On 5 January 2022, the Turkish Medicines and Medical Devices Agency (Agency) announced on its website that a guideline on drugs that are counterfeit, smuggled or out of the legitimate supply chain has been published. The guideline aims to define the responsibilities of stakeholders in combatting drugs that are counterfeit, smuggled or out of the legitimate supply chain and to guide the procedures to be carried out accordingly. Notably, the guideline:
- States that regulated procedures are to be carried out by certain stakeholders including the Agency, marketing authorisation holders, responsible managers of drug warehouses and pharmacies, drug manufacturers, officials of healthcare centres, healthcare professionals and patients, if they determine medicines are potentially counterfeit or have been smuggled.
- States that the point where medicines left the legitimate supply chain will be tracked and determined by the Agency via the Medicine Tracking System following notification by stakeholders.
- Contains information on the relevant legal framework to be applied in case of recall and destruction of products that are not compliant with existing laws.
- States that if the Agency discovers online marketing, promotion or advertising activities concerning medicines that are counterfeit, smuggled or out of the legitimate supply chain during its routine controls, then it shall notify the Access Providers Association and judicial authorities to bar access.
- Includes a rapid alert system notification form which will be sent by the Agency to international organisations such as WHO, PIC/S and the EMA if requested by stakeholders.
First published by Practical Law Life Sciences Monthly Newsletter in Feb 02, 2022.