In the Official Gazette dated 15 June 2022 and numbered 31867, The Regulation on the “Pharmaceutical Trading House and the Products in Pharmaceutical Trading House” is published and entered into force. The below issues are covered in the regulation along with some various issues.
- The regulation covers products including medicinal products for human use, foods for special medical purposes, products to be used to make magistral drugs and active substances, excluding magistral drugs and research products to be used in clinical trials.
- Acting within the scope of the legal supply chain for products and active substances is required. The legal supply chain consists of individuals, institutions and organizations that have been given license/permit/authorization within the framework of the relevant legislation carrying out the activities of purchasing, selling, exporting, storing, brokering, distribution or transportation of products and active substances.
- Exporting activities have been arranged in detail, and it has been stipulated that the exporting activities can be carried out in accordance with the legislation of the country to be exported, without prejudice to the provisions of the relevant legislation and by making ITS notifications.
- Products that are detected or suspected to be unlicensed/unauthorized, counterfeit, incorrectly manufactured, modified and/or corrupted shall be reported to Turkish Medicines and Medical Devices Agency, the relevant institution/organization and the license holder. If necessary, the Agency may take measures to prevent the related products from entering the supply chain.
- Detailed arrangements have been made for transferring hubs and natural or legal person or persons who want to operate transferring hubs are obliged to apply to Provincial and District Health Directorates for opening.
- Detailed arrangements have been made concerning brokerage, inspection and sanctions.
You can reach the regulation via the link below:
https://lnkd.in/da9gjGsv