In today’s pharmaceutical sector, not only manufacturing but also distribution and logistics are processes of critical importance. Pharmaceutical distribution companies operating in Turkey play a vital role in protecting public health and are subject to a stringent legal framework.
1. Licensing Requirement for Pharmaceutical Distribution Activities
Companies intending to distribute human medicinal products in Turkey must obtain a pharmaceutical warehouse license issued by the Turkish Medicines and Medical Devices Agency (TMMDA / TİTCK). Any commercial activity conducted without this license is considered unauthorized pharmaceutical distribution and may result in severe administrative and criminal sanctions.
Key Requirements for Licensing:
- Architectural and technical compliance reports of the warehouse facility,
- Infrastructure capable of cold chain monitoring,
- Appointment of a Responsible Manager (a licensed pharmacist or qualified healthcare professional),
- Digital integration with the Pharmaceutical Track and Trace System (ITS).
Additionally, the warehouse premises must meet specific distance, fire safety, and hygiene criteria. TMMDA conducts on-site inspections prior to issuing a license.
2. Legal Issues Encountered During Storage Operations
Physical Inadequacies and Inspection Risks:
During routine inspections conducted by TMMDA, if physical noncompliance is identified, administrative actions may be taken against the company. Possible consequences include temporary suspension of the license, halting product distribution, and monetary fines.
Cold Chain Violations:
Technical failures during the transport or storage of temperature-controlled products can cause degradation and pose serious risks to public health. In such cases, liability for damages may extend to both the manufacturer and the distributor.
Storage of Unauthorized Products:
Storing products without a license or outside the scope of contractual agreements is considered illegal. This can lead to serious legal consequences under both administrative and criminal law.
3. Distribution Network and Contractual Arrangements
Pharmaceutical distributors in Turkey generally do not sell directly to pharmacies or hospitals but operate through sub-distributors and dealers. These commercial relationships must be clearly defined in written contracts.
Legal Considerations in Contract Drafting:
- Distribution agreements must include essential terms such as product delivery conditions, risk transfer points, pricing, and return policies.
- Commercial terms like non-compete clauses, exclusivity, and inventory management must be clearly articulated.
- Termination, default, penalty clauses, and indemnity provisions should be drafted with due care.
Restrictions under Competition Law:
Vertical restraints in the pharmaceutical sector are closely scrutinized by the Turkish Competition Authority. Market sharing, price fixing, or exclusive sale restrictions may lead to significant penalties. Therefore, all contracts must comply with the Law on the Protection of Competition.
4. Pharmaceutical Track and Trace System (ITS) and Digital Traceability
Turkey enforces one of the strictest traceability systems in Europe through the ITS, which enables box-level tracking of all pharmaceutical products. All storage and sales activities must be digitally reported via this platform.
In cases of missing or incorrect data entries:
- Product recalls may be delayed,
- Traceability of products reaching pharmacies or patients may be compromised,
- Failure to comply may result in administrative fines and suspension of the warehouse license.
5. Risk Allocation and Contractual Safeguards
Risks arising within the manufacturer-distributor-warehouse chain must be clearly allocated in written contracts between parties.
Key Clauses to Include in Contracts:
- Compensation for damages and losses,
- Insurance obligations,
- Force majeure provisions,
- Risk transfer points,
- Cold chain liability,
- Recall procedures.
These provisions are crucial to mitigate commercial disputes and limit liability during regulatory inspections.
6. Criminal and Administrative Sanctions
Unauthorized activities or possession of illegal medicines may trigger criminal liability under Law No. 1262, including imprisonment.
Companies involved in public procurement may face disqualification or license revocation in cases of ethical violations.
Misleading promotional activities are penalized under the TMMDA Promotion Regulation.
Conclusion
Pharmaceutical distribution is not merely a logistics operation; it is a high-responsibility field with direct implications for public health. Therefore, distribution companies must:
- Ensure full compliance with relevant legislation,
- Build legally robust contractual frameworks,
- Operate in full integration with regulatory and data systems,
- Act with continuous legal counsel and compliance support.
Such measures are essential for long-term success and reliability in the pharmaceutical supply chain.
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