosae form %includinsustained release dosae form' and route of administration5 or

%c' a formulation of a fixed dose combination of two or more herbalsubstances or inredients, indi(idually a(ailable earlier for certainclaims, which are proposed to be combined for the first time in afixed ratio, or if the ratio of inredients in a mar$eted combinationis proposed to be chaned, with certain claims, namely,

indications, dosae, dosae form %includin sustained releasedosae form' and route of administration5

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(lxii) nosode homeopathic preparations of patholoical orans or tissues,causati(e aents such as bacteria, funi, o(a, parasites, (irus particlesand yeast, disease products, excretions or secretions5

(lxiii) nutritional supplements means a product that is used to supplementa diet beyond that of normal nutrients to support or maintain thehealthy body functions in humans and animals5

(lxiv) prebiotics means the non diestible nutritional inredient thatstimulates the rowth or acti(ity of bacteria in the diesti(e system andproduce health benefits5

(lxv) production process or manufacturin process meanssteps,procedures,instructions and manufacturin techni9ue tocon(ert startin materials into finished product which in(ol(es a series

of manufacturin operations and process control tests for batch tobatch consistency of finished products in terms of 9uality, efficacy andeffecti(eness- Manufacturin process also includes process desin,process (alidation and 9ualification, precautions or process criticalparameters which could chane the results and inprocess controls5

(lxvi) #rincipals of *ood Manufacturin #ractice %*M#' means that partof 9uality assurance which ensures that medicinal products areconsistently produced and controlled to the 9uality standardsappropriate to their intended use and as re9uired by the mar$etinauthori8ation or product specification- *M# is concerned with bothproduction and 9uality control- .he basic principles of *M# are that,

%a' all manufacturin processes are clearly defined, systematicallyre(iewed in the liht of experience and shown to be capable ofconsistently manufacturin medicinal products of the re9uired9uality and complyin with their specifications5

%b' critical steps of manufacturin processes and sinificant chanesto the process are (alidated5

%c' appropriately 9ualified and trained personnel5%d' ade9uate premises and space5

%e' suitable e9uipment and ser(ices5%f' correct materials, containers and labels5%' appro(ed procedures and instructions5%h' suitable storae and transport5%i' instructions and procedures are written in an instructional form in

clear and unambiuous lanuae, specifically applicable to thefacilities pro(ided5

%' operators are trained to carry out procedures correctly5%$' records are made, manually or by recordin instruments, durin

manufacture which demonstrate that all the steps re9uired by thedefined procedures and instructions were in fact ta$en and that

the 9uantity and 9uality of the product was as expected- "nysinificant de(iations are fully recorded and in(estiated5

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%l' records of manufacture includin distribution which enable thecomplete history of a batch to be traced, are retained in acomprehensible and accessible form5

%m' the distribution %wholesalin' of the products minimi8es any ris$to their 9uality5

%n' a system is a(ailable to recall any batch of product, from sale orsupply5

%o' complaints about mar$eted products are examined, the causes of9uality defects in(estiated and appropriate measures ta$en inrespect of the defecti(e products and to pre(ent reoccurrence-

(lxvii) probiotic means an inredient or product containin micro oranismsthat confers health benefits on the host5

(lxviii) product enlistment holder an indi(idual with leal ownership of andresponsibility for the product- .he product enlistment holder may be

located in or outside of #a$istan- #roduct enlistment holders who arelocated outside of #a$istan must identify a #a$istani representati(e5

(lxix) prohibited substance means a substance that is not permitted to be

contained in any medicine or health product and include the followinnamely5

%a' allopathic inredients5%b' colours and additi(es, except the prescribed one5%c' toxic inredients containin plants or animals or their parts5%d' restricted inredients abo(e the prescribed limits5%e' steroids and anabolic hormones 5 or%f' any other substance which has been declared inurious to health

by the "uthority, throuh notification in the official a8ette+

#ro(ided that prohibited substances recorded in any reconi8edhomeopathic pharmacopoeia may be may used in homeopathicmedicine subect to compliance to the F/? safety uidelines forhomeopathic medicines-

(lxx) :proprietary medicines:+.means anysubstance, inredient or medicinal

product which is not included in any pharmacopoeias or publicationa(ailable in public domain and its manufacturin process, testinmethod and clinical data ha(e been enerated by the owner of thatmedicine-

(lxxi) "#hytomedicine: means herbal preparation or herbal products whichcontain processed or unprocessed standardi8ed materials deri(ed fromplants or parts thereof or combination of parts of plants, standardi8edor 9uantified extracts or fractions thereof in a dosae form for internalor external use of human beins or animals and intended to be usedfor the dianosis, treatment, mitiation or pre(ention of any disease or

disorder in human beins or animals but does not includeadministration by parenteral5

