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Aktualności

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 ...

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 ...

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, ...

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

18.08.2009
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

18.08.2009
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

14.08.2009
Finalised Community herbal monograph on Echinaceae pallidae radix Echinacea pallida Nutt., radix (pale coneflower root): HMPC opinion, herbal monograph, assessment report, list of references ...

EMEA: Community herbal monograph on Ribis nigri folium

14.08.2009
Community herbal monograph on Ribis nigri folium Ribes nigrum L., folium (blackcurrant leaf): draft herbal monograph, draft list of references ...

FDA: Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the International Conference on Harmonisation Regions. Annex 9: Tablet Friability General Chapter

14.08.2009
This annex is the result of the Q4B process for the Tablet Friability General Chapter. The proposed texts were submitted by the Pharmacopoeial Discussion Group (PDG). ...

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