News
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
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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
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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. ...
EMEA: Finalised Community Herbal Monograph
20.08.2009
Finalised Community Herbal Monograph on Hippocastani semen Aesculus hippocastanum L., semen (horse chestnut seed) ...
EMEA: Guideline on the Conduct of pharmacovigilance for vaccines for pre- and post-exposure prophylaxis against infectious diseases
20.08.2009
This guidance is addressed to Marketing Authorisation Holders and Competent Authorities. It should be read in conjunction with other pharmacovigilance guidance in Volume 9A and is not intended to
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EMEA: Electronic-only submissions
18.08.2009
As of 12 October 2009 (new procedures without pre-submission meeting) and 19 October 2009 (new procedures with Pre-submission meeting), the EMEA will only accept electronic submissions for
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EMEA: eCTD Plasma Master File guidance
18.08.2009
It is the intention that the eCTD format supports all marketing applications sent to EMEA, and related procedures. By analogy this is applicable also to submission of the Plasma Master File,
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