Centralized Marketing Authorization Procedures: Revised EMA Procedural Guidance

The EMA has revised several procedural documents related to centrally authorized medicinal products. The goal is to present requirements and procedures for applicants and marketing authorization holders in a clearer, more consistent, and up-to-date manner. The updated documents cover both the pre-authorization and post-authorization phases and are provided - as is customary at the EMA - in a structured question-and-answer format.

What has been updated overall?

• Procedural Advice (pre-authorization) for users of the centralized procedure
• Procedural Advice (post-authorization) for users of the centralized procedure
• Pre-notification Checks for variations (Type IA/IAIN, IB)
• Guidance on completing the "Precise Scope" section of the variation application form
• Templates for the transfer of marketing authorization, including cover letter and annex

Changes to the Pre-Authorization Procedural Advice

Several points in the Pre-Authorization Procedural Advice have been clarified in terms of content; these are particularly relevant for the planning and submission of centralized marketing authorization applications. They include issues related to the steps prior to submission (e.g., timing and submission logic), aspects of dossier preparation (including the handling of ATC/INN during the procedure), as well as topics related to validation and fees. Procedural issues during the evaluation-such as expected timelines, formal changes during the ongoing procedure (e.g., a change in the applicant), and fees related to inspections were also addressed.

Changes to the Post-Authorization Procedural Advice

The updates to the Post-Authorization Procedural Advice affect numerous sections that are relevant to post-authorization changes. Among other things, the requirements regarding submission deadlines and the presentation of variations (Type IA/IAIN, IB, II), the handling of extensions -including timelines - as well as the rules and procedures for grouping and worksharing have been updated. In addition, specific topics such as PASS (including the registration of studies and the publication of certain results), marketing authorization transfers, and Article 61(3) notifications (definition, parties involved, submission deadlines, procedures, and possible outcomes) have been revised.

Further details and the complete documents are available on the EMA's website under the "pre-authorisation" and "post-authorisation" sections.