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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, ...

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). ...

FDA: Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the International Conference on Harmonisation Regions. Annex 10: Polyacrylamide Gel Electrophoresis General Chapter

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

Polish Ministry of Health: Regulation project concerning the changes in The Decree of Ministry of Health relating to the payment for Marketing Authorization of the veterinary medicinal products

10.08.2009
The regulation project introduce the updated basic amount (from 1126 PLN to 1276 PLN). The payment for MA of the veterinary medicinal products is established in relation to the basic amount. ...

EMEA: Revised Questions and Answers related to PSURS

10.08.2009
Revised Questions and Answers related to Management and assessment of Periodic Safety Update Reports (PSURS) ...

EMEA: Announcement of European Medicines Agency priorities for adverse drug reaction research

07.08.2009
At its plenary meeting on 19 March 2009, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) adopted its 2010 priorities for drug safety research based on ...