Promotion and advertising control as a component of device market surveillance, under the national advertising authorisation regime
Two instruments together govern promotion and advertising of medical devices in Senegal. First, Décret n° 2023-2419 art. 43 makes 'le contrôle de la promotion et de la publicité' an express component of the medical-device post-marketing surveillance system, so device advertising is a regulated post-market activity controlled by the pharmaceutical-regulation structure. Second, the substantive authorisation regime is Décret n° 2023-2424 du 27 décembre 2023 fixant les conditions d'autorisation de la promotion ou de publicité sur les médicaments et autres produits de santé, taken under art. 55 of Loi n° 2023-06: art. 1 fixes its object as the conditions for authorising promotion or advertising of 'médicaments et autres produits de santé'; art. 3 subjects promotion through an advertising medium or by the giving away of free units to an authorisation issued by the pharmaceutical-regulation structure; art. 33 reserves advertising to products for which a marketing authorisation has been obtained and requires any advertisement to respect the marketing authorisation, to conform to the summary of product characteristics, to favour rational use and not to harm public health; art. 34 lists prohibited elements (presenting the medical act as superfluous, suggesting the effect is acquired, suggesting absence of side effects, claiming superiority or equivalence over another product, claiming that a normal state of health can be improved, assimilating the product to a foodstuff, referring to certificates of cure, insisting that a marketing authorisation has been obtained); art. 35 forbids anticipating pending variations; art. 36 requires comparative advertising to be based on comparable and relevant characteristics and not to be denigrating or misleading; art. 37 prohibits advertising to the general public; art. 38 reserves advertising strictly to public-health professionals and requires the information to be exact, up to date, verifiable and sufficiently complete; art. 39 makes professional advertising controlled by the regulation structure and lists the permitted channels; art. 40 creates an evaluation and validation commission for advertising requests; art. 42 provides that the composition of the advertising-authorisation dossier is fixed by decision of the Director-General; art. 43 permits campaigns for priority health programmes to address the general public only where preventive or public-health protective. Sanctions for advertising or promoting without authorisation are listed in art. 44: urgent stopping of the advertising campaign, urgent stopping of the promotion of the product, suspension of the marketing authorisation, withdrawal of the marketing authorisation, and a fine of 1,000,000 to 2,000,000 CFA francs, with the same fine for advertising on an unauthorised medium. The ARP also lists the UEMOA 'LIGNES DIRECTRICES POUR LE CONTRÔLE DE L'INFORMATION ET LA PUBLICITE SUR LES MEDICAMENTS AUPRES DES PROFESSIONNELS DE LA SANTE DANS LES ETATS MEMBRES DE L'UEMOA' in its official guideline library, matching the Décision n° 10/2010/CM/UEMOA cited in the visas of Décret n° 2023-2424.
- Décret n° 2023-2424 never uses the word 'dispositif': its operative articles are drafted in terms of 'médicament' and 'autres produits de santé'. Senegal's device decree is taken under the law 'relative aux médicaments, aux autres produits de la santé et à la pharmacie' (its rapport de présentation records that Loi n° 2023-06 art. 244 referred device implementation to a decree, and art. 45 sanctions non-compliance with the device decree under that same law), so devices fall within the 'autres produits de santé' limb of the statute whose scope words the advertising decree repeats.
- Décret n° 2023-2424 regulates promotion and advertising; it does not create a separate device-claims substantiation rule or a claims register.
- The ARP's public reminder 'rappel de la réglementation sur la publicité des médicaments et autres produits de santé' is listed on https://arp.sn/publications/ but its published file is not a readable text instrument, so it is not relied on.
Effective from 2023-12-27
Source is French. The passages are quoted verbatim below with an English translation. The device-specific hook is Décret n° 2023-2419 art. 43; the substantive authorisation regime is Décret n° 2023-2424. The supporting source r204-sn-decret-2023-2419 was re-read in full for this fact (arts. 27-48 and Annex 1).
