Commercialisation of healthcare in France: overview

A Q&A guide to the commercialisation of healthcare in France.

This Q&A provides an overview of the regulatory framework for the commercialisation of medical products in France. It covers the key requirements for manufacturing, advertising and selling drugs, medical devices, biological products and natural health products.

To compare answers across multiple jurisdictions, visit the commercialisation of healthcare Country Q&A tool.

This Q&A is part of the Commercialisation of Healthcare Global Guide. For a full list of jurisdictional Q&As visit www.practicallaw.com/healthcare-guide.

Evelyne Friedel, Taylor Wessing - France
Contents

Regulatory overview

1. What is the regulatory framework for medical products?

Legislation

The legislation and decrees applicable to medical and health products are for the most part codified in the Public Health Code and the Social Security Code. The national rules result primarily from the EU rules regulating these products.

Regulatory authorities

Public agencies, under the authority of the Health Ministry, are in charge of monitoring and regulating health products, including:

  • Medical products.

  • Cosmetics.

  • Food supplements.

Human health products are under the control of the National Agency for Medicines and Health Products Safety (Agence nationale de sécurité du médicament et des produits de santé) (ANSM).

The ANSM works with the:

  • National Agency for Food, Environmental and Occupational Health and Safety (Agence nationale de sécurité sanitaire de l’alimentation, de l’environnement et du travail) (ANSES).

  • National Authority for Health (Haute Autorité de Santé) (HAS).

  • Economic Committee for Health Products (Comité économique des produits de santé).

The ANSM:

  • Monitors clinical trials taking place in France.

  • Monitors the manufacture, distribution, importation, exportation, advertisement and sale of health products and authorises the companies and their facilities to carry out these operations.

  • Issues the marketing authorisations and registrations of medical products.

  • Monitors the safety of health products through pharmacovigilance, materiovigilance and cosmetovigilance.

For more information on the ANSM see box: The regulatory authorities.

Private parties

The health industry federation is the umbrella federation of the industry organisations of this sector (Fédération française des industries de santé) (FEFIS).

Drug companies can refer to the following national organisations:

  • LEEM (Les Entreprises du Médicament) dedicated to the whole pharmaceutical industry.

  • GEMME (Générique Même Médicament) dedicated to producers and distributors of generics.

The producers and distributors of medical devices can refer to the SNITEM (Syndicat National de l’Industrie des Technologies Médicales).

These private organisations are in charge of:

  • Lobbying the public authorities.

  • Drawing up professional codes of conduct and monitoring compliance of the industry through self-regulation procedures.

  • Informing their members and the public about the applicable regulations.

 
2. What types of medical products are regulated?

The following products fall within the scope of the control of the National Agency for Medicines and Health Products Safety (Agence nationale de sécurité du médicament et des produits de santé) (ANSM):

  • Drugs, including insecticides and pest control products for human use.

  • Extemporaneous preparations, hospital and officinal preparations.

  • Narcotic, psychotropic and poisonous substances used in human medicine.

  • Essential oils and medicinal plants.

  • Pharmaceutical raw materials.

  • Contraceptives and abortifacient products.

  • Biomaterials, medical devices and in vitro diagnostic medical devices.

  • Labile blood products.

  • Organs, cells, tissues and products of human or animal origin.

  • Cell products for therapeutic purposes.

  • Breast milk collected, prepared and preserved in milk banks.

  • Ancillary therapeutic products.

  • Contact lenses (corrective and non-corrective).

  • Contact lens care products and solutions.

  • Biocidal products and equipment for cleaning and disinfecting rooms and transport vehicles used in the medical sector.

  • Cosmetic products.

  • Certain micro-organisms and toxins.

  • Tattooing products.

  • Devices and software used in biomedical laboratories.

 

Drugs

3. What are the general requirements for a drug to be manufactured, advertised and sold?

Manufacturing

The establishment of a pharmaceutical laboratory in charge of the manufacture of drugs must be authorised by the National Agency for Medicines and Health Products Safety (Agence nationale de sécurité du médicament et des produits de santé) (ANSM).

Equivalent requirements are imposed for the importation, exportation, distribution or exploitation of drugs (exploitation covers wholesale distribution, advertising, pharmacovigilance activities and batch control).

