National marketing authorisation

A national marketing authorisation is granted by the competent authority of a single Member State, following a purely national procedure, for a medicinal product intended for the market of that State. In France, it is granted by the ANSM under Article L. 5121-8 of the French Public Health Code, within the framework harmonised by Directive 2001/83/EC. Its scope has narrowed as the European procedures developed, and today it remains the route for medicinal products aimed at a single market.

Scope of the national procedure

The national route is closed to medicinal products that must go through the centralised procedure. It is also closed as soon as an authorisation exists or has been applied for in another Member State for the same medicinal product, in which case the application must follow the mutual recognition procedure. It remains open, for example, to older medicinal products marketed in a single country, to certain generics intended solely for the French market or to products adapted to local practice. The authority has 210 days to decide from receipt of a valid application.

Scope and life of the authorisation

A national authorisation has effect only in the territory of the State that granted it. It is granted for five years and may then be renewed on the basis of a re-evaluation of the benefit/risk balance, renewal in principle being valid for an unlimited period. Variations are governed, like those to European authorisations, by the framework laid down in Commission Regulation (EC) No 1234/2008. Decisions of the ANSM, whether refusal, suspension or withdrawal, fall within the jurisdiction of the administrative courts.

The national authorisation, the patent and the market

A valid national authorisation may serve as the basis for an application for a supplementary protection certificate in the State that granted it. Where the medicinal product was first authorised elsewhere in the Union, however, the duration of the certificate is calculated from that first authorisation. The national authorisation also opens the way to the application for inclusion on the reimbursement list and to price negotiation, whose published stages enable a patent holder to detect the arrival of a generic.

Key points

A national authorisation is granted by the authority of a single State, in France the ANSM, for a medicinal product intended for that market alone. It is excluded for medicinal products falling within the centralised procedure and as soon as another Member State is involved. It may found a supplementary protection certificate, but the duration of the certificate depends on the first authorisation obtained in the Union. The full authorisation history of the product in the Union should therefore be reconstructed before relying on a French authorisation.

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This glossary entry is general in scope and does not constitute legal advice.

Dhenne Avocats acts in pharmaceutical patent disputes and on the medicines regulatory questions that accompany them, from the marketing authorisation to the supplementary protection certificate.

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