Internet Sales of Medicinal Products in France
Beware counterfeit medicines over the internet. Do not risk your health. Make sure you use websites that are authorised to sell medicinal products. For France, the National Chamber of Pharmacists updates a list of authorised French websites on its website.
Since 2 January 2013, pharmacists established in France, be it community pharmacy owners or pharmacy managers in co-operative pharmacies and in regional mining social security insurance offices (CARMI), can sell medicinal products on the Internet.
This practice is governed by the Public Health Code (Articles L. 5121-5 , L. 5125-33 et seq., And R. 5125-70 et seq. of the CSP) and the decrees of 28 November 2016 relating to good practices in the dispensing of medicinal products and the technical rules applicable to medicinal product e-commerce websites.
Which medicinal products can be sold on the Internet in France?
E-commerce means the economic activity whereby the pharmacist electronically and remotely provides or distributes medicinal products for human use to the public as well as on-line health information.
In France, only medicinal products that do not need a prescription can be sold online.
It is forbidden to sell medicinal products that need a prescription over the internet.
Which pharmacists can sell medicinal products on the Internet?
Pharmacists established in France, be it community pharmacy owners or pharmacy managers in co-operative pharmacies and regional mining social security insurance offices (CARMI), can sell medicinal products on the Internet. This can only be done from the pharmacy's website. If the pharmacy ceases its activities, it must shut down its website. The pharmacist is responsible for the content published on the website and the conditions under which the medicinal product e-commerce is exercised. All these pharmacists are registered with the National Chamber of Pharmacists.
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In addition, before opening a medicinal product e-commerce website, these pharmacists must obtain authorisation from their Regional Health Agency [agence régionale de santé] (ARS). After this authorisation, they must inform the Council of the Chamber of Pharmacists of the website’s creation.
In the event of a breach of the rules applicable to medicinal product e-commerce, the local ARS Director General may (under the conditions specified in the texts) give notice and/or order the temporary closure of the website for a maximum period of five months, impose an administrative fine on the pharmacist, or impose a daily penalty payment. If the pharmacist does not comply after the closure of the website, the ARS Director General may issue a new closure under the same conditions (articles L. 5424-4 , L. 5472-2 of the CSP).
If natural or legal persons legally authorised to sell medicinal products online in a Member State of the European Union wish to sell medicines to people located in France, they must only sell non prescription medicines that are legally authorised in France (Article L. 5125-40 of the CSP) as amended by Law No. 2014-201 of 24 February 2014).
How do you know if a website is authorised in France?
The World Health Organization (WHO) estimates that about 50% of medicinal products sold on the Internet are falsified medicinal products (counterfeit medicines, unauthorised medicines, etc.). Also, the National Chamber of Pharmacists strongly recommends that internet users first verify if the online pharmacy is authorised. We encourage you to consult our list to find French websites that are authorised by the ARS.
Under the Public Health Code, the National Chamber of Pharmacists provides and updates a list of websites that have been authorised to sell medicines by the Regional Health Agencies (ARS). This is based on the information provided by pharmacists who have received authorisation. The ARS’s are the competent authorities that are responsible for examining authorisation applications and granting them, as well as subsequently supervising licensed pharmacy websites (Articles L. 5125-35 , R. 5125-71 , L. 5424-4 and L. 5472-2 ).
In addition, French websites that are authorised to sell medicinal products online must contain at least the following information:
- pharmacy name
- full name of the managing pharmacists of the website
- pharmacy address
- e-mail address
- phone number
- name and contact details of the web hosting company
- name and address of the regional health authority with territorial jurisdiction
- contact details of the National Agency for Medication Safety [Agence Nationale de Sécurité du Médicament et des Produits de Santé]
And optionally:
- individual VAT number
- registration number in the Trade and Companies Register
- SIRET number
Also, the medicinal product website must provide a hypertext link to the following websites:
- National Chamber of Pharmacists
- Ministry of Health
Since 1 July 2015, authorised websites must also display the Member State logo for the European Union on each webpage relating to the online sales of medicinal products (see the decree of the Ministry Of Health of 20 April 2015 ). By clicking on this logo, you will be able to verify that the said website is authorised for medicinal product e-commerce (see Article 85c of the European directive 2001/83 EC and the implementing regulation no. 699/2014 of 25/06/2014 on the European logo for online sales of medicinal products).
Also, since 1 February 2017, medicinal product e-commerce websites have been required to comply with the technical rules defined in the decree of 28 November 2016. For example, the website must:
- mention the name of the natural person offering medicinal products
- include specific tab for medicinal product sales
- have a warning system for the pharmacist when the quantities of medicinal products ordered is over the recommended dose for each active substance...
Why is it risky to buy medicinal products over the internet?
According to the European Parliament and the Council of the European Union (Directive 2011/62/EU ), "The illegal sale of medicinal products to the public via the Internet is an important threat to public health as falsified medicinal products may reach the public in this way. It is necessary to address this threat. In doing so, account should be taken of the fact that specific conditions for retail supply of medicinal products to the public have not been harmonised at Union level and, therefore, Member States may impose conditions for supplying medicinal products to the public within the limits of the Treaty on the Functioning of the European Union .”
They add that " When examining the compatibility with Union law of the conditions for the retail supply of medicinal products, the Court of Justice of the European Union (‘the Court of Justice’) has recognised the very particular nature of medicinal products, whose therapeutic effects distinguish them substantially from other goods. The Court of Justice has also held that health and life of humans rank foremost among the assets and interests protected by the TFEU and that it is for Member States to determine the level of protection which they wish to afford to public health and the way in which that level has to be achieved. Since that level may vary from one Member State to another, Member States must be allowed discretion as regards the conditions for the supply on their territory of medicinal products to the public. In particular, in the light of the risks to public health and given the power accorded to Member States to determine the level of protection of public health, the case-law of the Court of Justice has recognised that Member States may, in principle, restrict the retail sale of medicinal products to pharmacists alone.”
They acknowledge that " The falsification of medicinal products is a global problem, (...). To that end, the Commission and the Member States should cooperate closely and support ongoing work in international fora on this subject, such as the Council of Europe, Europol and the United Nations. In addition, the Commission, working closely with Member States, should cooperate with the competent authorities of third countries with a view to effectively combating the trade in falsified medicinal products at a global level.”
En savoir plus
- Directive 2011/62/EU on the prevention of falsified medicinal entering the legal supply chain
- Decree of 20 April 2015 establishing the entry into force of the provisions of Articles R. 5125-70 and R. 5125-74 of the Public Health Code relating to the common logo that shall appear on the medicinal product e-commerce websites, JORF of 30 April 2015
- Articles L. 5125-33 et seq. of the Public Health Code
- Articles R. 5125-70 et seq. of the Public Health Code
- Decree of 28 November 2016 relating to the technical rules applicable to medicinal product e-commerce websites provided for in Article L. 5125-39 of the Public Health Code
- Decree of 28 November 2016 relating to good medicinal product dispensation practices in community pharmacies, co-operative pharmacies, or regional mining social security offices as stipulated in Article L. 5121-5 of the Public Health Code
- WHO - Fact sheet: Substandard, spurious, falsely labelled, falsified and counterfeit medical products