Regulatory updates from the CMDv relating to veterinary medicines

Zinc oxide pigs CMDv regulation veterinary medicines
16 May, 2018

The Co-ordination Group for Mutual Recognition and Decentralised Procedures - Veterinary (CMDv) has provided the following updates concerning regulatory affairs for veterinary medicines

Type II variations

Updated best practice guide for Type II variations (Link), with a track changes version (Link). There is only one minor change to this document, concerning supporting documentation for minor use / minor species (MUMS) products (section 5.2).

Zinc oxide marketing authorisation withdrawal

CMDv has issued information from EU member states regarding the timeline for withdrawal of marketing authorisations for VMPs containing zinc oxide for use in pigs (Link).

Adminstrative burden for the animal health industry

Information Release - Rev.4 19.04.18 has been issued regarding "Reduction in Administrative Burdens Relating to Variations" (Link). Specifically discussed in this document are the following topics:

  • Change in the Name and / or Address of the Marketing Authorisation Holder
  • Change in the Product Name of a Veterinary Medicinal Product
  • Supergrouping
Business Units: 

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