If you’re planning to promote medicines, medical devices, food supplements or cosmetics in Estonia, Latvia or Lithuania, it’s important to understand how European Union regulations apply – alongside the specific local requirements in each of these countries. While the EU provides a harmonised legal framework for the regulation of health-related products, enforcement and interpretation often differ from one Member State to another.
Our expert team in the Baltics has compiled key information on promotional material compliance by product category to clarify how requirements differ and what they mean for your promotional activities. See also our other blogs on pharma marketing compliance in the Nordics and in Finland.
Promotional materials for medicines: highly regulated and closely supervised
The promotion of medicinal products in the EU is governed by Directive 2001/83/EC, which sets strict boundaries, especially when it comes to medicines that require a prescription. Across the EU, including the Baltic countries, prescription-only medicines cannot be advertised to the general public. Promotion to healthcare professionals, on the other hand, is allowed but must be factual, balanced, and include essential information about the product’s characteristics, such as dosage and side effects. Over-the-counter (OTC) medicines may be advertised to the public, but even then, there are clear rules about what information must be included and how the messaging is delivered.
In Estonia, the State Agency of Medicines oversees pharmaceutical promotion and requires that all promotional materials comply with both EU law and national legislation, including the Medicinal Products Act and the general Advertising Act. In certain cases, compliance with the Code of Ethics for Medicinal Product Promotion is also expected. Materials must be in Estonian, include disclaimers and, depending on the product and target audience, may require submission for approval. In Latvia, pharmaceutical promotion must be compliant with national Advertising Law, Unfair Commercial Practices Prohibition Law and Regulation No. 378 “Procedures for Advertising Medicinal Products and Procedures by Which a Medicinal Product Manufacturer is Entitled to Distribute Free Samples of Medicinal Products to Physicians”. Prior approval of promotional materials is not required, but the Health Inspectorate constantly monitors pharmaceutical promotion. Ads must be written in Latvian and include disclaimers such as encouragement to read the package leaflet carefully, consult with a physician or pharmacist on the use of the medicinal product. In Lithuania, the promotion of medicinal products is regulated by the State Medicines Control Agency. All materials must meet detailed national standards regarding content and language.
Promotional materials for medical devices: a mix of EU rules and national interpretation
The regulation of medical device advertising in the EU has become more harmonised with the introduction of the Medical Devices Regulation (EU) 2017/745. Although this regulation does not lay out detailed promotional requirements, it prohibits misleading claims and insists that promotional messages must align with the device’s declared intended purpose. This leaves some room for interpretation, and as a result, local rules and practices play a significant role in how promotional activities are managed.
In Estonia, the promotion of medical devices is primarily regulated under general Advertising Act, with no requirement for prior approval. However, companies are expected to ensure that their advertisements are not misleading and that all claims can be substantiated. In Latvia, the Consumer Rights Protection Center monitors promotional practices to ensure compliance. While there’s no mandatory pre-approval, advertisements must be truthful, evidence-based, and aligned with the product’s intended use. Lithuania takes a similarly pragmatic approach as other Baltic countries – medical device advertisements must be accurate and consistent with the approved labeling, and material must be compliant according to Law on Advertising of the Republic of Lithuania.
Promotional materials for food supplements: strict on claims, flexible on promotion
Food supplements occupy a unique regulatory space. While they are widely available and frequently advertised, several EU laws impose strict limitations on what can be said about their benefits. Only nutrition and health claims that have been authorised by the European Commission can be used in promotional materials. Companies must avoid suggesting that supplements can prevent, treat, or cure disease, as doing so would classify the product as a medicine under EU law.
In Estonia, the promotion of food supplements is monitored by the Agriculture and Food Board. All promotional materials must be in Estonian, scientifically sound, and compliant with both EU and national regulations, primarily general Advertising Act. Latvia requires that food supplements be notified to the Food and Veterinary Service before they are placed on the market. Consumer Rights Protection Center monitors promotional content to ensure that health claims are not misleading and that no medicinal effects are implied. The advertisement shall include the indications “Food supplement and Food supplement does not replace a nutritious and balanced diet”. Lithuania’s State Food and Veterinary Service takes a similarly cautious approach. Promotional messaging must not overpromise or mislead consumers, and claims must align with the EU Register of nutrition and health claims.
