Compliance quarterly

Turkish Medicine and Medical Devices Agency announced the fourth quarter results regarding the supervision and audit of cosmetic and biocidal products

Turkish Medicine and Medical Devices Agency (Agency) has announced the results regarding the supervision and audit of cosmetic and biocidal products such as hand disinfectants, antibacterial liquid soaps and fly repellents which directly contacts with human body for the period between October to December of 2021. Accordingly, administrative fines aggregate amount of which is (i) TL 1,480,000 is imposed on the liable companies regarding incompliance of biocidal products and (ii) 310,000 is imposed on the liable companies regarding incompliance of cosmetic products by the Cosmetic Audit Chamber. Furthermore, a number of biocidal and cosmetic products is found incompliant with the regulations or unlicensed.

The Regulation on Pharmaceutical Businesses and the Products Stored in Pharmaceutical Businesses is published

The Regulation on Pharmaceutical Businesses and the Products Stored under Pharmaceutical Businesses (Regulation) is published on 15 June 2022 and repealed the Regulation on the Pharmaceutical Warehouses and the Products Stored in Pharmaceutical Warehouses. The Regulation aims to regulate the principles and procedures for the purchase, sale, storing, brokering, distribution, export and transportation of products and active substances in compliance with good distribution practices and locally and globally established standards. The Regulation covers the pharmaceutical business opened and to be opened as per the Law No:984 on Pharmacy Trading Houses and Law No: 1262 on on Pharmaceutical and Medical Preparations and Regulation on Promotional Activities of Human Medicinal Products.

Medical Device Clinical Research Regulations is published

The Regulation on Medical Device Clinical Research is published in the Official Gazette dated 8 July 2022 (Regulation) and entered into force on the date of its publication with the purpose of regulating the procedures and principles regarding post-marketing studies and medical device clinical trials and protecting the rights of the volunteers participating in these trials, within the framework of international agreements which Turkey is party to, European Union standards and good clinical practices. The Regulation covers post-market studies and medical device clinical trials, the places where research can be conducted and the real persons or legal entities who will carry out researches. It is noted that retrospective studies and performance evaluation studies with vitro diagnostic medical devices are outside the scope of the Regulation. The Regulation further states that clinical trials shall find a field of application by referring to the relevant provisions in the Regulation. All financial responsibilities of the clinical trial shall belong to the sponsor and, if applicable, its legal representative, contracted research institutions to which the task has been transferred, and the research team. It is further regulated that no fee shall be charged to the volunteers for any investigational product used in the study, any materials for the use of these products, the cost of examination, examination, analysis and treatments. Researches are recorded in a public database, provided that the confidentiality of personal data is regarded. 

Regulation on Safety of Drugs is amended

Turkish Medicines and Medical Devices Agency (Agency) published the Regulation on the Amending the Regulation on Safety of Drugs on 21 July 2022. The amendment sets forth a definition for district pharmacovigilance manager and his/her obligations as provincial health director to appoint the relevant head or vice-president of the provincial health directorate as the provincial pharmacovigilance officer and informs the Agency of this person's name and contact information. The amendment further stipulates obligations to the Agency in case of any update by the license owner of the risk management plan. Furthermore, the Agency will be able to account the evaluations made by other comparable drug authorities or regional/international institutions within the scope of trust and share information.