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(lxxii) quality assurance means the sum total of the orani8edarranements made with the obecti(e of ensurin that alternati(emedicine and health product are of the 9uality re9uired for theirintended use- .he system of 9uality assurance for the manufacture of

alternati(e medicine and health products should ensure that5

%a' medicine and health products are desined and de(eloped in away that ta$es account of the re9uirements of *oodManufacturin #ractice 5

%b' production and control operations are clearly specified and *M#adopted5

%c' manaerial responsibilities are clearly specified5%d' arranements are made for the manufacture, supply and use of

the correct startin and pac$ain materials5%e' all necessary controls on intermediate products, and any other in

process controls and (alidations are carried out5%f' finished product is correctly processed and chec$ed, accordin to

the defined procedures5%' alternati(e medicine and health products are not sold or supplied

before an authori8ed person has certified that each productionbatch has been produced and controlled in accordance with there9uirements of the mar$etin authori8ation and any otherreulations rele(ant to the production, control and release ofmedicine and health products5

%h' satisfactory arranements exist to ensure, as far as possible, thatthe medicine and health products are stored, distributed andsubse9uently handled so that 9uality is maintained throuhouttheir shelf life5 and

%i' there is a procedure for selfinspection andGor 9uality audit, whichreularly appraises the effecti(eness and applicability of the9uality assurance system-,

(lxxiii) 9uality control means that part of *ood Manufacturin #ractice whichis concerned with samplin, specifications and testin, and with theorani8ation, documentation and release procedures which ensure thatthe necessary and rele(ant tests are actually carried out and that

materials are not released for use, nor products released for sale orsupply, until their 9uality has been uded to be satisfactory- .he basicre9uirements of 9uality control are that5

%a' ade9uate facilities, trained personnel and appro(ed proceduresare a(ailable for samplin, inspectin and testin startinmaterials, pac$ain materials, intermediate, bul$, and finishedproducts, and where appropriate for monitorin en(ironmentalconditions for *M# purposes5

%b' samples of startin materials, pac$ain materials, intermediateproducts, bul$ products and finished products are ta$en by

personnel and by methods appro(ed by 9uality control5%c' test methods are (alidated5

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%d' records are made, manually or by recordin instruments, whichdemonstrate that all the re9uired samplin, inspectin and testinprocedures were actually carried out- "ny de(iations are fullyrecorded and in(estiated5

%e' the finished products contain acti(e inredients complyin with the

9ualitati(e and 9uantitati(e composition of the mar$etinauthori8ation, are of the purity re9uired, and are enclosed withintheir proper containers and correctly labelled5

%f' records are made of the results of inspection and that testin ofmaterials, intermediate, bul$, and finished products is formallyassessed aainst specification- #roduct assessment includes are(iew and e(aluation of rele(ant production documentation andan assessment of de(iations from specified procedures5

%' no batch of product is released for sale or supply prior tocertification by an authori8ed person that it is in accordance withthe re9uirements of the rele(ant authori8ations5 and

%h' sufficient reference samples of startin materials and products areretained to permit future examination of the product if necessaryand that the product is retained in its final pac$ unlessexceptionally lare pac$s are produced5

(lxxiv) recall means any action ta$en by the manufacturer, importer, supplieror reistrant or enlistment holder of a product to remo(e it from themar$et or to retrie(e from any person to whom it has been suppliedbecause of the reason that the product5

%a' may be ha8ardous to health5%b' may fail to conform to any claim made by its manufacturer,

importer, reistrant or enlistment holder relatin to the 9uality,safety, efficacy or its usefulness5 or

%c' may not meet to the re9uirement of the D!"# "ct5

(lxxv) recommended conditions of use recommended conditions of userefer to information about an alternati(e medicine or health product thatenables consumers to ma$e an informed choice reardin its use- Itincludes the followin elements5

%a' recommended use or purpose5%b' dosae form5%c' recommended route of administration5%d' recommended dose5%e' recommended duration of use, if any5 and%f' ris$ information, includin any cautions, warnins,

contraindications or $nown ad(erse reactions associated with itsuse5

(lxxvi) re(iew of application means screenin, assessment and e(aluation ofinformation and contents included in the application dossiers submitted

for the rant of enlistment certificates5

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(lxxvii) ris$reduction claim which describes the relationship between usin aproduct and reducin the ris$ of de(elopin a chronic disease orabnormal physioloical state by sinificantly alterin a maor ris$ factoror factors reconi8ed to be in(ol(ed in its de(elopment5

