If the above does not apply, the updated RMP should be submitted as a stand-alone variation. For more details on how to submit amendments to the list, please refer to the EURD list cover note sections 2 and 5. However, they shall provide case narratives in the relevant risk evaluation section of the PSUR where integral to the scientific analysis of a signal or safety concern in the relevant risk evaluation section. If the date is after the submission deadline specified in the EURD list , submission is mandatory irrespective of whether the date is before or after the start date of the procedure. The information and data contained in the individual submissions will be assessed and reflected in the single assessment report. Marketing authorisation holders are not required to systematically include listings of individual cases, including case narratives, in the PSUR. The PSUR should focus on summary information, scientific assessment and integrated benefit-risk evaluation.

The EURD list facilitates the harmonisation of DLPs and frequency of submission of PSURs for medicinal products containing the same active substance or the same combination of active substances subject to different marketing authorisations , authorised in more than one Member State. PSURs and any related submissions using the existing file naming conventions are no longer possible. MAHs or national competent authorities can request the inclusion of the fixed combination in the EURD list for reasons related to public health, in order to avoid duplication of assessment or in order to achieve international harmonisation. It is important that changes proposed to the product information which are based on the submitted PSUR data are not submitted in parallel via a separate variation procedure. The MAH s will implement the required changes.

Where the proposed changes are not based on the data submitted within the PSUR, these will not be considered and a variation will have to be submitted as appropriate to the relevant national competent authority. Start of the procedure according to the published letter. For more details on PSUR submissions for generics, products containing well-established substances, homeopathic or herbal medicinal productsplease refer to the question Do I have to submit a PSUR my medicinal product if it is a generic, a product containing a well-established substance, a homeopathic or herbal medicinal product?

The European Union reference date EURD corresponds to the date of the first or the earliest known date of the marketing authorisation in the EU of a medicinal product containing the active substance or combination of active substances.

cover letter renewal cmdh

Day 1 — 14 1 to 14 days after position: Depending on the date of the EC decision on the revocation or withdrawal, or ,etter date of expiry of the marketing authorization in case of non- renewalmarketing authorisation holders may still be required to submit a PSUR: In case of a CMDh position by consensusthe Agency will compile the Annexes in all languages, send the final copies to the Member States and, where applicable, the full set of Annexes will be published on the EMA website.


For more information on the EURD list and answers to frequently-asked-questions, see the following document: The explanatory note highlights and addresses challenges specific to the EU single assessment for nationally authorised products.

Submission and assessment is expected to take place at national level and, as necessary, be coordinated across the Member States. This should be clearly discussed in both the rsnewal and actions section of the body of the PSUR as well as in fmdh EU regional appendix. The submission requirements for responses to requests for supplementary information are the same as those for the submission of the PSURs.

For the submission of responses to the PSUR Repository, the xml delivery file is filled in the same way as the original PSUR submission apart from the selection of ‘response’ as a regulatory activity submission unit. The Agency will monitor the quality of the translations, the review by the Member States and industry’s compliance with the Member States’ comments as part of the Performance Indicators. National competent authorities can also request PSUR for generic medicinal products at any time on the grounds detailed in Article c 2 of the Directive.

Once the translations are received from the MAH, the Agency will check if all Member States’ comments have been implemented.

Renewal Procedure

Where a marketing authorisation is withdrawn, revoked or not renewed, the former marketing authorisation holder is encouraged to continue to collect spontaneous reports of suspected adverse reactions occurring in the EU see GVP Module VI to, for example, facilitate review of delayed onset adverse reactions or of retrospectively notified cases of adverse reactions.

The request and its grounds should be considered by the PRAC and the CHMP if it concerns at least one marketing authorisation granted in accordance with the centralised procedure or the CMDh otherwise, which will either approve or deny the request. The MAH is expected to provide, as applicable, by Day They, however, remain part of the Commission Decision in the Community Registry on the Commission’s webpage. The fee will be due to the EMA within 30 calendar days from the date of the invoice.


Heads of Medicines Agencies: Applications for MA

Standards of translation of Annexes The structure of the English Annexes has to be strictly followed and should be exactly translated as per the adopted English version i. Expand section Collapse section. Use of the PSUR repository is mandatory for both centrally and nationally authorised medicines, whether they follow the EU single assessment or a purely national assessment procedure. After the translation process Once the translations are received from the MAH, the Agency will check if all Member States’ comments have been implemented.

It is the responsibility of the marketing authorisation holder to check regularly the list of EU reference dates and frequency of submission published in the European medicines web-portal to ensure compliance with the PSUR reporting requirements for their medicinal products.

In this communication the MAH should indicate whether they would wish to make use of the opportunity of an oral explanation to defend their position before the PRAC.

cover letter renewal cmdh

If a parallel importer receives a notification of an adverse drug reaction from a patient, a doctor or any other source, the parallel importer should inform this person that the adverse drug reactions should be reported directly to the MAH of the medicinal product concerned.

Procedures that contain centrally authorised products CAP s. No specific template needs to be followed for the responses to the request for supplementary information RSI. Following receipt of the final compiled translations, the Commission will start the day Standing Committee consultation, addressing only legal and public health matters which means in principle no further linguistic review.

The clinical overview submitted in the renewal application should include relevant information to support the benefit-risk re-evaluation of the medicinal product. You should type the full details of your query in the appropriate space.

Periodic safety update reports (PSURs)

In case of incomplete or incorrect data in the web form, the request may not be processed. At start of the procedure, the invoice will be sent to each MAH with the relevant chargeable units calculation.

Timeframe for submission of variation.