Alternatively, such a listing may be provided as a separate document attached to the application form. The MAH must submit the variation application for worksharing at the latest by the recommended submission dates published under submission dates. 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. The Agency applies the existing post-opinion timeframes, as set-out in the linguistic review process of product information in the centralised procedure — human. 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.
Within 60 days from the receipt of the grounds for re-examination , the CHMP will consider whether its opinion is to be revised. Veterinary regulatory Overview Research and development Marketing authorisation Post-authorisation. Upon receipt of a favourable CHMP opinion that requires amendments to the decision granting the marketing authorisation , the 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. 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. 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. Where at least one of the concerned marketing authorisations has been authorised via the centralised procedure , the Agency will be the ‘reference authority’.
Revised topics are marked ‘New’ or ‘Rev. How useful was this page? 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’.
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. If nationally authorised medical products are part of the worksharing procedure, relevant lehter and Member State details should be provided as vsriation B to the application form using the template for annex B.
Worksharing procedures for type-IB variations At submission day 0: Highlighted changes should be indicated via ‘Tools — Track changes’.
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. If amendments are requested by the Agency as a result of the validation, updated documentation should also be submitted to the MSs. 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 vafiation months, for the variations listed under Article 23 1a a or within one year for the other variations.
An cofer acknowledgement email is sent from the system confirming whether the submission has passed the relevant technical validation criteria and whether it has been uploaded to the Agency’s review tool and made available via the Common Repository.
Worksharing: questions and answers
The QRD convention should be followed. Worksharing procedure for multiple centrally authorised medicinal products ‘duplicates’. Two Commission guidelines have been issued in connection with the a. 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. 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.
Worksharing procedures have to be applied for at the CMD h. Where applicable changes in Word documents should be indicated using ‘Tools-Track Changes’. 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 cover letter should include the e-mail address of the person in charge. 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.
Subsequently, the Agency will initiate the Rapporteur appointment procedure.
Worksharing: questions and answers | European Medicines Agency
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.
Clean versions should have all changes ‘accepted’. However, in exceptional cases where MAHs take the opportunity to introduce minor linguistic amendments in the texts e. Leave this field blank.
References The linguistic review process of product information in the centralised procedure — Human. This applies to all applications for human medicines.
The MAH must submit the variation application for worksharing at the latest by the recommended submission dates published under submission dates. Annex B includes information on the nationally authorised medicinal products included in the worksharing application if applicable. A new procedure code abbreviation is used for worksharing procedures i.
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 variations subject to worksharing affects the summary of product characteristics SmPClabelling or package leafletthe revised product information annexes must be submitted as follows:.
Upon receipt of the letter of intent, the Product Lead if the worksharing procedure contains at least one Type II variation will review and decide whether the proposed worksharing procedure is acceptable. In the variation application form, use the full German name of the medicinal product as it is authorised, and indicate the German marketing authorisation holder as well as the Germanmarketing authorisation number.