A condition for being authorised is that each pharmaceutical laboratory must be managed by a "qualified person" and in France this must be a pharmacist (pharmacien responsable). Each of the laboratory's establishments must also have a pharmacist (pharmacien délégué). Depending on the size of the company, other pharmacists may need to be appointed.

The qualified person or responsible pharmacist is in charge of, and liable for, all the pharmaceutical operations (production, batch controls, advertisement, information, stocks, pharmacovigilance, distribution, importation and exportation) depending on the purpose of the establishment (manufacture, distribution or exploitation).

The manufacture, importation and distribution of active substances are subject to specific authorisations. The manufacture, importation and distribution of excipients simply need to be declared.

Finally, the preparation or manufacture of drugs must be compliant with the good manufacturing practices defined by the ANSM.

Advertising

The promotion of drugs is strictly regulated. Any advertising must receive prior authorisation by the ANSM, whether it is targeted at health professionals or consumers.

Any information that is provided about a drug with a "commercial intent" constitutes a "promotion" and is governed by the provisions applicable to the advertising of drugs.

The advertising of a drug must:

  • Not endanger public health.

  • Be truthful and objective.

  • Strictly comply with the marketing authorisation.

Specific provisions govern the advertising of prescription-only drugs, which must be targeted at health professionals only. The advertising of drugs that are not covered by a marketing authorisation or by an import authorisation is strictly prohibited.

Sale

Any establishment of a pharmaceutical laboratory in charge of the distribution of drugs must be authorised by the ANSM.

Companies that sell drugs but do not physically handle the drugs do not need a distribution authorisation but must be declared as brokers with the ANSM under a specific procedure.

Marketing authorisations

For marketing authorisations, drugs are authorised as follows:

  • The European centralised procedure is required for products derived from biotechnology processes, for orphan drugs and for products that contain new active substances and are intended for the treatment of certain diseases. Applications for the centralised procedure must be filed with the European Medicines Agency (EMA) and not with the ANSM.

  • The mutual recognition procedure is based on the principle of recognition of existing national marketing authorisations. Applications for mutual recognition are addressed to one or several member states and must be identical. National marketing authorisations are finally granted in the "reference member state" and then in the concerned member states.

  • The decentralised procedure is applicable to the majority of drugs. Under this procedure, which is also based on the principle of mutual recognition, identical applications for marketing authorisation are filed simultaneously with several national agencies. One of the states is chosen as the "reference member state". At the end of the procedure, national marketing authorisations are granted in this state and in the other member states concerned.

  • Pure national authorisations are available for drugs that are to be marketed in one member state only.

French rules apply for the last three bullet points.

The marketing authorisation file must contain the following:

  • Chemical, pharmaceutical and biological data.

  • Pre-clinical and clinical studies.

  • A summary describing the pharmacovigilance system.

  • The risk management system.

  • Therapeutic indications, contra-indications and undesirable effects.

  • Posology and method of administration.

  • Precautions for storage and disposal.

  • A declaration asserting that the ethical requirements retained for the clinical studies conducted outside of the EU are equivalent to those imposed within the EU.

  • A declaration asserting that the manufacturer of the active substance complies with the applicable good manufacturing practices.

  • Samples of packaging and draft of the notice.

  • Copies of the national or foreign manufacturing authorisations.

  • Copies of the national marketing authorisations obtained in the EU or in the European Economic Area (EEA), or obtained in a third country.

  • A list of the states in the EU or in the EEA where applications have been submitted.

  • Copies of refusals.

  • The evaluation of the potential environmental risks posed by the drug.

Marketing authorisations are given for five years and can be renewed indefinitely.

Experimental drugs

Specific rules apply to experimental drugs defined as active ingredients or placebos tested or used in clinical research. They include drugs covered by marketing authorisations, when these are used in a different way, for other indications, or when they are presented or packaged differently.

Clinical research conducted in France must be authorised by the ANSM, which evaluates the experimental drugs used for the medical research, with the aim of ensuring the safety of the persons and patients involved in the clinical trials. The sites where the clinical trials are conducted must also be authorised.

The file to be submitted to the ANSM for obtaining an authorisation for a clinical trial must include:

  • Data on the pharmaceutical, chemical or biological quality of the active substance of the finished product.

  • Non-clinical data resulting from pharmacological and toxicity studies.

  • Clinical data resulting from previous clinical studies on the same experimental drug.

