IMP Import into Türkiye for Clinical Trials

The investigational medicinal product, the IMP, is the heart of a clinical trial; but before the trial can begin, that product must enter the country lawfully. In Türkiye this entry passes through a chain of permissions rather than a single permit: a trial completed through ethics committee evaluation and TİTCK review provides the legal basis for import; at customs the pharmaceutical GTİP codes fall under competent-authority control and the declaration is tied to the trial's acceptance record; the goods are received into a depot operating under good distribution practice and prepared for site use with Turkish trial labelling. Each link of the chain carries its own file, its own responsibility and its own timing. This article walks through the permit basis of IMP import, the choice of importer, the customs and depot steps, the labelling rules and the shipment planning. It offers a practical frame for sponsors centralised abroad, CROs operating in Türkiye and clinical supply teams.

Who is this for?

This guide is prepared for every role in the IMP supply chain. Sponsors headquartered abroad, teams running their Turkish operations through a local representative or CRO, clinical supply and logistics units, companies that will act as importer of record, customs brokers and depot operations teams all share the same chain. Regulatory teams preparing the ethics committee and TİTCK submission also need to know how the import steps reflect into the application file, because the shipment plan is bounded by the products and quantities defined in the protocol. Quality units own the depot receipt and release decisions. Finance teams carry import expenses, depot and testing costs into the trial budget. Site coordinators benefit too: when and under what conditions the product reaches the site directly shapes the enrolment plan. The chain may not run through a single pair of hands, but the responsibility matrix must sit in a single file.

Which products does it cover?

The scope is every pharmaceutical form defined by intended use in the trial protocol. The investigational product itself, its dose strengths and formulation versions; placebo manufactured within the clinical supply programme; products procured for comparison purposes and temperature-sensitive biological formulations all pass through this chain. Active substance samples, samples sent for analysis and auxiliary medicines draw the edge of the scope: these can follow different rules and each one's status must be clarified separately. On the GTİP side, the pharmaceutical family sits under the tariff headings for medicaments for human or veterinary use; investigational products also enter the declaration under these positions. The product's trial status does not change its customs classification; classification flows from composition and form, status from the protocol context. Keeping this distinction clear in the file prevents confusion on both the customs and the regulatory side.

When does it apply?

IMP import applies to every shipment that follows the trial approval, but some moments weigh the process down visibly. The first shipment is when the entire permit and contract infrastructure is built and carries the longest preparation time. Protocol amendments, when they change the product version or quantity, bring the permit file's update onto the agenda; shipment cannot proceed before the evaluation completes. As the trial extends, shelf-life management triggers imports: if the on-site stock's expiry dates no longer cover the site's need, fresh stock arrives and the fate of the old stock is planned. Additional centres, patient number increases and re-scheduled cohorts are further shipment reasons. In multi-product trials the permit status must be tracked product by product; one product's approval can lag while another ships. For products exported and returning to be corrected, re-import rules engage and the status is assessed separately.

Legal framework and authority

The legal frame has two layers. The first layer is the legislation on clinical trials: the manufacture, import, labelling and accountability of investigational medicinal products are regulated within that frame; the ethics committee evaluation and the TİTCK review form the legal basis of the trial and therefore of product supply. The second layer is foreign-trade legislation: the Import Regime Decision subjects pharmaceutical GTİP codes to competent-authority control, and the declaration at customs is supported with the documentary counterpart of that control. The competent authority is TİTCK; it evaluates clinical trial applications, issues the acceptance information and audits product safety and traceability requirements. On the customs side the transaction runs through the Ministry of Trade customs administrations. For investigational products the inspection route of the product safety communiqués generally does not engage; medicines pass through their own regime. The point where the two layers intersect is the declaration: unless both classification and status are correctly built, the transaction either stops or is questioned. Current regulation texts and guides must be tracked on TİTCK's official pages.

Step-by-step process

1. Complete the trial file: let the protocol, investigator's brochure and product dossier go into ethics committee and TİTCK evaluation in current versions; the acceptance information is the basis of the import.
2. Designate the importer in Türkiye: local sponsor, local representative or contracted importer; bind the role in writing to the responsibility matrix.
3. Select depot and logistics providers for GDP compliance, defining cold chain, quarantine and receipt controls in the contracts.
4. Prepare the product file for import: GTİP rationale, origin, invoice structure, cold chain specification and Turkish label mock-ups.
5. Synchronise the shipment calendar with the trial calendar: plan backwards from the first enrolment date and build customs and depot receipt time in as buffers.
6. Support the shipment with pre-notification: tracking numbers, temperature monitoring plan and expected arrival information communicated to the depot in advance.
7. Run customs processing: file the declaration under the pharmaceutical GTİP code and present the document set referencing the trial record in the competent-authority control.
8. Perform quality checks at depot receipt: verify quantity, batch, expiry, labelling and temperature record; record deviations in minutes.
9. Give the release decision and plan delivery to site; operate the accountability records from day one.

Document checklist

• Ethics committee approval and TİTCK evaluation outcome, in the version matching the trial number.
• Current version of the protocol and its product-related annexes.
• Investigator's brochure, in the version used in the application.
• GMP certificate of the product's manufacturing site and certificate copies.
• GTİP classification note and draft declaration.
• Purchase documents: proforma, invoice, consistency of the product description with the file.
• Turkish trial label mock-up and its approval record.
• Cold chain specification: transport mode, monitoring method, intervention plan.
• Depot receipt minutes and temperature records.
• Importer designation and responsibility matrix.

Parties and responsibilities

The matrix must be kept in a single file and current. In an audit the question is concrete: who imported this shipment, on which permit, with which document. The pieces of the answer can sit in different hands; the integrity of the file must sit in one place.

Exceptions and edge cases

Not every trial product enters through the same gate. A comparator product licensed in Türkiye can be sourced from the local market; no import is involved then, but procurement and labelling rules still apply. Auxiliary medicines are usually clinical need medicines and do not carry investigational product status; their procurement differs. Samples sent solely for analysis may not count as investigational product, though purpose and quantity must be recorded. Patient-specific formulations and rare-disease products carry person-specific quantities and calendars. For products exported and returning for correction or modification, whether a return or a re-import takes place must be clarified. Research material that is a medical device rather than a medicine falls under device legislation and outside this article's scope. In biological and gene therapy products, cold chain and especially permit requirements tighten; every edge case must be assessed with its own file.

Common mistakes

The most common mistake is dispatching the shipment before the permit completes; the goods wait at the port and the cold chain risk grows. The second is calling the importer at the last moment; without the contract and authorisation chain no declaration can be filed. The third is starting label production without approval; if the Turkish trial label approval lags, the product stays in quarantine at the depot. The fourth is a mismatch between the protocol's product version and the shipped version; the acceptance record is questioned. The fifth is leaving the cold chain plan to the carrier; monitoring and intervention responsibility cannot be delegated. The sixth is keeping depot receipt records incomplete; accountability starts on day one. The seventh is failing to match the shelf-life calendar with site need; stock runs out of time and an emergency shipment is born.

Important notice

This article is general information, not legal or customs advice; for the product supply of a specific trial, TİTCK legislation and current guides must govern and qualified advisers consulted where necessary. GTİP codes mentioned here are illustrative only; the GTİP examples are not binding and classification must be reasoned separately for every product. Legislation and guide versions can change; official sources must be checked before any transaction.