Legal & Regulatory > Turkey > Traditional Medicines and OTC Products

The lowdown on the situation regarding traditional medicines and OTC products in Turkey. Prepared in association with Moroğlu Arseven, a leading Turkish law firm, this is an extract from The Pharma Legal Handbook: Turkey, available to purchase here for GBP 75.

1. What are the regulatory requirements for traditional, herbal, complementary, or alternative medicines and devices?

Traditional herbal medicinal products are pharmaceutical preparations which have specific indications for use, which are specifically administered according to the specified dose and posology, and which are administered either orally, externally or via inhalation. In relation to the composition and intended use, traditional herbal medicinal products are designed with the intent to be used without the physicians’ diagnostic monitoring, prescription, nor therapeutic monitoring. There must be sound justification by bibliographic data that the medical herbs within the product’s composition have been used within Turkey or the European Union for at least fifteen years, or for at least thirty years within other countries, prior to applying for a marketing authorization. Such products can be provided from pharmacies via warehouses.

Marketing authorization procedures for traditional herbal medicinal products are regulated under Regulation on Traditional Herbal Medicinal Products. Food supplements, herbal cosmetic products or herbal devices are not included in the scope of this Regulation.

TİTCK supervises license application. The requirements for traditional, herbal, complementary, or alternative medicines and devices are defined as follows:

• The manufacturing site where herbal medicine is produced must have the Certificate of Good Manufacturing Practices,
• Applicants must be resident in Turkey,
• Real person applicants must have graduated from one of the higher education institutions providing education in the fields of pharmacy or medical science and they must practice their profession in Turkey,
• Legal Person applicants must employ a representative who was graduated from one of the higher education institutions that provide education in the fields of pharmacy or medical science and they must practice their profession in Turkey (Article 6, Regulation on Traditional Herbal Medicinal Products),
• A separate file must be prepared for each pharmaceutical dosage form according to the information and documents specified in this Regulation,
• Applications must be made in the Common Technical Document format.

The Regulation on Traditional Herbal Medicinal Products lists the required documents, such as the product’s name, pharmaceutical dosage form, application route, amount in the unit package and the product’s qualitative as well as quantitative composition.

2. Can these traditional, herbal, complementary, or alternative products be advertised directly to the public?

The Regulation on Promotional Activities of Medical Products for Human Use shall be applicable for advertising activities of traditional, herbal, complementary, or alternative products (Article 29, Regulation on Traditional Herbal Medicinal Products). Rules, restrictions and procedures for advertising medicinal products for human use are the same for traditional, herbal, complementary, or alternative products.

Please see the Marketing, Manufacturing, Packaging & Labelling, Advertising overview.

3. What health, advertising, and marketing claims may be made for traditional, herbal, complementary, or alternative products?

Penalties regarding obligations arising from the traditional, herbal, complementary, or alternative products are not regulated under a specific regulation. Procedures of the claims to be made under this Regulation shall be same with the human medicinal products and regulated under Pharmaceutical and Medical Preparations Law and Turkish Criminal Code.

4. What are the regulatory requirements for over-the-counter (non-prescription) medications?

In Turkey, OTC products are defined as drugs that have been found to be safe and appropriate for use without supervision from a health care professional, such as a physician. Therefore, consumers can purchase OTC products without a prescription. OTC products which are accepted as effective and safe for the disclosed indications are used to treat simple diseases which are commonly encountered in daily life.

According to the Regulation on the Classification of Human Medicinal Products, pharmaceuticals are classified only as prescription and non-prescription pharmaceuticals. A pharmaceutical is classified as a prescription pharmaceutical if it meets any of these criteria (Article 6):

• Using the pharmaceutical under medical supervision causes direct or indirect danger to health, even if the pharmaceutical is applied correctly,
• Using the pharmaceutical poses a risk to human health due to frequent and common misuse of the pharmaceutical,
• With respect to preparing the active substance or formulation, the activity and/or adverse effects need further research,
• The pharmaceutical is applied via parenteral methods.

