The Medicines Act stipulates that a marketing authorisation has a limited period of validity when first granted. After 5 years, the MEB must decide based on a benefit-risk assessment if this authorisation can be renewed and, if so, whether the renewal can be granted with unlimited validity or, as a result of aspects related to pharmacovigilance, with one additional 5-year period.
Once a year, the MEB will make a decision with respect to renewal of the marketing authorisation, for each product that has been authorised via the national procedure for which the marketing authorisation expires in that year. Exceptions to this are parallel import products and products which have subsequently gone through a Mutual recognition procedure.
Marketing authorisation holders are not asked to submit a request for renewal together with a renewal dossier. The decision on renewal is based on the information available in the dossier (including the PSUR data) and the current knowledge about the active ingredient(s) in relation to the indication(s) of the product concerned. However, if the MEB is of the opinion that renewal cannot be granted for a product, the marketing authorisation holder will have the opportunity to submit additional information and/or argumentation in response to the MEB’s substantiation of the negative benefit-risk assessment.