(lxxviii) substandard means alternati(e medicine or health product,inredient, raw material or finished product which does not conform tothe specifications or prescribed standards of 9uality, identity, purity andstrenth as defined in the specified publication or prescribed under therules or expired medicine and expired health product which haspassed its shelf life5

(lxxix) specified publication means any of the official publications reconi8edby the "uthority which contain material information reardin themanufacturin, analytical standards or recommended conditions foruse of alternati(e medicines or health products as specified under

these rules includin British #harmacopoeia or British #harmaceuticalodex or British /erbal #harmacopoeia, @nited >tate #harmacopoeia,"merican /erbal #harmacopoeia, uropean #harmacopoeia, *erman#harmacopoeia, Hapanese #harmacopoeia, orean #harmacopoeia,Indian #harmacopoeia, hinese #harmacopoeia and hina Dru>tandards5

(lxxx) specifications means list of tests, references to analyticalprocedures, and appropriate acceptance criteria which are numericallimits, ranes, or other criteria for the tests described- It establishes theset of criteria to which a herbal preparation or herbal substance orherbal medicinal product should conform to be considered acceptablefor its intended use- >pecifications are bindin 9uality standards thatare areed to between the "uthority and the applicant-Conformance tospecifications means that the herbal substances or herbal preparationor active ingredients or medicine or health product, when testedaccording to the analytical procedures listed in the specified publicationor rules, will meet the listed acceptance criteria;

(lxxxi) spurious alternati(e medicines or health products means alternati(emedicines or health products which5

%a' is imported under a name which belons to another product 5 or%b' label or the container bears the name of an indi(idual or company

purportin to be the manufacturer of the medicine or healthproducts, which indi(idual or company is fictitious or does notexist5 or

%c' has been substituted wholly or in part by another dru, medicine,health product or substance5 or

%d' is purports to be the product of a manufacturer of whom it is nottruly a product 5 or

%e' contains prohibited substance as inredient which is oriinally

not part of appro(ed formulation5 and%f' is manufactured without manufacturin and mar$etin

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authori8ations of the "uthority-

(lxxxii) standards of e(idence means clearly defined criteria used byreulators to e(aluate the safety, 9uality and effecti(eness of a claimreardin an alternati(e medicine, or health product- .he criteria define

the amount and type of data re9uired to support the safety of a productand all health claims that are associated with it- "lthouh standards ofe(idence may differ from one type of product to another, they areconsistent within a similar cateory of products li$e full e(aluation of9uality, safety and efficacy data shall be re9uired for disease reductionclaims or therapeutic claims and simplified e(aluation for nutritional,structure function or traditional use claims5

(lxxxiii) >tandard ?peratin #rocedure %>?#' means an authori8ed writtenprocedure i(in instructions for performin operations not necessarilyspecific to a i(en product or material %e-- e9uipment operation,

maintenance and cleanin5 (alidation5 cleanin of premises anden(ironmental control5 samplin and inspection'- ertain >?#s may beused to supplement productspecific master and batch productiondocumentation5

(lxxxiv) stoc$s means substances, products or preparations used as startinmaterials for the production of homoeopathic preparations- " stoc$ isusually a mother tincture or a lycerol macerate, for raw materials ofbotanical, 8ooloical or human oriin, or the substance itself, for rawmaterials of chemical or mineral oriin5

(lxxxv) >tructure)unction laim a claim which describes the effect of aproduct on a structure or physioloical function in the human body, or aproductupply means to+%a' sell the alternati(e medicine or health product for distribution or

retail sale%b' transfer possession of finished product by exchane, ift,loan,hire

or sale5 and%c' transfer product by way of administration to or application in anyperson in the course of any dianosis ,treatment or testin5

(lxxxvii) synthetic duplicate means a substance that shares an identicalchemical structure and pharmacoloical properties with its naturalcounterpart- ;atural means a product that is isolated or comes from anatural source %e--, plant or mineral'- >ynthetic means a product thatis chemically produced- )or example, most of the (itamin in productsmar$eted in #a$istan is a synthetic duplicate of the ascorbic acid thatoccurs naturally in plants and animals5

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(lxxxviii) traditional medicine means the sum total of the $nowlede, s$ills andpractices based on the theories, beliefs and experiences indienous todifferent cultures, used in the maintenance of health, as well as in thepre(ention, dianosis, impro(ement or treatment of physical andmental illness- .raditional medicine has a lon history of usae and has

established efficacy and safety for traditional use indications5

(lxxxix) therapeutic claim means a claim which relates to the dianosis,treatment, mitiation or pre(ention of a disease, disorder, or abnormalphysical state or its symptoms in humans5

