Incorporation of a risk based approach in Market surveillance testing of OMCLs

The aim of this position paper of the GEON is to underline the great importance of using risk analysis for selection of products for market surveillance testing at OMCLs and to stress the importance of involvement of the OMCLs in the market surveillance testing process. Different types of possible risks are listed in the document, and sampling and testing strategies are proposed. Moreover, alternative risk-based strategies to market surveillance testing approaches are discussed. This paper may be read in connection with other documents on risk assessment for targeting Market Surveillance by OMCLs, which have been developed over time in the GEON and by other bodies such as the EMA, the HMA Working Group on Product Testing and its successor, the HMA Drafting Group for Risk-based Approach to Product Testing. The HMA pre-authorisation risk assessment model has become compulsory as of 8 March 2020 for all new MRP and DCP product registrations.