Variations to marketing authorisations

The procedure for changes to a marketing authorisation is outlined in Chapter III of the Veterinary Medicinal Products Regulation. 

The Veterinary Medicinal Products Regulation describes the following types of variations:

• A Variation Not Requiring Assessment (Article 61) is a minor variation and is also known as a VNRA. Implementing Regulation (EU) 2021/17 contains a list of variations that do not require assessment.
• A Variation Requiring Assessment (Article 62), also known as a VRA, is a more substantial change. Implementing Regulation (EU) 2021/17 establishes a list of variations that do not require assessment. Any variations that are not included on this list will require an assessment. 
• Groups of variations (Article 64). Variations can be grouped together in a number of instances. These are then referred to as grouped variations (GV).
• Work-sharing (Article 65). Variations can be grouped by means of the work-sharing procedure for variations. This is usually referred to as work-sharing (WS). This is a work-sharing arrangement between the evaluating authorities, whereby only one of these authorities completes the main assessment.

The Veterinary Medicinal Products Regulation outlines the general categories of variations. In addition, the CMDv has drawn up Best Practice Guides for the various types of changes.

The Veterinary Medicinal Products Regulation does not describe all variations. Some variations are processed at national level.

If you would like to apply for a transfer of a marketing authorisation to a different marketing authorisation holder (MAH), please see the Transfer of marketing authorisation page for more information.

If you would you like to withdraw your marketing authorisation, more information is available on the Withdrawal of marketing authorisation page.

National agreement on implementation period following amendment of marketing authorisation for a veterinary medicine

Neither Regulation 2019/6 nor the national legislations state how long a veterinary medicine can continue to be produced and supplied following approval of an amendment to the product information  (SPC, labelling and package leaflet) or dossier information relating to the marketing

The following national policy agreement applies to veterinary medicines authorised via the national, decentralised or mutual recognition procedure:

Following publication of the decision in the Veterinary Medicines Information Database to amend the marketing authorisation:

• the marketing authorization holder of the veterinary medicinal product has to implement the change(s) to product or dossier information within:
  • 6 months;
  • 12 months after only a single G.I.18 update of the product information;
• the manufacturer may continue to release batches of the veterinary medicine featuring unchanged product or dossier information (labelling and package leaflet) for a maximum of:
  • 6 months;    
  • or 12 months after a single G.I.18 update to the product information;
• wholesale suppliers may continue to supply existing stock of previously released batches featuring unchanged product or dossier information to retailers until(shortly before) the end of the shelf life.
• Other suppliers such as a veterinarian and/or retailer trader are prohibited from delivering veterinary medicinal products for which the shelf life has expired, to animal keepers, with reference to art. 3.2, paragraph 1 under b. of the Veterinary Medicines Regulations 2022. By extension, this also applies to an animal keeper when using the veterinary medicinal product.

The above periods may be reduced if the amendment is made for reasons such as:

• Reduced efficacy;
• Changes to safety;
• Changes in the quality of the veterinary medicine