If a product is not classified as prescribed, it is deemed to be a non-prescription pharmaceutical. Turkey does not define OTC products, nor regulate requirements for advertisement or specific sale channels. Therefore, under Turkish regulations, non-prescription pharmaceuticals are effectively equivalent to OTC products. As a result, general Turkish regulations regarding pharmaceuticals apply for non-prescription OTC products, including advertising bans.

5. Are there any limitations on locations or channels through which OTC products may be sold?

In Turkey, sales channels of all kinds of medicinal products are strictly regulated. Pharmacists are liable for ensuring non-prescription products are supplied in a safe and rational manner that is appropriate to the needs of the patient and the pharmacists must provide counselling in this regard (Article 7/1-ç, Regulation on the Pharmacists and Pharmacies). Accordingly, OTC products can only be sold in the pharmacies, the same as for prescription drugs.

6. What health, advertising, and marketing claims may be made for OTC products?

Turkish law makes no strict distinction between OTC products and prescription drugs regarding product claims. Please see the Product Liability overview.

7. Can OTC products be marketed or advertised directly to the public?

There is no strict distinction between OTC and prescription pharmaceuticals in Turkish pharmaceutical legislation for marketing and advertisement. However, preparations which must be sold under prescriptions may only be advertised in medical publications (Article 13, Pharmaceutical and Medical Preparations Law). Regulations distinguish between OTC and prescription pharmaceuticals. Therefore, arguably OTC products can be marketed or advertised directly to the public, without being subject to any restriction. However, rules, restrictions and procedures for the advertisement of medicinal products for human use apply for OTC products too.

Pursuant to the Article 11/3 of the Establishment of Radio and Television Enterprises and their Media Services Law numbered 6112 published in the Turkish Official Gazette dated 3 March 2011 and numbered 27863 (“Radyo ve Televizyonların Kuruluş ve Yayın Hizmetleri Hakkında Kanun”), “Advertisements for pharmaceuticals and medical treatments that are not subject to prescription shall be prepared under the principle of integrity, and in such manner that they will comprise elements that reflect the truth and can be verified.” The same article can be found in the Article 12/b of the Regulation on Broadcast Service Procedures and Principles published in the Turkish Official Gazette dated 2 November 2011 and numbered 28103 (“Yayın Hizmeti Usul ve Esasları Hakkında Yönetmelik”)

8. What is the mechanism by which a prescription-only product can be converted to an OTC product?

The Ministry re-examines the classification of pharmaceutical products for human use when it renews medicine licenses, or where it is notified regarding the new product developments (Article 10, Regulation on Classification of Human Medicinal Products). The Ministry will convert an OTC product into a prescription-only product whether:

• Using the pharmaceutical under medical supervision causes direct or indirect danger to health, even if the pharmaceutical is applied correctly,
• Using the pharmaceutical poses a risk to human health due to frequent and common misuse of the pharmaceutical,
• With respect to preparing the active substance or formulation, the activity and/or adverse effects need further research,
• The pharmaceutical is applied via parenteral methods.

9. What are the requirements for the importation of either traditional medicines or OTC products?

There is no distinction between importing traditional medicines, OTC products, or prescription pharmaceutical. There are three ways to import pharmaceuticals:

• Market consumption of licensed products:

The most common method. The Turkish Pharmaceutical and Medical Device Institution and the Ministry grant a license to pharmaceutical products. The Licensing Regulation on Human Medicinal Products includes the necessary information and documents to obtain the license. This license includes the permission to import the traditional medicines or OTC products.

• Patient Sales / Named Patient Program:

This method is especially for pharmaceuticals for treating serious or rare diseases. According to a guideline published by the Ministry, to use this method, the product must be either unlicensed in Turkey, not produced in Turkey, or the product cannot be found in the Turkish market.

• Compassionate Use Program:

The compassionate use program is a strict method. This method provides pharmaceuticals to patients whose treatment have failed with existing licensed products, who suffer from a serious or urgent life-threatening disease and who have not been included in the scope of clinical trials. These pharmaceuticals are not registered in Turkey.