EC, Directive reference is made to the 'current edition' in the dossier of an authorised .. stability parameters, on at least two pilot or industrial scale batches, covering a
European Commission - EudraLex - Volume 2 - Notice to Applicants Human. and regulatory requirements such as renewal procedures, dossier requirements
Dossier requirements for referral, active substance master files (ASMF) and nationally authorised products (NAPs) submissions (PASS107, workshare, signal
High quality of a registration dossier facilitates the registration procedure - Essential for Generics! This Module focusing on the specific regional EU requirements for Module 1 including discussion of the relevant legislation. Cover Letter.
22 Apr 2016 This guidance covers the submission of electronic regulatory . new dossier (or the first sequence using EU M1 version 3.0 or later), and it must
term “medicinal product" covers both pharmaceutical and biological The current requirements for the content of the European application dossier are set out in.
2 Sep 2013 Guidance for Industry on Providing Regulatory Information in Electronic Format .. Figure 2 (A3) – Illustration of what an eCTD covers for a product with the .. especially module 3, as a baseline eCTD dossier in sequence
25 Sep 2017 To be inserted in each procedural submission cover letter. PSUR Period Covered (for both PSUSA and Non-EU procedures) does not fall under any categories of the Classification guidance on variations and that the data
Dossier submission: Regulatory and procedural guidance Formatted table template to be inserted in each procedural submission cover letter, (English only)

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March 2018