Work-sharing of variations

Article 65 of the Veterinary Medicinal Products Regulation defines work-sharing as follows: The option for a marketing authorisation holder to combine a change or group of changes that are identical for one or more marketing authorisations.

Timetable

The standard timetable for a WS procedure is 60 days. However, a longer timetable is possible if all parties involved agree to extend it. Shorter timetables are only possible if the necessary variations relate to an urgent safety concern.

Definition of marketing authorisation

In the context of the work-sharing approach described above, a marketing authorisation is defined as follows:

All strengths and pharmaceutical forms of a particular product. In the context of MRP/DCP products, this means that all products associated with the same root number (e.g., AT/V/1234/001-n) must be considered as falling under the same marketing authorisation.

The marketing authorisations in question may have been issued in the national procedure, the Mutual Recognition Procedure (MRP) or the Decentralised Procedure (DCP).

Only variations requiring assessment are eligible

A WS procedure will always relate to variations that require assessment (VRA). The WS procedures do not cover variations not requiring assessment (VNRA).

A VRNA is not eligible for inclusion in a WS procedure, even if the variation is related to changes that are being assessed in the WS procedure. In these circumstances, you must submit both types of variations in a way that makes it possible to approve the variations simultaneously.

Harmonised result following approval

Although the marketing authorisations do not all need to be identical at the start of the WS procedure, the change request form should indicate an identical “proposed” state. This is the state that will apply to all the marketing authorisations included in the WS procedure. You cannot apply for a WS procedure if part of the information will only apply to some of the authorisations. In the procedure, approval of the information submitted must always lead to a harmonised result.

Selection of a Reference Authority (RA)

To submit a WS procedure in relation to an MRP or DCP, you must contact the national competent authority (NCA) in your preferred Member State in advance. You must ask whether the authority is prepared to act as the Reference Authority. To do this, use the request template published on the CMDv website (in the annex to the Best Practice Guide for worksharing). The information that is required prior to submission must be submitted to the designated RA no later than two weeks before the CMDv meeting. In this information, you must provide details of the WS procedure and include a request for agreement. The CMDv will ultimately decide which of the competent authorities will assess the application. If a veterinary medicinal product is registered centrally, the EMA will handle the procedure.

Submission of an application

To submit a WS procedure, you must provide all the required information to the Veterinary Medicinal Products Unit. You can read how to do this under Submission of a dossier. Please include the documents listed below.

Required documents

If you would like to submit a WS procedure, the standard rules for variations requiring assessment apply. Please see the Best Practice Guide for variations requiring assessment.

You must provide a single submission pack that contains all variations for all of the veterinary medicinal products, including:

• The accepted work-sharing request;
• A copy of the confirmation email sent by the RA;
• A digital application for each relevant marketing authorisation, together with:
  - supporting documents for each authorisation;
  - revised product information (if applicable).

You must send the submission pack to all Member States where the associated marketing authorisations are valid. The documentation for the WS procedure is identical for all relevant Member States.

More information

This and other information on work-sharing can be found in the CMDv Best Practice Guide for worksharing. If you have any further questions about the WS procedure or if you would like the Veterinary Medicinal Products Unit to act as the RA, please contact the Veterinary Medicinal Products Unit.