Updated 17 September 2025:
All questions and answers.
This worksharing guidance applies only for Variations requiring assessment (veterinary medicines).
Marketing authorisation holders (MAH) should use the eSubmission Gateway / Web Client for all variations requiring assessment (VRA) submitted to the Agency. For more information, including links to guidance on registration with the system see the Veterinary eSubmission website.
In order to avoid duplication of evaluation, according to Article 65 of the Regulation (EU) 2019/6 the MAH has to submit in a single application one or more identical variations requiring assessment (VRA) affecting more than one marketing authorisation, which may be nationally or centrally authorised, from the same marketing authorisation holder1. In this ‘worksharing procedure’, one authority (the ‘reference authority’), chosen amongst the competent authorities of the Member States and the Agency, will examine the variation on behalf of the other concerned authorities.
Where at least one of the concerned marketing authorisations has been authorised via the centralised procedure, the Agency will act as the ‘reference authority’. In all other cases, a national competent authority chosen by the Coordination Group for Mutual Recognition and Decentralised Procedures – veterinary (CMDv), taking into account the recommendation of the MAH, will act as the ‘reference authority’. The MAH will be informed of the decision.
Purely national marketing authorisations can be included in worksharing procedures.
Based on Articles 64 and 65 of the Regulation (EU) 2019/6, respectively, grouping or worksharing of variations is possible only for variations that do not appear in the list of variations not requiring assessment (VNRA) established in accordance with Article 60(1). However, when applying for a single change which consists of both VRA(s) and VNRA(s) and where the VNRA(s) is/are necessary and is/are a direct consequence of the “lead” VRA the MAH has the option to include these changes within the VRA submission as consequential changes, and therefore it would not be necessary to record them as separate VNRA in the UPD. For more details, please see Q&A no. 6 "My VRA has a number of consequential immediate changes that are classified as VNRA. Can the VNRA be included with the VRA application?".
1 Marketing authorisation holders belonging to the same mother company or group of companies and marketing authorisation holders having concluded agreements or exercising concerted practices concerning the placing on the market of the veterinary medicinal products concerned, have to be taken as the same marketing authorisation holder.
In order to be eligible for the worksharing procedure, identical change(s) should apply to the different veterinary medicinal products concerned, with either no or very limited need for assessment of a potential product-specific impact.
Therefore, where the ‘same’ change(s) to different marketing authorisations require the submission of individual supportive data sets for each veterinary medicinal product concerned which each require a separate product-specific assessment, such changes will not be able to benefit from the worksharing procedure.
At the start of a worksharing procedure the ‘present’ situation does not have to be identical for all MAs included in the WS application, as long as the variation application form reflects the same ‘proposed’ situation for all MAs involved.
Grouped VRA can be subject to a worksharing procedure, provided that the same group of variations requiring assessment applies to all veterinary medicinal products concerned by the worksharing procedure and the changes must be identical for all products. Please refer to Q&A on VRA for more information on groupings.
Examples of changes which would be considered suitable for evaluation under worksharing:
Clinical / pharmacovigilance
Quality
References
In order to facilitate the planning of a worksharing procedure, MAHs are advised to inform the Agency in advance of the intended submission of a variation or group of variations1 to be subject to a worksharing procedure:
MAHs are advised to send a notification of intent, including details of the change via Service Now by selecting Veterinary Regulatory > Post-Authorisation-Vets. The notification may be submitted in a free-text form and should include the following information:
When products authorised by the mutual recognition procedure, decentralised procedure, or national procedure are included in a worksharing, it is highly recommended to submit a signed ‘letter of intent’.
A template is available:
If the proposed worksharing procedure includes the aforementioned products, the Agency will share the letter of intent with the CMDv.
Upon receipt of the relevant information, the Agency will reach out to the Rapporteur (and Co-rapporteur, when applicable)to decide whether the proposed worksharing procedure is acceptable.
A Rapporteur (and Co-rapporteur, when applicable) will be one of those of the centrally authorised veterinary medicinal products or a CVMP member representing one of the RMSs for the nationally authorised veterinary medicinal products.
The submission requirements as set out in the post-authorisation Q&A for variations requiring assessment will also apply to variations subject to worksharing, but the application should be provided as one integrated submission package per product, covering all variations applied for.
This should include a cover letter and an application form, together with separate supportive documentation for each veterinary medicinal product concerned and revised product information (if applicable) for each veterinary medicinal product concerned.
