EMA procedural advice for medicinal products intended exclusively for markets outside the European Union in the context of co-operation with the World Health Organisation

A scientific opinion under the EU-M4all procedure is adopted by the CHMP, in collaboration with WHO based on the evaluation of an application submitted to the EMA and containing data on the quality, safety and efficacy of the medicinal product to support the licensing by third countries; the CHMP opinion concludes on the benefit-risk balance of the medicinal product applied for. [...] The results of the tests are reported to the Agency, (Co-)Rapporteur and the CHMP for consideration for the finalisation of the CHMP assessment report. [...] Can I submit a user testing of the Package Leaflet as part of the EU-M4all application? Submission of the results of a user testing of the Package Leaflet in the EU-M4all application is recommended to ensure the adequacy and the readability of the design and content of the package leaflet. [...] What is the timetable for the validation and the evaluation of applications under the EU-M4all procedure? The validation process and the evaluation procedure by the CHMP for EU-M4all applications follow by analogy the same steps and timeframes as the centralised marketing authorisation procedure. [...] Within 15 days of receipt of the scientific opinion, the applicant should inform the EMA of its intention to request a re-examination and submit the grounds for the request for re-examination within 60 days of receipt of the opinion.