European Commission consultation – Draft Implementing Acts on manufacturing of veterinary medicinal products

The European Commission is seeking feedback from stakeholders on two draft Implementing Acts in accordance with Regulation 2019/6 on veterinary medicinal products. The Acts aim to ensure that good manufacturing practice for active substances and veterinary medicinal products are applied in a harmonised way throughout the EU.

In accordance with Regulation (2019/6), formal legal adoption of GMP requirements is needed for veterinary medicinal products (VMPs) and their active substances. These requirements will be specified in Implementing Regulations and will replace the existing GMP Guidelines in EudraLex Volume 4 when they come into force. 

Stakeholders can provide feedback via the Commission's website. The closing date for is 19 February 2025. The draft text of the Implementing Acts is also available to view on the Commission’s site:

• Rules on good manufacturing practice for veterinary medicinal products
• Rules on good manufacturing practice for active substances used as starting materials in veterinary medicinal products

If in addition, you wish to inform the HPRA of the feedback you have provided to the Commission you can email us at compliance@hpra.ie with the subject line: Comments on Draft Implementing Regulations on GMP for VMPs and APIs used in VMPs