Importance of Regulations for Advertising Medicines and Medical Devices

Healthcare regulations safeguard public health by ensuring accurate information and ethical marketing. They prevent misleading claims, promote responsible advertising, and require scientific evidence for product claims. This empowers patients with reliable information and protects them from misuse of medications. Regulations also ensure fair competition within the industry.

1. Which are applicable laws regarding advertising of medicines and medical devices in Bulgaria?

Medicines

Advertising of medicines is mainly regulated by the Medicinal Products in Human Medicine Act (MPHMA) and Ordinance No. 1/2012.

Medical Devices

Medical devices are governed by the Medical Devices Act (MDA), Regulation (EU) 2017/745 (Regulation 745), and Regulation (EU) 2017/746 (Regulation 746).

Other Relevant Laws

• Protection of Consumers Act
• Competition Protection Act
• Radio and Television Act
• Codes of Ethics for healthcare professionals

2. What are self-regulatory codes of conduct?

• Code of Conduct 2020 (Medicines for Europe / BG Pharma)
• Consolidated Code of Ethics (Arpharm)
• National Ethical Standards for Advertising (National Council for Self-Regulation)

3. What are the Licenses, Approvals, and Fees for advertising medicines and medical devices?

General Public

Pre-approval is required from the Bulgarian Drug Agency (BDA) for advertising medicines. An application with project details and supporting documents must be submitted.

Healthcare Professionals

Notification to the BDA is required for advertising medicines to healthcare professionals. There are no specific approvals or fees required for advertising medical devices.

4. What is the difference in regulation between prescription-only and over-the-counter medicines?

• Prescription-only medicines (POMs) cannot be advertised to the general public, except for vaccination campaigns.
• Only over-the-counter (OTC) medicines may be advertised to the general public.

5. What are the restrictions on advertising medicines and medical devices to the general public?

Medicines

• Advertisements must be truthful and correspond to approved product information.
• Effects must not be exaggerated or imply that medical consultation is unnecessary.
• Offering gifts or benefits is prohibited.
• Healthcare professionals must not advertise medicines directly or indirectly.
• Advertisements must be clearly identifiable as medicine advertising.
• Advertisements must not imply that children can use the medicine unsupervised or guarantee absence of side effects.
• Narcotic substances and distribution of samples to the public are prohibited.

Medical Devices

• Advertising must not mislead users regarding purpose, safety, or performance.
• Uses not stated in the intended purpose must not be suggested.
• Only CE-marked medical devices may be advertised.

6. Which are the main restrictions applicable to the advertising of medicines and medical devices to healthcare professionals?

Medicines

• Advertising is permitted only for medicinal products with a valid marketing authorization.
• Advertisements must align with approved summaries of product characteristics and include only authorized therapeutic indications.
• Advertisements must promote correct use and avoid exaggeration or misleading claims.
• Offering gifts or benefits is prohibited.
• Healthcare professionals must not advertise medicines publicly.
• Advertising must not imply elimination of the need for medical consultation or surgery.
• Guarantees of effect without side effects are prohibited.
• Advertising narcotics or providing samples to the general public is forbidden.

Medical Devices

• Misleading text, names, trademarks, or images are prohibited.
• Users must be accurately informed of associated risks.
• Only intended uses stated during conformity assessment may be promoted.
• Only CE-marked devices may be promoted and sold.
• Non-CE-marked devices may be exhibited for demonstration purposes only, with clear labeling indicating non-compliance.

7. What information is required in advertisements directed only at healthcare professionals for medicines and medical devices?

7.1 Medicines

• Information consistent with the approved Summary of Product Information (SPN).
• Date of last SPN approval.
• Detailed prescribing methods.
• Quality and quantity of ingredients.
• International Nonproprietary Name (INN) of active substances and any necessary additional substances.
• Name and contact details of the marketing authorization holder or representative.
• Price and reimbursement conditions by the National Health Insurance Fund (optional).

7.2 Medical Devices

• No misleading text, names, or images regarding purpose, safety, or performance.
• Truthful representation of device functions and properties.
• Clear information on any likely risks associated with use.
• Promotion only of approved intended uses.
• Clear indication of intended use in all materials.

8. What are the advertising requirements for medicines and medical devices?

Medicines

• Brand name of the medicine.
• INN (International Nonproprietary Name).
• Explicit statement that the advertisement promotes a medicine.
• Instructions for safe and effective use.
• Indication of minimum age for use.
• Prompt to consult the information leaflet.
• Identification as a homeopathic product, where applicable.

Medical Devices

• Name of the medical device.
• Purpose of the medical device.
• Information essential for correct use.
• Clearly visible indication of possible adverse effects.

9. What are the requirements for scientific data in advertisements for medicinal and medical device products?

• Data from published medical literature must be precisely reproduced with clear source references.
• Advertising must not use information from unpublished trials or data with unverified clinical significance.
• The advertised purpose must align strictly with the manufacturer’s label, instructions for use, and the advertisement itself.

10. Are there any rules governing comparative advertising of drugs and medical devices?

Comparative advertising is regulated under general competition law and the Consumer Protection Act.

• Advertising must not be misleading or unfair.
• Objective comparison of essential and representative characteristics is permitted.
• Advertising must not cause confusion between advertisers or their products.
• It must not discredit competitors or take unfair advantage of their reputation.
• Products must not be presented as imitations of trademarked products.
• References to studies not designed for direct comparison must be clearly stated.

Arpharm Code Specifics

• Information must be correct and substantiated with references.
• Comparisons must clarify key properties without confusion.
• Derogatory statements and misuse of competitors’ trademarks are prohibited.

11. How to advertise medicines and medical devices on the internet and social media?

Advertising prescription-only medicines on the internet is expressly prohibited. This applies to websites and social media platforms in accordance with the MPHMA, its Ordinance, and the Arpharm Code.

12. What are the enforcement mechanisms and legal consequences?

Authorities Monitoring Compliance

• Bulgarian Drug Agency (BDA)
• ARPharM Ethics Committee
• Competition Protection Commission (CPC)
• Consumer Protection Commission

Penalties for Violations

• MPHMA fines: €5,000 to €10,000
• ARPharM Code fines: €1,000 to €3,500 depending on severity
• Competition law sanctions: Up to 10% of annual turnover, plus civil damages
• Consumer law penalties: Fines up to €7,500 for distance selling of POMs and additional fines for unfair practices

13. Are there any future developments in Bulgaria?

Currently, there are no upcoming changes in the short term regarding the advertising regulations for medicinal products in Bulgaria.

How can OMC help?

• OMC offers professional review of marketing and advertising materials and provides reports.
• Services to obtain authority approvals where required.
• Translation of marketing materials by a professional translation agency certified with ISO 17100.