The amended German texts are not needed before the national phase is started. 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 outcome , as well as whether the Commission decision granting the Union marketing authorisations requires any amendments. We provide consulting and training regarding eCTD and xEVMPD requirements and support the implementation of electronic submission and tracking systems in the pharmaceutical industry. Worksharing procedure for multiple centrally authorised medicinal products ‘duplicates’ The submission of a formal letter of intent is not required, however applicants are advised to request a WS number from PA-BUS ema. Introduction or changes to the pharmacovigilance system. View all 15 ratings.
A template cover letter for worksharing procedures including centrally authorised products and nationally authorised products only is available. If nationally authorised medicinal products are part of the worksharing procedure, the MAH should also include a confirmation that the worksharing applications have been submitted to all Member States where the products concerned are authorised and that the relevant national fees have been paid. This Page Recommend page. For queries relating to the presentation of the application, please contact the Agency. This applies to all applications for human medicines. The grounds for the re-examination request must be forwarded to the Agency within 60 days of receipt of the opinion. Retweet on Twitter exalon Retweeted.
For queries relating to the presentation of the application, please contact the Agency. Cofer same general principles as for grouped variations applies. This means that the MAH may give written notice to the Agency or CHMP that it wishes to 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. A PDF version of the entire post-authorisation guidance is available: 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 clver new indication for the procedure.
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. Schematic structure of the CHMP opinion and annexes for an application under worksharingconsisting of centrally and nationally authorised medicinal products: This Page Recommend page.
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In such cases, and in cases where any other ongoing procedures may affect the product information annexes, the MAH is advised to contact the Agency in advance of submission or finalisation of the procedure concerned. In the cases where the changes to the product information may vary between products, the product with the most complex changes will generally be the one subject to linguistic check. Examples of changes which would be considered suitable for evaluation under worksharing: References Fees payable to the European Medicines Agency.
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. Complete set of Annexes for all centrally authorised products CAPs electronically only in Word format highlighted. 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.
All the other variations will follow a yearly timeframe for update of the respective Commission decision.
Worksharing: questions and answers
Marketing-authorisation-updating process for nationally authorised medicinal products if applicable. Worksharing procedure for multiple centrally authorised medicinal products ‘duplicates’. Annex A for each centrally authorised medicinal product variatino in the worksharing procedure will be annexed to the CHMP opinion. Worksharing procedures for type-IB variations At submission day 0: The details of the applicant where the invoice should be sent to should be clearly stated in the cover letter.
Clean PDF versions should have all changes ‘accepted’.
Further current information is available on the CMD h Web page:. Retweet on Twitter exalon Retweeted. Expand section Collapse section. 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.
Our services include submission hosting, processing of individual submission documents as well as consultancy in all questions of electronic drug regulatory business. 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 to why the holder believes that a worksharing procedure is suitable, by means of a ‘letter of intent’.
Only one centrally authorised medicinal product will undergo a linguistic check.
If nationally authorised medicinal products are part of the worksharing procedure, the MAH should also include a confirmation that the worksharing applications have been submitted to all Member States where the products concerned are authorised and that the relevant national fees have been paid.
Electronic Common Technical Document. References The linguistic review process of product information in the centralised procedure — Human.
A template cover letter cmdb worksharing procedures including centrally authorised products and nationally authorised products only is available. If Type IA templae 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.
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: