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European News Updates

EU flagThese European updates are some of the recent key regulatory news items we have noted, including those from the regulatory agencies and authorities in Europe. A two-letter code is used at the beginning of each item to indicate the country or region, according to the ISO list.

[EU] EDQM: Blood Transfusion Guide

Blood Transfusion Guide Guide to the preparation, use and quality assurance of blood components - 15th Edition (2009). More information...

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[DK] Danish Medicines Agency: Minutes of Reimbursement Committee meeting no. 335

The meeting was held on Tuesday 20 April 2010 at the Danish Medicines Agency.

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[DK] Danish Medicines Agency: Minutes of meeting no. 27 of the Council for Adverse Drug Reactions

The meeting was held on Tuesday 25 May 2010 from 13:00-15:30 at the Danish Medicines Agency.

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[DE] BfArM: Update of eValidator (Software for technical validation of e-submissions)

BfArM have updated their eValidator (Software for technical validation of e-submissions)

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[EU] EMA: Regulatory and procedural guideline: Guideline for the specifications of e-submissions of parallel distribution notification documents

The European Medicines Agency have published: Regulatory and procedural guideline: Guideline for the specifications of e-submissions of parallel distribution notification documents

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[EU] EMA: Regulatory and procedural guideline: Guidance on centrally authorised products requiring a notification of a change for update of annexes

The European Medicines Agency have published: Regulatory and procedural guideline: Guidance on centrally authorised products requiring a notification of a change for update of annexes

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[IE] IMB: Drug Safety Newsletter 38th Edition

Topics covered in this edition of the newsletter include: Rosiglitazone (Avandia/Avandamet) Isotretinoin (Roccutane) Warfarin Carbapenems BCG Vaccine Bevacizumab (Avastin) Panitumumab (Vectibix) Drug Safety Newsletter - 38th edition

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The European Medicines Agency on Twitter

The European Medicines Agency have created a news feed on Twitter (https://twitter.com/EMA_News). However, some companies have chosen to block access to Twitter for employees. To help regulatory professionals in those companies, we render recent items from their news feed on our site, for accessibility.

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