Mutual recognition procedure

The mutual recognition procedure makes it possible to extend to other Member States a marketing authorisation already granted by a Member State. Provided for by Directive 2001/83/EC, it relies on the assessment carried out by the State that granted the first authorisation, which becomes the reference Member State and whose assessment the States concerned are asked to recognise. Like the decentralised procedure, it results in separate national authorisations based on a common dossier and summary of product characteristics.

The mandatory nature of recognition

Where a medicinal product is already authorised in a Member State, or an application is under examination there, the applicant cannot start a purely national procedure in another State for the same medicinal product. It must use mutual recognition or the decentralised procedure. This rule prevents divergent assessments from leading to conflicting authorisations for the same product. It explains why the national authorisation has become a residual route, reserved for medicinal products intended solely for the market of one State.

Conduct of the procedure

At the holder’s request, the reference Member State prepares or updates its assessment report within 90 days and sends it to the States concerned, together with the approved summary of product characteristics, labelling and package leaflet. Those States have 90 days to recognise them and then adopt their national decisions within 30 days. A State may refuse recognition only on the ground of a potential serious risk to public health, the disagreement then being referred to the coordination group of the Member States and, where appropriate, to arbitration by the Committee for Medicinal Products for Human Use followed by a Commission decision. The holder may use the procedure several times to add new States, a practice known as repeat use.

Implications for protection and free movement

The date of the first authorisation in a Member State is decisive. It triggers regulatory data protection throughout the Union and is used to calculate the duration of the supplementary protection certificate, even where the certificate is applied for in a State where authorisation was obtained later through mutual recognition. The harmonised nature of the authorisations also facilitates parallel import, as the authority of the State of destination may rely on the authorisation of the reference product already granted in its territory.

Key points

Mutual recognition extends to other States an authorisation already obtained in the Union, on the basis of the reference State’s assessment. It is mandatory once a medicinal product is authorised or under examination in a Member State. The authorisations obtained remain national, but the first of them sets the starting point for regulatory protection and for calculating the certificate. That first authorisation in the Union should be dated precisely before any certificate application or any analysis of the timetable for generic entry.

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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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