A medicinal product must undergo extensive preclinical and clinical testing before a marketing authorization is granted by the relevant regulatory authorities. Market surveillance of a medicinal product after the medicinal product is placed on the market is also required.

The stages of process and the key legislation are outlined below. Note that all European “Directives” referred to are not directly effective in each Member State of the European Union (EU). They must be implemented into the law of each Member State by national legislation. For the time being, this legislation will continue to apply in the UK by virtue of national law, after Brexit on 29 March 2019.

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