On 15 June 2022, the Regulation on Pharmaceutical Warehouses and Products Available in Pharmaceutical Warehouses (Turkish language) (Regulation) was published in the Official Gazette numbered 31867. The Regulation abrogated the prior regulation dated 20 October 1999 and is now in line with Directive 2001/83/EC on medicinal products for human use.
Pharmaceutical warehouses are defined as establishments where one or all of the activities of procurement, storage, sale, distribution and export of products and active substances are carried out. As well as this definition, the Regulation also defines a transfer centre as a temporary storage centre where products are kept for a maximum of 72 hours, if they are properly unloaded, reloaded or temporarily stored while they are waiting to be moved onto the next stage of the transportation route, and provided that all necessary precautions regarding storage conditions are taken.
Pharmaceutical warehouses, for which a licence was issued before the entry into force of the Regulation, are obliged to align their permits in compliance with the Regulation within 18 months from the date of publication of the Regulation. The Regulation is in force as of the date of publication.
First published by Practical Law Life Sciences Monthly Newsletter in Jul 18, 2022.