CMS | Romania regulates advertising of medicines via social networks and mobile apps

On 18 December 2024, the Romanian Ministry of Health published Order no. 5930/2024 amending the current norms for the evaluation and approval of advertising for medicines for human use (approved by Order no. 194/2015) to allow for advertising over social media. 

Advertising on social media and mobile applications now allowed

The Order explicitly allows for the advertising of medicines to the general public through social networks, mobile applications, online platforms, websites, or similar digital applications with official webpages offering similar services and content, under certain conditions.

Before this amendment, advertising of drugs on social media and mobile applications was expressly prohibited.

Although allowed, advertising for drugs via social networks, mobile applications, online platforms, websites or any other type of application is subject to strict conditions:

→    “Like” buttons and other types of reactions, comments and the possibility of sharing ads must be disabled;
→    marketing materials must encourage users to consult a health professional for more information and include a clear, legible message to carefully read the instructions on the package leaflet or packaging;
→    live links in the marketing content must not connect to pages containing promotional materials that have not been approved by the Romanian National Authority for Medicines and Medical Devices (ANMDMR).

According to the Order, marketing authorisation holders or their representatives will be responsible for the content of advertising materials appearing on social media, mobile apps and other online platforms; and for the design, distribution, and usage of such materials.

Under certain conditions, educational materials aimed at the public are also permitted on billboards, social networks, mobile applications, online platforms, websites or any other type of application.

Other important parts of the amendment are the following: marketing authorisation holders must monitor and address any non-compliant advertising or educational materials posted by web domain providers; and website owners and providers must ensure that published materials not infringe national and international regulations.

In addition, advertising to the general public cannot include promotional offers, discounts, or references to special prices, etc.

Advertising, educational materials, and sponsorship activities must be reported to the ANMDMR through an online application via the ANMDMR portal.

Sanctions

Non-compliance with the Order will result in fines of between RON 10,000 (approximately EUR 2,000) and RON 30,000 (EUR 6,000). Other sanctions may also apply.

Conclusion

Order 5930/2024 represents a significant opportunity for pharmaceutical companies to expand their digital advertising strategies. They must, however, adhere to the Order’s specific rules and the broader regulations governing advertising to the public.

Moreover, the updated rules now extend responsibility to other stakeholders, including advertising agencies and other marketing partners of pharmaceutical companies. All parties involved must understand and comply with these new requirements to avoid potential sanctions.