Upon finalisation of the review of the variations subject to the worksharing procedure, the Agency will issue an opinion reflecting the final outcome of the procedure. However, in exceptional cases non-critical deviations may be considered on a case-by-case variation. Any documentation submitted should either be accompanied by an letter or as research paper about teenage drug addiction to an existing application. This will allow the Agency and the national competent authorities to update the dossier of each marketing authorisation included in the worksharing procedure with the relevant amended or new information. Therefore, where the ‘same’ changes to different marketing authorisations require the submission of individual supportive data sets for each medicinal product concerned, which each require a separate product-specific assessment, such changes will not benefit from worksharing. The details of the applicant where the invoice should be sent to should be clearly stated in the cover letter. 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.
The dossier requirements for post-authorisation submissions in the centralised procedure should be followed. Worksharing procedure for type-II variations. 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. 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. 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. If the variations subject to worksharing affects the summary of product characteristics SmPC , labelling or package leaflet , the revised product information annexes must be submitted as follows:.
Heads of Medicines Agencies: Applications for MA
In order to facilitate the planning of a worksharing procedure, MAHs are advised to inform the Agency at least two months in advance of the submission of a variation or group of variations to be subject to a worksharing procedure, together with an explanation as covwr why leter holder believes that a worksharing procedure is suitable, by means of a ‘letter of intent’.
Worksharing procedures for type-IB variations At submission day 0: Such applications may be required letter the product in letter compliance with the details of the marketing authorisation cannot be sourced for a short, defined period of cmdh maximum of 6 months. The annexes provided should only reflect the changes introduced by the variation concerned. The response from the Agency on the acceptability of the worksharing application, further to the variatin of the letter of intent should be attached to the application form.
Within 60 days from the receipt of the grounds for re-examinationthe CHMP will consider whether its opinion is to be revised. Subsequently, the Agency will initiate the Rapporteur appointment procedure. Other submission types e. References The linguistic review process of product information lette the centralised procedure — Human. Skip to main content.
Worksharing: questions and answers
Variations related to safety issues, including urgent safety restrictionsmust be implemented cmh a timeframe agreed by the marketing authorisation holder and the Agency. In such cases, and in cases where any other ongoing procedures may affect the product information annexes, cvoer MAH is advised to contact the Agency in advance of submission or finalisation of the procedure concerned.
Worksharing procedure for type-II variations At submission day 0: For variations that affect annex A e. A shorter presubmission phase is envisaged in cases where: 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. The applicant must ensure that the approval letter where applicable from another member stated pertains to the variation being submitted, that is, lettr scope of the variation must be covered [URL] the approval letter.
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 variztion the proposed worksharing and grouping if applicable in the ‘precise scope and background’ section of the application form.
New variations regulation: Regulatory and procedural guidance | European Medicines Agency
The box containing the Cover Letter should cmdh easily identified. Examples of changes which would be considered suitable for evaluation under worksharing:. Annex A for each centrally authorised medicinal product included in the worksharing procedure will be annexed to the CHMP opinion. Placebo samples rather than drug containing samples should be submitted: Where applicable, revised product information Annexes including Annex A, if applicable should be included in electronic Word and PDF format in the same eSubmission Gateway or eSubmission Web Client package within a folder called ‘working documents’.
Only the worksharing applicant will be invoiced for the worksharing procedure. In principle, identical modules will have to be provided for each product included in the worksharing. Applicants belonging to the same mother company or group of companies and applicants having mcdh 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.
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. In order to avoid duplication of work in the evaluation of such variationsa worksharing procedure has been established under which one authority the ‘reference authority’chosen amongst the competent authorities of the Member States and the Agency, will examine the variation on behalf of the other concerned authorities.
If considered necessary, an oral explanation can be held within this day timeframe. However, in exceptional cases non-critical deviations may be considered on a case-by-case variation. For nationally authorised medicinal products eCTD strongly recommened. The CHMP will appoint a different co- rapporteur to coordinate the re-examination procedure. 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 outcomeas well as whether the Commission decision granting the Union marketing authorisations requires any amendments.
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. Any changes not listed will not be considered as part of the variation application.
The worksharing application must be submitted at the same time to all relevant authorities, i. Also see ‘when do I have to submit revised product information?