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European Commission: Implementation of the Advanced Therapies Regulation

09.09.2009
Commission Regulation (EC) No 668/2009 of 24 July 2009 implementing Regulation (EC) No 1394/2007 of the European Parliament and of the Council with regard to the evaluation and certification of ...

Polish Office for Registration: The statement of the President of the Office for Registration relating to Braille

07.09.2009
The statement of the President refers to documents required to put the Braille on the packaging of the medicinal products. ...

EMEA: Mandate, objectives and rules of procedure of the Scientific Advice Working Party (SAWP)

07.09.2009
As a main objective, the Scientific Advice Working Party shall provide scientific advice for medicinal products for human use and protocol assistance for orphan medicinal products to facilitate ...

MHRA: Direct Healthcare Professional Communications: New guidance on letter drafting for market authorisation holders

07.09.2009
New guidance on letter drafting for market authorisation holders has been added to the Safety warnings section. ...

European Commission: Implementation of the Advanced Therapies Regulation

02.09.2009
Commission Regulation (EC) No 668/2009 of 24 July 2009 implementing Regulation (EC) No 1394/2007 of the European Parliament and of the Council with regard to the evaluation and certification of ...

FDA: Labeling of Nonprescription Human Drug Products Marketed Without an Approved Application as Required by the Dietary Supplement and Nonprescription Drug Consumer Protection Act: Questions and Answers

01.09.2009
This document is intended to assist industry in complying with the labeling requirements of the Dietary Supplement and Nonprescription Drug Consumer Protection Act. These requirements apply to ...

EMEA: Community herbal monograph

31.08.2009
Community herbal monograph on Urticae radix Urtica dioica L,; Urtica urens L., radix (nettle root) ...

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

25.08.2009
Polish Ministry of Health: The project of Act of the medical devices. ...

EMEA: Updated EMEA Pre-Submission Procedural Advice

25.08.2009
Updated EMEA Pre-Submission Procedural Advice -Q53 - What do I have to consider regarding the MA of my centrally authorised medicinal product in Norway, Iceland and Liechtenstein? ...

MHRA: Complaints about advertising of medicines

25.08.2009
MHRA has published the outcomes of the investigations into six complaints about the advertising of medicines. ...