Where applicable, revised 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’. Icelandic and Norwegian language versions must always be included. How useful was this page? Decision-making process for centrally authorised medicinal products. MAHs must in all cases comply with the requirements of Community legislation. 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.
References The linguistic review process of product information in the centralised procedure — Human. 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. Applicants belonging to the same mother company or group of companies and applicants having concluded agreements or exercising concerted practices concerning the placing on the market of the medicinal products concerned, have to be taken as ‘the same MAH’ 1. Supporting documentation for each product including the revised summary of product characteristics , labelling and package leaflet , if applicable. 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.
Applications for Marketing Authorisation
The letter should be sent to pa-bus ema. 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.
If the MAH requests that the Committee consult a scientific advisory group in connection with the re-examinationcmvh applicant should inform the CHMP as soon as possible. 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 coved reflect the approved variations within two months, for the variations listed under Article 23 1a a or within one year for the other variations.
However, in exceptional cases where MAHs take the opportunity to introduce minor linguistic amendments in the texts e. The complete set of annexes must be presented sequentially i. The worksharing application must be submitted at the same time to all relevant authorities, i. The cover letter should include the e-mail address of the person in charge.
The response from the Agency on the acceptability of the worksharing application, further to the submission of the letter of intent should be attached to the application form.
BfArM – Variations – Submission of Variations
Where a worksharing application is considered invalid i. For all worksharing procedures, including those which contain nationally authorised medicinal productsthe vairation procedure number should be systematically obtained from the Agency shortly before submission by vafiation your request with a letter of intent to: Subsequently, the Agency will initiate the Rapporteur appointment 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.
See grouping of variations: This means that the MAH may give written notice to the Agency or CHMP that it wishes to request cmhd re-examination within 15 days of receipt of the opinion after which, if it does not appeal, the opinion will be considered final. A template for annex B is available.
Worksharing: questions and answers
Upon finalisation of the review of the variations subject to the worksharing procedure, the Agency will issue an opinion reflecting the final outcome of the procedure. Worksharing procedures have to be applied for at the CMD h. Annex B includes information on the nationally authorised medicinal products included in the worksharing application if applicable. Revised topics are marked ‘New’ or ‘Rev. 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’.
Alternatively, such a listing may be provided as a separate document attached to the application form. Complete set of annexes of one CAP electronically only in Word format highlighted. Where applicable changes in Word documents should be indicated using ‘Tools-Track Changes’.
Questions and answers relating to practical and technical aspects of the implementation and the eSubmission Gateway web client: The same general principles as for grouped variations applies. Icelandic and Norwegian language versions must always be included. Provisions that extend to Iceland, Liechtenstein and Norway by virtue of the European Economic Area agreement are outlined in the relevant sections of the text.
A shorter presubmission phase is envisaged in cases where: Clean PDF versions should have all changes ‘accepted’. Skip to main content.
For information on the fees applicable for worksharing applications, please refer to fees payable to the European Medicines Agency. The dossier requirements for post-authorisation submissions in the centralised procedure should be followed. Submission to the Rapporteur and Committee members. Page numbering should start with ‘1’ bottom, centre on the title page of annex I.