Smuggling of Medical Products and Medicines in Turkey (2025): A Complete Legal, Compliance, and Litigation Guide

yazarı lawyerfbc

açık Ekim 27, 2025

Summary:

Core offences arise under Anti-Smuggling Law No. 5607, Pharmaceuticals Law No. 1262, Pharmacy Law No. 6197, and TCK arts. 186–187 for dangerous/altered medicines. Confiscation and destruction are standard outcomes, with prison terms and judicial fines, plus closure and e-commerce bans where applicable.
Licensing & traceability: Import/manufacture requires TİTCK licensing; medicines must be authorized; devices must comply with the Medical Device Regulation (EU-aligned, 02.06.2021). ÜTS (Product Tracking System) records are mandatory for devices and monitored by authorities.
Common fact patterns: postal/courier imports, personal-use abuse, gray market hospital supplies, cross-border e-commerce, misdeclared cargo, and counterfeit/expired stock.
Defenses focus on chain-of-custody gaps, product classification (medicine vs device vs cosmetic), mens rea, and procedural legality of search & seizure under CMK via 5607 art. 9.
Practical compliance: Verify product authorization, keep ÜTS/batch records, restrict online content, train distributors, and prepare an incident & recall plan (including TİTCK notification).

1) Why smuggling of medical products is a priority risk in Turkey

Medical products—medicines (beşerî tıbbi ürünler) and medical devices (tıbbi cihazlar)—sit at the intersection of public health protection and customs/market surveillance. Turkey’s regime combines:

Criminal laws targeting unlawful entry, unlicensed sale, and public-health endangerment;
Regulatory licensing (TİTCK) for medicines and devices;
Traceability via ÜTS for devices; and
Strict sales channels, especially bans on internet sale of medicines.

This interplay means even seemingly minor paperwork gaps can escalate into smuggling charges, confiscation, and parallel regulatory sanctions.

2) Legal definitions & scope: medicine vs device vs “borderline”

2.1 Medicines

A “medicine” requires authorization (ruhsat/izin) by TİTCK before being placed on the market or imported. The Licensing Regulation details dossiers, GMP/GDP, pharmacovigilance duties and who may import.

2.2 Medical devices

Since 02.06.2021, Turkey aligns with the EU MDR/IVDR through the Medical Device Regulation and IVD Regulation—covering CE conformity, clinical evaluation, post-market surveillance, and ÜTS traceability obligations.

2.3 Borderline & classification disputes

Disputes over whether a product is a medicine, device, or cosmetic/food supplement can decide the applicable crime and penalty. Authorities and courts consider intended purpose, claims, and mechanism of action. When claims imply diagnosis, treatment, or prophylaxis, 1262/6197 rules typically apply (even if marketed as “supplement”).

3) Core offences and sanctions

3.1 Anti-Smuggling Law No. 5607

5607 criminalizes unlawful introduction, possession, transport, and sale of goods bypassing customs rules. Penalties include imprisonment, judicial fines, and confiscation. Searches and seizures follow CMK; confiscation and disposal rules provide for destruction or special handling of seized pharmaceuticals and devices. Recent practice emphasizes tailored procedures for medical devices when sampling is impossible (identify and minute device specifics).

Seized medicines/devices: Items may be destroyed or otherwise disposed of per secondary legislation under 5607; where non-destructive methods are allowed, the relevant ministries’ opinions guide disposal.

3.2 Pharmaceuticals Law No. 1262

Unlicensed manufacture or sale of medicinal products is punishable with imprisonment (with increases if therapeutic qualities are missing/compromised). This is frequently layered onto smuggling counts if the product lacks Turkish authorization.

3.3 Pharmacy Law No. 6197

Turkey prohibits online sales of medicines and limits sales channels to authorized pharmacies/depots. Violations attract administrative and potentially criminal consequences; professional bodies actively report cases.

3.4 Turkish Penal Code (TCK) arts. 186–187

Selling, supplying, or possessing spoiled/altered medicines (or producing/selling medicines in a way that endangers life/health) triggers TCK 186–187—with imprisonment and fines, and sentence increases for professionals (e.g., pharmacists/doctors) who commit the offence in the course of their profession.

4) Typical smuggling patterns in practice

Postal/Courier “personal use” abuse
Small consignments declared as “vitamins,” “supplements,” or “cosmetics” conceal prescription drugs or unregistered devices. If intent for commercialization or systematic import is shown, authorities proceed under 5607 plus 1262/6197.
Gray market hospital supplies
Parallel imports of authentic but unregistered lots of stents, implants, surgical kits: even if genuine, lack of authorization/ÜTS traceability leads to seizure and charges.
Cross-border e-commerce & social media
Listings offering antibiotics or prescription drugs direct-to-consumer violate 6197 and often 1262, with smuggling charges if sourced abroad. Professional bodies routinely move to shut such sites.
Counterfeit/expired stock
Expired or counterfeit batches trigger TCK 186–187 (public-health endangerment) and parallel 1262/5607 counts, with mandatory confiscation.
Misdeclaration in customs
Declaring devices as “cosmetics” or “spare parts” to evade oversight is a classic 5607 scenario; revised practice rules address how to identify devices when sampling isn’t possible.

