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

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

EMEA: Updated EMEA Pre-Submission Procedural Advice

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

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

EMEA: Finalised Community Herbal Monograph

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

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 ...

EMEA: Electronic-only submissions

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 ...

EMEA: eCTD Plasma Master File guidance

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, ...

MHRA: MHRA excercise to update product information following European paediatric work-sharing procedures

Following our announcement on 18 November 2008, requests have now been sent to marketing authorisation (MA) holders for products containing salmon calcitonin and ranitidine where product ...

MHRA: Progress review: MHRA best practice guidance for processing national marketing authorisation applications - pilot phase

Following on from the best practice guidance for national marketing authorisations (MA) pilot initiative announced in June 2007 we have reviewed the current progress and concluded that this fixed ...

EMEA: Community herbal monograph on Echinaceae pallidae radix

Finalised Community herbal monograph on Echinaceae pallidae radix Echinacea pallida Nutt., radix (pale coneflower root): HMPC opinion, herbal monograph, assessment report, list of references ...

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