In all three countries, food supplements must be notified to the local authority before being placed on the market. Marketers should be particularly cautious when using language that suggests medical benefits or targets vulnerable populations such as children or the elderly.
Promotional materials for cosmetics: transparency and evidence-based claims
Cosmetic products are subject to Regulation (EC) No 1223/2009, which outlines product safety and labeling requirements, and Regulation (EU) No 655/2013, which sets out common criteria for marketing claims. These regulations aim to protect consumers from misleading marketing and require that all claims about cosmetic products be truthful, substantiated, and fair. This includes frequently used phrases such as “clinically tested,” “reduces wrinkles,” or “hypoallergenic,” which must be backed by appropriate evidence.
In Estonia, the promotion of cosmetics is overseen by the Health Board. While there is no requirement for pre-approval of promotional materials, products and advertisements must comply with general consumer protection rules and be based on verifiable product claims. Latvia’s Health Inspectorate enforces compliance by regularly reviewing promotional content and ensuring that information about a product’s effects is not exaggerated or misleading. In Lithuania, oversight falls under the State Consumer Rights Protection Authority, which conducts market surveillance and responds to consumer complaints.
Authorities in all three countries are vigilant when it comes to protecting consumer trust, particularly in the highly competitive and image-driven cosmetics market.
Health product marketing in the Baltics: three distinct approaches
While EU regulations create a common baseline for promoting health-related products, Estonia, Latvia, and Lithuania each apply their own layers of national legislation and regulatory oversight. To advertise successfully and compliantly in the Baltics, it’s not enough to understand EU law – you must also be familiar with local expectations, language requirements, and enforcement practices.
Whether you’re launching a new OTC medicine, promoting a medical device, or running a campaign for a food supplement or cosmetic line, it’s essential to localise your compliance strategy. Working with local regulatory consultants or legal advisors can help ensure your marketing materials meet both EU and national standards, allowing you to enter these dynamic markets with confidence and credibility.
How Medfiles supports your promotional material compliance in the Baltics
Navigating the regulatory landscape across Estonia, Latvia, and Lithuania requires both local insight and EU-wide expertise. At Medfiles, our regulatory affairs professionals have in-depth knowledge of national requirements and extensive experience in reviewing promotional materials across all product groups – medicines, medical devices, food supplements, and cosmetics. Our experts review over 200 promotional materials each year.
We support clients with a wide range of materials, from traditional print (such as leaflets, posters, and pharmacy point-of-sale materials) to digital content, including websites, banners, social media, e-pharmacy listings, and audio-visual ads for TV and radio.
Compliance is critical for successful product promotion. If you’re looking for a trusted partner to ensure your campaigns meet all legal requirements, Medfiles is here to help. Let us manage the complexity of regulatory compliance so you can focus on achieving your commercial goals.
Get in touch with us to learn how we can support your success in the Baltic markets.
Author: Kristi Plaas
Head of Operations, Pharma Regulatory Affairs, Baltics
Kristi Plaas joined the Medfiles Baltics Regulatory team in early 2019 as a Regulatory Affairs Officer. She quickly progressed through roles, becoming a Regulatory Expert after two years and taking on her current leadership position two years later. With a strong academic background – holding a Bachelor’s degree in Gene Technology and a Master’s degree in Biomedicine from the Faculty of Medicine – she brings a solid scientific foundation to her regulatory work.
Before joining Medfiles, she gained extensive experience in clinical and diagnostic laboratory, ensuring accuracy in patient sample analysis and supporting quality management in line with ISO 15189. Her role as a Quality Manager in pharmaceutical cell line development further enriched her understanding of quality assurance and regulatory compliance.
Over the past six years, Kristi has developed deep expertise in regulatory affairs and has led a major cross-country promotional material project Baltics for the last five years. Her active involvement in daily promotional material reviews across all product groups in Estonia underscores her dedication to maintaining compliance and quality in communications.
See also:
- Outsourcing local regulatory affairs: 4 examples of tailored support in the Nordics and Baltics
- Cooperating with Baltic medicines authorities in regulatory submissions: Practical experiences from Estonia, Latvia and Lithuania
- How to implement common Baltic packs for human medicines
- Planning a marketing authorisation transfer in the Baltic countries: key considerations