5) Authorities and processes you will face

Customs Enforcement (Gümrük Muhafaza) and KOM execute search/seizure under CMK via 5607 art. 9;
TİTCK (Türkiye İlaç ve Tıbbi Cihaz Kurumu) handles market authorization, ÜTS, recalls, and administrative measures;
Public Prosecutors lead criminal proceedings; criminal courts adjudicate 5607/1262/TCK counts;
Professional bodies (pharmacy chambers) report illegal internet sales.

ÜTS is central for device traceability—from production/import to end-use—allowing retrospective tracking and quick removal.

6) Evidence: what prosecutors need—and where defenses live

6.1 Key proof points for the prosecution

Classification & authorization status (Is it a medicine? Is it a device? Licensed or not?) via TİTCK/ÜTS records;
Intent to smuggle or to market (volume, frequency, commercial context);
Chain of custody for seized goods under 5607; proper documentation when sampling devices is impracticable;
Public-health risk for TCK 186–187 (e.g., expired/altered medicines).

6.2 Defense levers

Product classification: challenge medicine/device characterization; argue cosmetic/supplement status if warranted (avoid medical claims);
Procedural legality: suppression arguments if searches/seizures stray from CMK rules referenced by 5607 art. 9;
Mens rea & scale: single, non-commercial consignments; absence of sale intent; mitigation under proportionality and value-based sentencing (recent 5607 reforms include value-based reductions in some contexts—used by analogy where applicable).
Traceability records: for devices, ÜTS proof can exculpate or mitigate; for medicines, authorization and lawful channel evidence (pharmacy/depot).

7) Confiscation, destruction, and disposal

Under 5607, smuggled goods are confiscated; pharmaceuticals/devices are typically destroyed, but secondary rules allow non-destructive methods in limited cases with ministry input. Where a device cannot be sampled, authorities must log identifying features instead. Early, proactive engagement helps minimize collateral damage (e.g., preventing lawful stock from being swept into a mass seizure).

8) The online sale problem: zero-tolerance for medicines

Turkey categorically bans selling medicines over the internet and forbids pharmacies from operating sales websites. Trade bodies actively monitor and file takedown requests; repeat violations bring sanctions and strengthen criminal cases if stock crosses borders. E-commerce platforms hosting such listings risk secondary liability and administrative penalties.

9) Compliance roadmap for pharmaceutical and device companies

9.1 Before import/manufacture

Confirm authorization: For medicines, ensure TİTCK licensing is in place; for devices, ensure CE conformity and registration, then ÜTS entry before import.
Verify distributors: Contractually require no cross-border online sales, no gray market purchases, and prompt incident reporting.

9.2 During customs & distribution

Accurate declarations: Use correct HS codes, exact product descriptions, and attach TİTCK/ÜTS documents.
Track & trace: Enter batch/UDI events into ÜTS (devices) and maintain robust GDP records for medicines.
Marketing compliance: No therapeutic claims for non-authorized products; no internet sales of medicines.

9.3 Incident & recall readiness

Recall plan: Define triggers, contact trees (TİTCK, distributors, hospitals), and destruction protocols.
Evidence preservation: Keep import, batch, and ÜTS proofs ready for dawn-raids.
Training: Educate field staff on red flags (too-cheap offers, misdeclared shipments, “personal-use” bulk parcels).

10) Litigation strategy: from investigation to appeal

Early assessment memo: Identify applicable statutes (5607, 1262, 6197, TCK 186–187), product classification, and procedural issues.
Forensics & documentation: Engage technical experts to verify product authenticity/stability; scrutinize chain of custody (especially when sampling was skipped for devices).
Parallel administrative track: Handle TİTCK notifications, ÜTS corrections, and market-surveillance responses in sync with the criminal case.
Case law positioning: Cassation jurisprudence weighs intent, scale, and proper classification; multi-count convictions (e.g., 5607 + TCK 186) appear when both smuggling and public-health endangerment are established.
Mitigation: Cooperation, voluntary surrender of stock, and immediate recall/destruction can influence sentencing; argue value-based proportionality under 5607 where relevant.

11) Special notes for pharmacies, hospitals, and e-commerce

Pharmacies: Strictly no online medicine sales; keep İTS/ÜTS (as applicable) and prescription controls tight. Violations invite 6197 measures and aggravate criminal exposure.
Hospitals: Ensure all devices are ÜTS-registered and medicines are from authorized channels; isolate and report suspect stock.
Platforms & couriers: Proactive monitoring, takedowns, and KYC/AML on sellers; recurring listings of prescription drugs can trigger regulatory scrutiny and enforcement.

