What you need to know
- Prescription medicines must never be advertised to the general public online.
- Advertisements for non-prescription medicine must comply with strict national regulations.
- Influencers and brand ambassadors are bound by the same strict advertising laws as traditional media.
- Companies must ensure all marketing materials about a product must, among other things, align with the information in its Summary of Product Characteristics (SmPC).
- The HPRA closely monitors all online medicine promotions.
What counts as advertising
The starting point is the definition of advertising under the Medicinal Products (Control of Advertising) Regulations 2007, as amended[2]. This definition is not limited to obvious promotional campaigns. Instead, it broadly covers any communication or activity intended to encourage the prescription, use, sale, or supply of a medicine.
In practical terms, this captures a wide range of content, including:
- Social media posts and stories
- Blog articles and website material
- Testimonials or user experiences, and
- Influencer or affiliate content
There is no requirement for a formal commercial link between the person making the communication and the product. Content can fall within scope simply because of its intended effect or purpose.
The rules also extend beyond direct references to medicines. Services that promote or lead to the prescription, supply, sale or consumption of a medicine may also be treated as advertising. This is particularly the case where the messaging encourages engagement with a specific treatment pathway.
The regulator’s focus is broader than expected
The HPRA’s guidance[3] is not directed at a narrow group of pharmaceutical manufacturers. Any person or business that promotes a medicine to the public in Ireland may fall within the regulatory scope. This includes:
- Online pharmacies
- Telehealth providers
- Wellness brands, and
- Individuals posting content
This approach reflects how medicines are now discussed and marketed. Social media, websites and digital services are treated as mainstream advertising channels rather than informal or secondary platforms. The regulator has also made clear that it will intervene where necessary, including requiring the removal of non-compliant content.
At a high-level, some of the key advertising rules include:
- Unauthorised medicines: Medicines that are not approved or registered in Ireland cannot be advertised.
- Prescription-only medicines: These must never be advertised to the public, in any format.
- Free samples: Medicines cannot be offered as samples to anyone who is not authorised to prescribe them.
- Endorsements: When medicines are advertised to the public, they must not include recommendations from healthcare professionals, scientists or celebrities.
- Non-prescription medicines: Certain non-prescription medicines may be advertised to the public. This is subject to certain restrictions. The content must be accurate and not misleading. It must also be presented in a balanced and objective manner. In addition, it must be based on the SmPC, which is the official document setting out the medicine's properties, indications and conditions of use. The advertising must also encourage the rational use of the medicine, present it objectively and without exaggerating its effects, and must not be misleading.
What this means for your business
The HPRA’s new webpage is a strong reminder that their monitoring of social media for medicine advertising is both active and ongoing. Any business that mentions medicines online, should treat this as a prompt to review its current practices and ensure they comply with all rules for advertising to the public. Those in the sector should ask the following questions:
- Do any of the medicines you reference online have prescription-only status in Ireland?
- Does your content encourage people to seek, buy or use a specific medicine?
- Are you working with influencers, content creators or affiliate partners whose posts refer to your products?
If the answer to any of these questions is yes, a compliance review is a sensible next step.
For more information, contact a member of our Life Sciences team.
The content of this article is provided for information purposes only and does not constitute legal or other advice.
[1] HPRA - Promoting medicines to the public on social media
[2] S.I. No. 541/2007 - Medicinal Products (Control of Advertising) Regulations 2007
