Q&A: Renewals

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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. What guidance is available for the renewal of Marketing Authorisation?

A Guideline on the processing of the renewals in Centralised Procedure for veterinary medicinal products” is published in Volume 6 C of the Notice to Applicants Veterinary Medicinal Products on the Commission’s website.

References

2. How long is my marketing authorisation valid?

The initial marketing authorisation is normally valid for 5 years, i.e. until the renewal. Once a marketing authorisation has been renewed and no further renewal is considered necessary, the marketing authorisation will be indefinite. However, other restrictions might apply e.g. the sunset clause or safety restrictions.

Marketing authorisations under exceptional circumstances are also valid for 5 years but are subject to an annual reassessment (See “How will the renewal of products authorised under exceptional circumstances which are subject to Annual Re-assessment, be handled?”)

References

3. When shall I submit my renewal application?

A Marketing Authorisation Holders (MAH) must submit the application for the renewal of the Marketing Authorisation at least six months before the expiry date of the Marketing Authorisation (which is 5 years after the Commission Decision granting the Marketing Authorisation).

The renewal application should be submitted at a recommended submission date published on the Agency’s website.

Flexibility will be maintained as to the basis of the renewal submission date, provided it is at least six months before MA expiry, and will take account of the International Birth Date, and the maintenance of synchronisation of PSURs e.g. linked to the International Birth date (See also " What is the difference between the International birth date (IBD) and the European birth date (EBD) of my medicinal product? "). In addition, the renewal application (incl. PSUR) should be submitted no later than 60 days after the PSUR data lock point. (See also "What is a data lock point (DLP) and how shall I calculate the first data lock point? ")

In order to allow sufficient time for assessment and in order to ensure that the Decision on the renewal application can be issued before expiry of the MA, MAHs should take into account the following principles when planning for their renewal submission:

MAHs or the Agency may therefore consider it prudent to plan for the renewal application to be submitted 7-9 months before expiry.

In addition, as the quality of the renewal application and of the product information translations will be key to ensure a timely start and finalisation of the renewal procedure, MAHs are strongly advised to contact the Agency for a pre-submission dialogue at least 1 year in advance of MA expiry.

Reference

4.What should the summary bridging report on safety and PSUR addendum report cover Rev. July 2015

For the renewal, the MAH needs to submit a periodic safety update report (PSUR) summary bridging report which is supported, if needed, either by:

  • a PSUR addendum report, or
  • one PSUR in circumstances where the PSUR submission schedule is in synchrony with the renewal submission schedule.

The PSUR summary bridging report provides a summary of previously submitted consecutive PSURs and should not contain any new data. If, however, a PSUR covering the period since authorisation or last renewal is due at the time of submission of the renewal application, the PSUR replaces the need for a PSUR summary bridging report.

When the period to be covered falls outside the usual PSUR reporting cycle, the use of a PSUR addendum report is recommended to cover the data outside the defined period for PSUR submission.

The addendum report is an update to the most recently completed PSUR and needs to include the additional safety reports received since the end date of the previous PSUR reporting cycle up to 60 days before the agreed submission date. The proposed simplified presentation should include the following sections, containing any new information or changes beyond the most recent PSUR to which the addendum report refers:

  • Introduction (purpose; cross-reference to most recent PSUR);
  • Changes to the sections of the summary of product characteristics (SPC) relevant to pharmacovigilance (including a copy of the most recent document if it differs from the one in the PSUR);
  • Significant worldwide regulatory authorities’ actions relevant to safety;
  • Line-listing(s) and/or summary tabulations;
  • Conclusions (brief overview)

The format of the PSUR summary bridging report should be identical to that of the usual PSUR, but the content should consist of summary highlights and an overview of data from the referenced PSURs. The summary bridging report should contain the following for the period covered by all previously submitted PSURs:

  • Introduction;
  • Worldwide marketing authorisation status;
  • Overview of regulatory authority or MAH-initiated actions for safety reasons;
  • Overview of changes to the SPC and product information based on pharmacovigilance grounds;
  • Overview of exposure data as well as incidence data and overview of human reactions;
  • Overview of individual reports;
  • Overview of studies;
  • Overview of the reported information related to investigations of insufficient withdrawal period arising from the use of the veterinary medicinal product, lack of expected efficacy, adverse events related to off label use or any potential environmental problems;
  • Significant safety information received after the data lock point (DLP);
  • Overview of the safety concerns and conclusion.