  • The evaluation of the risk or benefit analysis.

This file can be simplified if the experimental drug either:

  • Is already covered by a marketing authorisation or a temporary use authorisation (autorisations temporaires d’utilisation) (ATU).

  • Already exists under different pharmaceutical forms or different strengths.

Temporary authorisations for use

Temporary authorisations for use include cohort authorisations and individual temporary authorisations for use.

ATUs can be delivered by the ANSM in the following exceptional circumstances:

  • If the drugs are aimed at treating, preventing or diagnosing serious or rare diseases, no other treatment exists and treatment cannot be delayed.

  • If their efficacy and safety are strongly presumed on the basis of existing scientific data.

  • If applications for their marketing authorisation are pending.

Exceptions can be made to this last requirement and in certain specific circumstances. Individual authorisations can be granted at the request on a named patient basis, under the supervision and responsibility of medical practitioners for patients who cannot participate in a clinical trial.

Temporary recommendations for off-label uses

The ANSM can issue temporary recommendations for off-label uses for three years (renewable), after informing the holders of the marketing authorisations and if (as a rule subject to exceptions) no other product containing the same active substance, the same dosage or the same pharmaceutical form exists.

 
4. Are there different requirements for patented and generic drugs?

Specific rules apply to generic drugs. Marketing authorisation applications are simplified for generic drugs. Although generic drugs must meet the same requirements in terms of quality, efficacy and safety, the marketing authorisation application file does not need to include the results of pre-clinical and clinical studies.

The application file only needs to contain chemical, pharmaceutical and biological data, as well as bioavailability studies demonstrating bioequivalence with the reference drug. The reference drug must have been authorised in France or in any other state of the EU of or the European Economic Area (EEA) for at least eight years.

A marketing authorisation can be delivered for a generic drug before the expiry of the intellectual property rights of the holder of the initial authorisation. The latter must be informed of the filing of the simplified marketing authorisation application. Once this marketing authorisation is delivered, the National Agency for Medicines and Health Products Safety (Agence nationale de sécurité du médicament et des produits de santé) (ANSM) must also inform the holder of the initial authorisation.

Although a marketing authorisation for a generic drug can be delivered before the expiration of the intellectual property rights of the holder of the initial authorisation, the marketing of generic drugs cannot start before the expiry of these rights except with the express consent of the holder. In any event, the marketing of generic drugs can only begin ten years after the initial marketing authorisation granted to the originator drugs. This period can be extended to 11 years if, during the first eight years of this initial marketing authorisation, its holder obtained an authorisation for one or more new therapeutic indications providing significant clinical benefits.

 
5. What authority is responsible for regulating the manufacture, advertising and sale of drugs?

The rules codified in the Public Health and Social Security Codes are voted by the parliament (legislative part) and enacted by the government (regulatory part).

The National Agency for Medicines and Health Products Safety (Agence nationale de sécurité du médicament et des produits de santé) (ANSM) also has regulatory powers and draws the applicable good practices guidelines such as manufacturing practices and distribution practices.

The ANSM is in charge of monitoring compliance by the pharmaceutical laboratories with the Public Health and Social Security Codes and the good practices guidelines. The ANSM is in charge of granting the requisite authorisations.

For more information on the ANSM see box: The regulatory authorities.

 
6. Are there fewer or different requirements for drugs that have already been licensed/approved in another jurisdiction?

Drugs can be authorised under the centralised, mutual recognition or decentralised procedures (see Question 3).

The last two procedures reduce the requirements for obtaining marketing authorisations in several or all European states. These procedures require the marketing authorisation application filed with the reference member state to be extended to the other concerned member states.

The concerned member states can only refuse to recognise the authorisation granted by the reference member state on the grounds of potential serious risks to public health. The member states must reach a consensus via the co-ordination group set up at the European level. Without a consensus, the procedure is submitted to the appropriate European Medicines Agency (EMA) scientific committee for arbitration. The opinion of the EMA committee is then forwarded to the European Commission for a final decision.

 
7. Is it possible to sell drugs to or buy drugs from other jurisdictions?

Exportation

Pharmaceutical laboratories intending to export drugs must be duly authorised by the National Agency for Medicines and Health Products Safety (Agence nationale de sécurité du médicament et des produits de santé) (ANSM) to carry on this activity.

