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 laws apply when it comes to promoting medicines and medical devices?

1.1 Medicines

• Consumer Protection Law No. 6502 (“Law No. 6502”)
• Trade Advertising and Unfair Trade Practices Regulation
• Pharmaceuticals and Medical Preparations Law No. 1262 (“Law No. 1262”)
• Advertising Measures for Medicinal Products for Human Use Regulation ("Medicinal Products Advertising Regulation")
• Establishment and Broadcasting of Radio and Television Services Law No. 6112 (“Law No. 6112”)
• Organization and Duties of the Ministry of Health and Related Institutions Decree-Law
• Turkish Commercial Code No. 6102 (“Law No. 6102”)

1.2 Medical Devices

• Decree-Law on Organization and Duties of the Ministry of Health and Related Institutions
• Placing on the Market, Advertising and Notification of Medical Devices Regulation (“Medical Devices Advertising Regulation”)
• Law No. 6502
• Law No. 6102
• Product Safety and Technical Regulations Law No. 7223

2. Are there any additional legislative frameworks, such as self-regulatory codes of conduct, that control the advertising of pharmaceuticals and medical devices?

2.1 Medicines

• The Association of Research-Based Pharmaceutical Companies (AIFD)
  • Competition Rules Compliance Guideline
  • AIFD Code of Practice
• The Pharmaceutical Manufacturers Association of Türkiye (IEIS)
  • Self-regulatory policies since 1990
• The Pharmaceutical Industry Association of Türkiye (TISD)
  • TISD Advertising Guidelines
• The Turkish Pharmaceutical Exporters Platform (TIIP)
  • Strategies and guidelines for international promotion
• Turkish Medical Doctors Association (TTB)
  • TTB Principles on Medical Doctors and the Advertisement of Pharmaceutical Products

2.2 Medical Devices

No specific self-regulatory code applies to medical devices. However, AIFD and IEIS rules may apply where relevant.

3. What licenses, approvals, or fees (if any) are required for advertising medications and medical devices to the general public and healthcare professionals?

3.1 Medicines

Advertising of over-the-counter and prescription medicines to the public is prohibited. However, the public may be informed about products used in vaccination campaigns, epidemic control actions, or other health campaigns conducted by the Ministry of Health, subject to Ministry approval and in line with its policies and procedures.

Medicines may be promoted to healthcare professionals, including doctors, dentists, and pharmacists, through:

• Presentation materials
• Scientific meetings and product advertisement meetings
• Visits by pharmaceutical sales representatives

Products must be registered or authorized by the Turkish Agency for Medicine and Medical Devices. Pharmaceutical sales representatives must obtain a “Qualification Certificate” in order to promote medicines to healthcare professionals.

3.2 Medical Devices

Medical devices that require use or application by healthcare professionals or at specific sales centers cannot be advertised to consumers.

Medical device sales centers must employ at least one advertising staff member. This staff member must have a certificate of work and an identity card issued by the Provincial Directorate of Health and be registered in the Agency’s electronic system.

4. Does Türkiye law govern the advertisement of prescription and over-the-counter medications differently?

Both prescription and over-the-counter medicines are prohibited from being advertised to the public. Advertising to healthcare professionals is permitted under certain conditions.

5. What are the primary limits on promoting drugs and medical devices to the public?

5.1 Medicines

Advertising medicinal products to the public through any media, including the Internet, is prohibited. This includes programs, films, TV series, and news reports. Prescription medicines and their samples cannot be supplied directly to the public.

Exceptions apply for vaccination campaigns, epidemic control, and other health campaigns approved by the Ministry of Health.

5.2 Medical Devices

Medical devices requiring professional use or application at specific sales centers cannot be advertised to the public. Announcements approved by the Ministry or the Agency aimed at healthcare professionals, as well as information about distribution centers on websites, are allowed.

Law No. 6502 prohibits misleading advertising that endangers public health or exploits vulnerable groups. Using the names of the Ministry, associated institutions, healthcare institutions, or researchers without permission is forbidden.

Devices sold in specialized centers and those requiring professional application cannot be advertised to the public. Devices outside this scope may be advertised online where they are sold. Products such as toothpastes, denture care items, cotton wool, and plasters are exempt.

Advertising must not involve lotteries or games of chance and must not endanger patients, users, or the environment.

6. What are the primary limits on promoting drugs and medical devices to healthcare professionals?

6.1 Medicines

Exceptions to advertising restrictions include:

• International congresses held in Türkiye
• Information activities by the scientific service of the licence or permit holder upon written request by healthcare professionals

Advertising is prohibited for:

• Unregistered or unapproved products
• Indications not approved by the Agency
• Products sourced internationally and purchased by the Social Security Agency, except for pharmacovigilance purposes with Agency notification
• Registered or authorised products imported due to domestic unavailability

6.2 Medical Devices

• Prohibition on using names of the Ministry, associated institutions, healthcare institutions, or researchers without permission
• Advertising that endangers health or the environment
• Use of lotteries, games of chance, or similar tools
• Advertising leading to unfair competition

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

7.1 Medicines

• Alignment with claims approved by the Agency
• Informative and evidence-based medical data enabling independent evaluation of therapeutic value
• Authentic reproduction of quotations, tables, or visuals from medical journals or scientific publications with full references
• Prohibition on offering or promising benefits, in cash or kind, to doctors, dentists, or pharmacists

7.2 Medical Devices

• Clear indication that the display refers to the unit
• Declaration of conformity, EC certificate, and technical dossier details
• Label and operating instructions compatible with intended use
• Scientific reports and certificates including issue date, contact information, and field of expertise
• Evidence-based medical information on therapeutic effects

8. What information must be included in public-facing advertisements for drugs and medical devices?

8.1 Medicines

Advertising of medicines to the public through any public media or communication channel, including the Internet, is prohibited.

8.2 Medical Devices

Advertising must comply with general principles and provide information in line with the honesty principle to the general public.

9. Are there any constraints on the data used to support promotional claims?

Quotations, tables, or visuals from medical journals or scientific publications must be reproduced authentically with full references. Claims must be substantiated and must not be misleading, exaggerated, or unverified.

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

• Law No. 6502 permits comparative advertising for goods or services meeting the same needs or purposes
• Law No. 6102 prohibits advertising that violates honesty principles or unfairly disparages competitors
• Medicinal Product Advertising Regulation prohibits misleading or exaggerated comparative claims

11. Are there special guidelines for advertising drugs and medical devices on the internet or social media?

Advertising to the public through any public media or communication channels, including the Internet, is prohibited.

Companies are responsible for ensuring their websites and social media accounts do not contain content that may be perceived as advertising medicines to the public. Informational content about diseases and medical practices is permitted.

12. Which bodies oversee compliance and what are the legal ramifications for noncompliance?

Civil Law Claims

• Declaration of unfair competition
• Injunctions
• Payment of damages
• Compensation for non-pecuniary losses
• Restraining orders
• Restitution of profits

Administrative Supervision

The Turkish Agency for Medicine and Medical Devices supervises compliance and may issue warnings, impose fines, or initiate criminal complaints, potentially leading to prison sentences of up to five years.

Self-Regulatory Commission for Advertising

This body monitors compliance with Law No. 6112. Its advisory decisions are not legally binding but carry practical authority.

Self-Audit

Self-regulatory mechanisms may lodge complaints, report violations, recommend disciplinary action, or file reports with the Ministry.

13. Are there any future developments in Türkiye?

There are no planned developments in the current regulatory framework.

How can OMC help?

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