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Page 1: €¦ · The authorisation holder must provide and maintain such personnel, ... This authorisation permits the authorisation holder to distribute by way of wholesale dealing within
Page 2: €¦ · The authorisation holder must provide and maintain such personnel, ... This authorisation permits the authorisation holder to distribute by way of wholesale dealing within
Page 3: €¦ · The authorisation holder must provide and maintain such personnel, ... This authorisation permits the authorisation holder to distribute by way of wholesale dealing within
Page 4: €¦ · The authorisation holder must provide and maintain such personnel, ... This authorisation permits the authorisation holder to distribute by way of wholesale dealing within
Page 5: €¦ · The authorisation holder must provide and maintain such personnel, ... This authorisation permits the authorisation holder to distribute by way of wholesale dealing within
Page 6: €¦ · The authorisation holder must provide and maintain such personnel, ... This authorisation permits the authorisation holder to distribute by way of wholesale dealing within
Page 7: €¦ · The authorisation holder must provide and maintain such personnel, ... This authorisation permits the authorisation holder to distribute by way of wholesale dealing within
Page 8: €¦ · The authorisation holder must provide and maintain such personnel, ... This authorisation permits the authorisation holder to distribute by way of wholesale dealing within

Public Version Application for Authorisation · The NPSA is a peak industry body representing pharmaceutical wholesalers in Australia. NPSA Members distribute to all pharmacies and

CHAPTER 1 MARKETING AUTHORISATION · DATA EXCLUSIVITY AND MARKET PROTECTION ... the applicant/marketing authorisation holder must submit an application in the Member States concerned

Between - NMVO€¦ · Marketing Authorisation Holder: for the purpose of this paper this term relates to the entities that hold a marketing authorisation. Master Data - data related

CHMP extension of indication variation assessment report · Marketing authorisation holder (MAH): ... Alexion Europ e SAS submitted to the European Medicines Agency on 5 December

Procedure under Article 5(3) of Regulation EC (No) 726 ... - …€¦ · MA Marketing Authorisation . MAH Marketing Authorisation holder . Methyl-CCNU 1-(2-Chloroethyl)-3-(4-methylcyclohexyl)-1-nitrosourea

Undertaking to the Secretary of the Department of …...Mining Act. KEPCO Bylong Australia Pty Limited (ACN 075 361 769) (KEPCO) is the holder of Authorisation 342 (A342) and Authorisation

AC-PHTOCOPIER2-20180808172902€¦ · The authorisation holder must provide and maintain such personnel, ... This authorisation permits the authorisation holder to distribute by way

Bexsero, common name - meningococcal group B Vaccine (rDNA, … · accordingly. In addition, the Marketing authorisation holder (MAH) took the opportunity to make some 26/03/2020

GMP inspection system in the EEA - ema.europa.eu · Directives lay down three types of licence – Marketing authorisation • Holder must be established in EU/EEA • Authorisations

Semglee, insulin glargine - ema.europa.eu · Marketing authorisation holder: Sanofi-Aventis Deutschland GmbH ... Problem statement The prevalence of diabetes across adults from 20

Cinacalcet Accordpharma, INN-cinacalcet...• Product name, strength, pharmaceutical form: Mimpara 30 mg, 60 mg and 90 mg film coated tablets • Marketing authorisation holder: Amgen

… · The authorisation holder must not sell or supply a medicinal product, or offer it for sale or supply, unless: there is a marketing authorisation, Article 126a authorisation,

BENGALLA MINE MINING OPERATIONS PLAN 2017-2021 · Department means the NSW Department of Planning and Environment. Authorisation Holder means the holder of the relevant authorisation(s)

ANNEX I LIST OF THE NAMES, PHARMACEUTICAL FORMS, … · 2 Member State Marketing Authorisation Holder Invented name Strength Pharmaceutical Form Route of administration Content (concentration)

