Implementation date

In principle, for VRAs, the date of approval by the BASG (“Approval Date”) is adopted as the date of the amendment to the dossier (“Implementation Date”).
However, an extension of the implementation date to 12 months over the course of the QRD adaptation is possible and can be initiated in two ways:

• in the Cover letter or
• in the eAF.

In accordance with the Statement of DG SANTE on Article 152(2) of Regulation 2019/6 on veterinary medicinal products, marketing authorisation holders may place veterinary medicinal products on the market until 29 January 2027 at the latest, provided they comply with the packaging and labelling requirements of Directive 2001/82/EC or Regulation (EC) No 726/2004. Consequently, an extension of the implementation deadline can now only be accepted until 29 January 2027.

Renewal

According to Article 152 Paragraph 1 of Regulation (EU) 2019/6 as amended in conjunction with Section 93 Paragraph 2 of the Veterinary Medicines Act as amended (TAMG), veterinary medicinal specialties that were approved before 28 January, 2022 on the basis of the provisions of the Medicinal Products Act (AMG) are considered to be unlimited authorised.

It is therefore neither necessary to submit an application for a renewal nor to have the marketing authorisation updated.

MAH transfer / Change of Ownership

Please find detailed information at Life-Cycle - BASG.

Withdrawal of the marketing authorisation / registration

A veterinary withdrawal acc. to TAMG §15 is carried out in practice analogously to the human withdrawal acc. to AMG §23. Please find further information Life-Cycle - BASG.