Guidelines on Named Patient Programme Amended

On 25 September 2020, the Turkish Medicines and Medical Devices Agency amended the Guidelines on the Named Patient Programme (Turkish language). The most important amendments are:

  • Introduction of a new procedure to add products to the Foreign Drug List and to keep them on the list.
  • Removal of the provision establishing the liability of the entities authorised to supply on a named patient basis.

The guidelines establish the Foreign Drug Evaluation Commission to evaluate applications made to add a product to the list. Six months prior to the three-year anniversary of a product being added to the list, the Commission will commence an evaluation exercise. Those products deemed appropriate to remain on the list shall be submitted for Presidential approval.

The provision stating that the suppliers, namely Uluslararası Sağlık Hizmetleri AŞ (USHAŞ), Turkish Pharmacist Association and Social Security Institution İbn-i Sina Sağlık Sosyal Güvenlik Merkezi, will be liable for the quality, efficacy and safety of the products has been removed from the guidelines. The suppliers will now be responsible only for ensuring that the delivery of the drug to the patient is made in accordance with Good Distribution Practices.

The guidelines took effect on 25 September 2020.

First published by Practical Law, in 03.11.2020

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