01 December 2016 - Authored by:Eveline Van Keymeulen
On 1 December 2016, two decrees regulating the online sales of non-prescription medicines were published. The decrees (available here and here) follow the Council of State’s March 2015 annulment of the 2013 Decree on good dispensing practices for the online sales of medicines, and the unfavourable opinion of the French Competition Authority of April 2016 on two draft decrees regulating online sales of medicines (see our previous post here). In contrast with the 2013 Decree, the new decrees separately regulate good dispensing practices and technical regulations.
The decree on good dispensing practices (GDP) for the online sales of medicines by pharmacies sets out generic GDP and adapts them to the online sales of medicines (pharmacovigilance, duty of advice, delivery of orders, recommended maximum quantities, control mechanisms, and so on). The decree confirms the possibility for the pharmacist to dispense generic medicines, provided the prescribing physician has not marked the prescription as “non-substitutable”.
The decree on technical regulations applies to pharmacy websites selling medicines, in particular:
The running of pharmacy websites which require a patient private section (“My Account”) and a separate window tab for medicines as well as an alert device when “exoneration” doses are exceeded, among other things. The decree also prohibits links to pharmaceutical companies’ websites, subcontracting (except for technical maintenance) and referencing in search engines or price comparators.
The online presentation of medicines must only contain certain information, in particular, the invented name and common denomination, therapeutic indication, conditions of use (including PDF formatting for package leaflets), price, and links to the summary of the product characteristics. Medicines must be classified per intended use and sub-classified per active substance.
Provisions for the protection of personal data, including rules to ensure data confidentiality and security (such as for data encryption, personal access code, and so on).
The decrees will enter into force on 1 February 2017.
A prior version of this post was originally published by the same authors in Practical Law – Life Sciences, December 2016 Issue (Thomson Reuters).
This post was originally co-authored by Patricia Carmona Botana.