This guidance only applies for procedures started under Directive 2001/82/EC and Regulation (EU) 726/2004 before 28 January 2022.

The guidance provides an overview for different types of post-authorisation procedures that occur frequently and, in each case, addresses a number of questions which marketing authorisation holders (MAHs) may have.

Applicants should use the eSubmission Gateway / Web Client for all veterinary procedural submissions to the Agency. For more information, including links to guidance on registration with the system see the Veterinary eSubmission website.

Additional information

The invented name of the medicinal product will be the same for the extension as it is for the existing marketing authorisation of the medicinal product.

The addition of a qualifier (suffix) (e.g. invented name + qualifier) exclusively for the line extension is not possible within the same marketing authorisation as this would result in a different (invented) name.

It should be clear that the complete name of the medicinal product is commonly composed of the ‘invented name, followed by the strength, pharmaceutical form and, if necessary, target species in order to avoid any confusion over different presentations’. The pharmaceutical form should be described by the European Pharmacopoeia’s full standard term. If the appropriate standard term (e.g. pharmaceutical form or unit of measurement) does not exist, or an update of an already existing term is needed, the competent authority  (EMA for centrally-authorised products) should be asked to request this from the European Directorate for Quality of Medicines (EDQM) of the Council of Europe). In practice, this should be done as early as possible pre-submission by submitting a request through the SPOR Portal - providing as much supporting documentation as possible (e.g. name of the product concerned, SPC, etc.). Please note that you need to be registered with SPOR prior to submission of change requests. Guidance can be found on the user guide for managing referential and organisation data in eAF.
 

References

Extension applications should be presented as follows in accordance with the appropriate headings and numbering of the dossier format:

  • Cover letter (for groupings, include a short overview of the nature of the changes and indicate whether it is an allowed grouping in Annex III of the Variations Regulation or the grouping has been agreed with the Agency).
  • The completed MAA-Vet application form dated and signed by the official contact person as specified in the application form. The EMA strongly recommends the use of a single electronic application form per submission, even if the submission concerns multiple strengths/pharmaceutical forms. The MAH should carefully fill in the following sections of the application form:
    • In case of an extension of application, section 1.2 “Yes” should be ticked;
    • The type of change also needs to be selected;
    • The legal basis for an extension application corresponds to the legal basis of the initial application for the medicinal product.
  • If the extension application is grouped with other variations, the completed variation application form should be added to the dossier submission. See also the Q&A on Q&A: Grouping of variations.
  • Supporting data relating to the proposed extension must be submitted. NB Part 2 of the application should only contain the relevant quality information related to the proposed extension.
  • If the changes affect the SPC, labelling and/or package leaflet, the revised product information Annexes must be submitted (see also: “When do I have to submit revised product information? In all languages?”).

It should be noted that the responsibility for the quality of the submitted documentation lies with the MAH and is crucial to the overall process.
For queries related to the presentation of the application, or to request a pre-submission meeting with the Agency to clarify any outstanding points, please contact vet.applications@ema.europa.eu.

References

Marketing authorisation holders may choose to group the submission of one or more extensions together with one or more other variations for the same product into one application, provided that this corresponds to one of the cases listed in Annex III of the Variations Regulation or when this has been agreed previously with the Agency.

It is possible for a MAH to group extensions with other variation submissions (e.g. Type II, Type IB or IA variations). Such grouped submissions will follow the review procedure of the highest variation in the group. Please also refer to theQ&A: Grouping of variations.

However, no worksharing of extension applications is foreseen in the Variations Regulation.

References

All submissions should be made in accordance with the guideline on e-submissions.

Applicants should use the eSubmission Gateway / Web Client for all veterinary procedural submissions to the Agency. For more information, including links to guidance on registration with the system, see the Veterinary eSubmission website.

All VNeeS submission for centrally authorised products (CAP) sent to EMA via the eSubmission Gateway/Web Client will be considered delivered to all National Competent Authorities (NCA) representatives, alternates and scientific experts.

Extension applications are generally supported by a substantial amount of data, particularly for extension of indication or other changes to the authorised therapeutic indication. As a result, the assessment timeframe is typically the same as for an initial marketing authorisation and significant assessment resources need to be committed for the assessment by the rapporteur and often also from the co-rapporteur. For this reason, MAHs are requested to give advance notice of their intention to submit an extension application 7 months in advance of submission, by emailing vet.applications@ema.europa.eu, copying the rapporteur and co-rapporteur, summarising the scope of the intended application and specifying the target submission date. The information will be used for planning purposes by the Agency and the rapporteurs’ assessment teams.

The MAH should submit the extension application at the latest by the Recommended submission dates for veterinary medicinal products published on the Agency website.

