Our highly experienced team of regulatory affairs, documentation and IT professionals provides a comprehensive set of services covering all aspects of the electronic drug regulatory affairs business. Worksharing procedure for type-II variations. In principle, identical modules will have to be provided for each product included in the worksharing. Complete set of Annexes for all centrally authorised products CAPs electronically only in Word format highlighted. 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.
This will allow all the involved Parties The Agency, MSs and Committee Members to receive the full data for the worksharing application. Type-II variations approved via a worksharing procedure, which do not require any amendment of the marketing authorisation or which follow a yearly update of the respective Commission decision can be implemented 30 days after receipt of the favourable CHMP opinion. Page numbering should start with ‘1’ bottom, centre on the title page of annex I. References The linguistic review process of product information in the centralised procedure — Human. Examples of changes which would be considered suitable for evaluation under worksharing:. 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 CP , Decentralised Procedures DCP or the Mutual Recognition Procedures MRP. 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.
The lerter of intent should provide the following information: References The linguistic review process of product information in the centralised procedure — Human. Additional examples will be regularly included to reflect accumulated experience. The same general principles as for grouped variations applies. The cover letter should include the e-mail address of the person in charge. A letter of intent template is available.
Heads of Medicines Agencies: Variations
Variations related to safety issues, including urgent safety restrictionsmust be implemented within a timeframe agreed by the marketing authorisation holder and the Agency. Submission to the Rapporteur and Committee members. Where the outcome of the procedure is favourable and the Commission covee granting templats marketing authorisation requires amendments, the Ketter will inform the Commission accordingly.
The letter should be sent to pa-bus ema. Following an expression of interest and based on a rota system, the Chair of the Committee for Medicinal Products for Human Use CHMP will appoint a rapporteur and co-rapporteur when the application includes a new indication for the procedure.
A single decision will be issued for each centrally authorised medicinal product. Only one centrally authorised medicinal product will undergo a linguistic check.
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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 cdh the rules governing medicinal products in the European Union, volume 2, notice to applicants.
Type-II variations approved via a worksharing procedure, which do not require any amendment of the marketing authorisation or which follow a yearly update of the respective Commission decision can be implemented 30 days after receipt of the favourable Variatlon opinion.
Article 23 1a a provides for a two-month timeframe for amending the decision granting the marketing authorisation for the following variations:. The following remarks may be helpful: The grounds for the re-examination request must be forwarded to the Agency within 60 days of receipt of the opinion.
Marketing Authorisation Holders are advised to submit such variations as usual. Revised topics are marked ‘New’ or ‘Rev.
Heads of Medicines Agencies: Variation
Worksharing procedures vsriation type-IB variations. Where applicable changes in Word documents should be indicated using ‘Tools-Track Changes’. Worksharing procedure for multiple centrally authorised medicinal products ‘duplicates’. Templahe 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 procedure together with a short overview of all medicinal products concerned, with their respective rapporteursRMSs and national competent authorities, as applicable, as well as an overview of the submission format for the different products, if applicable e.
Changes to a single-substance MA and a fixed-combination MA containing the same active substance. This will allow the Agency and the national competent authorities to update the dossier of each marketing ,etter included in the worksharing procedure with the relevant amended or new information.
The dossier requirements for post-authorisation submissions in the centralised procedure should be followed. Annex B includes information on the nationally authorised medicinal products included in the worksharing application if applicable. In case of comments, it will be up to the MAH to correctly implement the same amendments in the other centrally authorised productsas appropriate. This means that the MAH may give written lteter to the Agency or CHMP that it wishes cpver request a re-examination within 15 days of receipt of the opinion after which, if it does not appeal, the opinion will be considered final.
Worksharing procedures have to be applied for at the CMD h.
Worksharing: questions and answers
The details of the applicant where the invoice should be sent to should be clearly stated in the cover letter.
Also see ‘when do I have to submit revised product information? We provide consulting and training regarding eCTD and xEVMPD requirements and support the implementation of electronic submission and tracking systems in the pharmaceutical industry.
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. Veterinary regulatory Overview Research and development Marketing authorisation Post-authorisation.