TÜRKIYE Law and Practice Contributed by: Tansu Akin, Akin Legal
resulted from the defective product. This means that the manufacturer must prove they were not negligent. 1.2 Regulatory Authorities for Product Safety Generally, the Ministry of Industry and Ministry of Commerce are the two main regulators (authorities) for product safety matters. While the Ministry of Industry focuses on the manu - facturing aspect, ensuring compliance with the techni - cal regulations and initiating recalls for serial defects. Conversely, the Ministry of Trade concentrates on the market side, preventing the entry of defective goods into the market and restricting their marketing. In essence, the Ministry of Industry adopts a bottom-up approach, while the Ministry of Trade regulates with a top-down approach. Apart from the two main authorities, specific ministries or semi-independent agencies have their own surveil - lance and regulatory responsibilities. The key regula - tory bodies and their respective legislation include the following: • The Ministry of Commerce has a series of com - muniques for import inspection and market sur - veillance of almost all types of products, including medical, agricultural, textile, etc (Communiques 2026/01 to 2026/27 on Product Safety and Inspec - tion). • The Ministry of Industry implements extensive regulations for the inspection of industry goods (General Inspection and Market Surveillance Regu - lation and Special Inspection and Market Surveil - lance Regulation for Automotive Products). • The Pharmaceuticals Law No 1262 establishes specific rules for pharmaceuticals and vaccines, serving as the basis for detailed secondary legisla - tion and authorising the Ministry of Health and its semi-autonomous agencies. • The General Directorate of Customs has the authority to test all products imported to Turkey for homologation and standardisation compliance. • The Ministry of Agriculture and Forestry conducts inspections on foods, substances and materials intended to come into contact with foodstuffs.
The authority of those government bodies varies depending on the nature of the product. For strictly regulated products like pharmaceuticals, food, or automotive products, the relevant authority acts as the approval agency. Manufacturing or import - ing these products necessitates homologation and approval from these authorities. The second tier of the regulators’ authority involves monitoring and surveillance of the market. In this capacity, they collect samples from the market and conduct tests to ensure compliance with product safety requirements. In the event of a product safety issue, these govern - ment bodies have the power to order the suspen - sion of marketing of such products, the correction of defects, and the withdrawal of defective products from the market, including both voluntary and com - pulsory recalls. The final level of regulatory intervention includes the cancellation of homologation, type/product approvals, orders to cease manufacturing, and the issuance of monetary fines. These government bodies also hold the authority to bring matters before consumer courts to protect the overall interests of consumers and even involve public prosecutors in cases of criminal allega - tions. 1.3 Obligations to Commence Corrective Action The Product Safety Law requires that manufacturers, importers and distributors (collectively referred to as the “Enterprise(s)”) continuously test and monitor their products. Manufacturers are obligated to continuously monitor, inspect, and test products introduced to the market, maintain records of complaints and non-compliant or recalled products, and inform their distributors and customers accordingly. They must also take corrective measures to bring the product into conformity and, if necessary, stop placing it on the market, withdraw it, or initiate a recall.
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