References

The MAH shall submit the extension application in accordance with the Recommended submission dates for veterinary medicinal products.

The Agency shall ensure that the opinion of the CVMP is given within 210 days in accordance with the following standard timetable, which can be shortened in certain circumstances, upon request of the MAH to the CVMP, agreement from the rapporteurs and adoption by CVMP.

DAYACTION
1Start of the procedure.
70CVMP members and Agency receive the assessment report and comments on the product information from rapporteur. The Agency sends the assessment report and comments on the product information to the MAH making it clear that it only sets out the rapporteur’s preliminary conclusions. The report in no way binds the CVMP and is sent to the MAH for information only.
85Co-rapporteur critique of the rapporteur's assessment report and comments on the product information sent to rapporteur, CVMP members and the Agency. The Agency sends the co-rapporteur critique and comments on the product information to the MAH making it clear that it only sets out the co-rapporteur’s preliminary conclusions. The report in no way binds the CVMP and is sent to the MAH for information only.
100Rapporteurs, other CVMP members and the Agency receive comments from Members of the CVMP.
107CVMP members and Agency receive a draft list of questions (including draft overall conclusions and draft overview of the scientific data) from rapporteurs.
120CVMP adopts the list of questions, the overall conclusions and overview of the scientific data, and comments on the product information which are sent to the MAH by the Agency.
Clock stop.
121*Submission of the responses including revised SPC, labelling and package leaflet text in English and restart of the clock.

* Recommended submission dates for veterinary medicinal products are published under recommended submission dates.

After receipt of the responses, the following standard timetable will apply:

DAYACTION
160CVMP members and Agency receive the joint assessment of responses and comments on product information from rapporteurs. The Agency sends these documents to the MAH making it clear that it only sets out the rapporteurs’ preliminary conclusions. The report in no way binds the CVMP and is sent to the MAH for information only.
170Rapporteurs, other CVMP members and Agency receive comments from Members of the CVMP.
180CVMP discussion and decision on the need for adoption of a list of outstanding issues (LoOI) and/or an oral explanation by the MAH. CVMP adopts the LoOI, the overall conclusions and review of the scientific data, and comments on the product information which are sent to the MAH by the Agency. 
The clock stops.
181Submission of the responses, including revised SPC, labelling and package leaflet text in English and oral explanation (if needed) 
Restart of the clock.
190Joint assessment of responses and comments on product information from rapporteur and co-rapporteur received by CVMP members and the Agency. The Agency sends these documents to the MAH (making it clear that they only set out their preliminary conclusions, that are sent for information and do not represent the position of the CVMP). 
Rapporteur and co-rapporteur circulate Draft CVMP assessment report to CVMP members and the Agency.
197Deadline for comments from CVMP members to be sent to rapporteur and co rapporteur, the Agency and other CVMP members
By 210Adoption of CVMP opinion, CVMP assessment report and product information.

Re-examination

Article 34(2) of Regulation (EC) No 726/2004 also applies to CVMP opinions adopted for extension applications. This means that the MAH may give written notice to the Agency/CVMP that it wishes to request a re-examination within 15 days of receipt of the opinion.

A positive opinion may be subject to re-examination as long as the request to re-examination relates to aspects of the opinion for which there had been objections by the Committee, further to which the MAH opted to amend the application. In such case, the MAH, when submitting the amended documentation, (e.g. revised product information) prior to the opinion, will need to reserve the right to re-examination in the covering letter.

MAHs should refer to the EMA webpage for further specific Procedural advice to applicants/marketing authorisation holders on re-examination of CVMP opinions (according to Regulation (EC) No 726/2004).

Decision-making process

Upon receipt of the final CVMP opinion, the Commission shall, where necessary, amend the marketing authorisation to reflect the extension within the timeframes set out in Article 34(1) of Regulation (EC) No. 726/2004. Detailed practical guidance on the linguistic review process for the amended product information annexes during the post-opinion phase is available on  Linguistic review.

The outcome of the evaluation of an extension application in the centralised procedure will result in an extension or a modification of the initial marketing authorisation. Extensions may only be implemented once the Commission has amended the decision granting the marketing authorisation and has notified the MAH accordingly.

References

For information on the fee applicable for an extension application for each new strength, new pharmaceutical form or new route of administration, please refer to theFees payable to the European Medicines Agency. Reduced extension fees may apply to certain quality extensions.

If variations are grouped with an extension application, whether consequential or not, they will each attract a separate relevant fee.
The Agency will issue an invoice following the notification of the administrative validation to the applicant and fees will be payable within 30 calendar days of the date of the invoice. The invoice will be sent to the billing address indicated by the MAH and will contain clear details of the product and procedures involved, the type of fee, the amount of the fee, the bank account to where the fee should be paid and the due date for payment.

