Q&A: Post-authorisation measures (Recommendations, Conditions and Specific Obligations)

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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 are Recommendations, Conditions, Specific Obligations? Rev. July 2015

Where the Committee is prepared to grant an opinion (initial or a post-authorisation opinion) but where some issues remain to be addressed by the applicant, Conditions or Specific Obligations (SOs) may be imposed.

Conditions are post-authorisation measures which, whilst not precluding the approval of a marketing authorisation or other post-authorisation procedure(s), are considered to be key to the benefit / risk balance of the product. As the conditions are binding and are mentioned in Annex II of the Annexes to the Commission Decision for the product, any modification proposed by the MAH with regard to their description or due date is to be submitted within a type II variation application.

Specific Obligations (SOs) data are specific to marketing authorisations granted under exceptional circumstances due to limited efficacy and/or safety data available at the time of the CVMP opinion because:

  • The indications for which the product in question is intended are encountered so rarely that the applicant cannot reasonably be expected to provide comprehensive data or
  • In the present state of scientific knowledge, comprehensive information cannot be provided or
  • The authorisation of the product is considered necessary on public or animal health grounds or
  • The disease control is subject to Community law and there are restrictions to conduct clinical trials.

The SOs are included in Annex II of the Commission Decision (and detailed in the letter of undertaking or commitment of the MAH) as adopted at the time of the CVMP opinion.

The Marketing Authorisation Holder has to apply annually for the re-assessment and, after validation of the (new) data, to provide all CVMP members every year with an update of the outstanding issues. The Rapporteur will assess the fulfilment of these SOs annually and the assessment will result in an annual CVMP opinion until the outstanding issues have been resolved.

With regard to Recommendations, these may be made during the assessment of the application and be related to the further development of the medicinal product, e.g. in terms of optimising some quality aspects. Although these recommendations for further development are not binding to the marketing authorisation, they should be seen as important considerations in view of the potential future use of a medicinal product by the MAH.

Reference:

2. When shall I submit my Recommendations/Conditions/Specific Obligations data? Rev. July 2015

For Recommendations, the MAH should submit the data according to the timeframe agreed at the time of the opinion..

For Conditions and SOs, the timeframe is highlighted in Annex II of the Commission Decision. Conditions will be reviewed by the rapporteur once the data are submitted. SOs are to be reviewed by the CVMP at the intervals indicated and at the latest annually (at the time of the annual re-assessment). The data should in principle be submitted on the anniversary date of the Commission Decision granting the Marketing Authorisation.

The MAH shall provide data within the agreed timeframe. If a MAH is unable to provide the required data on time, the Agency should be informed in writing in advance of the due time of submission. The reason for the delay should be justified and a new submission date proposed. In the case of a non-satisfactory or non-justifiable delay, the Committee/Agency may make this information public.

The Agency will check whether the annual re-assessment application for SOs is correct and complete before start of the procedure (“validation”). Any additional information/documentation requested by the Agency prior to the start of the procedure should be equally provided to Rapporteur.

Where considered appropriate, in view of the urgency of the matter especially for safety issues, MAHs may submit any variation application resulting from the fulfilment of the Recommendations/Conditions/SOs and/or Periodic Safety Update Reports (PSURs) at the same time as the fulfilment of the Recommendations/Condition/SO or submission of the PSUR to minimise the processing and review time. In the case of Type II variations, the Agency shall start the procedure in accordance with the starting dates published on the EMA website (see also recommended submission dates).

3. How shall I present my Recommendations/Conditions/Specific Obligations data at submission? Rev. July 2015

The submission of Recommendations/Conditions/SOs data should include:

  • A cover letter indicating the full title and the reference procedure number of each Recommendation/Condition/SO, i.e. the number of the procedure during which the measure was requested. The letter should also indicate whether the Recommendation/Condition/SO relates to Quality, Safety or Efficacy. Where a variation is submitted to fulfil Recommendations/Conditions/SOs, this should clearly be stated in the cover letter, in the formatted table template.

