New guidance from EMA on CMC, safety and residues, MUMS, anticoccidials, bioequivalence, varroa destructor, immunologicals, pharmacovigilance and esubmissions

VMPs in the EU for Minor Use and Minor Species
15 January, 2019

The January meeting of the CVMP will take place 22nd – 24th, and will be summarised in the February Cyton news review, but since the December meeting of the CVMP, a number of documents have now been published.

Chemistry, Manufacturing and Controls (CMC): finished dosage form

  • Guideline on Manufacture of the Veterinary Finished Dosage Form (Link).

Safety: mutagenic impurities and data requirements for VMPs for minor use and minor species

  • Draft revised guideline on safety and residue data requirements for pharmaceutical VMPs intended for MUMS (Link).
  • Guideline on assessment and control of DNA reactive (mutagenic) impurities in VMPs (Link).

Efficacy: anticoccidials, bioequivalence and Varroa destructor

  • Demonstration of efficacy for veterinary medicinal products containing anticoccidial substances (Link).
  • Conduct of bioequivalence studies for veterinary medicinal products (Link).
  • Question and answer document on the CVMP guideline on VMPs controlling Varroa destructor parasitosis in bees (Link).

Immunologicals: allergen products and multi-strain dossiers

  • Requirements for the quality (production and control), safety and efficacy of allergen products for use in horses, dogs and cats (Link).
  • Revised guideline (and overview of comments and Q & A) on data requirements for multi-strain dossiers for inactivated vaccines against Avian Influenza, Bluetongue and Foot-and-Mouth disease (Link).

Pharmacovigilance Q & A

  • A new Q & A page is now online, regarding pharmacovigilance inspections (Link).

Other news from the EMA: 2018 highlights, regulatory science, esubmissions and EMA organisation

  • Presentations are now available from “Multi-stakeholder workshop to launch consultation on European Medicines Agency (EMA) veterinary regulatory science to 2025” (Link).
  • The annual review document "Veterinary medicines: highlights of 2018" has been published (Link), summarising the new EU authorisations for veterinary medicines.
  • The organisation chart for the veterinary division at the EMA has been updated (Link).
  • A reminder has been issued that, since 1st January, VNeeS format is mandatory for all submissions through the national procedure (Link).




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