(xc) Validationmeans action of pro(in, in accordance with the principlesof *M#, that any procedure, process, e9uipment, material, acti(ity orsystem actually leadsto the expected results5

'$ .he words and expressions used but not defined herein shall ha(e the same

meanins as are assined to them in the "ct, D!"# "ct, odex "limentarious of)ood and "riculture ?rani8ation and Forld /ealth ?rani8ation or Internationalonference on /armoni8ation uidelines for medicines and health products-

/$ Procedure for 0nlistment$, (&).he "uthority shall enlist alternati(e medicineand health products, their manufacturers and importers subect to fulfillment of thecriteria prescribed below$

%2' .he followin shall be eliible to apply for enlistment namely5

%a' manufacturers ha(in manufacturin and 9uality control facilities5%b' contract i(er as prescribed in rule 5%c' importers authori8ed by the o(erseas principal manufacturer5 and%d' manufacturers holdin manufacturin license under the "ct may

also apply for appro(al of dedicated sections for manufacturin ofalternati(e medicines or health products and probiotics or foodsupplements to the "uthority and thereafter become eliible toapply for enlistment-

%3' "pplication for enlistment shall be made to the "uthority, addressed to theDirector of Di(ision of /ealth and ?. #roducts %nondrus' in the followin

manner, namely+

%a' application for the enlistment of manufacturer or any sectionthereof, and manufacturin on contract basis for contract i(ershall be in #orm &as prescribed in schedule "5

%b' application for the enlistment of importer shall be made on #orm 'as prescribed in schedule "5

%c' application for the enlistment of locally manufactured product foreneral health claim, or traditional use claim, or nutritional claims,or structure function claims shall be made on #orm / asprescribed in schedule "5

%d' application for the enlistment of locally manufactured product fordisease reduction or therapeutic claims shall be made on #orm %

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as prescribed in schedule "5%e' application for the enlistment of imported product shall be made

on #orm 1as prescribed in schedule "5%f' application shall be accompanied with a fee of rupees ten

thousand for enlistment of manufacturer, contract i(er or importer

and two hundred and fifty rupees for enlistment of each product ofalternati(e medicine and two thousand rupees for each product ofhealth products5 and

%' application for contractin manufacturin shall be accompaniedwith fee as prescribed by the "uthority, as well as applicationdocuments and 9uality areement between the contract i(er andcontract acceptor-

%4' )ee shall be deposited in the head of account of "uthority at thedesinated ban$s and oriinal receipt of deposit of money shall be attachedwith the application-

%- A22lication evaluation- %1' "pplications shall be scrutini8ed by the Di(isionof /ealth and ?. #roducts %nondrus' for conformance to the e(aluation criteria-

%2' "pplicants shall be re9uired to submit documents with e(idence anddocumentary proof for 9uality, safety, efficacy or effecti(eness andrecommended conditions for use as per standards of e(idence-%3' "uthority may (erify contents or information pro(ided in the applicationdossier throuh panel of Inspectors or any authori8ed Inspector of "uthority or#ro(incial Inspector-%4' "pplicants shall be re9uired to submit a declaration on notari8ed stamppaper that the contents of the application are correct-

1$ 0valuation criteria, %1' "pplications shall meet the followin criteria, namely+

%a' applications shall be complete and meet all the criteria prescribed5%b' applicants shall possess manufacturin and 9uality control

facilities5%c' applicants shall submit necessary e(idence to support

applications for manufacturin unit, import or products as definedin the rules5

%d' applicants shall conform to the principles of 9uality assurance forcontract manufacturin or contract testin and analysis5%e' application containin false, incorrect or misleadin information

shall be liable to reection5%f' the formulation of the applied product shall not contain prohibited

substance or inredient or inredients that ha(e been declareddanerous or inurious to health by any international body or asmay be prescribed5

%' the formulations as a whole or containin any of its inredientsthat ha(e been withdrawn due to safety concerns shall be liable toreection5

%h' the applicants of new formulation or new inredients shall submitsafety, efficacy and 9uality data as per reconi8ed e(idence and

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standards5%i' applicant shall support applications throuh necessary proof or

e(idence, to pro(e 9uality, safety and efficacy of the products5 and%' import documents shall be attested by the reulatory authority of

the country of oriin and (erified by the embassy or consulate of

#a$istan in the said country-

3$ Contract manufacturing- %1' .he application for enlistment of product formanufacturin on contract basis submitted to the "uthority shall be re(iewed anddecided in the liht of fulfillment of criteria prescribed-

