For these active substances , the frequency of submission is established at national level. The changes proposed to the labelling can be based on the reference product information. Leave this field blank. Where nationally authorised medicinal products are part of the worksharing , the same application as submitted to the Agency should be submitted to all Member States, even if some products are not relevant to some MSs. In the latter case, a justification should be provided for the appropriate language s stating why certain comments are not reflected in the final texts.
It provides an overview of the European Medicines Agency’s position on issues that are typically addressed in discussions or meetings with MAHs in the post-authorisation phase. Veterinary regulatory Overview Research and development Marketing authorisation Post-authorisation. Human regulatory Overview Research and development Marketing authorisation Post-authorisation Herbal products. For more information on GVP modules, see Good pharmacovigilance practices. To further facilitate the check and assessment, the MAH should present clean and tracked changes Word versions of the RMP in the submission. Upon receipt of a favourable CHMP opinion that requires amendments to the decision granting the marketing authorisation , the Commission shall amend the marketing authorisation for each centrally authorised medicinal product to reflect the approved variations within two months, for the variations listed under Article 23 1a a or within one year for the other variations. The grounds for the re-examination request must be forwarded to the Agency within 60 days of receipt of the opinion.
Submission to the National Competent Authorities Where nationally authorised medicinal products are part of the worksharingthe same application lettfr submitted to the Agency should be submitted to all Member States, even if some products are not relevant to some MSs. Regarding centrally authorised productsthe marketing status should also be provided as a stand-alone report through the relevant mailbox and using the dedicated template as indicated in the EMA Post-authorisation Guidance on ‘marketing and cessation notification’ — What is the reporting format to the agency and to whom to report.
For more details on how to submit amendments to the list, please refer to the EURD petter cover note sections 2 and 5. Changes to a single-substance MA and a fixed-combination MA containing the same active substance. The list overrules the ‘standard’ PSUR submission cycle and any conditions related to the frequency of PSUR submission included in a marketing authorisation.
In case of CMDh position by consensus, Member States may perform a voluntary linguistic review in the translation process, therefore the following timelines apply: 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.
Periodic safety update reports (PSURs)
This will allow all the involved Parties The Agency, MSs and Committee Members to receive the full data for the worksharing application. Lwtter B includes information on the nationally authorised medicinal products included in the worksharing application if applicable.
From 1 Marchthe use of the eSubmission Gateway or web client is mandatory for all electronic Common Technical Document eCTD submissions through the centralised procedure. If nationally authorised medical products are part 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.
However PSURs should be submitted as specified in the conditions of the marketing authorisation for the combination product if anyor otherwise according to the standard submission cycle i.
For generic products or others not directly involved in the PSUSA procedure itself, the changes have to be submitted via a variation procedure according to the timelines indicated in the table below.
For translations of Annexes QRD templates for each language should be used Make sure that the title pages are adjusted and all brackets i. It addresses specific challenges in the EU single assessment procedure for nationally authorised productsbut the issues may also apply to centrally authorised products: References Fees payable to the European Medicines Agency.
Provisions that extend to Iceland, Liechtenstein and Norway by virtue of the European Economic Area agreement are outlined in the relevant sections of the text. Expand section Collapse section.
Heads of Medicines Agencies: Renewal
If considered necessary, an oral explanation can be held within this day timeframe. 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.
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. When submitting the full set of annexes in PDF format, this should be accompanied by the completed formatting checklist and following the user guide on how to generate PDF versions of the product information – human.
In order to benefit from a worksharing procedure, it is required that the same changes will apply to the different medicinal products concerned, with either no or limited need for assessment of a potential product-specific impact.
Upon receipt of the final opinion, the Member States concerned shall approve the final opinion, inform the Agency accordingly ttemplate where necessary, amend the national marketing authorisations within 60 days. The fee will be due to the EMA within 30 calendar days from the date of the invoice.
Information on the outcome of centrally reneewal medicinal products is made available in the European Public Assessment Report EPAR page of the relevant medicine. For variations that affect annex A e.
Where a marketing authorisation is withdrawn, vmdh or not renewed, the former lettter 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. It is the responsibility of the marketing authorisation holder to check regularly the list of EU reference dates and frequency of submission rehewal in the European medicines web-portal to ensure compliance with the PSUR reporting requirements for their medicinal products.
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. Highlighted changes should be indicated via ‘Tools — Dover changes’.
Complete set of Annexes for all centrally authorised products CAPs electronically only in Word format highlighted.
Once the translations are received from the MAH, the Agency will check if all Member States’ comments have been implemented.
Worksharing: questions and answers | European Medicines Agency
However as the reference product information might be different for the various EU product informationit is essential that the MAH considers the proposed changes for the reference product information in the context of the different EU product information for the products covered by the submitted PSUR.
This will include a cover letter and electronic application form, together with separate supportive documentation for each medicinal product concerned and revised product information if applicable for each medicinal product concerned.
Start of the procedure according to the published timetable. Veterinary regulatory Renewa, Research and development Marketing authorisation Post-authorisation.