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EMEA: Guideline on Dossier Structure and Content for Pandemic Influenza Marketing Authorisation Application

28.02.2009
EMEA:
Guideline on Dossier Structure and Content for Pandemic Influenza Marketing Authorisation Application. This guideline provides the basis for a fast track authorisation procedure for ...

The Polish Office for Registration: The statement of the President of the Office for Registration relating to the notification of withdrawals of the medicinal products

28.02.2009
The Polish Office for Registration:
The statement of the President of the Office for Registration relating to the notification of withdrawals of the medicinal products to the President of ...

Ministry of Health: The project of Act of the medical devices

28.02.2009
Ministry of Health:
The project of Act of the medical devices ...

Ministry of Health: Minister of Health Regulation of the readability of the labelling and package leaflet of medicinal product for human use

28.02.2009
Ministry of Health:
Minister of Health Regulation of the readability of the labelling and package leaflet of medicinal product for human use (20 February 2009). ...

European Commision: Draft revision of

28.02.2009
European Commision:
Draft revision of \"Note for Guidance on Minimising the Risk of Transmitting Animal Spongiform Encephalopathy Agents via Human and Veterinary Medicinal Products\" for ...

FDA: Office of Nonprescription Products

28.02.2009
FDA:
Office of Nonprescription Products, Over-the-Counter (OTC) Related Federal Register Notices, Ingredient References and other Regulatory Information. ...

European Commission: Ethical considerations for clinical trials on medicinal products conducted with the paediatric population

16.02.2009
European Commission:
Ethical considerations for clinical trials on medicinal products conducted with the paediatric population. This document is intended to provide recommendations on ...

HMA: Cover letter for Variation Applications in the Mutual Recognition Procedure January 2009

16.02.2009
HMA:
Cover letter for Variation Applications Dossier for Type IA/Type IB/Type II in the Mutual Recognition Procedure January 2009 ...

HMA: Procedural Advice on Repeat Use (MRP/DCP)

16.02.2009
HMA:
Procedural Advice on Repeat Use (MRP/DCP). This procedure can be used in the following situations: either by application to new Concerned Member States (CMS) not involved in the first ...

HMA: Request for Marketing Authorisation Holders for medicinal products presented as pressurised metered dose inhalers

16.02.2009
HMA:
Request for Marketing Authorisation Holders for medicinal products presented as pressurised metered dose inhalers. The aim of that document is to ensure that studies have been ...

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