%2' ontract acceptor shall ha(e predetermined surplus capacity in termsof manufacturin facilities, sections, e9uipment, testin procedures, 9ualifiedtechnical personnel and 9uality control operations-%3' ontract acceptor shall be possessin established systems of 9ualityassurance and (alidation of manufacturin process and testin methods and

no maor deficiencies or non conformities has been identified durin theinspection of manufacturin unit of the contract acceptor-%4' (ery operation of cleanin and saniti8ation, (alidation, calibration,manufacturin, inprocess controls, 9uality control, stability protocol,pac$ain and release shall be clearly defined and documented throuhstandard operatin procedures-%J' =uality control laboratory shall be e9uipped with hemistry,#harmaconosy and Microbioloy facilities and e9uipment, as applicable-

4$ 0valuation Committee- %1' .he nlistment (aluation ommittee shallcomprise of the followin members, namely+

%a' Director /ealth and ?. #roducts exofficiohairpersonGmember5

%b' Deputy D* /ealth and ?. #roductsKice hairpersonGmember5

%c' hief Dru control and .raditional Medicine Di(ision ;I/Member5

%d' hief ;utrition Di(ision ;I/Member5

%e' ?ne xpert of homeopathy to be nominated by the "uthorityMember5

%f' ?ne expert of 9uality control to be nominated by the "uthority-Member5

%' ?ne expert of unani to be nominated by the authorityMember5

%h' Deputy Drus ontroller /ealth and ?. #roductsMember5

%2' .he Deputy Drus ontroller %/ealth and ?. products' shall act as>ecretary of the ommittee-%3' .he "uthority may increase or decrease the member throuh

notification in the official *a8ette5%4' =uorum to constitute a meetin shall be abo(e fifty per cent of the totalmembership-

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%J' .he e(aluation committee shall e(aluate the applications as per criteriaand may rant appro(al or reection of the application recordin reasonsthereof-%' .he secretary shall call the meetin on the direction of hairperson orKice hairperson-

%7' .he Kice hairperson shall preside the meetin in the absence ofhairperson-%L' .he secretary or desinated officer of the Di(ision shall sin thecorrespondence on behalf of the committee-%6' .he committee shall examine and in(estiate the reports of theinspector and fix the responsibility in case of any (iolation-%10' .he committee shall issue a show cause notice or a notice for personalhearin prior to decide the cases of (iolation-%11' .he ommittee may ma$e procedure for the conduct of its businesssubect to ratification by the "uthority-%12' .he ommittee may pass appropriate orders includin referrin the

case to Drus ourts for (iolations of the "ct or D!"# "ct-%13' .he ommittee may direct the applicants for explanation about anymatter or refer the matter to experts of rele(ant specialty for expert opinion-%14' .he committee may call any person for personal hearin or showincause of (iolations to the D!"# "ct or rules framed there under-%1J' .he arie(ed person or party may prefer appeal before the "ppellateBoard aainst the decision of committee within a period of one month as perprescribed procedure for appeal-%1' nlistment ertificate for manufacturer or importer shall be issued on#orm 3as prescribed in schedule "-%17' nlistment ertificate for products shall be issued on #orm 4 asprescribed in schedule "-%1L' nlistment ertificate for contract manufacturin shall be issued on#orm 5as prescribed in schedule "-

5$ Res2onsi6ilities of 0nlistment Holder-%1' nlistment holder shall beresponsible and liable for 9uality, safety and efficacy of the authori8edenlisted product-

%2' .he enlistment is an interim arranement for a specified period and itdoes not confer any riht for unlimited continuation of manufacture, import

and export, or rant of manufacturin license or product authori8ations-%3' !ele(ant pro(isions of the D!"# "ct reardin 9uality, safety, andefficacy shall be applicable upon all enlisted companies or firms or products-%4' nlistment holder shall be responsible for compliance to the conditionsof enlistment as defined in the enlistment certificate-%J' nlistment holder shall be authori8ed to procure raw materials formanufacturin of enlisted products at the authori8ed premises stated in theenlistment certificate as manufacturer and mar$et such products throuhout#a$istan under prescribed warranty-%' nlistment holder shall be responsible to follow the principals of oodmanufacturin practices-

%7' )inished products shall be supplied after certification and release bythe authori8ed person-

