€¦ · The authorisation holder must provide and maintain such personnel, ... This authorisation...

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Transcript of €¦ · The authorisation holder must provide and maintain such personnel, ... This authorisation...

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
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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

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

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

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

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

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

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

SCIENTIFIC DISCUSSION Marketing Authorisation Holder · It is presented as a canary yellow homogeneous clear solution, miscible with water. ... The bottle is closed with a polypropylene

SCIENTIFIC DISCUSSION Marketing Authorisation Holder · It is presented as a canary yellow homogeneous clear solution, miscible with water. ... The bottle is closed with a polypropylene

… · 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,

… · 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,

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

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

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

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

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

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

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

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

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

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

Guidance on applications according to Article 13 TPA for ...€¦ · 1.2.2.13 Form Change of Marketing Authorisation Holder Not applicable for Article 13 TPA procedure. 1.2.2.14++

Guidance on applications according to Article 13 TPA for ...€¦ · 1.2.2.13 Form Change of Marketing Authorisation Holder Not applicable for Article 13 TPA procedure. 1.2.2.14++

€¦ · The authorisation is not transferable to another legal entity. The authorisation holder must not sell or supply a medicinal product, or offer it for sale or supply, unless:

€¦ · The authorisation is not transferable to another legal entity. The authorisation holder must not sell or supply a medicinal product, or offer it for sale or supply, unless:

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

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

ANNEX I LIST OF THE NAMES, PHARMACEUTICAL FORMS, … · Marketing Authorisation Holder Invented name Strength Pharmaceutical form Route of administration Greece VIANEX S.A. Tatoiou

ANNEX I LIST OF THE NAMES, PHARMACEUTICAL FORMS, … · Marketing Authorisation Holder Invented name Strength Pharmaceutical form Route of administration Greece VIANEX S.A. Tatoiou

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

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

Marketing Authorisation Holder and ManufacturerGeneral dose: Levetiracetam is taken twice daily, in two equally divided doses, each individual dose being measured between 0.07ml (7mg)

Marketing Authorisation Holder and ManufacturerGeneral dose: Levetiracetam is taken twice daily, in two equally divided doses, each individual dose being measured between 0.07ml (7mg)

CHMP extension of indication variation assessment report€¦ · MAH Marketing authorisation holder MRI magnetic resonance imaging ... Biogen Idec Ltd submitted to the ... P/0252/2012

CHMP extension of indication variation assessment report€¦ · MAH Marketing authorisation holder MRI magnetic resonance imaging ... Biogen Idec Ltd submitted to the ... P/0252/2012

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).

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).

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

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