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Animal Health regulatory news in August 2021

Summer may be nearing its end, but the regulatory news keeps on coming. There is still plenty to read up on, even during the 'quiet' month of August!

EMA/CVMP

Several scientific guidelines have been adopted by the EMA/CVMP since our last news update. These  are updated to be in line with terminology and definitions in the new VMP-Reg, with the scientific content unchanged:

SCIENTIFIC GUIDELINES

ANTIMICROBIALS

CVMP have drawn up a reflection paper on promoting the authorisation of alternatives to antimicrobial veterinary medicinal products in the EU. The paper defines what these alternatives may be, and recommends co-operation within the EU agencies and national authorities to improve support for development of such products. 

MISCELLANEOUS 

  • Issue 6 (July) of the EMA's VMP-Reg Highlights newsletter is available to view and download;
  • The EMA has published pre-authorisation Q&A reference information, in line with the new VMP-Reg. Further information will continue to be published on this page;
  • The EMA's SME Office Newsletter for July has also been published, which contains a round-up of regulatory news of relevance to smaller enterprises;
  • There was a Union Product Database (UPD) release note for July; the present version of the UPD only allows National Competent Authorities (NCAs) to upload data;
  • EMA will host a web seminar to 'walk through' use of the UPD. The free training event will take place on 15th September 2021 (register here by 14th);
  • EMA monthly reports on VMPs for May and June were also published.

 

HMA/CMDv

A handful of key procedural guidance documents were updated and re-issued, and have been published on the HMA website:

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