The European regulatory system for medicines

Authorisation and supervision of manufacturers

Manufacturers, importers and distributors of medicines in the EU must be licensed before they can carry out those
activities. The regulatory authorities of each Member State are responsible for granting licences for such activities
taking place within their respective territories. All manufacturing and importing licenses are entered into EudraGMDP, the publiclyavailable European database operated by EMA. Manufacturers listed in the application of a medicine to be marketed in the EU are inspected by an EU competent authority. This includes manufacturers located outside the EU unless a mutual recognition agreement (MRA) is in place between the European Union and the country of manufacture. Inspection outcomes can be accessed by all Member States and are made publicly available across the EU through EudraGMDP. Equivalence between Member States’ inspectorates is ensured and maintained in a variety of ways, including common legislation, common good manufacturing practice (GMP), common
procedures for inspectorates, technical support, meetings, trainings, and internal and external audits.
In order to be imported into the EU, an active pharmaceutical ingredient needs to be accompanied by a Written Confirmation issued by the competent authority of the country where it is produced, confirming that the good manufacturing practice (GMP) applied is at least equivalent to the recognised EU GMP standards. A waiver applies for some countries which have applied to have their regulatory systems for the supervision of manufacturers of active pharmaceutical ingredients assessed by the EU and have been found to be equivalent to the EU. Every batch of medicines must be certified as having been manufactured and tested in accordance with GMP and in conformance with the marketing authorisation before it can be released onto the market in the EU. If the product is manufactured outside the EU and has been imported, it needs to undergo full analytical testing in the EU, unless a mutual recognition agreement (MRA) is in place between the EU and the exporting country.

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