The agreed changes should be included in the annexes of any subsequent regulatory procedures. In all other cases, a national competent authority chosen by the Coordination Group, taking into account the recommendation of the holder, will act as the ‘reference authority’. An automated acknowledgement email is sent from the system confirming whether the submission has passed the relevant technical validation criteria and whether it has been uploaded to the Agency’s review tool and made available via the Common Repository. Article 23 1a a provides for a two-month timeframe for amending the decision granting the marketing authorisation for the following variations:. Within 60 days from the receipt of the grounds for re-examination , the CHMP will consider whether its opinion is to be revised.
If considered necessary, an oral explanation can be held within this day timeframe. This applies to all applications for human medicines. Human regulatory Overview Research and development Marketing authorisation Post-authorisation Herbal products. Submission to the Rapporteur and Committee members. All the other variations will follow a yearly timeframe for update of the respective Commission decision. Worksharing procedure for type-II variations.
The grounds for the re-examination request must be forwarded to the Agency within 60 days of receipt of the opinion.
A template cover letter for worksharing procedures including centrally authorised products and nationally authorised products only is available. Extensions are excluded from worksharing. Introduction or changes to the pharmacovigilance system. Purely national marketing authorisations can be included in worksharing procedures submitted as of 4 August A PDF version of the entire post-authorisation guidance is available: In order to facilitate the planning of a worksharing procedure, MAHs dover advised to inform the Agency at least two months in advance of the submission cver a variation or group of variations to be subject to a worksharing procedure, together with an explanation as to why the holder believes that a worksharing procedure is suitable, by means of a ‘letter of intent’.
Article 23 1a a provides for a two-month timeframe for amending coverr decision granting the marketing authorisation for the following variations:.
Worksharing: questions and answers | European Medicines Agency
Where applicable, covet 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’.
Article 23 1a a provides for a two-month timeframe for amending the decision granting the marketing authorisation for the following variations: Questions and answers relating to practical and technical aspects of the implementation and the eSubmission Gateway web client: In order to avoid duplication of work in the evaluation of such variationsa covet 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.
Worksharing procedures for type-IB variations. If nationally variatiom medical products are part of the vraiation procedure, relevant product and Member State details should be provided as annex B to the application form using the template for annex B. Also see ‘when do I have to submit revised product information?
The Agency applies the existing post-opinion timeframes, as set-out in the linguistic review process of product information in the centralised procedure — human.
Such opinions will also list any variations e. The QRD convention should be followed. Human regulatory Overview Vagiation and development Marketing authorisation Post-authorisation Herbal products. Marketing-authorisation-updating process for nationally authorised medicinal products if applicable. Decision-making process for centrally authorised medicinal products. Where nationally authorised medicinal products are part covdr the worksharingthe same application as submitted to the Agency should be submitted to all Member States, even if some products are not relevant to some MSs.
Heads of Medicines Agencies: Variations
Schematic structure of the CHMP opinion and annexes for an application under worksharingconsisting of centrally and nationally authorised medicinal products: Page numbering should start with ‘1’ bottom, centre on the title page of annex I. Worksharing procedures have to be applied for at the CMD h. Expand section Collapse section.
If considered necessary, an oral explanation can be held within this day timeframe. Supporting documentation for each product including the revised summary of product characteristicslabelling and package leafletif applicable. For information lettrr the fees applicable for worksharing applications, please refer to fees payable to the European Medicines Agency.
Clean PDF versions should have cober changes ‘accepted’. In all other cases, a national competent authority chosen by the Coordination Group, taking into account the recommendation of the holder, will act as the ‘reference authority’.
Where the outcome of the procedure is favourable and the Commission decision granting the marketing authorisation requires amendments, the Agency will inform the Commission accordingly. One completed electronic EU variation application form, listing all medicinal products variqtion 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.
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Refer to the eCTD variations question-and-answer document for cmdb on the submission of variations in eCTD format. The amended German texts are not needed before the national phase is started. This will allow all the involved Parties The Agency, MSs and Committee Members to receive the full data for the worksharing application.