At the end of 2024, the Ministry of Health issued Order No. 5930/2024 (OMS 5930/2024) amending and supplementing the annex to Order No. 194/2015 of the Minister of Health on the approval of the Rules for the evaluation and approval of advertising for human-use medicines (OMS 194/2015). It was published on December 18, 2024, in the Official Gazette of Romania, representing a revival in adapting legislation on advertising for over-the-counter (OTC) medicines to everyday practices in the digital era.
This update marks a significant step in aligning the legal framework with current technological realities, where digital tools have become an essential component in informing and educating consumers. The regulation establishes well-defined and clear rules for monitoring advertising content placed in the virtual environment, thereby contributing to the consolidation of a safe, transparent, and balanced OTC medicine advertising environment and ensuring accurate and complete information for consumers and patients in Romania.
OMS 5930/2024 introduces new provisions allowing the use of modern digital channels for disseminating advertising materials on OTC medicines, including social media, mobile applications, online platforms, websites, or any other type of application corresponding to an official web page with similar services and content. These channels now receive legal recognition as instruments for promoting OTC medicines to the general public.
However, the dissemination of advertising content regarding OTC medicines—content that must be pre-approved by the National Agency for Medicines and Medical Devices (ANMDMR)—is subject to restrictions aimed at limiting interactions with such promotional material online. OMS 5930/2024 establishes the following rule:
“Advertising intended for the general public through social media, mobile applications, online platforms, websites, or any other type of application corresponding to an official web page with similar services and content is permitted, provided that ‘Like’ buttons and other reaction types, comments, and sharing options are disabled.”
Additionally, the Order states that advertising materials displayed online that contain activatable links cannot include links to pages with promotional materials not approved by ANMDMR. Such materials must always contain a recommendation for users (consumers and patients) to consult a healthcare professional for more information and a clear, readable indication to carefully read the instructions in the package leaflet or on the packaging, in accordance with Article 815, paragraph (1), letter b), third bullet point of Law No. 95/2006, as republished and subsequently amended and supplemented.
The permission for online distribution/sharing equally applies to the distribution/sharing of educational materials on OTC medicines to the general public through social media, mobile applications, online platforms, websites, or any other type of application corresponding to an official web page with similar services and content. The same conditions apply as for advertising content—namely, that ‘Like’ buttons, other reaction types, comments, and sharing options must be disabled and that educational messages containing activatable links must not include links to pages containing unapproved educational materials.
The primary goal of these innovative updates is to ensure industry accountability in providing consumers with clear, truthful information, free from misleading or incorrect practices, thereby increasing collective trust in online advertising for this specific category of products. In this regard, according to OMS 5930/2024, the holders of marketing authorizations for medicines or their representatives are fully responsible for the content of advertising/educational materials regarding OTC medicines that are created and disseminated digitally through modern channels, including the manner in which advertising materials are designed, distributed, and used by third-party contractors via social media, mobile applications, other online platforms, and websites.
For further information or any additional inquiries, please do not hesitate to contact us:
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Bianca Arhire – Attorney at Law
