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KNOELL’S ANIMAL HEALTH REGULATORY UPDATE: APRIL 2022

A slower month than March, but the big news for April is that more Delegated and Implementing Regulations (of 2019/6) are now officially available...

EMA/CVMP

PHARMACOVIGILANCE

  • A Veterinary Signal Assessment Report template has been issued by EMA and HMA (Link to Word document)
  • Revision 1 of the Q&A on describing adverse events in the product information has been published.

REFERENCE AND PROCEDURAL

  • EMA’s recommended submission dates for VMPs have been published
  • The Union Product Database (UPD) release notes 1.6.2 are now available
  • Version 3 of the User guidance for creating PDF versions of Product Information for Centrally Authorised Products has been published.

 

HMA/CMDv

  • CMDv has issued a guidance document on changing the Reference Member State (RMS) for VMPs authorised through MRP or DCP
  • There is also updated guidance on Marketing Authorisation transfers, per Member State. 

 

EUROPEAN COMMISSION

DELEGATED AND IMPLEMENTING REGULATIONS

Three Delegated Regulations and one Implementing Regulation, foreseen by Regulation 2019/6 and adopted in 2021, have now been published in all EEA languages:

  • Delegated Regulation 2021/1760 of 26 May 2021 - Establishing the criteria for designation of antimicrobials to be reserved for treatment of certain infections in humans (Art 37 (4))
  • Delegated Regulation 2021/578 of 29 January 2021 - requirements for collection of data on the volume of sales and on the use of antimicrobial VMPs (Art 57 (3))
  • Delegated Regulation 2021/805 of 8 March 2021 - Amending Annex II to Regulation (EU) 2019/6 (Art 146 (2))
  • Implementing Regulation 2021/1248 of 29 July 2021 - Good Distribution Practice for Veterinary Medicinal Products (Art 99 (6))
     

 

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