Annex B includes information on the nationally authorised medicinal products included in the worksharing application if applicable. From 1 March , the use of the eSubmission Gateway or web client is mandatory for all electronic Common Technical Document eCTD submissions through the centralised procedure. View all 15 ratings. An electronic copy containing the relevant eCTD sequence for each product, should be submitted to the Agency. Retweet on Twitter exalon Retweeted.
Where a worksharing application is considered invalid i. Worksharing procedures for type-IB variations. In the variation application form, use the full German name of the medicinal product as it is authorised, and indicate the German marketing authorisation holder as well as the Germanmarketing authorisation number. 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. 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. A shorter presubmission phase is envisaged in cases where:
The letter should be sent to pa-bus ema. 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. Clean PDF versions should have all changes ‘accepted’.
This new Variation Regulation establishes new rules for the examination of variations to the terms of marketing authorisations for medicinal products for human use and veterinary medicinal products, granted in Centralised Procedures CPDecentralised Procedures DCP or the Mutual Recognition Procedures MRP. The Agency applies the existing post-opinion timeframes, as set-out in the linguistic review process of product information in the centralised procedure — human.
View all 15 ratings. The dossier requirements for post-authorisation submissions in the centralised procedure should be followed.
This applies to all applications for human medicines. European Medicines Agency post-authorisation procedural advice for users of the centralised procedure 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.
The MAH will be informed accordingly. Examples of changes which templare be considered suitable for evaluation under worksharing:. This will allow all the involved Parties The Agency, MSs and Committee Members to receive the full data for the worksharing application.
Any changes not listed will not be considered as part of the variation application. Xover the outcome of the procedure is favourable and the Commission decision granting the marketing authorisation requires amendments, the Agency will inform the Commission accordingly. Gemplate Quality Review of Documents QRD linguistic check will be performed on one set of annexes of one centrally authorised medicinal product. One original cover letter addressed to the Agency and national competent authorities, if nationally authorised medicinal products are part of the worksharing procedure, clearly indicating that the application is submitted for a worksharing temllate together with a short overview of cocer medicinal products concerned, with letteg respective rapporteursRMSs and national competent authorities, as applicable, as well as an overview of the submission format for the different products, if applicable e.
The cover letter should include the e-mail address of the person in charge. Retweet on Twitter exalon Retweeted. An electronic copy bariation the relevant eCTD sequence for each product, should be submitted to the Agency. Alternatively, such a listing may be provided as a separate document attached to the application form.
This page lists questions that marketing-authorisation holders MAHs may have on worksharing. For all worksharing procedures, including those which contain nationally authorised medicinal productsthe ‘high-level’ procedure number should be systematically obtained from the Agency shortly before submission by sending your request with a letter of intent to: Upon receipt of a favourable CHMP opinion that requires amendments to the decision granting the marketing authorisationthe 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.
Heads of Medicines Agencies: Variations
Also variahion ‘when do I have to submit revised product information? A single decision will be issued for each centrally authorised medicinal product. Type-IB variations te,plate via a worksharing procedure may be implemented upon receipt of the favourable CHMP opinion. Type-II variations listed in Article 23 1a a may only be implemented once the Commission has amended the marketing authorisation and has notified the MAH accordingly.
Decision-making process for centrally authorised medicinal products Upon receipt of a favourable CHMP opinion that requires amendments to the decision granting the marketing authorisationthe 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 te,plate variations.
Submission to the Rapporteur and Committee members. Letyer the variations subject to worksharing affects the summary of product characteristics SmPClabelling or package leafletthe revised product information annexes must be submitted as follows: 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.
BfArM – Variations – Submission of Variations
Only the worksharing applicant will be invoiced for the worksharing procedure. The submission requirements as set out in the post-authorisation-guidance sections for lftter 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. Questions and answers relating to practical and technical aspects of the implementation and the eSubmission Gateway web client: Electronic Common Technical Tmeplate.
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.