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France issues good dispensing practices for online sale of medicines

 

19 July 2013

The implementing decree regulating the online sale of medicines was published on 23 June 2013 and enters into force on 12 July 2013.

The Decree of 20 June 2013 regarding good practices for online dispensing of medicines (“Arrêté relative aux bonnes pratiques de dispensation des médicaments par voie électronique”) now sets out the practical guidelines for the online sale of non-prescription medicines, which was first authorised in France by the Order of 19 December 2012 and the Decree of 31 December 2012 on the strengthening of the security of the medicines supply chain and supervision of the online sale of medicines.

  1. Which medicines can be sold online in France?

All non-prescription medicines can be sold online in France.  In a decision of 14 February 2013, the Council of State (“Conseil d’Etat”) decided that the distinction made by Article L. 5125-34 of the French Public Health Code between “Over The Counter” (OTC) medicines and other non-prescription medicines is illegal.

  1. Who can sell medicines online in France?

Only pharmacists owning a brick-and-mortar pharmacy are allowed to sell medicines online, and an online pharmacy is considered as an immediate extension of the existing brick-and-mortar pharmacy.  The Decree explicitly prohibits (partially or fully) subcontracting the online sales of medicines to third parties except for the design, technical set-up and maintenance of the website.  However, even the latter activities may not be delegated to pharmaceutical companies (as defined in Article L. 5311-1 PHC).

In order to create an online website, a pharmacist must obtain the authorisation of the Director of the relevant Health Regional Authority (i.e., “les Agences Régionales de Santé”) and inform the National Order of Pharmacists.  A list of authorised online pharmacy websites will be made available on the websites of the relevant Health Regional Authority, the Ministry of Health and the National Order of Pharmacists.

  1. What must websites for online sales of medicines look like?

CLEAR INDICATION OF PHYSICAL PHARMACY – Websites that provide for the online sale of medicines must clearly indicate the pharmacy (its name, address, contact details, license number, etc.) and the pharmacists (their name and license number) so that patients can identify the website as linked to an officially licensed (physical) pharmacy.  In this respect, it is also highly recommended that the domain name of the website is comprised of the name of the pharmacist, possibly linked to the name of the pharmacy.  The domain name should not be fanciful or misleading and should not have a promotional purpose.

OBLIGATORY INFORMATION – The Decree also requires that other specific information, such as the name and address of the regionally competent health authority, be listed and be “easily, directly and permanently” accessible.  All information must be in French (though translations are allowed).  The online pharmacy’s website must also contain hyperlinks to the websites of (i) the National Order of Pharmacists (“l’Ordre national des pharmaciens”); (ii) the Ministry of Health (both of which will contain a list of approved online pharmacies); and (iii) the French Medicines Agency (“l’Agence nationale de sécurité du médicament et des produits de santé” or “ANSM”), the latter for purposes of pharmacovigilance reporting.  However, hyperlinks to the websites of pharmaceutical companies are strictly prohibited.

In the near future, as required by the EU Falsified Medicines Directive, authorised websites of online pharmacies should contain a common logo recognisable throughout the EU, the specifics of which yet have to be set out by a European Commission implementing act.  All aforementioned information must be listed in a specific section of the website entitled “Who are we” (“Qui sommes nous?”), a link to which should appear on every page of the website.

SPECIFIC TAB FOR ONLINE SALES OF MEDICINES – The website must contain a specific tab for the sales of medicines in order to make a clear distinction with other products sold by a pharmacy (e.g., cosmetics, food supplements, etc.).  The medicines must be presented in “an objective, clear, and not misleading way” and are categorised by indication, and within each indication, alphabetically per active substance. 

The Decree contains a limitative list of information that may be mentioned with regard to the medicinal product, e.g., the commercial name and INN, therapeutic indications, dosage form (e.g., tablets, capsules), and price (in euros, taxes included).  A hyperlink to the Summary of Product Characteristics (SmPC) on the European or French Medicines Agency must be made available.  Simplified summaries are, however, prohibited.

  1. What are the duties of the E-Pharmacist?

All ethical and professional rules applicable to the dispensing of medicines, most notably the professional independence of the pharmacist, the non-solicitation of patients, and the compliance with the rules on advertising, also apply to the online sale of medicinal products.  In order for a pharmacist to comply with its professional obligations of pharmaceutical advice and supervision, medicines may only be sold online after an interactive exchange of information between the pharmacist and the patient (for example, by means of a questionnaire), and the pharmacist must personally ensure the delivery of the medicine(s).

 

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