Import Inspection of Substances Subject to Special Authorization by the Ministry of Health (PSD: 2026/4)

Import Inspection of Substances Subject to Special Authorization by the Ministry of Health (PSD: 2026/4)

The Import Inspection of Substances Subject to Special Authorization by the Ministry of Health Communique, designated as Product Safety and Inspection: 2026/4 and published in the Official Gazette, has brought the import of substances and preparations listed in Annex 1 of the Communique within the scope of conformity inspection. The Communique enters into force on January 1, 2026, and the previous regulation PSD: 2025/4 has been repealed.

This regulation will apply to products within the scope of Annex 1 that will be subject to the Free Circulation Entry Regime as well as the Inward Processing, Processing under Customs Control, and Temporary Import regimes.

While the Annex 1 list covers a large number of chemical substances, the most commonly encountered examples in practice and their primary areas of use are as follows. Toluene, also known as toluol, is a solvent used in paint, thinner, adhesive, and chemical production. Hydrochloric acid, commonly known as muriatic acid, is an acid used in metal cleaning, surface treatment, and industrial processes. Sulphuric acid and oleum are strong acids widely used in battery production and the chemical industry. Potassium permanganate is an oxidizing agent used in treatment and chemical processes. Diethyl ether is a volatile chemical used as a solvent in industry. Acetone, also known as propanone, is a chemical widely used for cleaning and solvent purposes. Butanone, also known as Methyl Ethyl Ketone or MEK, is a chemical used as a solvent in production processes. Acetic anhydride is a compound used as an intermediate substance in chemical production. Red phosphorus is a controlled substance used in the chemical industry.

For import procedures to be completed within the scope of the Communique, the conformity of the product must be documented by a Control Certificate issued on the basis of documents submitted to the Ministry of Health. In certain cases, a Registration Certificate may also be issued. The Control Certificate or Registration Certificate will be presented to the relevant customs administration at the time of customs declaration registration.

Applications for the Control Certificate are made to the Turkish Medicines and Medical Devices Agency, and the application generally requires submission of an application petition, a proforma invoice or invoice, a certificate of analysis, and the Import Application Form set out in Annex 2. Additional information and documents may be requested depending on the intended use of the product and the method of importation.

The validity period of the Control Certificate is 6 months, while the validity period of the Registration Certificate has been set as until the end of the year in which it is issued.