Export certifications are then delivered by the ANSM. The ANSM can refuse the exportation of drugs, for public health reasons, if they are not covered by a marketing authorisation or if they may present health risks for the concerned patients, which are disproportionate in comparison to their benefits. If the drugs to be exported are not covered by a marketing authorisation, the laboratory must make a declaration to the ANSM explaining the reasons why such a marketing authorisation was not granted. Exportations of drugs are also prohibited if their marketing authorisations have been suspended or withdrawn for public health reasons or have not be renewed for the same reasons.

Importation from third countries

The importation of drugs from third countries (that is, not a member of the EU or not party to the European Economic Area (EEA)) must be authorised by the ANSM. This authorisation must be delivered prior to the importation of the drugs.

If the drugs benefit from a marketing authorisation or from a temporary authorisation, or are experimental drugs to be used for authorised clinical research, the authorisations are considered as import authorisations.

Import authorisations are not required for consumers or patients that personally carry their own drugs, provided that these imports are for personal use and limited to three months' use. When these individuals import their own drugs by other means, they do not need prior import authorisations if the drugs are covered by a marketing authorisation.

Import authorisations can be refused if the drugs present or may present a risk for public health and, in the case of experimental drugs, if the clinical research has not been authorised.

Parallel imports and parallel distribution within the EU and the EEA

Parallel imports and parallel distribution of drugs take place without the consent of the holders of the marketing authorisations. They are external to their distribution networks.

However, parallel imports and parallel distribution of drugs within the EU and the EEA cannot be impeded under the principle of free circulation of goods, which is one of the core principles of EU law.

Parallel imports can only concern drugs that are covered by national marketing authorisations. To be imported through a parallel channel, the drug must be covered by a marketing authorisation issued by the exporting state and the importing state.

Parallel importers must obtain prior authorisations from the ANSM. These authorisations are granted if the drugs that are authorised in the exporting state are identical to those authorised in France. The quantitative and qualitative composition of their active ingredients and excipients, the pharmaceutical form and the therapeutic effects must be the same. Differences are only allowed if they have no therapeutic effect and do not present any risk to health.

The parallel importers must also declare the parallel imports to the holders of the marketing authorisations.

Parallel distribution concerns the drugs that are covered by marketing authorisations issued by the European Commission under the centralised procedure. Although parallel distribution falls within the control of the European Medicines Agency (EMA), the parallel distributors must declare their intention to proceed to such parallel distribution in France to the ANSM and to the holders of the marketing authorisations.

 
8. Is it permitted to advertise drugs to consumers? Are there restrictions on advertising?

Any advertising and promotion of drugs targeted at consumers are strictly limited in terms of scope and must be authorised by the National Agency for Medicines and Health Products Safety (Agence nationale de sécurité du médicament et des produits de santé) (ANSM) before release.

The advertising and promotion of drugs to consumers can only be authorised for drugs:

  • That are non-prescription drugs, which means self-medication drugs.

  • That are not reimbursed by the public health insurance system, for any of their pharmaceutical forms.

  • Whose marketing authorisations do not stipulate any restrictions on advertising.

However, vaccination campaigns (for certain vaccines) and the public advertising of stop-smoking aids are permitted under certain conditions.

 

Medical devices

9. What are the general requirements for a medical device to be manufactured, advertised and sold?

A medical device is any instrument, appliance, equipment, material, product (with the exception of products of human origin) or other article, used alone or in combination, including the accessories and software involved in its functioning. Used for medical purposes, its principal intended action cannot however be obtained by pharmacological or immunological means or by metabolism, but the function can be assisted by these methods.

Active implantable medical devices are designed to be implanted in whole or in part in the human body or placed in a natural orifice, and depend, for their proper functioning, on a source of energy other than that generated directly by the human body or gravity.

Specific definitions and rules also apply to in vitro diagnostic medical devices.

Manufacturing

The manufacturers, their representative (mandataires), the individuals or legal entities that manufacture, distribute, export or import medical devices must register with the National Agency for Medicines and Health Products Safety (Agence nationale de sécurité du médicament et des produits de santé) (ANSM) and specify the medical devices concerned.

Before medical devices of classes IIa, IIb, III and of active implantable medical devices are used, specific data, including their labelling and their notice of use, must be given to the ANSM.