All supportive documentation relevant to the fulfilment of the Recommendations/Conditions/SOs should be presented in accordance with the appropriate headings and numbering of a dossier as indicated in Vol. 6B of the Notice to Applicants.

Reference:

4. How and to whom shall I submit my Recommendations/Conditions /Specific Obligations data? Rev. January 2017

Conditions/Recommendations’ data should be sent to the Agency and the Rapporteur electronically.

SOs should be sent to the Agency and to the Rapporteur as outlined in the dossier requirements for CVMP members.

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

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.

In addition, all the other CVMP members should receive a copy of the documentation as outlined in the dossier requirements for CVMP members.

Should a variation be requested as a result of the fulfilment of the Recommendations/Conditions/SOs, this should be clearly indicated on the cover letter. In this case, the usual procedure for variations applies.

Any additional information/documentation requested by the Agency prior to the start of the procedure should be equally provided to the Rapporteur.

References:

5. What is the timetable and possible outcome of the evaluation Recommendations, Conditions and Specific Obligations? Rev. July 2015

Timeframe:

For the timeframe of Recommendations/Conditions, the Agency will liaise on a case-by-case basis with the Rapporteur. A 60-day timetable will normally apply.

For SOs, a 60-day timetable will normally apply. For recommended submission dates see the document linked here.

Outcome:

The Agency will inform the MAH of the outcome of CVMP evaluation. The following may be envisaged depending on CVMP’s conclusion:

  • The Recommendation/Condition/SO is fulfilled and no further action is required.
  • The Recommendations/Conditions /SO are fulfilled but additional data are required.
  • The Recommendation/Condition/SO is fulfilled but a variation is needed to implement the conclusion.
  • The variation submission is normally requested within 60 days after adoption of the CVMP conclusion. If the MAH is unable to submit the variation within this timeframe, he must justify the delay and inform the Agency/Rapporteur and propose a new submission date.
  • The Recommendation/Condition/SO is not fulfilled and further data are required.
    The Agency will propose new submission dates that should be agreed with the CVMP for the fulfilment of the concerned Recommendation/Condition/SO.
  • If the fulfilment of a given Recommendation/Condition/SO results in a negative benefit/risk ratio profile of the medicinal product, the Committee will consider the possibility to recommend a suspension or the withdrawal of the Marketing Authorisation / relevant presentation.

Reference:

  • Centralised Procedure, The Rules governing Medicinal Products in the European Union Notice to Applicants,Volume 6A, Chapter 4
6. Can I submit a variation to fulfil Recommendation/Condition/Specific Obligations? Rev. July 2015

Where considered appropriate, MAHs may submit a variation application resulting from the fulfilment of the Recommendations/Condition/SOs at the same time as fulfilling the Recommendations/Condition/SOs.

7. Do I have to pay fees for the Recommendations/Conditions/Specific Obligation data submission? Rev. July 2015

There is no fee payable for Recommendations/Condition/SOs. However, where a variation is requested as a result of Recommendations/Conditions/SOs, the relevant fees will apply.

Reference:

8. Will there be any publication on the outcome of my Recommendations/Conditions/Specific Obligations? Rev. July 2015

The EPAR (published on the EMA website) will be revised, if appropriate, to implement the CVMP conclusions in relation to the SOs.SOs are reflected in the Annex II.E of the Commission Decision and revised product literature will be required (in all languages).

For Recommendations, the outcome is usually not published.

For Conditions listed in Annex II of the Commission Decision, following the fulfilment of such condition, Annex II should be revised at the next procedural opportunity (i.e. a renewal or a variation affecting the Product Information, where and as appropriate).

9. How shall my 5th annual re-assessment be handled?

The fifth annual re-assessment of medicinal products authorised under exceptional circumstances will normally be included as part of the renewal procedure. Therefore, it will not initiate a separate procedure and the renewal timetable will be applied to the 5th annual re-assessment procedure.

Marketing Authorisation Holders are advised to discuss and agree the 5th annual re-assessment submission date with the Agency and the Rapporteur well in advance.

Reference:

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