Regulatory classification of medicinal products for human use under Turkish law

Our latest article “Regulatory classification of medicinal products for human use under Turkish law” by Nihan Bacanak, Bengüsu Güvendi and Selen Toma is published on Lexology.

This article aims to discuss what falls within the scope of “medicinal product for human use” under Turkish pharmaceuticals regime.

The Law No. 1262 on Pharmaceuticals and Medical Preparations (“Law”) defines medicinal products for human use as any simple or formulated curative preparation traded under the manufacturer’s name or under a private name in a fixed form in compliance with the scientific principles (except in form or formulation described in the codex). The Regulation on Classification of Medicinal Products for Human Use (“Regulation”), on the other hand, focuses on the purpose of the product and defines medicinal products for human use as any natural and/or synthetic origin active substance or combination of substances administered to human beings with a view to diagnosing, preventing and/or treating a disease, rectifying or modifying a physiological function.

In relation to the medicinal products for human use, the Regulation classifies medicinal products for human use based on supply by prescription or non-prescription, which classification shall be made within the license application of the relevant product and, if necessary, reclassification can be made under license renewal applications. As per the Regulation, non-prescribed products are medicinal products for human use that can directly be procured from pharmacies without need to prescription. On the other hand, medicinal products for human use that meet one of the following criteria require to be prescribed in order to be sold:

The medicinal product giving rise to direct or indirect health risk when not used under medical supervision, although used in the correct manner (i.e. exposure to direct health risk through toxicity, drug interactions, adverse effects or an indirect health risk by concealing a condition which requires medical supervision).

1. The medicinal product frequently and commonly misused, which misuse leading to a direct or indirect health risk (i.e. use of medicinal products for sleeping disorders or increasing the effects of alcohol).
2. The medicinal product requiring further research in respect of activities/adverse effects based on its formulation or substances it contains (i.e. newly licensed medicinal products with limited experience).
3. The medicinal product which is normally applied via parenteral methods (i.e. parenteral medicinal products are required to be prescribed for administrative tracking purposes as they are injected).

The medicinal products for human use meeting at least one of the above-mentioned criteria and therefore subject to prescription are further sub-segmented under the Regulation as follows:

1. Medicinal products that are procured based on repeatable or unrepeatable prescription.
2. Medicinal products that are subject to special medical prescription due to (x) containing a narcotic substance (i.e. red prescription) or psychotropic substance (i.e. green prescription) under international agreements, in amounts higher than as determined by the Ministry of Health (“Ministry”), (y) potential risks that misuse or overuse of the medicinal product entail such as leading to addiction or drug abuse, or (z) the uniqueness of the product.
3. Medicinal products that are subject to restricted medical subscription since (x) the product is prescribed only to be implemented in hospitals due to its pharmaceutical specifications, being new or posing threat to public health, (y) the product is used in treatment of diseases that are diagnosed in hospitals or healthcare institutions having sufficient diagnosing opportunities although implemented or monitored elsewhere, and (z) medicinal products used by outpatients but requires to be prescribed by a specialist and special surveillance during treatment due to serious adverse effects.

In terms of the above-mentioned sub-segmentation, prescribed medicinal products for human use can only be procured upon submission of the relevant prescription that is subject to the coloured prescription system, consisting of prescriptions with different colours as red, green, orange, purple or normal (i.e. uncoloured). Turkish Medicine and Medical Devices Agency publishes on annual basis a list of medicinal products for human use indicating which products are required to be supplied under which prescription and which products can be sold without prescription. In order for a medicinal product to be classified as non-prescribed, documentation supporting that the medicinal product does not meet the above-mentioned criteria (e.g., an expert report on the safety, efficacy and product characteristics) is required to be included in the licensing application file.

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