Advertising

The advertising of medical devices is only permitted for medical devices covered by a CE marking.

As with drugs, the advertising of a medical device must:

  • Not endanger public health.

  • Be truthful and objective.

  • Comply strictly with their certificate of conformity.

For certain medical devices that present risks to human health (a list of which is published by administrative decrees), a prior authorisation from the ANSM is required before any advertising of these devices.

Sale

To market a medical device, the manufacturer must obtain the CE marking that corresponds to the class of the device. The classification of a medical device takes into consideration:

  • Its duration of use.

  • Whether or not it is invasive and, if so, to what extent.

  • The therapeutic or diagnostic aim.

  • The body part in contact with the device.

The level of risk for the patient, user and third parties, in terms of safety and health, is also taken into account. The requirements that are necessary for obtaining the CE marking vary for each class of device.

The CE marking can be affixed to a device once it has been shown that the device complies with the essential health and safety requirements laid down for the applicable class of that device.

For the vast majority of medical devices, with the exception of some class I devices, the manufacturers seeking certification must submit their devices to the authorised notified bodies listed by the European Commission, and designated by the states of the EU or of the European Economic Area (EEA). These notified bodies are in charge of evaluating and certifying the compliance of the devices with the essential requirements.

Medical devices that are used for clinical trials do not need to be covered by a CE mark. However, as for drugs, the provisions governing medical research still apply.

 
10. What authority is responsible for regulating the manufacture, advertising and sale of medical devices?

The rules codified in the Public Health and Social Security Codes are voted by the parliament (legislative part) and enacted by the government (regulatory part).

The National Agency for Medicines and Health Products Safety (Agence nationale de sécurité du médicament et des produits de santé) (ANSM) is in charge of monitoring the compliance by the manufacturers of medical devices with the rules laid down by the Public Health and Social Security Codes.

For more information on the ANSM see box: The regulatory authorities.

 
11. Are there fewer or different requirements for medical devices that have already been licensed/approved in another jurisdiction?

Because of the harmonisation of the applicable rules at the European level, medical devices bearing a CE mark are subject to additional requirements, apart from their registration with the National Agency for Medicines and Health Products Safety (Agence nationale de sécurité des médicaments et des produits de santé) (ANSM).

Medical devices from third countries must comply with the rules that are defined at the European level. If their manufacturers are not established in Europe, they must have an authorised representative (mandataire) to act on their behalf in Europe.

 
12. Is it possible to sell devices to or buy devices from other jurisdictions?

The CE marking guarantees the free circulation of medical devices within the EU and the European Economic Area (EEA), and Switzerland and Turkey.

Export of medical devices to third countries must have a free sale certificate granted by the National Agency for Medicines and Health Products Safety (Agence nationale de sécurité du médicament et des produits de santé) (ANSM) under a specific procedure.

Medical devices from third countries must comply with the rules that are defined at the European level. If their manufacturers are not established in Europe, they must have an authorised representative (mandataire) to act on their behalf in Europe.

 
13. Is it permitted to advertise medical devices to consumers? Are there restrictions on advertising?

Medical devices that are reimbursed, even partially, by the public health insurance system cannot be advertised to the public. An exception is that some medical devices (listed in an administrative decree) can be advertised to the public since they present a small or no risk to human health.

Medical devices can be advertised provided that the advertisement complies with detailed provisions specified in the Public Health Code.

 

Biological products

14. What are the general requirements for a biological product to be manufactured, advertised and sold?

Biological drugs are products whose active substance is biological substances. A biological substance is produced by, or extracted from, a biological source and needs a combination of physico-chemico-biological testing for its characterisation and the determination of its quality.

Manufacturing

The general requirements for the manufacturing of biological drugs are the same as those for ordinary drugs (see Question 3, Manufacturing). As with ordinary drugs, the establishments of a company that manufactures, imports, exports, exploits or distributes biological products must be authorised by the National Agency for Medicines and Health Products Safety (Agence nationale de sécurité du médicament et des produits de santé) (ANSM).

Advertising

The general requirements for advertising biological drugs are the same as those applicable to ordinary drugs (see Question 3, Advertising).

Sale

The general requirements for marketing biological drugs are the same as those for ordinary drugs (see Question 3, Sale).

