Variations to marketing authorisations
A variation is a change in the conditions of a marketing authorisation. If you are the marketing authorisation holder for a veterinary medicinal product, it is your responsibility to report any variation in the conditions of your marketing authorisation. This must be done using a change procedure.
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.
Deadlines following variation of a marketing authorisation
The Animals Act (Wet dieren) does not specify a permitted period for supplying a veterinary medicinal product following a change to the product information (SPC, labelling and package leaflet) or the dossier information belonging to the marketing authorisation.
For veterinary medicinal products that have been approved in a national procedure, a decentralised procedure or a mutual recognition procedure, the agreed policy is that, following publication of the decision to change the marketing authorisation in the Veterinary Medicines Information Bank in section ‘Nieuwe of niet meer toegelaten handelsvergunningen in vrij op te geven tijdvak’:
- the manufacturer is no longer permitted to manufacture the veterinary medicinal product with unchanged product or dossier information (labelling and package leaflet), and;
- existing stock with unchanged product or dossier information (labelling and package leaflet) can be delivered to the wholesale and/or retail trade for a maximum period of 6 months.
However, a different approach can be taken if, for example, the variation is the result of:
- a restriction of the efficacy;
- a change in safety;
- a change in the quality of the veterinary medicinal product.
In these cases, the manufacturer could be required to ensure his existing stock complies immediately with the amended 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).
With regard to veterinary medicinal products that have been approved in a centralised procedure, the implementation terms of the EMA (a maximum of 6 months) are applied.