In addition, the summary bridging report should also contain information highlighting any significant differences between the approved SPC and the proposed SPC.

The normal PSUR cycle is not affected by the PSUR addendum report nor the summary bridging report for the renewal application. The next PSUR should therefore also include all data already submitted via an addendum report.

Reference:

  • Volume 9B of The rules Governing Medicinal Products in the European Union - Guidelines on Pharmacovigilance for Medicinal Products for Veterinary Us
5. How and to whom shall I submit my renewal application? Rev. January 2017

At the recommended submission date, MAH should send the electronic copy of the renewal dossier to the Agency and to the (Co-)Rapporteurs only.

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

The Agency has published a new formatted table template to be inserted in cover letters, found here.

The Agency should receive one electronic copy of the renewal application form and a full set of all supportive documentation. The product literature should be provided electronically in word format. Any electronic submissions should be made in accordance with the guideline on e-submissions.

From 1 January 2017 it will be 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.

Each Rapporteur should receive one electronic copy of the renewal application form and supportive documentation.

The Agency will check whether the renewal application is correct and complete (“validation”) before start of the procedure. Any additional information/documentation requested by Agency prior to the start of the procedure should be equally provided to both Rapporteurs.

Upon validation by the Agency, the MAH should forthwith send one electronic copy of the renewal application, including any additional information supplied during the validation phase (as appropriate), to all the other CVMP members according to their dossier requirements.

References

6. How shall my renewal application be handled (timetable)?

A timetable of maximum 120 days for the scientific evaluation by the CVMP applies as follows:

The Agency will acknowledge receipt of a valid renewal application and shall start the procedure in accordance with the recommended starting dates published on the EMA’s website.

DAYACTION
Day 1Start of procedure
Around Day 45Rapporteur’s Assessment Report - sent to EMA, CVMP members and MAH
Around Day 60Co-Rapporteur’s Assessment Report - sent to EMA, CVMP members and MAH
Day 90(First) Discussion at CVMP.- Possible adoption of opinion.- In case of outstanding issues: adoption of List of Outstanding Issues + decision on possible oral explanation by MAH
Day 100MAH provides answers to list of outstanding issues to Rapporteur, Co-Rapporteur, CVMP and EMA
Day 110Joint Rapporteur / Co-Rapporteur Assessment Report on MAH’s responses - circulated to EMA, CVMP members and MAH
 Day 120Adoption of CVMP opinion. (Possible oral explanation by MAH)

Reference

7. What fees do I have to pay for a renewal?

For information on the fee applicable for renewal applications, please refer to the “Explanatory note on fees payable to the European Medicines Agency”.

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 page on the Agency website.

Where an inspection is required, please note that in addition to the renewal fee, an inspection fee will be requested (See also Inspections).

Reference

8. Can other non-renewal specific changes be included in the renewal application?

None of the changes introduced at renewal should substitute for the Marketing Authorisation Holder's obligation to update the marketing authorisation throughout the life of the product as data emerge.

Changes to the product, such as the introduction of a new indication or an extension of shelf life, should not be proposed through the renewal procedure but have to be submitted and assessed through separate variation procedures.

Where there are adequate and objective reasons not to renew the marketing authorisation in its existing terms and changes are necessary to the SPC arising from the renewal PSUR evaluation, the Marketing Authorisation Holder may submit additional information and/or change the product information as part of the renewal process to address the concerns raised. Such changes will not initiate a separate variation procedure.

Other issues arising from assessment and changes due to the revision of the SPC guideline, other relevant guidelines or Agency/QRD Product Information Templates should be considered within the renewal procedure.

The section “present/proposed” in the application form should clearly list all changes introduced to the product information (incl. any minor linguistic amendment introduced for each language). Alternatively, such listing may be provided as a separate document attached to the application form. Any changes not listed, will not be considered as part of the renewal application.

