Pharmaceutical establishment (établissement pharmaceutique)

A pharmaceutical establishment is the entity authorised to carry out the manufacture, import, exploitation or wholesale distribution of medicinal products and of certain other products falling within the pharmaceutical monopoly. The Public Health Code reserves these activities to undertakings and bodies that include such an establishment, the opening of which requires an authorisation issued by the ANSM. The regime implements the requirements of Directive 2001/83/EC on manufacturing and distribution authorisations, while retaining categories specific to French law.

Categories of establishment

French law distinguishes several categories according to the activity carried out, including the manufacturer, the importer, the exploitant, the depositary, which stores products on behalf of an exploitant, the wholesaler-distributor (grossiste-répartiteur) and the wholesale distributor. Each category entails its own obligations, in particular compliance with good manufacturing practice or good distribution practice. The same company may hold several authorisations for separate sites or activities.

The responsible pharmacist

An undertaking operating a pharmaceutical establishment must be managed, for that activity, by a responsible pharmacist (pharmacien responsable), who holds the status of corporate officer. The responsible pharmacist is personally accountable for compliance with the rules of the Public Health Code and relies, in each establishment, on a deputy pharmacist (pharmacien délégué). This requirement shapes the governance of the undertaking, since the responsible pharmacist must have the powers needed to carry out these duties and may incur both criminal and disciplinary liability.

Supervision and litigation

The ANSM inspects establishments, may suspend or withdraw the authorisation and may impose injunctions and financial penalties, subject to review by the administrative courts. For a patent holder, pharmaceutical establishment status makes it possible to identify the operators who hold, offer or put the disputed products on the market, and therefore the natural defendants to an infringement action. The establishment’s premises are also the usual place where saisie-contrefaçon operations are carried out.

Key points

No manufacture or wholesale distribution of medicinal products may take place in France outside an authorised pharmaceutical establishment placed under the authority of a responsible pharmacist. The authorisation is tied to a category of activity and to a site. Before any takeover or reorganisation, the category of the authorisations held, their fate in the transaction and the appointment of the responsible pharmacist 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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