Pharmaceutical advertising regulation and medical device advertising in Türkiye

1.1 Medicines

• Consumer Protection Law No. 6502 (“Law No. 6502”);
  • Commercial Advertisements and Unfair Commercial 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");
• Decree-Law No. 663 on Organization and Duties of the Ministry of Health and Related Institutions; and
• Regulation on the Duties and Working Procedures and Principles of the Service Units Affiliated to the Ministry of Health
• Turkish Commercial Code No. 6102 ("Law No. 6102");
• Law No. 6197 on Pharmacists and Pharmacies ("Law No. 6197”)

1.2 Medical devices 

• Decree-Law No. 663 on Organization and Duties of the Ministry of Health and Related Institutions;
• Regulation on the Sale, Advertising, and Promotion of Medical Devices (“Medical Devices Advertising Regulation”);
• Guide on the Implementation of the Regulation on the Sale, Advertising, and Promotion of Medical Devices;
• Law No. 6502;
• Law No. 6102; 
• Commercial Advertisements and Unfair Commercial Practices Regulation; and
• Product Safety and Technical Regulations Law No. 7223.

Yes, there are codes of self-regulation, and the most important ones are listed below: 

2.1 Medicines

• The Association of Research-Based Pharmaceutical Companies ("AIFD") is a member of the IFPMA Federation of International Pharmaceutical Manufacturers and Associations ("IFPMA") and Federation of European Pharmaceutical Industries and Associations ("EFPIA"). The AIFD consists mainly of foreign pharmaceutical companies such as Amgen and Novartis and provides self- regulatory codes of conduct for its members, such as:
  • Competition Rules Compliance Guideline; and
  • AIFD Code of Practice.
• The Pharmaceutical Manufacturers Association of Türkiye ("IEIS") provides the second major self- regulatory code of conduct for the advertising of medicines. IEIS has implemented its own policy since 1990. Prepared for the purpose of establishing a self-regulatory mechanism among its members, the policy allows for the monitoring of such activities by a Supervisory Board.
• The Pharmaceutical Industry Association of Türkiye ("TISD").
  • The TISD Advertising Guidelines regulate the advertising of medical products.
• The Turkish Pharmaceutical Exporters Platform (" TIIP") is an organization linked to the IEIS that develops strategies and guidelines to increase the export volume of Turkish pharmaceutical manufacturers and strengthen the international promotion of Turkish pharmaceuticals.
• Turkish Medical Doctors Association ("TTB").
  • The TTB Principles on Medical Doctors and the Advertisement of Pharmaceutical Products regulates the advertisement of medicinal products. Accordingly, TTB may oversee advertising activities through an ethics committee.

2.2 Medical devices 

Although there is no self-regulatory code of conduct specifically applicable to medical devices, the rules of the AIFD and the IEIS may be applied to medical devices on a voluntary basis.

3.1 Medicines 

Over-the-counter ("OTC") medicines and prescription medicines may not be advertised to the public. However, the public may be informed about products used in vaccination campaigns, organised actions to combat epidemics or other campaigns of the Ministry of Health (" Ministry") to promote health - as they are important for the protection of public health - with the approval of the Ministry and within the limits of the policies and procedures established by the Ministry for such products. 

Apart from that, medicines may be promoted to certain healthcare professionals, namely, doctors, dentists, and pharmacists. Promotion activities may be carried out by:

1. presentation materials advertising to doctors, dentists, and pharmacists,
2. holding or supporting scientific meetings and product advertisement meetings, and,
3. pharmaceutical sales representatives visiting doctors, dentists, and pharmacists. 

Products must be registered or authorised in accordance with the relevant Regulation. Accordingly, an authorisation/licence is a certificate issued by the Turkish Agency for Medicine and Medical Devices ("Agency") stating that the product in question can be manufactured and marketed in a specific formulation and in a specific pharmaceutical form or strength in accordance with the approved product information. 

In addition, pharmaceutical sales representatives must obtain a "Qualification Certificate" to promote a human medicinal product to: 

1. doctors,
2. dentists and
3. pharmacists ("healthcare professionals") through direct calls.

The certificate is valid for a specified period and must be renewed. Representatives may only promote products for which they have received appropriate training.

3.2 Medical devices 

Medical devices that can only be used or applied by healthcare professionals or required to be applied at medical devices sale centres and medical devices sales, extrapolation and application of which can only be carried out at hearing aid centres, custom-made prosthesis and orthosis centres, opticianry shops, or dental prosthesis laboratories cannot be advertised to the consumer.  

Under to the Medical Devices Advertising Regulation, a medical device bearing the CE mark must be registered in the Ministry of Health’s Product Tracking System (Ürün Takip Sistemi) prior to being placed on the Turkish market. Medical devices may not be marketed in Türkiye unless they are duly registered in the Product Tracking System. Such registration must be carried out by a Turkish entity responsible for placing the medical device on the market, such as a manufacturer, an affiliate, a distributor, or another locally established partner.

