Import Inspection of Certain Products Supervised by the Ministry of Health – Communiqué No: 2026/20 (Türkiye)

Scope

• Applies to products listed in Annex-1/A, Annex-1/B, Annex-1/C and Annex-2 imported under the Release for Free Circulation regime.
• The inspection purpose is human health and safety conformity, based on documentation submitted to the Ministry of Health (incl. TİTCK and the Public Health General Directorate depending on the annex list).

Control Certificate and Customs Declaration Practice

• Imports within scope must be covered by a Control Certificate, issued based on submitted documents.
• The Control Certificate must be presented to customs during registration of the customs declaration (practically: recorded/declared at registration and available for submission).
• Validity: 12 months; may be cancelled earlier upon holder request or in cases foreseen by Ministry of Health regulations.

Important operational note: For Annex-1/A items that are determined to fall under special permit requirements, the rules of Communiqué 2026/4 (Special Permit Substances) apply.

Application and Review Process

• Application is made prior to import to the Ministry of Health with required documentation.
• The Communiqué allows the Control Certificate to be issued as an e-document via the Single Window System (per the referenced 2016/16 General Circular).

Repeat imports facilitation: For the same product (same specifications) from the same country of origin and exporter, subsequent imports may be processed based on the previously submitted Health Certificate, unless the Ministry requests renewal.

Mandatory Documents

For a Control Certificate application, the Communiqué lists core documents including:

• Application petition
• Proforma invoice or invoice
• For Annex-1/C and Annex-2: Certificate of Analysis
• For Annex-1/C and Annex-2: Health Certificate approved by the competent authority of the origin country + translation
• For Annex-2 items: the Control Certificate form (three copies) is specifically referenced.

Also, the Ministry may request additional information/documents when deemed necessary.

Post-Import Reporting Obligations (Critical Compliance Point)

Beyond obtaining the Control Certificate, the Communiqué introduces strict post-import electronic feedback/reporting timelines to TİTCK:

• For certain pharmaceutical raw/starting materials and related inputs: within 30 days after import, submit declaration and invoice copies via the electronic feedback form.
• For products imported under Annex-1/A, 1/B, 1/C: within 15 days after import, submit declaration and invoice copies via the electronic feedback form.
• For inputs used in Foods for Special Medical Purposes (FSMP/ÖTAG): within 30 days after import, submit declaration and invoice copies via the electronic feedback form.

From a practical compliance standpoint, this is one of the highest-risk areas because it is time-bound and easy to miss operationally.

Exemptions and Fixed Reference Numbers (Box 44)

The Communiqué does not apply to:

• Personal goods (non-commercial, personal use)
• Samples (with specific limitations; e.g., certain public-health pesticides/pesticide-like substances limited to 10 kg/L)
• Returned goods meeting the listed conditions and evidenced accordingly

For these exemptions, specific fixed reference numbers must be entered into Box 44 of the customs declaration (as provided in the Communiqué for each category).

Enforcement and Compliance Risk

• Importer/representative declaration is fundamental; misleading/incorrect declarations, forged documents, or document tampering trigger sanctions under:
• The Ministry of Health may request import-related information/documents from the Ministry of Trade when needed.

Repealed Regulation and Entry into Force

• Communiqué 2025/20 is repealed.
• Entry into force: 1 January 2026.
• Transitional rule: Shipments for which a transport document was issued in the export country (or presented to customs per customs legislation) before entry into force remain subject to the repealed Communiqué for 45 days, but more favorable provisions of the new Communiqué may still apply.

Compliance Assessment

Operationally, this Communiqué should be treated as a pre-import licensing/document-based compliance gate for health-sensitive products, with two major practical action points for importers:

1. Pre-import readiness: ensure the correct annex classification and compile the full document set early (especially analysis certificate and health certificate + translation where required).
2. Post-import discipline: implement a firm internal control to meet 15-day / 30-day electronic feedback deadlines to TİTCK (declaration + invoice), as these obligations sit “after clearance” and are frequently overlooked.

This structure reduces customs-side uncertainty only if the importer’s internal workflow is aligned; otherwise it can lead to delays, certificate issues, and enforcement exposure.

See the legislation document.