The "Guideline on Counterfeit, Illegal or Out-of-Legal Supply Chain" (“Guide”) was published by the Drug Control Department of The Turkish Medicines and Medical Devices Authority (“TMMDA”) on 05.01.2022.
The Guide has been prepared to conduct the transactions to be carried out and determine the stakeholders' responsibilities in the combat against counterfeit, illegal or out-of-the-legal supply chain drugs in terms of public health and safety.
The Guide comprises all stakeholders engaged in combating these issues and individuals or organizations involved in the production, importation, storage, distribution and sale of counterfeit, illegal or out-of-the-legal supply chain drugs.
In the Guideline, counterfeit products are defined as the products having forged information as to the source of products (including information on origin country, license holder etc.) or the distribution channel of products, even deficiency on the components of ingredients. The issues with regard to IP rights are not within the scope of this Guideline.
The Guide stands noteworthy considering the subsequent matters:
- TMMDA, the license holder company, the pharmacy warehouse liable manager, the liable pharmacy manager, the hospital authorities, the drug production site, the physician and other health personnel, patients, the provincial health directorates and the Ministry of Health have distinct responsibilities concerning the products suspected of being a counterfeit or illegal drug.
- In case of the product sent to TMMDA is found inappropriate afterward the examination, TMMDA will initiate a procedure that of withdrawal of the product from pharmacies and pharmaceutical warehouses and destruction of the promotional materials.
- The sale or advertising of drugs over the internet is against the law. TMMDA is privately responsible for detecting the sale or promotion of drugs on the internet and taking the determination to block access.
- Notifications sent to TMMDA by international organizations such as WHO (World Health Organization), EMA (European Medicines Agency) are examined, and accordingly, required actions are taken. For instance, notifications can be made by TMMDA to other ministries, institutions affiliated with the Ministry of Health, Social Security Institution, and Turkish Pharmacists' Association. This system is called the Rapid Warning System.
For further details, you can access the Guide from the link below: Sahte, Kaçak veya Yasal Tedarik Zinciri Dışına Çıkmış İlaçlar Hakkında Kılavuz
Authors: Elif Arabacıoğlu, Melis Karadeniz