Annex I List of the names, pharmaceutical forms, strengths ...ec.europa.eu/health/documents/community-register/2014/20140901… · Applicant/Marketing Authorisation Holder ; Product

Falsified Medicines Directive - delegate.com · Manufacturers to inform the Competent Authority and marketing authorisation holder should they get information that products may be

ANNEX II THE MANUFACTURING AUTHORISATION HOLDER ...ec.europa.eu/health/documents/community-register/1998/199807243143/anx_3143_en.pdfTHE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE

Oilatum Cream Oilatum Cream Marketing Authorisation Holder ... · Marketing Authorisation Holder and Manufacturer: Thornton & Ross Ltd., Huddersfield, HD75QH,UK. PL 00240/0466 Date

SCIENTIFIC DISCUSSION - European Medicines Agency€¦ · Advocate Marketing Authorisation Holder: Bayer HealthCare AG 51368 Leverkusen Germany Active substances: Imidacloprid & moxidectin

OMEPRAZOLE 20MG CAPSULES PL 25099/0017 … · The marketing authorisation holder has provided adequate justification for not submitting an Environment Risk Assessment (ERA). ... submitting

Javlor, INN - vinflunine ditartrate · Invented name Javlor . Procedure No. EMEA/H/C/000983/II/0011 Marketing authorisation holder (MAH): Pierre Fabre Médicament Note Variation assessment

Guidance document concerning the parallel trade …...certificate is the authorisation holder rather than the manufacturing company that is simply following the instructions supplied

The biosimilar medicines decalogue · countries of the European Economic Area (EEA), paved the way in creating ... the marketing authorisation holder (MAH) must incorporate an explicit

List of medicinal products under additional monitoring Authorisation Holder (s) Link to Product Information Date of Inclusion Abasaglar (previously Abasria) Insulin glargine New biological

Care and Maintenance Mining Operations Plan€¦ · Name of Authorisation/Authorisation Holder(s): Shoalhaven Coal Pty Ltd Name of Mine Operator: Sedgman Limited Name and Contact

Assessment report - European Medicines Agency...In January 2019, the marketing authorisation holder communicated to the European Medicines Agency high level preliminary results of

The Journal of the Irish Practice Nurses Associationgreencrosspublishing.ie/attachments/NURSING_IN_GENERAL...Marketing authorisation holder: Sanofi Pasteur MSD SNC, 8 rue Jonas Salk,

ANNEX I LIST OF THE NAMES, PHARMACEUTICAL FORM(S), … · MARKETING AUTHORISATION HOLDER(S) IN THE MEMBER STATES . 1 . Marketing Authorisation . Holder ... 13, rue Jean Jaurès 92807

€¦ · The authorisation holder must not sell or supply a medicinal product, or offer it for sale or supply, unless: there is a marketing authorisation, Article 126a authorisation,

ANNEX I LIST OF THE NAMES, PHARMACEUTICAL FORM, … · 5 Member State Marketing Authorisation Holder Invented name Strength Pharmaceutical Form Route of administration Finland Merck

Study Protocol - University of Birmingham · 02_V4_8th March 2016 Non-substantial Correction of typo on page 19, Japanese ... 6.1.3 Marketing Authorisation Holder ..... 26 . GEM3

 · Web viewThe holder of a type-certificate, restricted type-certificate, supplemental type-certificate, European Technical Standard Order (ETSO) authorisation, major repair design

EudraVigilance and Risk Management · FUM Follow-up measure. MAH Marketing Authorisation Holder. Dr. Thomas Goedecke

Mount Owen Complex of Mine Mount Owen Complex MOP Commencement Date 01/1/2017 MOP Completion Date 31/12/2021 Name of Authorisation / Authorisation holder(s) Mt Owen Pty Limited Mining

Annex I List of nationally authorised medicinal …...A. List of nationally authorised medicinal products recommended for suspension Member State in EEA Marketing authorisation holder