9. How to handle other ongoing variation applications during the renewal procedure and what impact may ongoing procedures have on the renewal procedure?

Although MAHs are advised to avoid other procedures at the time of renewal, such situations cannot be excluded.

Where an ongoing variation (Type IA/IB or Type II) affects the product information and is not yet finalised at the time of the submission of the renewal application, the last product information adopted/accepted by the EC/CVMP/Agency should be used at the submission of the renewal application.

If the variation procedure is finalised (notification of a Type IA/IB or Opinion on the Type II) before or upon finalisation of the renewal procedure, the accepted/adopted variation changes should be reflected in the renewal product information.

In such cases where any other ongoing procedure may affect the product information, the MAH is advised to contact the Agency in advance of the submission or finalisation of the procedure(s) concerned.

10. Do I have to submit mock-ups?

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

References:

  • The Revised Checking Process of Mock-ups and Specimens of outer/immediate labelling and package leaflets in the centralised Procedure for Veterinary Medicinal Products
11. When do I have to submit revised product information? In all languages?

At submission, MAH should provide a full set of the English product literature, i.e. Annex A, I, II and III.

Only if the renewal application affects SPC, Annex II, labelling and/or package leaflet, revised product information should be submitted 5 days after the CVMP opinion.

The translations checking procedure is described in “The new Product Information linguistic review process for new applications in the centralised procedure”.

The MAH should send the revised translations directly to the Member States. The English product literature highlighting the changes to the text should always be included in the documentation sent to the Member States.

Individual members of Agency staff should not be copied directly; however, a copy should be sent to the functional Agency mailbox vet.translations@ema.europa.eu and to the product shared mailbox.

When preparing the (revised) product literature the “guidance documents for industry when dealing with product literature for a veterinary medicinal product” may be useful.

References

12. What do I need to do if I do not want to renew the Marketing authorisation of certain product presentations or the entire product?

Marketing Authorisation Holders (MAH) should only complete the renewal application form for those presentations which the MAH would like to renew. In cases where the MAH does not wish to renew certain product presentations (e.g. a certain pharmaceutical form, strength or pack-size) this should be clearly indicated in the cover letter.

Where the MAH does not wish to renew the entire Marketing Authorisation (i.e. all presentations) a letter to this effect should be addressed to the Agency and to the European Commission, at the latest 9 months prior to the expiry of the concerned Marketing Authorisation.

13. How will the renewal of products authorised under exceptional circumstances which are subject to Annual Re-assessment, be handled?

The fifth Annual Re-assessment of medicinal products authorised under exceptional circumstances will take place at the time of the renewal of the product concerned. Therefore, the Annual Re-assessment is expected to be incorporated in the renewal application and will follow the renewal procedure dossier requirements, timetable etc.

For such products, the CVMP will have to consider whether there remain grounds for the Marketing Authorisation to be kept under exceptional circumstances or not. If no such grounds remain, a recommendation will be made to renew the Marketing Authorisation under normal circumstances.

When a renewal Opinion is granted, stating that there remain grounds for the Marketing Authorisation to be renewed under exceptional circumstances, the Marketing Authorisation Holder is obliged to submit the requested data to the Rapporteur, Co-Rapporteur, CVMP Members and the Agency in the agreed timeframe after the renewal. These “specific obligations” to provide such data, are set out in Annex II of the Opinion and are detailed in the letter of commitment of the Marketing Authorisation Holder as adopted at the time of the Opinion. The specific obligations are to be reviewed at the intervals indicated and at the longest annually. The annual review includes a re-assessment of the benefit/risk profile.

14. Will there be any publication on the outcome of my renewal application?

The EPAR (published on the Agency’s website) will be updated to include the CVMP conclusions in relation to the renewal procedure.

The CVMP Press release following each CVMP meeting gives information on opinions in relation to renewal applications. This information includes the invented name of the product, its INN and the name of the MAH. In addition, it is stated whether or not there are remaining grounds to keep the MA under exceptional circumstances.

Reference

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