Marketing-authorisation-updating process for nationally authorised medicinal products if applicable. Any information included in this section, will be discussed by the CMDh for nationally authorised products with the aim of agreeing on any necessary action, which will then be transmitted to MAHs either in the CMDh minutes or as a press release dependent on the issue. For variations that affect annex A e. If considered necessary, an oral explanation can be held within this day timeframe. The Agency applies the existing post-opinion timeframes, as set-out in the linguistic review process of product information in the centralised procedure — human. Any changes not listed will not be considered as part of the variation application.
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. It addresses specific challenges in the EU single assessment procedure for nationally authorised products , but the issues may also apply to centrally authorised products: One completed electronic EU variation application form, listing all medicinal products concerned and declaring all variations included in the group in the section ‘type of changes’, as well as a justification for the proposed worksharing and grouping if applicable in the ‘precise scope and background’ section of the application form. For more details on how to submit amendments to the list, please refer to the EURD list cover note sections 2 and 5. Where the procedure includes only NAPs, the procedure ends with the CMDh position in case of consensus and in case of a majority vote, the CMDh position will be followed by a Commission decision CD to the Member States, which respectively have to be implemented according to the timetable indicated in the CMDh position or within 30 days of the CD receipt by the Member States. 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.
Skip to main content. The MAH will be informed accordingly.
Heads of Medicines Agencies: Applications for MA
The EMA will check at the beginning of the procedure whether the submission of an RMP has been correctly performed in accordance to the above criteria. Marketing-authorisation-updating process for nationally authorised medicinal products if applicable. Depending on the date of the EC decision on the revocation or withdrawal, or the date of expiry of the marketing authorization tfmplate case of non- renewalmarketing authorisation holders may still be required to submit a PSUR:.
This affects all PSURs irrespective whether they are for centrally or nationally cdh medicinal products and whether they follow the EU single assessment or purely national PSUR procedure. Article 23 1a a provides for a two-month timeframe for amending the decision granting the marketing authorisation for the following variations:.
Human regulatory Overview Research and development Marketing authorisation Post-authorisation Herbal products. Applicants belonging to the same mother company or group of companies and applicants having concluded agreements or exercising concerted practices concerning the placing on the market of the medicinal products concerned, have to be taken as ‘the same MAH’ 1.
Additionally, product information should be kept up-to-date by the MAH by submitting the appropriate variations taking account of the latest scientific knowledge or conclusions of assessments and recommendations made public by means of the EMA and national competent authority websites.
Points highlighted in this document may nevertheless also apply to the assessment of centrally authorised products and hence it is recommended that all MAHs consult the document prior to finalisation of their PSUR. Once the translations are received from the MAH, the Agency will check if all Member States’ comments have been implemented. You will be able to contact the RMS throughout the procedure. For centrally authorised products interim results not impacting on the product information or on the condition as stated in the Annex II of the marketing authorisation can be submitted as a post-authorisation measure PAM as described in question How and to whom shall I submit my PAM data see Post-authorisation measures: Please note that late submissions can no longer be accepted once the procedure has started.
Unless otherwise requested by competent authorities, the marketing authorisation holder shall prepare a single PSUR for all its medicinal products containing the same active substance with information covering all the authorised indicationsroute of administrationdosage forms and dosing regiments, irrespective of whether authorised under different names and through separate procedures.
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.
Only the worksharing applicant will be invoiced for the worksharing procedure. The response from the Agency on the acceptability of the worksharing application, further to the submission of the letter of intent should be attached to the application form. The worksharing application must be submitted at the same time to all relevant authorities, i.
The PSUR is not the appropriate procedure for submitting final or interim study reports to the EU regulatory authorities. Start of the procedure according to the published timetable. 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. Variations related to safety issues, including urgent safety restrictionsmust be implemented within a timeframe agreed by the marketing authorisation holder and the Agency.
In principle, identical modules will have to be provided for each product included in the worksharing.
Worksharing procedure for type-II variations At submission day 0: The Agency will allocate a ‘high-level’ cross-products procedure number, which will be used for the handling of worksharing procedures affecting more than one medicinal product.
Of note, MAHs cannot use the information and data contained in the submissions for any other purposes than those related to the concerned procedure. If the above does not apply, the updated RMP should be submitted as a stand-alone variation.
Periodic safety update reports (PSURs)
Within 60 days from the receipt of the grounds for re-examinationthe CHMP will consider whether its opinion is to be revised. These questions and answers have been produced for guidance only and should be read in conjunction with the rules governing medicinal products in the European Union, volume 2, notice to applicants. In such case, only the amended parts of the SmPC and package leaflet should be provided in track changes and in English language under the EU regional appendix.
For nationally authorised medicinal products i. Any amendment to the EURD list becomes effective six months after its publication. Quality Changes to the active-substance master file. The information and data contained in the individual submissions will be assessed and reflected in the single assessment report.