Guidelines on Donation of Non-Approved Drugs

On 28 September 2022, the Turkish Medicines and Medical Devices Agency (Agency) published guidelines (Turkish language) on donation from abroad of human medicinal products that are not approved in Turkey on its official website.

The guidelines have been prepared to determine the procedures and principles regarding donation from foreign companies within the scope of the Regulation on Licensing of Human Medicinal Products. The most significant provisions of the guidelines are as follows:

  • In general, donations shall be made in accordance with the World Health Organization's medicine donation guidelines.
  • The donations to be made are evaluated by the Directorate Generals of the Ministry of Health as per the list of medicines needed that is determined and published by the Ministry of Health.
  • In cases where there is no compassionate use programme in the world for a particular medicine, an exceptional application can be made to the Agency for donation on a patient basis.
  • The donation process is initiated by application of the pharmaceutical company that is willing to donate medicine.
  • If deemed necessary, the Licensing Department of the Agency may be consulted on quality, safety and efficacy of the products.

The guidelines also provide the main rules regarding customs clearance for donations and storage, distribution and delivery of the medicines.

The guidelines entered into force as of their date publication.

First published by Practical Law Life Sciences Monthly Newsletter in Dec 02, 2022.

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