Marketing authorisation holder and exploitant

The holder of the marketing authorisation is the person to whom the authorisation was granted and who is answerable to the authorities for placing the medicinal product on the market. EU law requires the holder to be established in the Union. French law also recognises the concept of the exploitant, defined by the Public Health Code as the undertaking or body that carries out wholesale, free supply, advertising, information, pharmacovigilance, batch tracking and withdrawal operations. The exploitant may be the holder itself or an undertaking acting on its behalf.

Allocation of roles

A separation between holder and exploitant is common where a foreign company entrusts marketing in France to a subsidiary or a partner. The holder remains responsible for the compliance of the authorisation dossier and of the variations made to it, while the exploitant, which must have an authorised pharmaceutical establishment, assumes the obligations relating to the presence of the product on the French market. A detailed contract should organise the reporting of pharmacovigilance data, the handling of complaints and recalls and the allocation of costs.

Transfer of the authorisation

The authorisation cannot be freely assigned like an industrial property right. Its transfer to a new holder requires a specific procedure before the authority that granted it, the European Commission for centralised authorisations or the ANSM for national authorisations, and the transferee must demonstrate its ability to fulfil the holder’s obligations. In asset sale transactions, the effective date of transfer determines when the purchaser may market the product under its own name.

Patent implications

Holder or exploitant status confers no rights in the patents protecting the product. The holder of the basic patent need not be the holder of the authorisation relied on in support of an application for a supplementary protection certificate, but the case of an authorisation held by a third party with no connection to the patent holder remains debated. In litigation, the exploitant, which offers the product and puts it on the market in France, is usually sued alongside the marketing authorisation holder.

Key points

The holder answers for the authorisation, the exploitant for the operations carried out on the French market, and the two roles may belong to separate entities. Their relationship rests on a contract that should cover pharmacovigilance, recalls and medical information. In any acquisition or commercial partnership, the timetable for transfer of the authorisation and the identity of the exploitant declared to the ANSM should be checked.

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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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