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Should I introduce a risk management plan for my medicinal product?

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.