The frequency of submission shall be in accordance with the conditions specified in the marketing authorisation MA , or otherwise according to the standard submission schedule of PSURs i. CMDh best practic guide Purely nationally authorised medicinal products are considered those which contain substances or a combination of actives substances which are only authorised in one Member State. Upon adoption of the CHMP opinion on the worksharing procedure, the Agency will inform the MAH and Member States concerned if applicable as to whether the opinion is favourable or unfavourable including the grounds for the unfavourable outcome , as well as whether the Commission decision granting the Union marketing authorisations requires any amendments. Worksharing procedure for type-II variations At submission day 0: This aims to harmonise and strengthen benefit-risk review of medicines across the European Economic Area. Timeframe for submission of variation. They shall be submitted by marketing authorisation holders at defined time points during the post-authorisation phase.
This format is a legal requirement for both nationally authorised products and centrally authorised products. The letter should be sent to pa-bus ema. Disagreements should be solved directly with the concerned MS. Where a marketing authorisation is withdrawn, revoked or not renewed, the former marketing authorisation holder is encouraged to continue to collect spontaneous reports of suspected adverse reactions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 changes proposed to the labelling can be based on the reference product information.
Upon finalisation of the ttemplate of the variations subject to the worksharing procedure, the Agency will issue an opinion reflecting the final outcome of the procedure. A template for annex B is available.
To further facilitate the check and assessment, the MAH should present clean and tracked changes Word versions of the RMP in the submission. If the variations subject to worksharing affects the summary of product characteristics SmPClabelling or package leafletthe revised product information annexes must be submitted as follows:.
The submission requirements as set out in the post-authorisation-guidance sections for the different types of variations will also apply to variations subject to worksharingbut the application should be provided as one integrated submission package electronic-common-technical-document [eCTD] sequence per product, covering all variations applied for. These should take into account all EU authorised indications for products containing that active substance or combination of active substances.
Worksharing procedure for multiple centrally authorised medicinal products ‘duplicates’. For CMDh position by majority vote: If nationally authorised medicinal products are part of the templaye procedure, the MAH should also covrr a confirmation yemplate the worksharing applications have been submitted to all Member States where the products concerned are authorised and that the relevant national fees have been paid.
The same general principles as for grouped variations applies. For more information on the EURD list and answers to frequently-asked-questions, see the following document: How useful was this page?
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. The CHMP will appoint a different co- rapporteur to coordinate the re-examination procedure.
For legter relating to the presentation of the application, please contact the Agency. PSURs are pharmacovigilance documents intended to provide an evaluation of the risk-benefit balance of a medicinal product at defined time points after its authorisation. If nationally authorised medical products are tdmplate of the worksharing procedure, relevant product and Member State details should be provided as annex B to the application form using the template for annex B.
Therefore, where the ‘same’ changes to different marketing authorisations vover the submission of individual supportive data sets for each medicinal product concerned, which each require a separate cmdb assessment, such changes will not benefit from worksharing.
Once the translations are received from the MAH, the Agency will check if all Member States’ comments have been implemented. The Quality Review of Documents QRD linguistic check will be performed on one set of annexes of one centrally authorised medicinal product. If considered necessary, an oral explanation can be held within this day timeframe. Any changes not listed will not be considered as part of the variation application.
Also see ‘when do I have to submit revised product information? If amendments are requested by the Agency as a result leter the validation, updated documentation should also be submitted to the MSs. Upon receipt of the final opinion, the Member States concerned shall approve the final opinion, inform the Agency accordingly and where necessary, amend the national marketing authorisations within 60 days. Do not leave sections out, do not update the Annex III, e.
Periodic safety update reports (PSURs) | European Medicines Agency
Day 15 15 days after the position: Annex B includes information on the nationally authorised medicinal products included in the worksharing application if applicable. Reenewal variations approved via a worksharing procedure may be implemented upon receipt of the favourable CHMP opinion. The grounds for the re-examination request must be forwarded to the Agency within 60 days of receipt of the opinion.
Amendments to the SmPC, labelling and package leaflet as a result of the PSUR assessment are implemented without subsequent variation submission for centrally authorised products and through the appropriate variation at national level for nationally authorised products including those reneal through the mutual recognition and decentralised procedures.
They shall be submitted by marketing authorisation holders at defined time points during the post-authorisation phase. The day period may be reduced having regard to the urgency of the matter, particularly for safety issues, or may be extended to 90 days for Type II variations concerning changes or additions to the therapeutic indication.
A shorter presubmission phase lrtter envisaged in cases where: For nationally authorised templatf products eCTD strongly recommened.