However, the marketing authorisations for new biological drugs are delivered by the European Commission, not by the ANSM. Indeed, the marketing of these drugs, which are derived from biotechnology, must be authorised under the EU centralised procedure.

Applications for the centralised procedure must be filed directly with the European Medicines Agency (EMA). The evaluation of the drugs is conducted by the relevant scientific committees. The opinions of these committees are given to the European Commission, which has the final authority for granting the marketing authorisations. The marketing authorisations that are issued by the Commission are valid throughout the EU and the European Economic Area (EEA).

The principles in relation to experimental drugs also apply to biological drugs (see Question 3). Medical research on biological drugs conducted in France must be authorised by the ANSM.

Because of their characteristics, clinical trials on biological drugs can only take place in specific centres and hospitals, after an express authorisation granted by the ANSM. The content of the file for clinical trials on cellular therapy products is also specific.

Equivalent drugs are qualified biosimilars and not generics of biological products. Biosimilars are biological drugs that have the same qualitative and quantitative composition in active substances and the same pharmaceutical form as a reference biological drug, but they cannot be considered as generics due to the differences regarding the variability of the raw materials or the manufacturing processes.

Since biosimilars are not strictly identical to their reference drugs, they are subject to stricter controls than generics. Therefore, to obtain marketing authorisations for biosimilars, additional pre-clinical and clinical data must be provided to demonstrate the similarity of their quality, safety and efficacy in comparison with the reference drugs. In particular, the applicants must demonstrate the safety and efficacy of the biosimilars for all their therapeutic indications. Because of this, biosimilars can have fewer indications than the reference biological drugs.

A marketing authorisation can be delivered for a biosimilar before the expiry of the intellectual property rights of the holder of the initial authorisation. The latter must be informed about the filing of the simplified marketing authorisation application. Once this marketing authorisation is delivered, the ANSM must also inform the holder of the initial authorisation.

Although a marketing authorisation for a biosimilar can be delivered before the expiry of the intellectual property rights of the holder of the initial authorisation, the marketing of the generic drugs cannot begin before the expiry of these rights except with the express consent of this holder. In any event, the marketing of biosimilars can only begin ten years after the initial marketing authorisation granted to the reference biological drug. This period can be extended to 11 years if, during the first eight years of this initial marketing authorisation, its holder obtained an authorisation for one or more new therapeutic indications providing significant clinical benefits.

 
15. What authority is responsible for regulating the manufacture, advertising and sale of biological products?

For biological drugs, the national rules codified in the Public Health and Social Security Codes are voted by the parliament (legislative part) and enacted by the government (regulatory part).

Both the European Medicines Agency (EMA) and National Agency for Medicines and Health Products Safety (Agence nationale de sécurité du médicament et des produits de santé) (ANSM) are in charge of monitoring the compliance by the pharmaceutical companies with the applicable EU and French rules. The EMA and the ANSM are in charge of granting the requisite authorisations.

For more information on the ANSM see box: The regulatory authorities.

 
16. Are there fewer or different requirements for biological products that have already been licensed/approved in another jurisdiction?

Since biological drugs are authorised under the centralised procedure, their marketing authorisations, which are issued by the Commission, are valid throughout the EU and the European Economic Area (EEA). See also Question 6.

 
17. Is it possible to sell biological products to or buy biological devices from other jurisdictions?

Biological drugs benefiting from marketing authorisations issued under the centralised procedure can freely circulate and be marketed throughout the EU and the European Economic Area (EEA). See also Question 7.

 
18. Is it permitted to advertise biological products to consumers? Are there restrictions on advertising?
 

Natural health products

19. Is there a category for natural health products (including, for example, traditional medicines, homeopathic medicines, supplements, vitamins and minerals)?

There is no single category covering traditional herbal medicines, homeopathic drugs, dietary supplements, vitamins, minerals or similar products.

Traditional herbal medicinal products and homeopathic drugs are governed by the Public Health Code. Traditional herbal medicinal products are drugs containing exclusively as active ingredients one or more herbal substances or one or more herbal preparations. Homeopathic drugs are prepared from substances qualified as homeopathic stocks pursuant to a manufacturing process described by the European Pharmacopoeia, the French Pharmacopoeia or one of the EU member states' pharmacopoeias.

Food supplements are regulated by the Consumer Code and specific administrative decrees. Under these texts, food supplements are food products whose purpose is to supplement the normal diet and that are concentrated sources of nutrients (vitamins or minerals) or other substances (such as plants and plant preparations) with a nutritional or physiological effect, alone or in combination. They are marketed in the form of doses, such as capsules, pastilles, tablets, pills and other similar forms, sachets of powder, ampoules of liquids, drop-dispensing bottles and other similar forms of liquids and powders designed to be taken in measured small unit quantities.

 
20. What are the general requirements for natural health products to be manufactured, advertised and sold?

Manufacturing

See Question 3, Manufacturing for the procedure applicable to the manufacturing authorisations for traditional herbal medicinal products.

See Question 3, Manufacturing for the procedure applicable to the manufacturing authorisations for homeopathic drugs.

Advertising

Advertising traditional herbal medicinal products and homeopathic drugs is subject to the same rules as for drugs (see Question 3, Advertising).

Advertising food supplements is not subject to a prior authorisation by the National Agency for Medicines and Health Products Safety (Agence nationale de sécurité du médicament et des produits de santé) (ANSM). However, the presentation and advertising of food supplements must not attribute to them any properties of preventing, treating or curing a human disease or refer to such properties (as they would then qualify as drugs) and must not include any statement claiming or implying that a balanced and varied diet cannot provide appropriate quantities of nutrients. Health claims that can be used on food supplements are specified by the applicable EU Regulation.

Sale

Traditional herbal medicinal products do not need a marketing authorisation but must be registered with the ANSM if they comply with the following criteria:

  • They are intended and designed for use without the supervision of a medical practitioner.

  • They are designed exclusively for administration in accordance with a specified strength and posology.

  • They are delivered in the form of an oral, external or inhalation preparation.

  • They have been used for more than 30 years overall and for more than 15 years within the EU or within the European Economic Area (EEA).

  • Sufficient data is available on the traditional use of the medicinal product.

The registration is valid for five years and can be renewed without limitation in time.

Homeopathic drugs do not need a marketing authorisation but must be registered with the ANSM if they comply with the following criteria:

  • They are administered orally or externally.

  • No specific therapeutic indication appears on the labelling of the product or in any information relating to it.

  • There is a sufficient degree of dilution to guarantee the safety of the product. In particular, the product must not contain either more than one part per 10,000 of the mother tincture or more than one hundredth of the smallest dose used in allopathy of the active substances, the presence of which in an allopathic drug results in the obligation to submit a doctor's prescription.

The registration is valid for five years and can be renewed without time limitation.

The person in charge of the first marketing in France of a food supplement must declare this marketing and forward a sample of its labelling to the Consumer Division of the Ministry for Economy (Direction Générale de la Concurrence, de la Consommation et de la Répression des Fraudes).

 
21. What authority is responsible for regulating the manufacture, advertising and sale of natural health products?

The rules codified in the Public Health and Social Security Codes are voted by the parliament (legislative part) and enacted by the government (regulatory part).

The National Agency for Medicines and Health Products Safety (Agence nationale de sécurité du médicament et des produits de santé) (ANSM) is in charge of monitoring the compliance of traditional herbal medicinal products and of homeopathic drugs with the specific provisions of the Public Health Code. The ANSM is in charge of granting the requisite authorisations. The Consumer Division of the Ministry for Economy is in charge of monitoring the compliance of food supplements with the applicable administrative decrees and with the Consumer Code.

For more information on the ANSM see box: The regulatory authorities.

 
22. Are there fewer or different requirements for natural health products that have already been licensed/approved in another jurisdiction?

Traditional herbal medicinal products can be imported into France provided that they have been used for at least 15 years within the EU or within the European Economic Area (EEA). An exception to this rule can be granted by the ANSM after seeking the opinion of the relevant committee of the European Medicines Agency (EMA).

Food supplements that contain unauthorised substances (including plants and plant preparations) that have a nutritional or physiological effect but which are lawfully manufactured or sold in a state of the EU or of the EEA can also be sold in France. In that case, the manufacturer that is established in the member state or the importer must file a specific declaration including various documents required by the applicable administrative decree.

 
23. Is it possible to sell natural health products to or buy natural health products from other jurisdictions and/or electronically?

Traditional herbal medicinal products and homeopathic drugs can be sold online if they are not subject to medical prescription. However, the selling of these products online is reserved to licensed pharmacies and pharmacists. Food supplements can be sold online without limitation.