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%L' Manufacturin, 9uality control, sale and distribution records shall bemaintained and $ept for one year beyond the expiry of the finished product-%6' ;on compliance to fulfillment of responsibilities by enlistment holdershall be liable to re(ocation of enlistment certificate-

7$ Certificate of free sale and Com2liance to G$M$P$,%1' "pplication for awardof free sale and *ood Manufacturin #ractices compliance certificate shall besubmitted to the Di(ision of /ealth and ?. #roducts of the "uthority on#orm 7 as prescribed in >chedule " accompanied by prescribed fee fortherapeutic oods-

%2' .he certificate for compliance to *ood Manufacturin #ractices to themanufacturer of alternati(e medicine and health products shall be issued toenlistment holder on #orm &+as prescribed in schedule " for compliance tothe re9uirements of *ood Manufacturin #ractice and conformance tointernational standard for manufacturin till the time of licensin-

%3' .he Di(ision shall issue free sale certificate to the applicant pro(idedthe product is freely a(ailable in the local mar$et where as the *M# certificateshall be issued after inspection and (erification by inspector notified for thepurpose-

&+$ Manufacturing and distri6ution$(&) .he manufacturin and testin ofalternati(e medicines and health products shall be conducted in accordancewith the criteria laid down in the current edition of specified publication or asmay be prescribed and appro(ed by the "uthority-

%2' .he baby mil$s and foods, nutritional products and probiotics shall bemanufactured and tested in accordance with the internationally reconi8edstandards, codes of practice, uidelines and other recommendations of odex"limentarius of )ood and "riculture ?rani8ation and Forld /ealth?rani8ation-%3' .he enlistment holder or his authori8ed aent shall issue warranty on#orm &&as prescribed in schedule " for the supplied alternati(e medicineand health product warrantin that these products does not contra(ene theany pro(ision of D!"# "ct and rules framed there under-%4' Manufacturer shall use only permitted excipients as prescribed in

Schedule 8complyin to the conditions and specifications%J' nlistment holder shall authori8e distributors as authori8ed aents forsupply and sale on #orm &'as prescribed in >chedule " to distribute hisenlisted finished products and issue warranty on behalf of enlistment holderin their desinated area of urisdiction stated in the authority letter-

&&$ Prohi6itions$, %1' ;o person himself or any other person on his behalf shallissue or cause to be issued any ad(ertisement by any means what so e(er,except obtainin permission after re(iew of contents of ad(ertisement materialby the "uthority-

%2' ;o person himself or any person on his behalf shall manufacture,import or sell any adulterated, misbranded, spurious, counterfeit or

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substandard medicine or health products-%3' Kiolation of this rule shall be offence under >chedule II and ispunishable under >chedule III of D!"# "ct-

23


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#orm &

[See of rule 3(3)]

APP9"CA!"N #R 0N9"S!M0N! # MAN:#AC!:R0R R CN!RAC! G";0R(Attach reada6le soft co2y herebyapply for enlistment of my firmGcompany established under companyGpartnership"ct-------------------------------- /a(in ;.; - located at the premises asunder---

%"' .hat I am manufacturin followin classes of therapeutic oods

1- "lternati(e Medicines- %"ttach detail information as "nnex"'a- /erbal Medicinal product or #hytopharmaceuticals%standardi8ed

extracts' or phytomedicineb- Indienous or @nani Medicines or traditional Medicines-c- /omeopathic Medicines-%mother tincture, sarcode, ;osode , "llersode,

Isode or any other homeopathic preparation or dosae form '

d- Biochemic Medicines-

e- /erbal oils G Balmsf- "ny other alternateG complementary medicines-

2- /ealth and ?. #roducts- %"ttach the information as "nnexB'a- )ood supplements %;eutraceuticals or dietary or health supplements'-b- ;utritional supplements, probiotics and prebioticsc- Baby Mil$s and )oods %infant or baby formulae, follow up formulae,

formulae for special medical purposes or complementary foodsintended for infants and youn children'-

d- Disinfectants-e- Medicated cosmetics, and shampoos containin natural inredients-

f- Medicated >oaps containin natural inredients- .ooth pastesGmouthwashesGthroat lo8enesGarles containin natural

inredients-h- Medicated cosmeticsGDermacare productsGBalmsG patchesG medicated

oils natural inredientsi- "ny other-

3- .hat my manufacturin unit has followin facilities+%"ttach the site master file as "nnex'

4- .otal si8e of the plotG buildin is ----s9Gfeet-

J- ;o- of sections are as under+ %"ttach list of e9uipment and instruments a(ailable

