Proposal for combination use affecting both MAs. Marketing Authorisation Holders are advised to submit such variations as usual. 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:. View all 15 ratings. In principle, identical modules will have to be provided for each product included in the worksharing. This applies to all applications for human medicines.
In order to avoid duplication of work in the evaluation of such variations , a 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. 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. For a full overview of dossier requirements for National Competent Authorities of Co- Rapporteur and Committee members, including delivery addresses, please refer to the following document: Submission to the National Competent Authorities Where nationally authorised medicinal products are part of the worksharing , the same application as submitted to the Agency should be submitted to all Member States, even if some products are not relevant to some MSs. Retweet on Twitter exalon Retweeted.
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 Covdr, will examine the variation on behalf of the other concerned authorities.
If the variations subject to worksharing affects the summary of product characteristics SmPClabelling or package leafletthe revised product information annexes must be submitted as follows: 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.
Applications for Marketing Authorisation
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.
For variations that affect annex A e. MAHs must in all cases comply with the requirements of Community legislation.
Skip to main content. Revision of test method for the active substance. See grouping of variations: Paper submissions are not accepted. 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.
Introduction or changes to the pharmacovigilance system. If Type IA or IB variations include alterations of the German texts, submit highlighted and clean versions along with the initial application; this applies to electronic submissions as well see the AMG -Submission Ordinance. Annex A for each centrally authorised medicinal product included in the worksharing procedure will be annexed to the CHMP opinion.
Welcome to Exalon Your partner for high quality eCTDs, regulatory submission services and EVMPD support 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. Quality Changes to the active-substance master file.
Heads of Medicines Agencies: Variations
The agreed changes should be included in the annexes of any subsequent regulatory procedures. Changes to a single-substance Variatuon and a fixed-combination MA containing the same active substance.
Further current information is available on the CMD h Web page:. It provides an overview of the European Medicines Variatiln position on issues that are typically addressed in discussions or meetings with MAHs in the post-authorisation phase. This page lists questions that marketing-authorisation holders MAHs may have on worksharing. The complete set of annexes must be presented sequentially i.
The grounds for the re-examination request must be forwarded to cver Agency within 60 days of receipt of the opinion. The CHMP will appoint a different co- rapporteur to coordinate the re-examination procedure. A template for annex B is available.
All the other variations will follow a yearly timeframe for update of the respective Commission decision. Where at least one of the concerned marketing authorisations has been authorised via the centralised procedurethe Agency will be the ‘reference authority’.
Upon receipt of the final opinion, the Member States concerned shall approve templatte final opinion, inform the Agency accordingly and where necessary, amend the national marketing authorisations within 60 days. For queries relating to the presentation of the application, please contact the Agency. Navigation and service Go to: Our services include submission hosting, processing of individual submission documents as well as consultancy in all questions of electronic drug regulatory business.
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. Only one centrally authorised medicinal product will undergo a linguistic check.
Where nationally authorised medicinal products are part of 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. 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.
Further current information is available on templste CMD h Web page: