A marketing authorisation holder is bound to operate and update a risk management system for each medicinal product. The risk management system must be proportionate to the identified risks and potential risks of a specific medicinal product and the need for collection of post-authorisation safety data (Section 91, Sub-section 2, Letter c) of the Amendment to AoP, Act No 378/2007 Coll., on Pharmaceuticals). This obligation does not relate to holders of marketing authorisation issued before July 21, 2012 (Article II, Temporary and Final provisions, Sub-section 3 of the Amendment to AoP), unless the Institute imposes on these marketing authorisation holders the obligation to introduce the risk management system by virtue of office (Section 92, Sub-section 1 of the Amendment to AoP).
The obligation to operate and update the risk management system does not automatically mean an obligation to submit and update a risk management plan (RMP, Section 1.8.2 in the registration dossier). For the majority of medicinal products this obligation means carrying out standard pharmacovigilance.
Should I attach the marketing authorisation application with the risk management plan (RMP, Section 1.8.2 in the registration dossier)?
Since Apr. 2, 2013 there has been an obligation to submit the RMP together with each marketing authorisation application for medicinal products (Section 26, Sub-section 5, Letter l) of the Amendment to AoP), apart from marketing authorisation applications for homeopathic medicinal products and traditional herbal medicinal products.
For marketing authorisation applications in progress it is not necessary to supplement the RMP.
Since Apr. 2, 2013 there has been an obligation to submit the RMP or its update subject to the new format.
Detailed information about the RMP format can be found in the Guideline on Good Pharmacovigilance Practices, Module V.
For the structure of the new RMP format see the website of the European Medicines Agency.
Marketing authorisation holders are obliged to introduce and update the risk management system (Section 91, Sub-section 1, Letter c) of the Amendment to AoP). Risk management system updates are to be recorded in the risk management plan. Routine (pre-planned) updates of the RMP are submitted according to the time schedule set in the marketing authorisation or together with the submission of the PSUR or the application for the marketing authorisation renewal. Unless an update of the RMP is necessary on the set dates, this information shall be provided in an accompanying letter and it shall not be necessary to submit the RMP. Moreover, the updated RMP must always be submitted upon an occurrence of important information influencing the benefit-risk profile. Details can be found in Chapter V.C.5., Module V of the GVP.
Furthermore, it shall be essential to update the existing RMP that is to say to submit the updated versions of the RMP subject to the new format. The deadline for the submission of the existing approved RMPs in the new format is not known at the time being.