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with copy of in(oice for each section'a- .ablets-b- apsules-c- Dry >yrup-d- Dry powder %s'-

e- Ni9uid >olution, >yrup, emulsion, suspensions, drin$in ampoules andDrops-

f- ?intment and reams-- >achetGherbal teasGoshanda-h- yeG arG ;asal Drops-i- #ac$ain and Nabelin-- =uality ontrol Nab %pharmaconosy, chemistry and microbioloy

laboratories'-$- Farehouses-l- Fater purification plant-m- >terili8ation facility-

n- "ny other section-

- ?ur facility has followin staff+ %"ttach the information as "nnexD'a- =ualified staff name, 9ualification, experience and trainin ->tate

responsibility and attach their Kupporti(e and non technical staff-

7- Nist of Manufactured and mar$eted products and product wise as well as totalturno(er+%"ttach the information as "nnex' -

L- )ee deposit ban$ receipt-

6- I underta$e and certify that the contents stated abo(e are correct and true to thebest of my $nowlede %please attach underta$in on the notari8ed stamp paper-

;ame of the owner

>inature

>eal of the )irmG ompany-

Dated----------------------------------

25


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#orm '[(See rule 3(3)]

APP9"CA!"N #R 0N9"S!M0N! # "MPR!0R(Attach reada6le soft co2y herebyapply for enlistment of my firmGcompany ha(in ;.; -located at the premises as under----

%"'- that I am importin followin classes of therapeutic oods %attach contract if

contract manufacturin'-

1- "lternati(e Medicines- %"ttach detail information as "nnex"'a- /erbal Medicinal #roduct or #hytomedicine or #hytopharmaceuticalsb- Imported Medicinec- /omeopathic Medicines-d- Biochemic Medicines-e- /erbal oils G Balms-f- /erbal preparations- "ny other alternateG complementary medicines-

2- /ealth and ?. #roducts- %"ttach the information as "nnexB'a- )ood supplements %;eutraceuticals or dietary or health supplements'-b- ;utritional supplements, probiotics and prebiotics-c- Baby Mil$s and )oods %infant or baby formulae, follow up formulae,

formulae for special medical purposes or complementary foodsintended for infants'-

d- Disinfectants-e- Medicated shampoos containin natural inredients-f- Medicated >oaps natural inredients- .ooth pastesGmouthwashesGthroat lo8enesGarles natural inredients-

h- Medicated cosmetics G Dermacare products G Balms G patches Gmedicated oils natural inredientsi- "ny other-

%B'- that o(erseas manufacturin unit has followin facilities+

%"ttach the site master file as "nnex'

3- .otal si8e of the plotG buildin co(ered area is--s9Gfeet

4- >torae facilities for storae of imported stoc$s+ %"ttach list of e9uipment andlicense of facility from the pro(incial health department if any-'

26


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J- .ype or class of finished products bein imported-

a- .ablets-b- apsules-c- Dry >yrup-d- Dry powder-

e- Ni9uid >olution, >yrup, emulsion, suspensions, drin$in ampoules andDrops-

f- ?intment and reams-- >achetGherbal teasGoshanda-h- yeG arG ;asal Drops-i- =uality ontrol Nab %pharmaconosy, chemistry and microbioloy

laboratories'-

- .he o(erseas manufacturer has licensed facility from the !eulatory "uthority ofcountry of oriin- %"ttach the information as "nnexD'-

7- Detail of manufacturin facility and 9ualified technical staffa- =ualified staff name, 9ualification, experience and trainin ->tate

responsibility and attach their Kupporti(e and non technical staff-

L- Nist of imported and mar$eted products and product wise as well as total annualturno(er- %"ttach the information as "nnex'

6- Manufacturin license and Nast inspection report of the o(erseas manufacturer-%"ttach information as "nnex)' -

10- opy of "ency areement between the #rincipal manufacturer and importer-

11- )ee deposit receipt

12- I underta$e and certify that the contents stated abo(e are correct and true to thebest of my $nowlede %please attach underta$in on the notari8ed stamp paper'-

;ame of the owner

>inature


Dated---------------------------------

27


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#RM,/

[(See rule 3(3)]

APP9"CA!"N #R 0N9"S!M0N! # 9CA99= MAN:#AC!:R0D

"ND"G0N:S :NAN" M0D"C"N0> H0R8A9 M0D"C"NA9 PRD:C!S(PH=!M0D"C"N0) HM0PA!H"C> M0D"C"N0 R H0A9!H PRD:C!S #R!RAD"!NA9 :S0 N:!R"!"NA9 R S!R:C!:R0, #:NC!"N C9A"MS

