Variations

Variation Application

Following the granting of a marketing authorisation of a veterinary medicine, the Marketing Authorisation Holder (MAH) is obliged to maintain the quality aspects of the product in line with scientific and technical progress and introduce appropriate changes to the underpinning dossier by way of variation.

The Veterinary Medicinal Products Regulation (Regulation (EU) 2019/6) applies from 28 January 2022. Variation notifications, for example the addition of a new manufacturing site or a new indication, are defined in Commission Regulation (EC) 2019/6 as variations not requiring assessment (VNRAs) or variations requiring assessment (VRAs).

Commission Implementing Regulation (EU) 2021/17 of 8 January 2021 establishes a list of VNRAs in accordance with Article 60(1) of the Regulation (EU) 2019/6.  The list of changes to be considered as ‘variations not requiring assessment’ are detailed in this implementing regulation as are, the conditions, documentation requirements and classification codes for those variations. 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.

VRAs according to Article 62 of Regulation (EU) 2019/6 for veterinary medicinal products are detailed in the EMA/CMDv Guidance on the details of the classification of variations requiring assessment. Guidance on the classification of the variation, the documentation requirements and the timeline are set out in this document. VRAs should be submitted to the relevant Competent Authority for review and approval as detailed below.

Variation Process

For a veterinary medicine which was authorised under a national procedure, 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 variations not requiring assessment 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 variations requiring assessment 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 UPD.

Worksharing variations

Worksharing is based on Article 65 of the Regulation (EU) 2019/6 and allows more efficient assessment of a one or more changes to a single or series of Marketing Authorisations (MAs) held by the same Marketing Authorisations Holder (MAH). This may include changes to MAs issued through the centralised, mutual recognition, decentralised or national procedures. Worksharing procedures are handled as variations requiring assessment.

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 required for variations. Please note however, that 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. In addition to the review of the labelling and package leaflet text/mock-ups during regulatory procedures, the HPRA will, as part of their routine sample and analysis programme, undertake compliance checks of product labelling from the market place to ensure compliance with the agreed texts.  

An FAQ document has been prepared to answer questions on how the Veterinary Sciences Department of the HPRA will handle and process the package labelling (immediate and outer) and package leaflet for new MA applications and variation applications to currently authorised MAs.