 
24. Is it permitted to advertise natural health products to consumers? Are there restrictions on advertising?

See Questions 8 and 20.

 

Reform

25. Are there any plans to reform the rules on the development, manufacture, advertising and sale of medical products?

There are currently no plans to reform the rules on the development, manufacture, advertising and sale of medical products.

 

The regulatory authorities

National Agency for Medicines and Health Products Safety (Agence nationale de sécurité du médicament et des produits de santé) (ANSM)

W http://ansm.sante.fr

Principal responsibilities. The ANSM is an independent public authority. It conducts expert assessment of health products and acts as a decision-making body in the field of sanitary regulation. It is entrusted with guaranteeing the safety of health products for human use and conducts inspections of the drugs companies and producers of medical devices.

National Authority for Health (Haute Autorité de Santé) (HAS)

W www.has-sante.fr

Principal responsibilities. The HAS is an independent public authority whose activities include the assessment of drugs, medical devices and procedures, the publication of guidelines and the accreditation of healthcare organisations.

Economic Committee for Health Products (Comité économique des produits de santé)

W www.sante.gouv.fr/comite-economique-des-produits-de-sante-ceps.html

Principal responsibilities. The Economic Committee for Health Products sets the prices of the drugs on the basis of the assessment carried out by the HAS and the negotiations carried out with the company.

National Agency for Food, Environmental and Occupational Health & Safety (Agence nationale de sécurité sanitaire de l’alimentation, de l’environnement et du travail) (ANSES)

W www.anses.fr

Principal responsibilities. The ANSES is an independent public authority. It undertakes monitoring, expert appraisal, research and reference missions in a broad field of competence that encompasses human health. The ANSES can apply a cross-cutting approach to its health risk or benefit assessments and submits its opinions and recommendations to the other authorities.

General Directorate for Competition, Consumers Affairs and Fraud Control (Direction générale de la concurrence, de la consommation et de la répression des fraudes) (DGCCRF)

W www.economie.gouv.fr/dgccrf

Principal responsibilities. The DGCCRF is a directorate of the Ministry of Economy in charge of controlling compliance with consumer rules and those applicable to health products. It regularly assists the ANSM.



Online resources

Legifrance

W www.legifrance.gouv.fr

Description. Legifrance is the official website of the French Government for the publication of legislation, regulations, and legal information. No translation of the Public Health Code or the Social Security Code is provided by Legifrance.



Contributor profile

Evelyne Friedel, Partner

Taylor Wessing - France

T +33 (0)1 72 74 03 33
F +33 (0)1 72 74 03 34
E e.friedel@taylorwessing.com
W www.taylorwessing.com/fr/home.html

Professional qualifications. Paris, France, Attorney at Law (Avocat au Barreau de Paris)

Areas of practice. EU law; competition law; commercial law; food law; drug law.

Non-professional qualifications. Doctor of Laws degree, University of Paris; post-graduate degrees in EU Law and in international trade law, University of Paris; LLM in Common law studies, Georgetown University Law Center, Washington DC

Recent transactions

  • Regulatory issues regarding the registration, marketing and advertising of drugs.

  • Marketing authorisation for a product developed in both an orphan and a non-orphan indication.

  • Co-development and co-marketing of same drugs (with different trade names) by two marketing authorisation holders.

  • Promotion of drugs by brokers.

  • Setting up pharmaceutical establishments in France.

  • Advertising of hybrid products (distinction between original products and generic products).

  • Challenging, before the relevant drug agencies, of competing dossiers and marketing authorisations that do not comply with the requirements in terms of clinical research.

  • Regulatory issues regarding the SPC's protection of a competitor's drug.

  • Clinical research agreements with French hospitals.

  • Parallel use of the national procedure and mutual recognition procedure in Europe.

Languages. English

Publications

  • Commercialisation of Healthcare: Jurisdictional Comparisons, Chapter France, Thomson Reuters, 2013.

  • European Community Harmonisation of the Licensing and Manufacturing of Medicinal Products, Food and Drug Law Journal, Vol. 49, No. 1, 1994, pp. 141-170.

  • Regulation of Cosmetics in the Common Market, Food Drug Cosmetic Law Journal, Vol. 46, May 1991, pp. 429-440.


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