France Pharmaceutical Licensing

This record is limited to retail pharmacies, wholesale and manufacturing of human medicines. Manufacturing, importing, exporting and wholesale distribution may only be carried out within pharmaceutical establishments; hospital pharmacies, medical devices, health supplements and pharmaceutical brokerage are not automatically covered.

The French one-stop shop for businesses handles general incorporation, amendments and cessation, but does not replace procedures with the ARS, ANSM, Ordre or those relating to AMM. The sources reviewed do not provide a general conclusion on foreign investment eligibility; overseas participation requires separate verification of company governance, pharmacist qualifications, premises and product pathways.

— Retail: ARS pharmacy licence.

— Wholesale/manufacturing: ANSM pharmaceutical establishment authorisation.

— Individuals: registration on the Ordre register.

— Products/cross-border: AMM, import and controlled-drug procedures.

ANSM is responsible for prior authorisation of pharmaceutical establishments and major changes, and administers pharmaceutical GDP/GMP, AMM, import and controlled-drug matters. The ARS director is responsible for local retail pharmacy licences; the Ordre manages the pharmacist register; Légifrance provides the current legal sources.

France is not a federal system in which manufacturing or wholesale licences are issued separately by provinces or states, but pharmacy application channels and location assessments are local. Verify requirements with the ARS for the location of the premises.

— ANSM: procedures relating to pharmaceutical establishments and products.

— ARS: pharmacy licences.

— Ordre: individual professional registration.

Establishment, relocation and merger of a pharmacy are all subject to an ARS licence. The ARS assesses whether the proposed location can meet residents' medicine-supply needs without undermining the necessary supply at the existing location; local implementation pages indicate that the ARS director will seek the opinions of the regional Ordre and industry representatives.

The pharmacy location must meet requirements concerning population, public accessibility, accessibility for persons with disabilities, minimum installations, and on-call/emergency services. The pharmacy must be owned by a pharmacist or a company meeting the statutory conditions; the holder must personally practise, and medicines must be prepared by a pharmacist or under their direct supervision.

— New establishment, relocation, merger: apply to the ARS for the location.

— Commencement, cessation, ownership and other changes: notify the Ordre.

— Online medicine sales, contract manufacturing or high-risk preparations: verify separately.

Wholesale distribution of human medicines is carried out by pharmaceutical establishments. The ANSM GDP page covers manufacturers, operators, importers, depositaries, wholesale distributors and other pharmaceutical establishments conducting wholesale activities from within France; the commercial description “wholesaler” does not replace authorisation specifying the scope of activities.

Prior ANSM authorisation is required to establish an establishment. The establishment's name and address should first be registered in SPOR/OMS and be consistent with the commercial registration; GDP requirements cover quality, personnel, premises, equipment, supply-chain qualification, storage and transport, recalls, documentation and self-inspection. ANSM, or the ARS under its coordination, may inspect.

— Define the establishment category and actual wholesale activities.

— Apply for ANSM authorisation before establishment and appoint a responsible pharmacist.

— Maintain GDP compliance and inspection readiness during operations.

Establishments manufacturing medicines or investigational medicinal products must be authorised by ANSM. Confirm the scope according to the actual activities, including manufacturing, contract manufacturing/contracting, packaging, importing, investigational medicinal products and wholesale; review of establishment or major changes may include an on-site inspection.

BPF/GMP applies to the manufacture of human medicines and investigational medicinal products. ANSM regularly updates its guidance, including the annex on importing medicines manufactured outside the European Union/European Economic Area; manufacturing establishment authorisation does not replace product AMM or import authorisation.

— Determine each activity for which authorisation is sought.

— Establish premises and a quality system that comply with applicable GMP.

— Apply for and manage major variations through the ANSM digital procedure.

As a rule, pharmacists practising in France must be registered on the Ordre’s register. The association reviews diplomas, competence, conduct, independence and any applicable pharmacy licence or experience requirements, according to the position. Practising without registration may constitute unlawful practice.

A pharmacy owner who has not completed the statutory six-month graduate internship will generally need at least six months’ experience as a pharmacy assistant or locum, although the legislation provides exceptions or special assessments for hospital interns, existing registrants and pharmacists from the EU/European Economic Area, among others. A responsible pharmacist is in charge of a pharmaceutical establishment; delegated pharmacists maintain compliance under the responsible pharmacist’s direction.

— Individuals: confirm qualifications and Ordre registration first.

— Pharmacies: verify the owner’s experience requirements and any exceptions.

