Türkiye – Import Inspection of Substances Subject to Special Authorization of the Ministry of Health (Product Safety and Inspection: 2026/4)

Executive Summary

With the Communiqué on the Import Inspection of Substances Subject to Special Authorization of the Ministry of Health (Product Safety and Inspection: 2026/4) published in the Official Gazette dated 31 December 2025 (No. 33124, 4th Repeated), Türkiye has renewed the regulatory framework governing the importation of controlled substances, precursors, psychotropic materials, narcotics-related chemicals and pharmaceutical raw materials. The Communiqué maintains a strict pre-import authorization model, anchored in public health protection, international drug control conventions, and enhanced customs enforcement. Imports without valid Ministry of Health approval are categorically prohibited.

Scope

The Communiqué applies to substances and preparations listed in Annex-1, when imported under the following customs regimes:

• Release for Free Circulation
• Inward Processing Regime
• Processing Under Customs Control
• Temporary Importation

The scope covers substances subject to international control frameworks, including narcotic drugs, psychotropic substances, chemical precursors, and certain pharmaceutical intermediates, regardless of commercial or industrial use.

Mandatory Surveillance Certificate

Imports under this Communiqué require mandatory authorization issued by the Ministry of Health, in the form of one of the following documents, depending on the substance and transaction structure:

• Control Certificate (Kontrol Belgesi) – valid for six months, or
• Registration Certificate for the Actual Importation of Controlled Chemicals at Customs, valid until the end of the calendar year, or
• Special Import License for Controlled Substances, where applicable.

These documents constitute absolute preconditions for customs clearance and must be presented at the time of customs declaration registration.

Application and Review Process

• Applications must be submitted prior to importation to the Turkish Medicines and Medical Devices Agency under the Ministry of Health.
• Core application documents include:
• For substances directly supplied to consumers, additional product information (composition, dosage, usage instructions, shelf life) may be requested.
• Authorizations are issued primarily as electronic documents, with physical issuance permitted in exceptional cases.

Incomplete, misleading, or unverifiable documentation results in automatic rejection, regardless of the declared use or quantity.

Customs Value Clarification and Practical Application

The Communiqué does not introduce valuation-specific provisions. However, in practice, customs value inconsistencies or atypical pricing may trigger heightened scrutiny due to the high-risk nature of the substances involved.Customs and health authorities assess imports holistically, combining chemical identity, declared use, quantity, and documentation coherence.

Validity and Legal Effect

• Control Certificates are shipment- and purpose-specific.
• Authorization does not constitute a general marketing or circulation permit.
• Documents may only be used for the specific import transaction for which they were issued.
• Post-import reporting obligations apply, including mandatory submission of customs declarations and license copies to the Ministry of Health within 15 days following importation.

Enforcement and Compliance Risk

This Communiqué establishes one of the highest enforcement thresholds within Türkiye’s import control system:

• Imports are directly linked to international narcotics and psychotropic control conventions.
• Misdeclaration, document falsification, or unauthorized importation exposes the importer to simultaneous administrative, customs, and criminal liability.
• Customs laboratories are explicitly empowered to verify chemical identity for GTIP classifications where chemical ambiguity exists.
• Post-clearance controls may retroactively invalidate previously accepted imports.

Sanctions may be applied under:

• Law No. 7223 (Product Safety and Technical Regulations),
• Customs Law No. 4458,
• Technical Regulations Regime Decision,
• Health-specific legislation and international control mechanisms.

Repealed Regulation and Entry into Force

• Repeals Product Safety and Inspection: 2025/4.
• Entered into force on 1 January 2026.
• A 45-day transitional period applies to shipments dispatched prior to entry into force, without prejudice to more favorable provisions of the new Communiqué.
• Previously issued control certificates remain valid for their original duration.

Compliance Assessment

From a professional customs and regulatory compliance perspective:

• These imports must be treated as zero-tolerance transactions.
• Classification, chemical composition, intended use, and authorization type must be aligned before shipment.
• Importers should implement pre-shipment chemical due diligence, including laboratory validation where classification ambiguity exists.
• Reliance on post-arrival correction or reclassification is not a viable compliance strategy under this regime.

See the legislation document.