The Medicines and Healthcare Products Regulatory Agency (MHRA) has issued guidance on how marketing authorisation holders (MAHs) should provide educational materials to the MHRA for assessment and approval prior to launching their products on the United Kingdom (UK) market.
As stated in Good Pharmacovigilance Practice (GVP) module XVI Addendum I, MAHs responsible for products that require 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. Educational materials should be accompanied by details of their planned distribution. Companies are advised to follow guidance offered in the addendum to GVP Module XVI for the content and format of educational materials.
Enquires 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 a product should be emailed to RMPallocation@mhra.gov.uk.
The MHRA states that they will endeavour to assess educational materials within 18 calendar days of submission. However, it is important to note that multiple rounds of submission and assessment may be required before educational materials receive final approval.
To read more on the guidance from the MHRA regarding educational materials and associated distribution plans, please click here.