Furthermore, only entities established in Türkiye and authorized by the Ministry of Health as medical device sales centres are permitted to sell medical devices. Accordingly, foreign companies are not allowed to commercialize medical devices directly in Türkiye, as the Medical Devices Advertising Regulation requires that sales activities to be conducted through locally established sales centres. As a result, foreign manufacturers must appoint a local distributor that is authorized as a medical device sales centre and is responsible for the registration and marketing of the devices in Türkiye.

In addition, the Agency has implemented Unique Device Identifier (“UDI”) requirements in line with international standards. Promotional materials must not reference outdated identifiers, and all claims must correspond to the specific device variant as identified by its applicable UDI. 

No, according to Law No. 1262 and the Medicinal Product Advertising Regulation, advertising of any type of medicinal product to the public is prohibited and advertising to healthcare professionals is only allowed under certain conditions. 

In general, all images, statements or references in advertising that give the impression that a product or service is recommended by health professionals are prohibited. 

5.1 Medicines 

The advertising of medicinal products to the public, directly or indirectly through any public media or communication channel, including the Internet, is prohibited, whether through programmes, films, television series, news reports or similar media. 

No prescription drug or its reduced sample may be supplied to the public directly or indirectly.  

Information for the general public may be provided on occasions such as vaccination campaigns and epidemic control, which are important for the protection of public health, or on other campaigns of the Ministry to promote health, with the approval of the Ministry and within the framework of the policies and procedures established by the Ministry for such products. 

5.2 Medical devices

Medical devices that can only be used or applied by healthcare professionals or require to be applied at medical devices sale centres and medical devices sales, extrapolation and application of which can only be carried out at hearing aid centres, custom-made prosthesis and orthosis centres, opticianry shops, or dental prosthesis laboratories may not be advertised to the public. Announcements approved by the Ministry or the Agency in media channels (i.e. health magazines) aimed at health professionals and website information about distribution centres are not covered by this restriction. 

In addition, Law No. 6502 prohibits commercial advertising that misleads consumers or exploits their lack of experience and knowledge, endangers their safety of life and property, encourages the commission of crimes, endangers public health and abuses the sick, the elderly, children and the disabled. 

Accordingly, it is prohibited to use the names of the Ministry and associated institutions, as well as the names of health care institutions and persons involved in the research of the medical device, without permission. 

According to the provisions of the Medical Devices Advertising Regulation, medical devices sold or used in hearing aid centres, prosthesis and orthosis centres, optician shops and dental prosthesis centres, as well as medical devices that can only be used or applied by healthcare professionals, may not be advertised directly or indirectly to the public. Medical devices that do not fall within this scope may only be advertised in the internet environment where the product is sold. Toothpastes, denture care products for individual use, cotton wool, plasters, etc. are exempt from these restrictions and may be advertised. 

Medical devices shall not be advertised by lottery, games of chance and similar tools. 

In summary, advertising of medical devices must not be done in a way that endangers the health of the patient, the user or the environment. 

6.1 Medicines 

• Products that have not been registered or approved in accordance with the relevant legislation;
• Indications other than those approved by the Agency for products registered or authorised under the Regulation;
• With the exception of promotional activities for the purpose of pharmacovigilance of products procured through international suppliers and purchased by the Social Security Agency under alternative reimbursement schemes, of which the Agency is informed; the products registered or authorised under the relevant Regulation, but for which the Agency grants permission to import against prescription because they are not available on the domestic market, may not be promoted to health professionals.
• Free samples may be provided solely to healthcare professionals who are authorised to prescribe the relevant product. The Medicinal Products Advertising Regulation imposes restrictions on the number of samples that may be provided per product per year, and samples must be clearly labelled as "Numune – Satılamaz" and must be accompanied by the approved product information. Any promotion of a product for unapproved or off‑label indications is strictly prohibited.
• By contrast, advertisements displayed at international congresses held in Türkiye, as well as information activities conducted in person by the scientific service of the licence or permit holder at the written request of a doctor, dentist, or pharmacist, fall outside the scope of these restrictions.

6.2 Medical devices

It is prohibited to use the names of the Ministry and associated institutions, as well as the names of health care institutions and persons who have been involved in the research of the medical device, without permission. 

Medical devices shall not be advertised in a manner that endangers the health of the patient, the user or the environment.

Medical devices shall not be advertised by lottery, games of chance and similar tools.

Advertising that may lead to unfair competition may not be made. 

7.1  Medicines 

Turkish law does not prescribe an exhaustive list of mandatory information  to be included in promotional materials addressed to healthcare professionals. Instead, the Medicinal Product Advertising Regulation sets out general principles regarding the type of information that should be communicated to healthcare professionals, without imposing specific content requirements.

Promotional content must be consistent with the product’s Agency-approved Summary of Product Characteristics (SmPC) and must present accurate and evidence‑based medical information to enable healthcare professionals to form an independent judgment regarding the product’s therapeutic value. 

If the advertising involves the use of documentation prepared using quotations, tables or other visual material from medical journals or other scientific publications, these materials must be reproduced authentically, with a full reference to the relevant sources. Citing evidence that is not reflected in the approved SmPC, including unpublished “data on file”, carries a high likelihood of being deemed off‑label promotion. Accordingly, such references must undergo rigorous review to ensure they do not suggest or promote unapproved uses.

