Activity in July & August at the EMA

26 August, 2016

21 July
The Veterinary Medicines Division of the EMA has issued the monthly report for June 2016, publishing statistics on all types of veterinary regulatory activities: MAAs, post-marketing, Scientific Advice, etc., and the publishing of guidance documents.  The report can be viewed and downloaded as a PDF (Link).

29 July
Annual report of the Pharmacovigilance Inspectors Working Group for 2015 (Link)
Draft review and update of EMA guidelines to implement best practice with regard to 3Rs (replacement, reduction and refinement) in regulatory testing of medicinal products (Link) and Draft guidance for individual laboratories for transfer of quality control methods validated in collaborative trials with a view to implementing 3Rs (Link)

2 August
Recommendations on minor-use-minor-species and limited-market classifications (Link)

4 August
EMA-HMA action plan for increasing the availability of vaccines published along with new webpage (Link)

5 August
Following the decision to recommend withdrawal of orally administered colistin combination products (Link), a Q & A document has been adopted (Link)

10 August
Publication of “Principles for ensuring the confidentiality of data supplied to the European Surveillance of Veterinary Antimicrobial Agent Consumption (ESVAC) project” (Link)

17 August
July monthly report on application procedures, guidelines and related documents for veterinary medicines (Link)

19 August
Updated versions of 4 electronic Application Forms (eAF v. have been published following reported issues. Use of the version 01.20 will become mandatory after an extended transitional period on19 September 2016 (Link).

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