Ema cover letter centralised procedure

Human eSubmission eCTD v3. Industry access. Paediatric submissions. Additionally some minor defects have been fixed.

Validation Procedure

Heads of Medicines Agencies: Variation

Type IA variations are minor variations. The assessment criteria are referred to using the term type IA in the Guidelines on the details of the various categories of variations , also referred to as Procedural and Classification Guideline. This concerns a category of variations which are processed administratively via a notification and which are subdivided into 2 categories, namely:. In the case of a type IA variation a distinction is made between the national procedure, the mutual recognition or decentralised procedure MRP or DCP and the centralised procedure. If a veterinary medicinal product has obtained a marketing authorisation via the national procedure, a minor variation can be requested in the conditions for the marketing of the veterinary medicinal product. For the national procedure, there is no Reference Member State RMS with which you first have to coordinate the variation.

Decentralised and mutual recognition reliance procedure for marketing authorisations

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. Two Commission guidelines have been issued in connection with the a. 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. The two guidelines are available on the Web page of the European Commission,. Notice to Applicants, Vol.
From 1 January , the electronic Common Technical Document eCTD is the only acceptable electronic format for all applications and all submission types in the context of the centralised procedure. These include new applications, supplementary information, variations , renewals , follow up measures FUMs , periodic safety update reports PSURs for centralised authorised products, Notifications etc. There is no obligation to submit a full, reformatted eCTD for already authorised products. However, if marketing authorisation holders wish, they may provide EMA with information reformatted as eCTD for their already authorised products. In particular, EMA would encourage the submission of reformatted quality information in eCTD, in order to facilitate the handling of variations and line extensions.
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