Variation Application
Following the granting of a marketing authorisation of a veterinary medicine, the Marketing Authorisation Holder (MAH) is obliged to keep the regulatory authority up-to-date with changes to their product. They do this by means of submitting an application to vary their marketing authorisation.
In accordance with EU legislation, variation applications are classified either as variations not requiring assessment (VNRAs) or variations requiring assessment (VRAs).
VNRAs are recorded by the MAH within 30 days of implementation in the Union Product Database (UPD). Details of the UPD and recording of these notifications are available on the EMA website.
Guidance on the classification of VRAs is given in the EMA/CMDv Guidance on the details of the classification of variations requiring assessment. The guidance also sets out the documentation requirements and timelines. The VRAs are submitted to the HPRA and other relevant EU national competent authorities (if relevant) for review and approval.
Variation Process
For a veterinary medicine which was authorised under a national procedure in Ireland, all variation applications should be made directly to the HPRA. Where a product has been authorised through the mutual recognition or decentralised procedure, applications must be made simultaneously to the reference member state (RMS) and concerned member states (CMS) involved in the procedure. The RMS is responsible for establishing a timetable for the procedure. For products authorised by the European Commission using the centralised procedure, variation applications must be submitted to the EMA.
Further information on procedures for mutual recognition variations are available in the CMDv Best Practice Guides.
Applications for variations requiring assessment are made using the EU Application form.
Notification of approval/rejection for VNRAs is made by the competent authority by recording the decision in the UPD and providing confirmation to the applicant by email. Notification of approval/rejection for VRAs is by automatic email for all national and mutual recognition /decentralised variations where Ireland is the RMS. For mutual recognition/decentralised variations where Ireland is a CMS, the MAH will receive notification of approval from the RMS. If the variation involves a change to the SPC, an updated SPC will be published on the HPRA website and in the UPD.
Worksharing variations
Worksharing allows the more efficient assessment by European regulatory authorities of one or more changes to a single or series of Marketing Authorisations (MAs) by the same MAH. This may include changes to MAs issued through the centralised, mutual recognition, decentralised or national procedures. Worksharing procedures are handled as VRAs.
Where one of the products included in the worksharing procedure has been authorised through the centralised procedure, the EMA will be the reference authority. In other cases, the MAH can select their chosen reference authority from the member states involved in the procedure. The MAH should discuss the application with the chosen reference authority before submitting a letter of intent to the CMDv secretariat. The applicant should use the template published on the CMDv website. Further details of the procedure are available at the following links:
Worksharing EMA guidance
Worksharing BPG
Labelling requirements for variations for veterinary products
Submission of full colour mock-ups is no longer routinely required for variations. However, the submission of mock-ups may be requested by the HPRA for any variation category on a case-by-case basis. The text versions of the labelling and package leaflet that have been approved by the HPRA during a regulatory procedure are now considered the registered labelling and package leaflet. Under the HPRA’s compliance activities, checks of labelling of products taken from the market place may be made in order to ensure compliance with the SPC and the agreed texts.
An FAQ document provides more information on the HPRA process for reviewing and approving the labelling (immediate and outer) and package leaflet for new MA applications as well as variation applications to currently authorised MAs.