Regulatory information - EMA introduces weekly start dates for the assessment of type II variations from March 2015

20/02/2015

The new timetables are expected to increase submission flexibility and streamline assessment of applications

From March 2015, the European Medicines Agency will introduce weekly start dates to facilitate the assessment of certain type II and worksharing variation applications for medicines for human use. These changes are one of the outcomes of the Agency’s structural reorganisation which was initiated in September 2013 to improve the efficiency and effectiveness of its operations. They are expected to offer more flexibility to applicants and streamline the assessment of applications by allowing certain variations to conclude outside of the plenary meeting of the Committee for Medicinal Products for Human Use (CHMP).

The new process will be applicable to most type II including grouped and worksharing variations. For these variations, companies will be able to send their applications to the Agency according to the weekly submission slots and the assessment will start on a weekly basis. The CHMP will adopt its scientific opinion at different time points either outside the CHMP meeting or at the meeting, depending on the start date of the review.

Assessment of responses to requests for supplementary information will also follow the weekly-start timetables.

The validation period between submission and procedure start as well as the assessment timelines as provided for in the legislation will remain unchanged. Linguistic review of product information changes for these variations will continue to follow the monthly review cycle starting five days after the CHMP monthly plenary meeting.

The new process will not apply to variations for which amendment of the marketing authorisation by the European Commission is required within two months from CHMP opinion. Similarly, it will not apply to variations involving the Pharmacovigilance and Risk Assessment Committee (PRAC) or the Committee for Advanced Therapies (CAT) either. These variations will continue to follow the existing monthly-start timetables.

Further details can be found in the post-authorisation guidance on type II variations which has been revised to reflect these changes. The new weekly-start timetables have also been published on the Agency’s website.