Q&A: Extension applications

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Once a veterinary product has received approval from the Commission (the “Commission Decision”) all further procedures connected with the product will fall under “Post-Authorisation Procedures”.

This guidance provides an overview for a number of procedures that occur frequently and addresses a number of questions which Marketing Authorisation Holders (MAHs) may have.

More information on this post-authorisation procedural advice Q&A.

As of 1 January 2017 it is mandatory for applicants to 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:

Additional information

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1. Will my invented name change?

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.

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”. The pharmaceutical form should be described by the European Pharmacopoeia’s full standard term. If the appropriate standard term does not exist, a new term may be constructed from a combination of standard terms (should this not be possible, the Competent Authority should be asked to request a new standard term from the European Directorate for Quality of Medicines (EDQM) of the Council of Europe).

References

2. How shall I present my Extension Application? Rev. June 2017

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

  • Cover letter - the Agency has published a new formatted table template to be inserted in cover letters.
  • The completed EU application form dated and signed by the official contact person as specified in the application form. The MAH should carefully fill-in the following sections of the application form i.e.:
    • In case of an extension of application, section 1.3 “Yes” should be ticked;
    • The precise scope of the change needs also to be filled-in;
    • The legal basis for an extension application corresponds to the legal basis of the initial application for the medicinal product. Therefore, relevant boxes of section 1.4.1 should be ticked.

Note: If the extension application is grouped with other variation(s), the variation application form should be appended to this application form. See also “What type of variations can be grouped?”

Supporting data relating to the proposed extension must be submitted. N.B. Part 2 of the application should only contain the relevant quality information related to the proposed extension. Where the changes affect the SPC, labelling and/or package leaflet, the revised product information Annexes must be submitted (see also: Extension applications - “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, please contact the Agency. Alternatively, MAHs may request a pre-submission meeting with the Agency to clarify any outstanding points.

References

3. Can I group the submission of Extensions with other types of variations?

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 marketing authorisation holder to group extensions with other variation(s) submission (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 ”What types of variations can be grouped?”.

However, no worksharing of extension applications is foreseen in the variations regulation.

References

4. How, when and to whom shall I submit my Extension Application? Rev. January 2017

Extension applications should be addressed to the attention of vet.applications@ema.europa.eu

One electronic copy of the complete extension application should be submitted to the Agency, together with a signed cover letter.

From 1 January 2017 it is mandatory for applicants to 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.

The extension application should also be submitted simultaneously to the (Co) Rapporteur.

Any additional information/documentation requested by the Agency prior to the start of the procedure should be equally provided to (Co-) Rapporteurs.

Upon validation by the Agency, the MAH should forthwith send the extension application to the other CVMP members, including any additional data or information supplied during the validation phase (as appropriate).

The MAH should submit the Extension application in accordance with the recommended submission dates published on the Agency website (see "Recommended Submission Dates").

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

Reference

5. How shall my Extension Application be handled (timetable)?

The MAH shall submit the Extension application(s) in accordance with the recommended submission dates published on the Agency’s website.

The submission deadlines are published on the Agency’s website.

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 Rapporteur and adoption by CVMP.

DAYACTION
1Start of the procedure.
70CVMP members and Agency receive the Assessment Report from Rapporteur. The Agency sends the Assessment Report 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.
100Rapporteur, other CVMP members and Agency receive comments from Members of the CVMP.
115CVMP members and Agency receive a draft list of questions (including draft overall conclusions and draft overview of the scientific data) from Rapporteur.
120CVMP adopts the list of questions as well as the overall conclusions and overview of the scientific data to be sent to the MAH by the Agency. 
Clock stop.
121*Submission of the responses and restart of the clock.

*Target dates for the submission of the responses are published on the Agency’s Website

After receipt of the responses, the CVMP will adopt a timetable for the evaluation of the responses. In general the following timetable will apply:

DAYACTION
150CVMP members and Agency receive the Response Assessment Report from Rapporteur.  The Agency sends the Assessment Report 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.
170Comments from CVMP Members to Rapporteur.
180CVMP discussion and decision on the need for an oral explanation by the MAH. If oral explanation is needed, the clock is stopped to allow the MAH to prepare the oral explanation.
181Restart of the clock and oral explanation.
By 210Adoption of CVMP Opinion + CVMP Assessment Report.

Re-examination

Art. 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 he wishes to request a re-examination within 15 days of receipt of the opinion (after which, if he does not appeal, the opinion shall be considered as final). The grounds for the re-examination request must be forwarded to the Agency within 60 days of receipt of the opinion. The CVMP will appoint a new (Co-) Rapporteur, to co-ordinate the appeal procedure. Within 60 days from the receipt of the grounds for appeal, the CVMP will consider whether its opinion is to be revised. If considered necessary, an oral explanation can be held within this 60 days timeframe.

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 post-opinion phase, including the linguistic checking of the amended product information annexes, is available on the Agency’s website.

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 holder accordingly.

References

6. What fee do I have to pay for an Extension Application?

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 the explanatory note on fees payable to the European Medicines Agency. Reduced extension fees apply to:

  • All quality extensions for which no new clinical data are submitted by the marketing authorisation holder.

If variations are grouped to this 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.

To facilitate this operation, applicants/MAHs who are requesting a Purchase Order Number on the Agency invoice should quote this Number clearly on the cover letter of a given application. The Agency will no longer accept separate notifications of Purchase Order Numbers not associated with the dossier.

If the applicants/MAHs do not require a Purchase Order Number on the Agency invoice, this must also be clearly stated in the cover letter.

For more information about fees and fee payment in the Centralised Procedure, please consult the dedicated part on the Agency website.

Where an extension application is considered ‘invalid’ (i.e. an assessment process can not be started), an administrative fee will be charged by the Agency (see also Explanatory note on fees payable to the European Medicines Agency).

References:

7. Do I have to submit mock-ups?

Please consult the Mock-ups section of this Q&A.

Reference

8. When do I have to submit revised product information? In all languages?

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

  • At submission and during assessment, only the English language version of the Product Information is submitted and reviewed.
  • Translations of the agreed SPC, Annex II, labelling and package leaflet text in all languages are to be provided after adoption of the CVMP opinion. Icelandic and Norwegian language versions of the extension Annexes must be included.

More details on the translation requirements and on the linguistic review process are available on the Agency’s Website: "The new Product Information linguistic review process for new applications in the Centralised Procedure" (EMEA/5542/02).

MAHs are reminded that, during assessment, the English product information Annexes should only include those SPC, Labelling and/or PL 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. The electronic copy of all languages should be provided on CD-ROM/DVD as part of the extension application.

The ‘QRD Convention’ published on the Agency’s website should be followed. When submitting the full set of Annexes in PDF format, this should be accompanied by the completed formatting checklist which provides guidance on how to correctly prepare the PDF versions.

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) this should be clearly mentioned in the cover letter. Alternatively, a listing of proposed changes may be provided as a separate document attached to the cover letter. Any changes not listed, 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 procedure(s) concerned.

For extension applications which affect the Annex A (e.g. introduction of a new strength), the following principles apply:

Upon adoption of the Opinion, the Agency will prepare and send to the MAH the revised English Annex A. After CVMP Opinion (Day 215), 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 document.

Reference

9. Will there be any publication on the outcome of my Extension application? Rev. July 2015

The monthly CVMP Press Release will provide information on any positive or negative opinion taken by the CVMP during that meeting.

Together with the CVMP Press Release, a “Summary of opinion” will also be published by the Agency for initial applications, as well as for extensions or major Type II variations. This document summarises the product 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.

Reference

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