— Pharmaceutical establishments: identify the responsible and delegated pharmacists and confirm that they perform their duties in practice.

No nationwide uniform minimum floor-area requirement applicable to pharmacies has been identified in this research. The Code requires premises to be accessible, or accessibility to be improved through visibility, pedestrian facilities, parking and, where necessary, public transport. Premises must also meet accessibility requirements, minimum installation requirements, and on-call/emergency accessibility requirements.

Wholesale operations are subject to GDP requirements for premises, equipment, storage and transport, and quality systems. The responsible pharmacist must ensure the preservation, integrity and security of medicinal products during transport. Manufacturing premises are subject to GMP, and ANSM may inspect their capabilities.

— Retail: address, accessibility, access for persons with disabilities and service needs.

— Wholesale: GDP-compliant premises, equipment, storage and transport.

— Manufacturing: GMP-compliant premises and quality systems.

General business formalities are handled through the single portal. Since 2020, pharmaceutical establishments have used ANSM Démarche numérique; their name and address must be entered in SPOR/OMS in advance and match the business registration. Pharmacies submit an application dossier to the local ARS for establishment, relocation or merger.

The Nouvelle-Aquitaine ARS provides the relevant application pack, which is an example of official regional implementation rather than a nationwide uniform list of required documents. ANSM authorisations are published in EudraGMDP; administrative changes, commencement or cessation of operations, the responsible pharmacist and annual status each have their own reporting procedures.

— Determine the activity and premises.

— Verify the legal entity’s details and the key pharmacists.

— Apply to the ARS for retail and to ANSM for wholesale/manufacturing.

— Review AMM, import and controlled-drug requirements in parallel.

The official sources reviewed do not provide a unified fee schedule or a standard review period that can safely be promised for all ordinary pharmacy, wholesale or manufacturing establishment projects. Accordingly, no fees, approval dates or expedited-processing commitments are invented.

An initial AMM/registration is generally valid for five years, but this concerns product authorisation; it cannot be taken to establish the validity period of a pharmacy licence or establishment authorisation. Ordinary import authorisations have separate statutory processing rules and do not determine the timeline for establishing an establishment.

— No unified establishment fee has been verified.

— No unified standard approval period has been verified.

— The five-year AMM rule does not apply to premises/establishment authorisations.

The responsible pharmacist of a pharmaceutical establishment must report its status for the preceding calendar year no later than 31/3 each year; a newly appointed responsible pharmacist must be declared within one month of appointment. Administrative changes, actual commencement of operations and cessation of operations also have corresponding reporting requirements.

Wholesale operations must continuously comply with GDP and are subject to periodic inspections; manufacturing operations must continuously comply with GMP. An official ARS implementation page states that pharmacies must submit an annual online report to the ARS on the preceding year’s activities and employee information, and comply with local on-call/emergency service arrangements.

— Establishments: annual status and changes to the responsible pharmacist.

— Wholesale: GDP, self-inspections and inspection readiness.

— Manufacturing: GMP quality systems.

— Pharmacies: ARS annual reporting and local service arrangements.

Pharmacy closure, relocation, merger or a change affecting ownership must be notified to the Ordre. A pharmacy licence may not be transferred separately from the business assets, and a transfer must be reported to the ARS.

A material change to an essential element of a pharmaceutical establishment’s authorisation requires prior ANSM authorisation; other changes must be reported. If a transaction changes the authorisation holder, activity, address, name, governance or responsible pharmacist, each change must be classified individually before completion. Registration through the company single portal does not automatically complete a change to a professional authorisation.

— Pharmacy ownership/operational changes: verify the ARS and Ordre procedures.

— Major establishment changes: obtain ANSM authorisation before implementation.

— New responsible pharmacist: report within one month.

An establishment authorisation does not mean that a product may be marketed. A product must obtain a French national, EU centralised, decentralised or mutual-recognition AMM through the applicable route. Certain herbal medicinal products and homeopathic medicinal products may be registered under specific conditions. Changes to a product’s composition or indications may also require approval.

As a rule, medicinal product imports require an ANSM import authorisation, but statutory exemptions must be assessed individually. Narcotic drugs, medicines subject to narcotics controls or medicines containing psychotropic substances require additional ANSM authorisation beyond the general rules; related imports and exports may be reported through NDS-Web.

— Products: verify the AMM/registration route.

— Cross-border trade: verify ordinary import authorisation requirements and exemptions.

— Controlled drugs: obtain separate additional authorisation.