Variation of a marketing authorisation veterinary medicinal product
A variation is a change in the dossier of an authorised veterinary medicinal product.
The Variations Regulation 1234/2008 describes 4 different types of changes:
- A type IA variation is a change which only has a minimal impact or indeed no impact on the quality, safety or efficacy of the veterinary medicinal product concerned.
- A type IB variation is a change which is neither a minor variation of type IA nor a major variation of type II nor an extension.
- A type II variation is a change which is not an extension and which may have a significant impact on the quality, safety or efficacy of the veterinary medicinal product concerned.
- A line extension is an application for a marketing authorisation in the name of the same marketing authorisation holder, whereby the marketing authorisation holder already has, or has applied for, a marketing authorisation, and a change takes place as described in Annex I of the Variations Regulation 1234/2008. A line extension does not always result in a new marketing authorisation with a separate REG NL number. It is also possible for an application for a line extension to result in a change to an existing marketing authorisation (change in the REG NL number).
The Variations Regulation:
- Establishes provisions relating to the investigation of changes in the conditions of all authorisations for the marketing of medicinal products for veterinary use. The Variations Regulation has been implemented in national legislation. These national provisions can be found in paragraph 6 of the Veterinary Medicinal Products Regulations.
- The Variations Regulation describes the main elements of the classification of type IA variations, type IB variations, type II variations and line extensions.
Further detailing of the Variations Regulation:
- The detailed description can be found in the Guidelines on the details of the various categories of variations. These European Commission Guidelines were published in chapter 5 of Volume 6 of the Notice to Applicants. These Guidelines state the conditions which variations have to fulfil and which documentation has to be submitted.
- In addition the CMDv has drawn up Best Practice Guides for the various types of changes.
Some changes are not included in the Variations Regulation 1234/2008 and 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), you can find more information on the page entitled Transfer of marketing authorisation.
If you would you like to withdraw your marketing authorisation, you can find more information on the page entitled Withdrawal of marketing authorisation.
Periods following variation of a marketing authorisation
The Animals Act [Wet dieren] does not stipulate how long a veterinary medicinal product may still be delivered after a change to product information (SPC, labelling and package leaflet) or dossier information belonging to the marketing authorisation.
For veterinary medicinal products that have been approved in a national procedure, a decentral procedure or a mutual recognition procedure, following the publication of the decision to change the marketing authorisation in the Government Gazette:
- the manufacturer is no longer allowed to manufacture the veterinary medicinal product with unchanged product or dossier information (labelling and package leaflet) and;
- the existing stock with unchanged product or dossier information (labelling and package leaflet) can be delivered to the wholesale and/or retail trade within 6 months.
However, exemption is possible if the change is the consequence of, for example, a restriction of the efficacy, a change in safety or quality of the veterinary medicinal product. In that case an indication can be given that the existing stock at the manufacturer must immediately comply with the changed product information (SPC, labelling and package leaflet) as determined by the Veterinary Medicinal Products Unit on behalf of the Minister of Agriculture, Nature and Food Quality (LNV).
Veterinary medicinal products that have been approved in a Central procedure follow the implementation terms of the EMA (a maximum of 6 months).