transfer of marketing authorisation cmdh

Applicant's template for post-authorisation commitments. Variations. Renewals (ceased to apply under Regulation ( EU) 2019/6), applies only to procedures still in progress) Pharmacovigilance. Guidance documents - Directive 2001/82/EC. Guidance for post authorisation activities after partial marketing authorisation transfer - Partial MAH transfer.

This page lists questions that marketing-authorisation holders (MAHs) may have on transfers of marketing authorisations. 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.Revised topics are marked 'New' or 'Rev.' upon publication.

Human Regulatory and procedural guidance. Commission Regulation (EC) No 2141/96 of 7 November 1996 concerning the examination of an application for the transfer of a marketing authorisation for a medicinal product falling within the scope of Council Regulation (EC) No 2309/93. (link is external) Q&A: Transfer of MA.

The marketing authorisation holder(s) of medicinal products concerned and identified at the start of the procedure, will receive the Committee for Medicinal Products for Human Use (CHMP) opinion or Co-ordination Group for Mutual Recognition and Decentralised Procedures (CMDh) position electronically via email/Eudralink during the week following ...

marketing authorisation in a Member State, the applicant/marketing authorisation holder must submit an application in the Member States concerned using the procedure of mutual recognition. The Member States concerned should then recognise the marketing authorisation already granted by the reference Member State and

The guidance describes the approach the MHRA takes to the processing of variations to marketing authorisations. Update to this guidance on 29 December 2020. ... (CMDh) before 1 January 2021.

Questions & Answers. Introduction: This Question and answers section gives advice on regulatory issues in connection with the Mutual Recognition and Decentralised Procedures. Reference is made, where additional information is available from CMDh guidance documents. For general regulatory guidance on the interpretation and implementation of the ...

also required from the clinical expert. Refer to the CMDh BPG on renewals on the CMDh website. Marketing authorisation holders (MAHs) are also advised to consider the GVP Module VII on PSURs as guidance for the preparation of the above sections of the clinical overview. 3.3 Risk management plan (RMP)

Please see relevant sections of the CMDh Best Practice Guide on the processing of renewals in the Mutual Recognition and Decentralised Procedures. Transfer applications. A marketing authorisation or parallel import licence may be transferred from the existing authorisation/licence holder to another holder using a transfer procedure.

associated regulatory submissions to the Agency (e.g. transfer of the marketing authorisation, addition of a manufacturing site). The EMA would like to emphasise the importance of these site/organisation registrations in OMS prior to pre- and post-authorisation submissions, in order to avoid any delay in the start of these

The Marketing Authorisation Holder (MAH) transfer procedure must be applied in case the medicinal ... (See CMDh Q&A 2.8 on variations). A type IB variation (category A.2) with the aim to change the name of the medicinal product, if any, should also be submitted in parallel.

Application form for variation to a marketing authorisation for medicinal products (human and veterinary) to be used in the national, mutual recognition and the centralised procedure (July 2013). CMDh recommendations for submission on variations; Validation and refusal of variations to the terms of marketing authorisations

In the majority of member states the marketing authorisation transfer takes between. 1 to 2 months. Only in two member states (Austria and Germany) can the transfer be implemented on receipt of the application, while in 5 member states implementation takes. 3 months or more (table 6 above).

CMDh practical guidance for Marketing Authorisation Holders of na tionally authorised products (incl. MRP/DCP) in relation to the Art. 5(3) Referral on Nitrosamines Page 2/9 cases where the risk evaluation has not yet been submitted within the deadline MAHs should submit the outstanding risk evaluations as soon as possible. 1.1.

Provided that module 3 is not impacted, with the exception of section 3.2.A.1 (for biological medicinal products), the changes listed below (not an exhaustive list) are covered under the company's quality management system and do not require a variation to the Marketing Authorisation: Transfer of a manufacturing activity from one building to ...

You need to apply for a change of ownership to transfer a marketing authorisation (MA), also known as a product licence, to a new owner. You can do this as the current or new owner as long as the ...

The CMDh guidance makes clear that "while the transfer of the MA to a new MAH is an independent purely national application, all other changes related to the consequences of this [Article 50] procedure may be grouped in one application according to the highest variation type for the single changes". Source: CMDh: Examples of acceptable and not ...

Requirements on submissions for Variations and Renewals within MRP and National Procedures. Languages to be used for Marketing Authorisation Application (MAA), Variations and Renewals. Mock-ups, Specimens and Samples for variations and renewals. Member State agreement upon conditions under which the RMS can start renewal procedures (March 2023 ...

Module 1: Administrative information Application Form, User guide for the electronic application form for a Marketing Authorisation, CMDh/332/2017, Rev 4, September 2023. 15. User guide for the electronic Application Form for a Marketing Authorisation and for specific Variations requiring assessment