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. Purely national marketing authorisations can be included in worksharing procedures submitted as of 4 August The details of the applicant where the invoice should be sent to should be clearly stated in the cover letter. Paper submissions are not accepted. Where the outcome of the procedure is favourable and the Commission decision granting the marketing authorisation requires amendments, the Agency will inform the Commission accordingly. 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.
The details of the applicant where the invoice should be sent to should be clearly stated in the cover letter. While the first guideline provides detailed operational advice as well as information on the documentation to be submitted, the second provides details of the variation categories i. 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. Based on Articles 7 and 20 of the Variations Regulation, when a group of variations only consists of type-IA or -IA IN variations affecting several marketing authorisations , this is considered as a ‘group’ of variations and not a ‘ worksharing ‘ procedure. The cover letter should include the e-mail address of the person in charge. The letter should be sent to pa-bus ema.
The agreed changes should be included in the annexes of any subsequent regulatory procedures. Upon adoption of the CHMP opinion on lettre 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 outcomeas well as whether the Commission decision granting the Union marketing authorisations requires any amendments. Decision-making process for centrally authorised medicinal products.
The annexes provided should only reflect the changes introduced by the variation concerned. Where at least one of the concerned marketing authorisations has been authorised via the centralised procedurethe Agency will be the ‘reference authority’.
Applications for Marketing Authorisation
If nationally authorised medical products are part of the worksharing procedure, relevant product and Member State details should be provided as annex Lettsr to the application form using the template for annex B. The QRD convention should be followed. Highlighted changes should be indicated via ‘Tools — Track changes’. This Page Recommend page. If the MAH requests that the Committee consult a scientific advisory group in connection with the re-examinationthe cmeh should inform the CHMP as soon as possible.
Based on Articles 7 and 20 of the Variations Regulation, when a group of variations only consists of type-IA or -IA IN variations affecting several marketing authorisationsthis is considered as a ‘group’ of variations and not a ‘ worksharing ‘ procedure. 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.
Worksharing procedure variafion multiple centrally authorised medicinal products ‘duplicates’. Type-II variations listed in Article 23 1a a may only be implemented once the Commission has amended the marketing authorisation and has notified the MAH accordingly.
In case of comments, it will be up to the MAH to correctly implement the same amendments in the other centrally variatiion productsas appropriate. For all worksharing procedures, including those which contain nationally authorised medicinal productsthe ‘high-level’ procedure number should be systematically obtained from the Agency shortly before submission by sending your request with a letter of intent to: Where the outcome of the procedure is favourable and the Commission decision granting the marketing authorisation requires amendments, the Agency will inform the Commission accordingly.
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 to reflect the approved variations within two months, for the variations listed under Article 23 1a a or within one year for the other variations.
A template cover letter for worksharing procedures including centrally authorised products and nationally authorised products only is available. 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 with the rules governing medicinal products in the European Union, volume 2, notice to applicants.
Provisions that extend to Iceland, Liechtenstein and Norway by virtue of the European Economic Area agreement are outlined in the variatiin sections of the text.
In all other cases, a national competent authority chosen by the Coordination Group, taking into account the variayion of the holder, will act as the ‘reference authority’.
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. This page lists questions that marketing-authorisation holders MAHs may have on worksharing.
When submitting the full set of annexes in PDF format, this should be accompanied by the completed formatting checklist and following the user guide on how to generate PDF versions of the product information – human. The CHMP will appoint a different co- rapporteur to coordinate the re-examination procedure. cvoer
Worksharing: questions and answers | European Medicines Agency
Annex B includes information on the nationally authorised medicinal products included in the worksharing application if applicable. 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.
If amendments are requested by the Agency as a result of the validation, updated documentation should also be submitted to the MSs.
Page numbering should start with ‘1’ bottom, centre on the title page of annex I. A template for annex B is available. A letter of intent template is available. The same general principles as for grouped variations applies. 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.
Within 60 days from the receipt of the grounds for re-examinationthe CHMP will consider whether its opinion is to be revised.