12) What in-house counsel should prepare (checklist)

✅ Authorization file (TİTCK licenses, CE/DoC, vigilance reports)
✅ ÜTS dashboard access and logs; batch/UDI movement proofs for devices
✅ Customs pack (HS codes, invoices, certificates, proper declarations)
✅ Distributor covenants against gray market & online medicine sales (6197)
✅ Dawn-raid playbook: CMK/5607 search-seizure protocols; document handling; privilege logs
✅ Recall & destruction SOPs (coordinate with TİTCK; preserve evidence; manage patient impact)

13) Comparative note: genuine but unauthorized vs counterfeit

Genuine but unauthorized (e.g., parallel import without Turkish authorization or ÜTS entry): usually 5607 + 1262/6197; focus is on regulatory breach and customs evasion.
Counterfeit/altered/expired: adds TCK 186–187 exposure (public health endangerment) and makes confiscation/destruction unavoidable.

14) Recent regulatory anchors you should know

Medical Device Regulation & IVD Regulation (02.06.2021, Official Gazette 31499) modernized device rules, aligning with EU MDR/IVDR.
Beşeri Tıbbi Ürünler Ruhsatlandırma changes (Dec 2023 updates published Feb 2024 coverage) refine licensing/variation practice.
5607 practice on device sampling & identification in seizures has been clarified—if you can’t sample a device, identify and minute its distinctive characteristics.

15) FAQs

Q1: Is it a crime to import a small number of prescription drugs “for friends” by post?
Yes, postal import circumvention can satisfy 5607 elements where commercial intent or systematic conduct is shown; even without 5607, 1262/6197 may apply if the product lacks authorization or sale violates channel rules.

Q2: We bought authentic hospital devices abroad; can we sell them here?
Not unless the devices comply with the Medical Device Regulation and are properly registered and tracked in ÜTS. Otherwise, you risk seizure and smuggling/regulatory charges.

Q3: Are online sales of prescription medicines allowed if a pharmacist verifies prescriptions?
No. Online sales of medicines are banned; pharmacies cannot run sales websites for medicines.

Q4: What happens to seized medicines/devices?
They are confiscated under 5607; pharmaceuticals are normally destroyed, with limited exceptions managed through secondary legislation and ministry opinions; special rules exist for devices when sampling is impracticable.

Q5: Which offences apply if medicines are expired or degraded?
TCK 186–187 (endangering life/health via altered/spoiled medicines) in addition to 1262 and potentially 5607.

Q6: Can we argue “supplement” to avoid licensing?
Only if claims avoid diagnosis/treatment/prevention and the product truly fits non-medicinal categories. Over-promising health claims can push you into 1262/6197 territory.

Q7: How should we prepare for a dawn raid?
Train teams on CMK/5607 procedures, appoint a response lead, preserve ÜTS/authorization records, and document every seizure step for later review.

Q8: Are there Court of Cassation decisions on smuggling of health products?
Yes—Cassation jurisprudence addresses 5607 interactions with public-health offences and procedural requirements; principles are accessible via reputable case-law databases and sample decisions.

Q9: Do devices require ÜTS events even after import?
Yes. ÜTS tracks movement to end-use; absence or gaps may be treated as serious compliance failures.

Q10: Can hospitals buy directly from abroad to save costs?
Only within the authorization/registration framework; bypassing it risks seizure and criminal exposure.

16) Sample compliance clauses (for distribution agreements)

No Parallel Imports: “Distributor shall not source or place on the market any product not authorized by TİTCK for Turkey or not properly registered in ÜTS (for devices).”
No Online Medicine Sales: “Distributor shall not offer for sale any medicine via internet or electronic channels in Turkey.”
Traceability & Records: “Distributor shall maintain batch/UDI records and promptly submit ÜTS events as required by law.”
Regulatory Cooperation: “In the event of inspection, seizure, or recall, Distributor must notify Supplier within 24 hours and cooperate with TİTCK and customs authorities.”

17) Action plan if your company is under investigation

Stop the bleeding: Suspend suspect stock movement; quarantine inventory.
Internal fact-finding: Verify authorization/ÜTS status; reconstruct import trail; secure CMK-compliant copies of seizure documents.
Regulatory remediation: Notify TİTCK where required; prepare recall/destruction proposals with counsel.
Forensic & legal review: Commission authenticity/stability tests; map applicable offences (5607, 1262, 6197, TCK 186–187) and develop a charge-by-charge defense.
Mitigation strategy: Demonstrate compliance investments (ÜTS upgrades, training, distributor terminations) and, where appropriate, voluntary surrender of suspect stock.

18) Key takeaways for executives

Authorization first, import second: No shortcuts.
Trace everything: If you can’t prove it in ÜTS (devices) or licensing files (medicines), regulators assume the worst.
E-commerce is a minefield for medicines—ban it contractually and audit for leakage.
Early counsel involvement lowers risk**,** especially during raids and sampling/identification for devices.

20) Final word (for clients and compliance teams)

Turkey’s regime on medicines and medical devices is strict, multi-layered, and vigorously enforced. The highest risks arise when companies treat health products like ordinary consumer goods—ignoring authorization, traceability, and the internet sales ban for medicines. A compliance-by-design approach—built around TİTCK authorization, ÜTS, robust distributor covenants, and dawn-raid readiness—is your best protection against 5607 charges, 1262/6197 violations, and TCK 186–187 exposure.

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