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.

Variation notifications, for example the addition of a new manufacturing site or a new indication, are defined in Commission Regulation (EC) 1234/2008 as minor Type IA variations, minor Type IB variations or major Type II variations.  

The 'Variations Regulation' (Commission Regulation (EC) 1234/2008) came into force on 1st January 2010 for medicines authorised through the centralised and mutual-recognition or decentralised procedures and on 4th August 2013 for medicines authorised through the national procedure.

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 in consultation with the MAH. For products authorised by the European Commission using the centralised procedure, variation applications must be submitted to the European Medicines Agency (EMA).  For more information, please consult the EMA website

Further information on variations is available at the following links:  

 

Variation applications are made using the EU Application for Variation to a marketing authorisation

Notification of approval is by automatic email of 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 within 14 days.

Worksharing variations

Worksharing allows more efficient assessment of a single change (type IB or Type II) or multiple changes (type IB, type II or grouped variations) 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.

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.  Further details of the procedure are available at the following links:

 

Worksharing procedural update Nov 2013
Worksharing BPG updated Nov 2013
Worksharing - applicants letter of intent

All of the above documents are also available on HMA website

A guide to Submission of Mock-Ups for Variations to veterinary products

Submission of full colour mock-ups is no longer routinely required for all variations which result in changes to the product labelling. 
The purpose of this document is to provide guidance on the routine requirements for mock-up submission for individual variation categories. 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 requirements for the different types and categories of variations are listed below. While most variation categories that potentially result in changes to the mock-ups are listed, it is not an exhaustive list and should changes to mock-ups occur in a variation category not listed in this guide, the applicant should seek clarification from the HPRA regarding the requirements for mock-up submission. 

For variations classified as ‘z’ variations, because of the variety of possible scenarios, it is not possible to state definitively if mock-ups will be required. The requirements for other foreseen variations in the same category will provide an indication as to whether or not mock-ups may be required. Where mock-ups are required for ‘z’ variations, they will be requested by the HPRA.  

 
Guide to submission of mock-ups for variation to veterinary products