Destruction of Human Medicinal Products: Legal Framework

Is the destruction of human medicinal products governed by a single regulation?

No. There is no single regulation called a "destruction procedure" for expired or unusable human medicinal products; the process is made up of complementary instruments. Tracking and the product's record in the system are governed by the Pharmaceutical Tracking System (İTS), operated by the Turkish Medicines and Medical Devices Agency (TİTCK), and by the Regulation on Packaging Information, Instructions for Use and Tracking of Human Medicinal Products, published in the Official Gazette of 25 April 2017 (issue 30048).

The withdrawal of defective or unsafe products from the market falls under the Regulation on the Withdrawal of Human Medicinal Products and Special Medical Purpose Foods, published in the Official Gazette of 23 October 2024 (issue 32701). The waste that arises after destruction is subject to environmental legislation, in particular the Waste Management Regulation published in the Official Gazette of 2 April 2015 (issue 29314).

How does destruction appear in the Pharmaceutical Tracking System?

Under Article 15 of the Tracking Regulation, İTS rests on recording the movements of stakeholders in a central data system and following them. Licence holders, pharmaceutical wholesalers, pharmacies and consumption centres must notify İTS of all movements and movement cancellations; deactivation is among the notification types listed.

According to a TİTCK announcement of 9 December 2021, from 10 December 2021 pharmacy deactivation of monitored medicines that must be dispensed with a red, green or white prescription is subject to the approval of the Provincial Health Directorate. Requests are created on the İTS portal and reviewed per QR code, and deactivation happens automatically for approved codes. The Agency may also set product-specific methods in some cases; for example, in an announcement of 22 August 2023, the sales block on certain expired products was lifted so that they could be destroyed, with the products delivered to the company and destroyed by it.

How are withdrawn products destroyed?

Under Article 16 of the Withdrawal Regulation, once the provincial or district health directorate has carried out its determination procedures for a product subject to withdrawal, the licence or authorisation holder either returns the product to its source or destroys it in a manner appropriate to its nature in line with the relevant legislation. Under Article 15, the licence or authorisation holder must remedy the harm suffered by those affected by the withdrawn products.

Once the licence or authorisation holder is sure that all defective products on the market have been withdrawn in line with the scope of the withdrawal, it prepares a final report and submits it to the Agency within twelve weeks at the latest (Article 17).

How does waste legislation classify pharmaceutical waste?

In the waste list annexed to the Waste Management Regulation, medicines appear under waste codes: 18 01 08* (cytotoxic and cytostatic medicines) and 18 01 09 (medicines other than those in 18 01 08); for separately collected municipal waste, 20 01 31* and 20 01 32. An asterisk (*) marks hazardous waste.

A waste producer collects and temporarily stores waste separately, keeps records, sends waste to facilities holding a permit or environmental licence, and completes the waste declaration form every year by the end of March. The Medical Waste Control Regulation (Official Gazette of 25 January 2017, issue 29959), for its part, defines medical waste as infectious, pathological and sharp waste.

What should be kept in mind for tax and practice?

• The product's status in İTS should be notified correctly before destruction; where deactivation needs approval, the provincial health directorate process must be awaited.
• A withdrawn product is returned to its source or destroyed by the licence or authorisation holder after the provincial or district health directorate's determination; the final report is submitted to the Agency within twelve weeks.
• Verify that the destroying facility holds the relevant permit or environmental licence, and determine the waste code correctly.
• For tax purposes, Articles 278 and 278/A of the Tax Procedure Law and Article 30/c of the VAT Law are assessed separately for destroyed products; the Communiqué on Article 278/A also mentions expired medicines and similar products as an example.