Promotional materials must refrain from misleading, overstated, or unverifiable claims and must not include imagery unrelated to the product. 

When advertising products, doctors, dentists and pharmacists may not be granted, offered or promised any benefits, either in cash or in kind. 

7.2 Medical devices 

Advertising for medical devices must contain the following information:

• Explicit information demonstrating that the promotional content is directly related to the device;
• The declaration of conformity of the appliance, its EC certificate, the name and information of the appliance in the documents such as a technical dossier and the compatible appliance names and information;
• Information on the label and in the operating instructions of the appliance compatible with the intended use;
• Scientific reports and certificates relating to the advertisement, date of issue, contact information and the field of expertise of the preparer (person or institution); and
• Evidence-based medical information on any therapeutic effect of the device. 

8.1 Medicines 

As mentioned above, advertising of products to the public, directly or indirectly, through any public media or communication channel, including the Internet, is prohibited, whether through programmes, films, television series, news reports or similar media. 

8.2 Medical devices

Advertising must be in accordance with general principles and the information required by the honesty principle must be made available to the general public. 

If the advertising involves the use of documentation prepared using quotations, tables or other visual material from medical journals or other scientific publications, these materials must be reproduced authentically, with a full reference to the relevant sources. 

As advertising of medicinal products to the public is prohibited in Türkiye, comparative advertising is permissible only when addressed exclusively to healthcare professionals.

According to Law No. 6502, comparative advertising may be made for competing goods or services that meet the same needs or are directed towards the same purpose. 

Law No. 6102 states that advertising that violates the principle of honesty (e.g. unnecessary disparagement of competing products) may lead to unfair competition. 

Medicinal Product Advertising Regulation provides that advertising must not be made with misleading, exaggerated or unsubstantiated information that could encourage unnecessary use of a product or lead to unexpected risks, or by using enticing imagery that is not directly related to the product. 

Furthermore, under the Commercial Advertisements and Unfair Commercial Practices Regulation, comparative advertising must be objective, supported by verifiable evidence, and must not mislead or unfairly harm or exploit a competitor’s reputation. 

Advertising of products to the public directly or indirectly through public media or communication channels, including the Internet, is prohibited, whether through programmes, films, television series, news reports or similar media.

However, the AIFD self-regulatory code regulates the advertising of medicines and provides for this: Companies are responsible for the websites and social media accounts they have set up or that have been created on their behalf. Appropriate measures must be taken to ensure that there is no content on the websites they support or on their social media accounts that can be perceived as advertising medicines to the general public. 

A company may make information about its medicines available to the general public on the company website, provided this is in accordance with laws and regulations. Pharmaceutical companies may develop and promote websites and social media platforms to inform patients and society about diseases and current medical applications. 

Monitoring bodies can be audited under three titles:  

Civil law claims 

The allegedly injured party can demand the following from the courts on the basis of unfair competition: 

• Declaration of unfair competition; 
• Prevention of unfair competition; 
• To pay damages;
• Compensation for non-pecuniary damage; 
• Restraining order;
• Reimbursement in kind; and
• The profit made from the unfair competition act.

Administrative supervision 

• The Agency for Medicine and Medical Devices monitors violations of the Medicines Advertising Regulation and the Medical Devices Advertising Regulation. 
  • The Agency may issue a warning or ban advertising activities;          
  • It may impose fines; and
  • It can file a criminal complaint, which can result in a prison sentence of up to five (5) years.

Repeated infringements may result in progressively more severe penalties, including the suspension of the relevant marketing authorisation. Furthermore, conducting sales, promotional, or advertising activities without the required authorisation certificate, or failing to register products with the Product Tracking System, may lead to additional sanctions. These measures may be taken ex officio or pursuant to third‑party complaints.

Self-audit

Self-regulatory mechanisms have their supervisory boards, which monitor the violations of their members. Although their decisions are not legally binding, they can make an application to medical chambers.

According to the monitoring of the medical associations,

1. The infringer may be disclosed by TTB;
2. It may be addressed to the TTB Disciplinary Committee; and           
3. A report may be made to the Ministry. 

Furthermore, the Self-Regulatory Commission for Advertising monitors instances of non-compliance with the applicable advertisement legislation. Within the framework of the joint commitment to the public, the advisory decisions are not legally binding; however, they are binding in practice. This practical binding effect is ensured by the parties’ adherence to professional and business ethical values of the parties.

Türkiye continues to harmonise its medical device regulations with the EU Medical Device Regulation 2017/745. In line with global trends, pharmaceutical and medical device companies may face enhanced disclosure requirements regarding environmental and sustainability practices in their promotional materials. Accordingly, companies should monitor the Agency for updated guidance on compliance timelines and requirements. 

Stricter enforcement is anticipated. The Agency has signaled increased scrutiny of online and social media advertising practices, particularly with respect to unregistered products and misleading health‑related claims. The Ministry of Health is also developing comprehensive regulations addressing digital health applications, telemedicine, and health-related mobile applications. These regulations may impact how medical devices with digital components are advertised and promoted.