One cover letter addressed to the Agency and national competent authorities, if nationally authorised veterinary medicinal products are part of the worksharing procedure, clearly indicating that the application is submitted for a worksharing procedure, together with a short overview of all veterinary medicinal products concerned with their respective rapporteurs and RMSs, as well as an overview of the submission format for the different products, if applicable. If nationally authorised products are part of the worksharing procedure, the MAH should also include a confirmation that the worksharing applications have been submitted to all Member States where the products concerned are authorised and that the relevant national fees have been paid. A letter of authorisation for the MAH contact person for the worksharing procedure should be provided with the worksharing application.
If a variation is submitted because it has been requested as an outcome arising from another procedure, then this should be clearly mentioned in the cover letter for the resulting variation, identifying the related EMA procedure number from which the variation arose.
If nationally authorised veterinary medicinal products are part of the worksharing procedure, relevant product and Member State details should be provided as annex B to the application form, using the
Annex B Word templateclearly differentiating between national MAs authorised via MRP/DCP and purely-national MAs.
For queries relating to the presentation of the application, please contact the Agency via Service Now by selecting Veterinary Regulatory > Post-Authorisation-Vets.
Reference
The worksharing application must be submitted at the same time to all relevant authorities, i.e. in case the application consists of centrally and nationally authorised veterinary medicinal products, to the Agency and all Member States where the products concerned are authorised.
Submission to the European Medicines Agency:
MAHs should use the eSubmission Gateway / Web Client for all variations requiring assessment (VRA) submitted to the Agency. The complete worksharing dossier should be submitted for each centrally authorised product included in the worksharing application.
For more information, including links to guidance on registration with the system see the Veterinary eSubmission website.
Submission to the National Competent Authorities:
Where nationally authorised veterinary medicinal products are part of the worksharing, the same application as submitted to the Agency should be submitted to all relevant Member States (MSs), i.e. all MS where the concerned marketing authorisations are authorised – the reference below on dossier requirements outlines the additional submission requirements for the national competent authorities in the case of worksharing procedures involving centrally- and nationally-authorised products. This will allow all involved parties (the Agency, MSs and CVMP members) to receive the full data for the worksharing application.
If amendments are requested by the Agency as a result of the validation, updated documentation should also be submitted to the MSs.
The dossier requirements mentioned in the references should be followed for worksharing applications.
Submission to the rapporteur and CVMP members:
All VNeeS submissions for centrally authorised products (CAP) sent to EMA via the eSubmission Gateway/Web Client will be considered delivered to all National Competent Authorities’ representatives, alternates and scientific experts.
The dossier requirements mentioned in the references should be followed for worksharing applications.
References
When the MAH informs the Agency about the intention to submit a worksharing procedure, as described in Q&A no. 3 "What pre-submission steps will apply to a worksharing procedure?", the Agency will register this intention in IRIS and assign a unique procedure number in the format EMA/VRA/0123456789. This number will be communicated to the MAH and should then be entered in the eAF on page 3, in the field "Variation procedure number(s)", and referred to in other relevant documentation, such as the cover letter.
The MAH should submit the variation application for worksharing at the latest by the recommended submission dates published on the Agency’s website.
In general, variations submitted for worksharing will follow the timetable of the lead variation.
Where nationally authorised products are included in a worksharing variation application, the procedure will generally follow a standard (60 days) timetable, unless the changes to be implemented concern urgent safety matters.
The Annex B includes information on the nationally authorised veterinary medicinal products included in the worksharing application, and it will be annexed to the CVMP opinion, if applicable. A template for Annex B is available below.
References
Upon adoption of the opinion on the worksharing procedure, the Agency will inform the MAH, the European Commission, and the Member States concerned (if applicable) as to whether the opinion is favourable or unfavourable (including the grounds for the unfavourable outcome).
If the Agency considers that some variations are not approvable, the list of variations that are not considered approvable will be attached in the opinion. Variations may be considered approvable for some of the concerned products only and the possibility of different outcomes for the various marketing authorisations concerned is not barred.
