Advertisement of OTC medicinal products

Infarmed issued a new regulation on Good Practices for Advertisement of Over-the-Counter Medicinal Products through Digital Channels to ensure that advertising of over-the-counter medicinal products on digital channels continues to comply with the requirements set out in the Medicines Statute. It came into force on March 8, 2024.

The Regulation reiterates the obligations already included in the Medicines Statute for advertising aimed at the general public regardless of the means of dissemination and introduces new practical features for advertising on digital channels by type of channel:

• General advertising: The typical warning text that the user should carefully read the medicine information and consult a doctor or pharmacist in case of doubt must be included in a blue background rectangle, highlighted and visible to users, and it should also include a direct link to the updated version of the medicine's information leaflet.

• Social media platforms: The warning text must be included on the main page of the platform used and with a zoom function.

• Mobile applications: The warning text must be properly highlighted.

• Other media with limited space or time such as microbanners, posts, or tweets: Only the following essential elements are allowed to be included: (i) the name of the medicine, (ii) the authorized indication, and (iii) the warning text, but in a reduced version and with a link to the updated leaflet. In a search engine marketing advertisement, only the first two elements and a direct link (with a single click) to the approved version of the information leaflet must be included, without any warning text.