The details of the applicant where the invoice should be sent to should be clearly stated in the cover letter. 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’. 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. Retweet on Twitter exalon Retweeted. For variations that affect annex A e.
The QRD convention should be followed. 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 procedure together with a short overview of all medicinal products concerned, with their respective rapporteurs , RMSs and national competent authorities, as applicable, as well as an overview of the submission format for the different products, if applicable e. 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’. Where at least one of the concerned marketing authorisations has been authorised via the centralised procedure , the Agency will be the ‘reference authority’. Changes to a single-substance MA and a fixed-combination MA containing the same active substance.
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’. Schematic structure of the CHMP opinion and annexes for an application under worksharingconsisting of centrally and nationally authorised medicinal products: Annex B includes information on the nationally authorised medicinal products included in the worksharing application if applicable.
Only the worksharing applicant will be invoiced for the worksharing procedure.
If considered necessary, an oral explanation can be held within this day timeframe. Page numbering should start with ‘1’ bottom, centre on the title page of annex I.
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Heads of Medicines Agencies: Applications for MA
Navigation and service Go to: References The linguistic review process coveer product information in the centralised procedure — Human. See grouping of coover Two Commission guidelines have been issued in connection with the a. Such opinions will also list any variations e. The details of the applicant where the invoice should be sent to should be clearly stated in the cover letter.
Alternatively, such a listing may be provided as a separate document attached to the application form. Grouped variations can be subject to a worksharing procedure, provided that the same group of variations applies to all medicinal products concerned by the worksharing procedure. Not a very wise move: Highlighted changes should be indicated via ‘Tools — Track changes’.
Annex A for vxriation centrally authorised medicinal product included in the worksharing procedure will be annexed to the CHMP opinion.
A new procedure code abbreviation is used for worksharing procedures i. 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.
Decision-making process for centrally authorised medicinal products. 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.
Paper submissions are not accepted. 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 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.
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. Worksharing procedures for type-IB variations. This applies to all applications for human medicines. Marketing Authorisation Holders are advised to submit such variations as usual.
The grounds for the re-examination request must be forwarded to the Agency within 60 days of receipt of the opinion. Submission to the National Competent Authorities 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. Only one centrally authorised medicinal product will undergo a linguistic check.
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.
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.
In general, variations submitted for worksharing will follow the day evaluation timetable of Type II variations and weekly-start timetables may apply to the assessment following the same principles as those applied to the assessment of Type II variations. For information on the fees applicable for worksharing applications, please refer to fees payable to the European Medicines Agency.
The worksharing application must be submitted at the same time to all relevant authorities, i. The complete set of annexes must be presented sequentially i.