Re-examination
Article 66(10) and (11) of Regulation (EU) 2019/6 establishes that the MAH may give written notice to the Agency that it wishes to request a re-examination within 15 days of receipt of the opinion. MAHs should refer to further specific guidance on re-examination of CVMP opinions:
Decision-making process for centrally authorised veterinary medicinal products
For all VRA procedures which require amendment of the Annexes to the Decision granting the marketing authorisation, upon receipt of the final CVMP opinion and the complete translations of the product information, the Commission shall amend the marketing authorisation, for each centrally authorised veterinary medicinal product, to reflect the approved variations within 30 days. A decision will be issued for each centrally authorised veterinary medicinal product.
The Agency will apply the post-opinion timeframes set out in
The linguistic review will be performed on one set of Annexes of one centrally authorised veterinary medicinal product. In case of comments, it will be up to the MAH to correctly implement the same amendments in the other centrally authorised products, as appropriate.
The Agency, in cooperation with the QRD members and the MAH, will aim at providing final, checked translations for all centrally authorised products included in the worksharing procedure to the Commission within 27 days after adoption of the opinion, i.e. by Day +27. (See also: “When do I have to submit revised product information? In all languages?”).
MA updating process for nationally authorised veterinary medicinal products (if applicable)
Upon receipt of the final opinion, the Member States concerned shall approve the final opinion, inform the Agency accordingly and amend the national marketing authorisations.
The outcome of the procedures will be handled by Member States as normal variations as described in the CMDv BPG for variations requiring assessment.
Implementation
VRAs which require amendment of the Annexes to the Decision granting the marketing authorisation may only be implemented once the Commission has amended the marketing authorisation. The time limit for the implementation of VRA is set by the Commission and will be included in the Commission Decision on the VRA (the default implementation time is 6 months unless otherwise stated in the Decision e.g., it is 12 months for non-grouped G.I.18 VRAs).
The agreed changes should be included in the product information annexes of any subsequent regulatory procedure.
VRAs which do not require any amendment of the Annexes to the Decision granting the marketing authorisation can be implemented once the MAH has been informed of the favourable outcome by the Agency.
References
For information on the fees applicable for worksharing applications, please refer to fees payable to the European Medicines Agency.
Where a worksharing application is considered ‘invalid’ (i.e. an assessment process cannot be started), an administrative fee will be charged by the Agency.
Only the MAH of the lead product in the worksharing procedure will be invoiced for the whole worksharing.
References
If the variations subject to worksharing affect the SPC, labelling or package leaflet, the revised product information annexes must be submitted as follows:
Only one centrally authorised veterinary medicinal product will undergo a linguistic check. In the cases where the changes to the product information may vary between products, the product with the most complex changes will generally be the one subject to linguistic check.
Overview in case of linguistic review:
| Day | Lang* | Post-opinion linguistic review timetable |
|---|---|---|
| At submission | EN | Electronically Word format (highlighted) |
| +5 | All EEA | Electronically Word format (highlighted) |
| +25 | All EEA | Electronically Word format (highlighted) PDF format (clean) |
* = complete set of Annexes i.e. Annex I, II, IIIA and IIIB submitted as one document per language
The ‘complete set of Annexes’ includes Annex I, II, IIIA and IIIB i.e. all SPC, labelling and package leaflet texts for all strengths and pharmaceutical forms of the product concerned, as well as Annex II. The complete set of Annexes must be presented sequentially (i.e. Annex I, II, IIIA, IIIB) as one document for each official EU language. Page numbering should start with "1" (bottom, centre) on the title page of Annex I.
All Annexes should be in compliance with
When submitting the full set of Annexes in PDF format, the
and
should be followed.
Highlighted changes should be indicated via ‘Tools – Track changes’. Clean versions should have all changes ‘accepted’.
Icelandic and Norwegian language versions must always be included. From 1 January 2022 onwards an Irish language version must be included for MAHs established in Ireland that have not submitted an Irish language derogation.
The Annexes provided should only reflect the changes introduced by the variations concerned. However, in exceptional cases where MAHs take the opportunity to introduce minor linguistic amendments in the texts or to align the product information with the latest QRD template, this should be clearly mentioned in the cover letter and in the precise scope section of the application form. In addition, the section “present/proposed” in the application form should clearly list the minor linguistic amendments introduced for each language. Alternatively, such listing may be provided as a separate annex to the application form. Any changes not listed will not be considered as part of the variation application. In such cases, and in cases where any other ongoing procedures may affect the product information Annexes, the MAH is advised to contact the Agency in advance of submission or finalisation of the procedures concerned.
References