Risk Minimisation Activities (RMA): clarifications for authorisation holders on Circular No. 635
Source: FAMHP
December 17, 2020
Circular No. 635 of 4 May 2018 details the approval procedure for risk minimisation activities (RMA). Certain paragraphs of this circular could be misinterpreted and specific situations were not considered. Therefore, the FAMHP would like to provide details on the RMA material included in the medicine package and on the addition / modification of RMA material for a medicine that is already available on the market.
Implementation period: basic rule
RMA must be implemented within 90 days after approval, unless the Minister or his delegate defines another deadline.
Additional time for implementation
Pharmaceutical companies may need more time in the particular situation where the approved RMA material consists of material included in the medicine package (e.g. a patient card placed in or attached to the medicine package).
For such implementation to take place within a reasonable period of time that takes not too long either, the FAMHP decided that this period could be aligned with the six-month legal period that is provided for the introduction of the new leaflets in accordance with article 35, § 4 of the Royal Decree of 14 December 2016.
This derogation implies that the QP (Qualified Person - GMP) will no longer release batches without RMA or with an old version of it, six months after the date of approval or after the date defined by the Minister or his delegate.
The measure also ensures that the RMA material and the package leaflet contain similar information.