Review your content's performance and reach.

Become your target audience’s go-to resource for today’s hottest topics.

Understand your clients’ strategies and the most pressing issues they are facing.

Keep a step ahead of your key competitors and benchmark against them.

Questions? Please contact [email protected]

The Ministry of Health (“Ministry”) published the Regulation on Pharmaceutical Businesses and Products in the Pharmaceutical Businesses (“Regulation”) in the Official Gazette on 15 June 2022.

What does the Regulation Introduce?

The Regulation sets forth the procedures and principles regarding the purchase, sale, storage, brokerage, distribution, export and transportation of products and active substances in accordance with good distribution practices and relevant national and internationally accepted standards.

The Regulation is available online here.

The Regulation covers the personnel and businesses where activities of export and transportation, purchase, sale, storage, brokerage and distribution of pharmaceutical business products and drug substances are conducted. and which have been/ will be operating pursuant to Law No. 984 on Pharmaceutical Businesses and Agricultural and Active Chemicals Shops and Law No. 1262 on Pharmaceutical and Medical Preparations.

Products and active substances are required to be moved within the scope of the legal supply chain consisting of persons, institutions and organizations that are licensed/permitted/authorized and that carry out the purchase, sale, export, storage, brokerage, distribution or transportation of products and active substances.

Unlicensed, counterfeit, expired, defectively manufactured, modified, spoiled, withdrawn or suspected products which cannot be sold, must be reported to the Turkish Pharmaceuticals and Medical Devices Authority (“TİTCK“). Upon certain examinations on the Pharmaceutical Track System (İTS), the TİTCK takes necessary precautions to avoid these products’ entry to the supply chain. These measures cover taking the products to a separate and locked area physically as well as terminating the sale of such products electronically. If necessary, the TİTCK can also carry out an inspection.

Transfer centers, commissioners and pharmaceutical businesses

The Regulation entered into force on 15 June 2022 and repealed the Regulation on Pharmaceutical Warehouses and Products in Pharmaceutical Warehouses.

The Regulation repealed the Regulation on Pharmaceutical Warehouses and Products in Pharmaceutical Warehouses and introduced new regulations regarding storage and transportation. The Regulation also introduced the concepts of supply chain, transfer center and commissioner. All relevant real persons and legal entities operating in the health sector should closely follow the regulations and fulfill their obligations in accordance with the requirements set forth by the Ministry and the TİTCK.

Content is provided for educational and informational purposes only and is not intended and should not be construed as legal advice. This may qualify as "Attorney Advertising" requiring notice in some jurisdictions. Prior results do not guarantee similar outcomes. For more information, please visit: www.bakermckenzie.com/en/client-resource-disclaimer.

If you would like to learn how Lexology can drive your content marketing strategy forward, please email [email protected] .

© Copyright 2006 - 2022 Law Business Research