A government’s legal authorisation to introduce a product to market after being thoroughly evaluated by the health and regulatory authorities. Before a medicine can be retailed in the UK, a number of licences are necessary.
The product must have a licence called a ‘marketing authorisation’ (also referred to as a ‘product licence’). Furthermore, the companies that are associated with each stage of the manufacture and distribution of the product must also have relevant licences.
Recently developed medicinal products cannot be administered to human subjects until they have also been licensed accordingly.