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EMA Guidance: Pre & Post Authorisation for Users of the Centralised Procedure

Recently this week (25 April, 20223) the European Medicines Agency updated and released the guidances on "Pre-authorisation procedural advice for users of the centralised procedure" and "Post-authorisation procedural advice for users of the centralised procedure".

The pre-authorisation procedural advice is designed to assist applicants in preparing and submitting applications for marketing authorisation under the centralised procedure.

This guidance provides information on the regulatory requirements and procedures for the evaluation of the quality, safety, and efficacy of medicinal products by the EMA's Committee for Medicinal Products for Human Use (CHMP) and the European Commission.

Through this guidance information and productive pre-submission meetings, applicants can submit applications that are compliant with legal and regulatory requirements, and which can be validated in a timely manner. In addition, applicants will be able to establish contact with the EMA staff closely involved with their applications at the pre-submission meetings.

The post-authorisation procedural advice, on the other hand, provides guidance to marketing authorisation holders on the post-authorisation procedures and regulatory obligations they need to comply with in order to maintain their marketing authorisation.

Marketing authorisation holders (MAHs) may have a variety of questions about post-authorisation procedures, and the guidance document provides a summary of the Agency's position on issues that are typically discussed in post-authorization meetings with MAHs.

This guidance includes procedures for variations to marketing authorisations, renewals, line extensions, and pharmacovigilance activities, as well as guidance on specific topics such as labelling, packaging, and advertising.


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