The EMA’s guidance document helps applicants for marketing authorisations in the European Union (“EU”) to prepare correct and timely pre-authorisation submissions within the centralised procedure.
The document provides guidance concerning a number of issues have within the centralised procedure related to pre-authorisation applications which the applicants may face.
The guide is structured into Question & Answers. It is reviewed regularly to reflect new developments and the implementation of new EU legislation. The document should be read in conjunction with The rules governing medicinal products in the European Union, Volume 2A, Notice to Applicants.
The revised topics
Updated topics in the guidance document are marked as “NEW” or “Rev.” with the relevant date of publication.
The recent version of the guidance includes changes referring to the marketing authorisation application numbers for the submissions concerning applications for:
- Committee for Medicinal Products for Human Use (CHMP) Opinions under Article 58 of Regulation (EC) No 726/2004. In accordance with this provision, the EMA may provide a scientific opinion in cooperation with the World Health Organisation when evaluating certain medicinal products for human use intended exclusively for markets outside the EU;
- EMA consultation procedures concerning an ancillary medicinal substance or an ancillary human blood derivative incorporated as an integral part in a medical device;
- Type-IA variations which must be submitted immediately to the EMA following implementation.
- Guidance concerning oral explanations has also been reviewed. Oral explanations are intended to give the applicants the opportunity to explain their position and arguments within the assessment procedure. The current version provides that the EMA Committees will plan and organise an oral explanation when there are still major objections at Day 180 of the assessment procedure preventing the relevant EMA Committee from adopting a positive opinion concerning the application. However, the need for an oral explanation would be finally decided after the applicant has submitted responses to the Day 180 List Outstanding Issues. The applicant themselves still has the possibility to make a request for an oral explanation.
Authored by Elisabethann Wright and Joanna Mrozinska