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Risk minimisation measures are put in place to facilitate the safe and effective use of medicines by healthcare professionals, patients and their carers or guardians.

It is a requirement for Marketing Authorisation Holders (MAHs) to implement routine risk minimisation measures, such as the legal status of a medicine (for example prescription-only), pack size of a medicine, and a Summary of Product Characteristics (SmPC) and Patient Information Leaflet (PIL) for every medicine. These measures are standard requirements to address safety concerns once a product is on the market. But for certain medicines, additional risk minimisation measures are required for their safe and effective use.