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’. 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. Schematic structure of the CHMP opinion and annexes for an application under worksharing , consisting of centrally and nationally authorised medicinal products: 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. The QRD convention should be followed. If the variations subject to worksharing affects the summary of product characteristics SmPC , labelling or package leaflet , the revised product information annexes must be submitted as follows:.
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. Introduction or changes to the pharmacovigilance system. The amended German texts are not needed before the national phase is started. Skip to main content. The MAH will be informed accordingly. This new Variation Regulation establishes new rules for the examination of variations to the terms of marketing authorisations for medicinal products for human use and veterinary medicinal products, granted in Centralised Procedures CP , Decentralised Procedures DCP or the Mutual Recognition Procedures MRP. For queries relating to the presentation of the application, please contact the Agency.
A letter of intent template is available.
Heads of Medicines Agencies: Variations
Update of the Certificate of European Pharmacopeia. In case of comments, it will be up to the MAH to correctly implement the same amendments in the other centrally authorised productsas appropriate. 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 letterr considered as a ‘group’ of variations and not a ‘ worksharing ‘ procedure.
For queries relating to the presentation of the application, please contact the Agency.
Worksharing procedure for type-II variations. A new procedure code abbreviation is used for worksharing procedures i. Changes to a single-substance MA and a fixed-combination MA containing the same active substance. 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. Our services include submission hosting, processing of individual submission documents as well as consultancy in all questions of electronic drug regulatory business.
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Proposal for combination use affecting both MAs. Leave this field blank.
Worksharing procedures have to be applied for at the CMD h. Article 23 1a a provides for a two-month timeframe for amending the decision granting the marketing authorisation for the following variations:. 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 ccmdh the favourable CHMP opinion.
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.
If the MAH requests that the Committee consult a scientific advisory group in connection with the re-examinationthe applicant should inform the CHMP as soon as possible.
Two Commission guidelines have been issued in connection with the a.
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.
Submission to the Rapporteur and Committee members. Worksharing procedures for type-IB variations. 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.
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A single decision will be issued for each centrally authorised medicinal product. Skip to main content. 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. 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.
If the variations subject to worksharing affects the summary of product characteristics SmPClabelling or package leafletvariatoon revised product tsmplate annexes must be submitted as follows: 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’.
Not a very wise move: This new Variation Regulation establishes new rules for the examination of variations to the terms of marketing authorisations for medicinal products for human use and veterinary medicinal products, granted in Centralised Fariation CPDecentralised Procedures DCP or the Mutual Recognition Procedures MRP.
References The linguistic review process of product information in the centralised procedure — Human. One completed electronic EU variation application form, listing coverr medicinal products concerned and declaring all cvoer 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.
In addition to our electronic publishing services we support the registration of your medicinal products in xEVMPD in acc. The details of the applicant where the invoice should be sent to should be clearly stated in lettter cover letter.
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 lether, for the variations listed under Article 23 1a a or within one year for the other variations.
The annexes provided should only reflect the changes introduced by the variation concerned. The complete dmdh of annexes must be presented sequentially i.