%"ttach readable soft copy with application'

IGFe-- ?wner %s' ofMGshereby apply forenlistment of followin products manufactured by my firmGcompany %has alreadyapplied as manufacturer' located at the premises as under

1- #roduct #rofile

S$No 8rand Name of Product$

Nist ofinredientsFithstrenth

ommon;ame ofinredients

!ecommended use #ac$ si8e Maximum!etail price

2- Master )ormula-

3- Manufacturin process-

3- .estin specifications-4- >helf life and storae-

J- !ecommended onditions for use-

- #ac$ain and labelin-

7- Maximum !etail price-

L- )ee deposit receipt-


;ame of the owner>inature

>eal of the )irmG ompany

Dated---------------------------

28


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#RM,%[(See rule 3(3)]

APP9"CA!"N #R 0N9"S!M0N! # 9CA99= MAN:#AC!:R0D

"ND"G0N:S :NAN"> H0R8A9 M0D"C"NA9 PRD:C!S R PH=!M0D"C"N0HM0PA!H"C> M0D"C"N0 R H0A9!H PRD:C!S #R !H0RAP0:!"C RD"S0AS0 R0D:C!"N C9A"MS


IGFe- ?wner %s' ofMGshereby apply forenlistment of followin products manufactured by my firmGcompany %has alreadyapplied as manufacturer' located at the premises as under

1- #roduct #rofileS$No 8rand Name of Product$

Nist ofinredientswithstrenth

ommon;ame ofinredients

!ecommended use #ac$ si8e Maximum!etail price

2- Master )ormula-

3- Manufacturin process and inprocess controls

3- .estin specifications for raw material and finished products-4- >helf life and storae-%shelf life shall base on stability data'In case data not

a(ailable then letter of commitment for submission of data be submitted-

J- !ecommended onditions for use %e(idence for therapeutic or disease reduction

claims as per standards of e(idence-

- #ac$ain and labelin information-

7- Maximum !etail price-

L- )ee deposit receipt-


;ame of the owner

>inature


Dated-------------------------------------

29


30/32

#RM,1

[(See rule 3(3)]

APP9"CA!"N #R 0N9"S!M0N! # N0? M0D"C"N0 (N0? #RM:9A!"NS)R "MPR!0D PRD:C!S


IGFe-- ?wner %s' ofMGshereby apply forenlistment of followin products manufactured byMGs--- situatedatcity---pro(ince---

-ountry of oriin of principal manufacturer-firmGcompany from %has already applied as importer' located at the premises asabo(e1- #roduct #rofile

>-;? Brand ;ame of #roduct-

ommon;ameinredients

Nist ofinredientswithstrenth

!ecommendedconditions for use

#ac$ si8e Maximum!etail price

2- Batch manufacturin formula or Master )ormulation-

3- Manufacturin process and Inprocess controls-

3- .estin specifications of startin materials and finished products, (alidation data

and certificates of analysis-

4- >helf life and storae- %(idence of lon term and accelerated >tability data'

J- !ecommended conditions for use %with e(idence of 9uality, safety and efficacy

data'-- (idence of clinical safety and efficacy based on #reclinical and clinical studies

alon with data-

7- #ac$ain and labelin %label moc$ up and pac$ae leaflet insert appro(ed in the

country of oriin-

L- Maximum !etail price-

6- Import documents

a- Manufacturin license of the #rincipal Manufacturer in the country oforiin-

30


31/32

b- "ppro(al of product reistration or mar$etin authori8ation in thecountry of oriin-

c- *-M-# ertificate of #rincipal Manufacturer by the local reulatory"uthority-

d- )ree sale certificate in the country of oriin and in other countries bein

mar$eted %certificate of pharmaceutical product %## on F/? )ormat'as replacement for )ree >ale, *M# and !eistration or mar$etin"uthori8ation'

e- ertification with any ?rani8ation or "uthority-f- ertificate of "nalysis of acti(e inredients and finished products from

the %preferably from #ublic >ector Naboratory or Independent"ccredited Nab'-

- Nast three years commercial in(oices-h- Bill of ladin and transport documents-i- .ax or duties payment e(idence-- "reement between the importer and principal manufacturer-

$- Nast inspection report by the local reulatory "uthority-l- >tate countries with e(idence where product is

appro(edGa(ailableGsubmitted for appro(alGreected and appro(edrecommended conditions for use %attach e(idence'-

10- )ee deposit receipt-


;ame of the owner

>inature


Dated----------------------------------------

31


32/32

drug regulatory authority of pakistan

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