Circular No. 635 (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 provided more 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.
As a 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, the FAMHP decided that this period could be aligned with the six-month legal period. The measure also ensures that the RMA material and the package leaflet contain similar information.
Addition of RMA material after commercialisation
For a medicinal product that is already on the market and to which RMA material is added post-marketing, the circular doesn’t specify a deadline for implementing the approved RMA material.
In order to limit the time between the decision to add RMA material and its implementation, the FAMHP requests that this RMA material is implemented within six months after the decision to add it, unless another deadline is specified by the authorities.
Due to this corrections, the Circular was amended in the following sections:
1. Section “1. Approval procedure”: introduction is completed by a third paragraph, as follows:
In case of adding RMA material to an already marketed medicine without RMA, the RMA material must be implemented either before the deadline specified by the authorities or, if no deadline is specified, within six months after adding RMA material.
In order to meet the deadline, the MAH must submit the application for approval of the material as soon as possible, taking into account the deadlines inherent in the RMA approval process.
Please note that RMA material must be approved prior to its release.
2. Section “1. Approval procedure”: point “f) Implementation” is completed and a second one is added, as follows:
Approved RMA must be implemented:
- Either when the medicine is placed on the market if RMA is imposed when the MA is granted.
- Either within 90 days after the approval date if RMA is imposed after the MA has been granted or if RMA is added or if an already approved RMA file is impacted by variations, unless the Minister or his delegate sets another deadline.
- In the very particular case where the RMA is included in the package, its implementation will be aligned with the legislation foreseen for introduction of new leaflets (art. 35, § 4, of the R.D. of 14.12.2006). This derogation implies that the QP will no longer release batches without RMA or with an old version, six months after the date of approval or after the date defined by the Minister or his delegate.
If the RMA file is not submitted within the specified period or if the approval procedure has not resulted in an approval of the material, the commercialisation of the medicinal product may be suspended.