Applicants requiring a purchase order number or similar references on the invoice are requested to clearly indicate it on the cover letter or application form accompanying the dossier, as well as in the “Customer reference” box of the delivery file to be generated for submission via the EMA Gateway. The Agency does not accept standalone notifications of purchase order numbers that are not associated with a dossier.
If an extension application is considered ‘invalid’ (i.e. an assessment process cannot be started), an administrative fee will be charged by the Agency.

References:

Please consult the Q&A: Mock-ups.

Where the extension application requires changes to the product information (e.g. new strength or pharmaceutical form), the same requirements as for a new MA application apply:

  • At submission (Day 0)
    • English language: revised complete set of product information annexes. The application must include a clean and highlighted version of the annexes, clearly showing all proposed changes in tracked changes. The clean version should be provided in Part 1b and the highlighted version should be provided as a word document as part of the 'working documents' – Add Info. The provision of a highlighted word version is mandatory as it facilitates the review of the application. The highlighted version should additionally be provided as a PDF document in Part 1b.
  • During the procedure
    • English language: The MAH should take into account the assessment feedback and provide revised versions of the highlighted product information as part of the responses to any requests for supplementary information during the procedure. The revised highlighted product information that is provided at these procedural milestones should be submitted in line with the requirements outlined above 'at submission'.
    • In addition, during the later stages of the procedure there is often a need for fast informal exchanges between the MAH and the rapporteur in preparation of the CVMP opinion. During this process the MAH can provide any revised versions of the product information as well as comments/justifications by Eudralink/email in Word format. These product information versions are considered 'working documents' only and there is consequently no need to submit these updated product information proposals as part of a formal Gateway submission (unless part of formal responses to a CVMP list of questions/outstanding issues).
  • After CVMP opinion (Day +5)
    • All EU languages (incl. NO+IS): complete set of annexes electronically only in Word format (highlighted)
  • After linguistic review (Day +25)
    • All EU languages (incl. NO+IS): complete set of annexes electronically only in Word format (highlighted) and in PDF (clean bookmarked)

More details on the translation requirements and on the linguistic review process are available on the The linguistic review process of product information in the centralised procedure – veterinary (EMEA/288844/2009) underLinguistic review .

MAHs are reminded that, during assessment, the English product information Annexes should only include the SPC, labelling and package leaflet relevant to the extension application concerned. After adoption of the CVMP opinion, however, a complete set of Annexes for the medicinal product concerned must be submitted. A ‘complete set of Annexes’ includes Annex, I, II, IIIA and IIIB i.e. all SPC, labelling and PL 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 the Quality Review of Documents (QRD) convention to be followed for the European Medicines Agency QRD templatespublished on the Agency website. When submitting the full set of Annexes in PDF format, the Submission of day +25 /235 final product information annexes (human and veterinary) - QRD Form 2 and checklist and the User guide on how to generate PDF versions of the product information - veterinaryshould 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.

The Annexes provided should only reflect the changes introduced by the extension application concerned. However, in exceptional cases where MAHs take the opportunity to introduce minor linguistic amendments in the texts (e.g. further to a mock-up check) or to align the product information with the latest QRD template, this should be clearly mentioned in the cover letter. Alternatively, a listing of present/proposed changes may be provided as a separate annex to the application form. Any changes not indicated will not be considered as part of the extension application.

In cases where any other ongoing procedures may impact on the product information of the extension application, the MAH is advised to contact the Agency in advance of submission or finalisation of the procedures concerned.

For extension applications which affect the Annex A (e.g. introduction of a new strength), the Agency will prepare and send to the MAH the revised English Annex A reflecting the new/amended presentation upon adoption of the CVMP opinion. At Day +5 after CVMP opinion, the MAH provides the Agency with the electronic versions of the complete set of Annexes in all languages as well as the translations of the revised Annex A as a separate word documents.

References:

At the time of the adoption of a CVMP opinion for an extension application that includes additional presentations, the Agency will assign new EU sub-numbers and include them in the revised annex A of the medicinal product, which will be transmitted to the MAH together with the CVMP opinion and respective annexes.

The MAH should include the newly assigned numbers in all language versions of annex A and in all applicable sections of the product information, which are submitted following the CVMP opinion for linguistic review.

The CVMP press release following each CVMP meeting provides information on opinions on extension applications, including MAH and the change concerned.

Together with the CVMP press release, a ‘summary of opinion’ is also published by the Agency for initial applications, extensions and major Type II variations. This document summarises the application concerned (e.g. MAH, indications, target species, pharmaceutical form).

The CVMP extension assessment report, with commercially confidential information deleted, will be published after adoption of the Commission Decision.

References:

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