Borderline products: distinguishing medicinal products, medical devices and cosmetics under Turkish law

A critical consideration before placing health and personal care products on the market is determining their correct regulatory classification. For borderline products – products that may exhibit characteristics of medicinal products, medical devices or cosmetics – this distinction has significant implications for the applicable regulatory requirements, market entry procedures, costs and ongoing compliance obligations.

In Türkiye, the classification of borderline products is governed by the applicable legislation and the regulatory approach of the Turkish Medicines and Medical Devices Agency (“Agency”). Although there may be certain common characteristics in these product categories, each product category is subject to a distinct regulatory framework, making accurate classification particularly important for manufacturers and distributors.

Regulatory framework and classification criteria

Under the Regulation on Licensing of Medicinal Products for Human Use (“Licensing Regulation”), a medicinal product is defined as a substance or combination of substances that is either (i) presented as having properties for treating or preventing disease in human beings; or (ii) used in or administered to human beings with a view to restoring, correcting or modifying physiological functions through pharmacological, immunological or metabolic action, or to making a medical diagnosis.

The Medical Device Regulation, on the other hand, defines medical devices by reference to their intended medical purposes and principal mode of action. In particular, a medical device does not achieve its principal intended action through pharmacological, immunological or metabolic means, although its function may be assisted by such means. The principal mode of action is therefore a key criterion in distinguishing medicinal products from medical devices.

A separate framework applies to cosmetic products. Under the Cosmetic Products Regulation, cosmetic products are substances or mixtures intended to be placed in contact with specified external parts of the human body, or with the teeth and oral mucous membranes, exclusively or mainly for purposes such as cleaning, perfuming, changing their appearance, protecting them or keeping them in good condition. Unlike medicinal products and medical devices, cosmetic products are not intended to treat or prevent diseases. The Cosmetic Products Regulation also expressly excludes substances and mixtures intended to be ingested, inhaled, injected or implanted into the human body for cosmetic purposes.

The distinction between these categories is not always straightforward. A product’s composition or the presence of a particular ingredient in such composition does not by itself determine its regulatory status. Instead, classification requires an assessment of several factors, including (i) the product’s composition, (ii) its intended purpose and method of application, (iii) its principal mode of action, and (iv) its presentation, including labelling, instructions for use and promotional claims.

The significance of these criteria varies depending on the categories being distinguished. For medicinal products and medical devices, the principal mode of action plays a particularly important role. This approach is consistent with the European Union legislation and the case law of the Court of Justice of the European Union, which distinguishes between medicinal products by presentation and by function. The Agency’s Guideline on Consultation Procedures under the Medical Device Regulation similarly recognises this distinction.

The fact that a product is intended to treat or prevent a disease does not necessarily distinguish a medicinal product from a medical device, as medical devices may also serve therapeutic or preventive purposes. Conversely, when assessing whether a product qualifies as a cosmetic, particular attention must be paid to its intended purpose, application and claims. Products presented as treating medical conditions may fall outside the cosmetics framework and require assessment under other applicable legislation.

The Agency has also issued the Guideline on Products Borderline with Cosmetic Products, which provides guidance on distinguishing cosmetics from other regulated product categories. Accordingly, the classification of borderline products requires consideration of the relevant regulatory frameworks together, rather than an assessment under a single set of rules.

An additional safeguard is provided under the Licensing Regulation. Accordingly, where a product, taking into account all its characteristics, may fall within both the definition of a medicinal product and a product governed by other legislation, and doubt remains as to its classification, the provisions of the Licensing Regulation apply.

Common examples of borderline products

The interaction between these regulatory frameworks can be illustrated through several commonly encountered product categories. The examples below demonstrate potential classification considerations rather than establishing the regulatory status of any product, which must be assessed on a case-by-case basis.

Hyaluronic acid-based products. Hyaluronic acid-based products illustrate how the same ingredient may be subject to different regulatory frameworks depending on the product’s intended purpose, method of application and principal mode of action. For example, skincare products intended primarily to moisturise the skin may qualify as cosmetics, while certain products relying on the physical properties of hyaluronic acid for a medical purpose may qualify as medical devices. Certain injectable aesthetic fillers may also fall within the medical device framework despite having no intended medical purpose.

Skincare and acne products. Skincare products provide another example of potential borderline classification. Products intended primarily for cleansing, moisturising or improving the appearance of the skin may qualify as cosmetics. However, products presented as treating or preventing acne or other dermatological conditions may fall outside the cosmetics framework and require assessment under medicinal product or medical device legislation, depending on their characteristics and principal mode of action. The distinction between cosmetic and therapeutic claims is therefore particularly relevant.

Nasal sprays. Nasal sprays may fall under different regulatory categories depending on their intended purpose and principal mode of action. For example, saline-based sprays intended primarily for cleansing or moisturising the nasal cavity may qualify as medical devices, whereas sprays designed to achieve their principal therapeutic effect through pharmacological action would generally fall within the medicinal product framework. The classification therefore depends on the characteristics of the individual product rather than its format.

Eye drops. Similarly, eye drops intended primarily to lubricate or physically protect the eye may qualify as medical devices, while those whose principal effect is achieved through pharmacological action would generally be classified as medicinal products. The classification cannot be determined solely by the products’ intended therapeutic use or the claims made in its promotional materials.

Reflux products. Products intended to alleviate reflux may also be subject to different regulatory regimes. For instance, products that principally act by creating a physical barrier may qualify as medical devices, whereas those that achieve their principal effect through pharmacological action, such as certain acid-suppressing medicines, would generally be classified as medicinal products.

Wound dressings and gel products. Products applied to the skin may be subject to different regulatory frameworks depending on their intended use. While products intended primarily to moisturise or protect healthy skin may qualify as cosmetics, products intended for wound management may fall within the medical device or medicinal product framework. For example, wound dressings and gels that principally provide physical protection or maintain a suitable environment for wound healing may qualify as medical devices, whereas products whose principal intended effect is achieved through pharmacological, immunological or metabolic action may be classified as medicinal products.

Final considerations

A comprehensive assessment of a borderline product’s characteristics and the applicable legal definitions is essential to identifying the correct regulatory framework and mitigating potential compliance risks. Classification of the product should be addressed at an early stage of product development or market entry.