Authorized Approval from TITCK Regarding Biocidal Products – 07.06.2024

Product type-1 human hygiene products are defined in Annex V of the Biocidal Products Regulation as "Biocidal products in this group are used for human hygiene; products applied to or in contact with human skin and scalp for the primary purpose of disinfection of skin and scalp". The relevant definitions are the same in the Biocidal Products Regulation No. 528/2012. In addition, the "Guidance on the Biocidal Products Regulation: Volume 2 Efficacy - Part B+C: Assessment and Evaluation" for product type-1 (PT-1) biocidal products, "Products intended for the disinfection of damaged skin (e.g. wound disinfection) or for the disinfection of undamaged skin prior to medical treatment of a patient (e.g. pre-surgical skin disinfection and pre-injection disinfection) and products with a medical use declaration are always covered by medicinal products for human use (covered by Directive 2001/83/EC on medicinal products for human use). Biocidal products within the scope of PT-1 can generally serve as hand sanitisers and disinfect forearms and wrists. When applying for an authorisation for a biocidal product under PT-1, a detailed description of the intended use must be given. This is necessary to prevent the authorisation of medicinal products for human use, cosmetic or medical uses as biocidal products (e.g. the declaration "skin disinfection" is insufficient).

In this context, the following has been announced to those concerned with the Presidential Authority Approval of the Turkish Medicines and Medical Devices Agency dated 07.06.2024 and numbered E-24931227-512.99-18893;

It is necessary to submit an application for authorisation for medicinal products for human use for products with medical use statements planned to be included on the label such as "wound circumference" and/or "preparation of the surgical site before surgery, disinfection/antisepsis of the area to be treated before injection/lumber puncture".
In case the labels of products authorised within the scope of biocidal product type-1 contain statements of use for medicinal purposes, if these products are requested to remain on the market as biocidal products, these statements should be removed from the labels and a label registration application should be made.
Accordingly, until 01.01.2027, biocidal products that have applied for a medicinal product registration for human health and for which this information has been forwarded to the Department of Cosmetic Products, or biocidal products that have been requested to remain on the market with a biocidal product registration and for which a label registration application has been made by removing the relevant medicinal product claims from the label, will be allowed to remain on the market in their current form until the end of their expiry date.
The authorizations of the above-mentioned biocidal products will be cancelled if no application for label registration has been made by removing the relevant phrases from the label or no application for a medicinal product for human use has been made before 1 January 2027.

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