Guidance

Educational materials and associated distribution plans

How marketing authorisation holders should provide educational materials to MHRA for assessment and approval prior to launching their products on the UK market.

As laid out in Good Pharmacovigilance Practice (GVP) module XVI Addendum I, marketing authorisation holders (MAHs) responsible for products requiring additional risk minimisation measures (aRMMs) in the form of educational materials are required to submit these materials to the national competent authority (NCA) and receive approval before their products can be marketed. These materials should be accompanied by details of their planned distribution.

Submission process

Enquiries about whether educational materials requested as part of a mutual recognition procedure (MRP) or de-centralised procedure (DCP) need to be implemented in the UK for your product should be emailed to RMPallocation@mhra.gov.uk.

Educational materials and their associated distribution plans should be emailed to RMPallocation@mhra.gov.uk. If you have already been working with the specific assessor for the product in question prior to submission of the material, please copy them directly or flag for their attention.

MHRA will endeavour to assess educational materials within 18 calendar days of submission.

Please note that multiple rounds of submission and assessment may be required before educational materials receive final approval. If you require rapid approval of educational material (e.g. because you plan to launch the product soon after receiving marketing authorisation), you are advised to contact RMPallocation@mhra.gov.uk as early as possible so that a suitable timetable for submission and assessment can be agreed with the assessor.

Guidance on content and format:

There is no specific guidance on the content and format of educational materials. Companies are encouraged to follow guidance offered in the addendum to GVP Module XVI.

Published 12 April 2018