PAR for refused marketing authorisation applications (January 2017)

The ICH Q3D Guideline on Elemental Impurities reached Step 4 of the ICH Process in December 2013 and now enters the implementation period (Step 5).

A dedicated webpage for PSUR Repository is now available here. News and announcements related to the system availability including all user guidance documents will be published on this page.

The SC agreed on the key issues relating to the reform of ICH in terms of governance, new membership and funding. ICH remains committed to enhanced communication, transparency and the openness of ICH to all relevant stakeholders.

The eAF term request process has been updated and the relevant documents can be found here

The filenaming conventions for Veterinary Submissions have been simplified. It is now easier to submit Veterinary submissions using the eSubmission Gateway and the Web Client. Updated Annex 2 can be found here

From 1 November 2014 all submissions for Referral Procedures for human medicinal products should be sent via the eSubmission Gateway or the Web Client. After 1 November 2014, the EMA is no longer accepting electronic submissions for referrals on CD or DVD. The European Medicines Agency (EMA) strongly recommends using the electronic submission channels (eSubmission [...]

Non Clinical / Clinical AR for Generics - MRP & DCP ( December 2017)

Recommendation for implementation of Commission Decisions or CMDh agreements following Union referral procedures where the marketing authorisation is maintained or varied (October 2025) [Track version]

Portugal has now joined the Common Repository to receive Centralised Procedure submissions.