As you may be aware, in January 2019, the European Union (EU) published Regulation (EU) 2019/6 on veterinary medicinal products (VMP) concerning approvals of veterinary medicines for use in the whole of the EU. The regulation enters into force in 2022. The regulation is significant as it prohibits Third Country operators from using antimicrobials reserved for human use and those with growth promotion claims in live animal and animal products exported to the EU. Canada is concerned regarding the potential negative trade implications that this regulation could pose for Canadian exports of live animals and animal products to the EU, and continues to express this concern to the European Commission at every appropriate opportunity. Canada also reminds the European Commission to provide sufficient and reasonable time for Canada to make comments on the draft implementing regulations when they are notified to the World Trade Organization. Meanwhile, Canada would also like to take every opportunity to influence the development of the implementing and delegating legislation.
Following previous correspondence to industry on this issue, this is to inform you that, today, the European Commission has released the European Medicines Association (EMA) Scientific Advice on implementing measures under Article 37(4) of Regulation (EU) 2019/6 on veterinary medicinal products – Criteria for the designation of antimicrobials to be reserved for treatment of certain infections in humans (EMA/CVMP/158366/2019).
The European Commission is inviting comments from stakeholders, and the Government of Canada invites Canadian industry and provincial stakeholders to submit comments directly to the Commission. Please note, comments are not intended to be applied as revisions to the EMA advice document, but for the Commission to take into consideration when drafting the Delegated Act listing the criteria.
The deadline for written comments to be submitted to the European Commission is December 31, 2019.
If you choose to submit comments, we would ask that you consider sending us, at the Market Access Secretariat (MAS /SAM email address) a copy of your comments, for our information.