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Recent Developments in the Healthcare Sector

Legal Alerts
Healthcare
Healthcare & Life Sciences

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The Turkish Pharmaceuticals and Medical Devices Authority (TİTCK) has published announcements on the supply of medicines from foreign countries and the exportation of products subject to pre-approval.

Please click on the relevant link below for our specific note regarding recent developments:

The Pre-Approval Provided by the TİTCK is Annulled
The Guideline on Use and Medicines Supply From Foreign Countries

The Pre-Approval Provided by the TİTCK is Annulled

Recent Development

Following the Communiqué Amending the Communiqué on Goods Whose Export is Prohibited and Subject to Preapproval (Export: 96/31) (“Communiqué“) published in the Official Gazette No. 31560 on 6 August 2021, the TİTCK announced that the preapproval requirement for exporting certain goods has been annulled. The announcement is available here.

What’s New?

As part of the measures to fight COVID-19, exporting certain products was subject to the
TİTCK’s approval to ensure the accessibility of safe products; the procurement management of critical products necessary for COVID-19 treatments; the smooth functioning of health services; and the protection of public health as per the Communiqué Amending the Communiqué on Goods whose Export is Prohibited and Subject to Pre-approval (Export: 96/31) published on the Official Gazette No. 31058 on 4 March 2020.

In this regard, companies needed to obtain the TİTCK’s approval to export protective masks supplied to the market within the scope of personal protective equipment (gas, dust and radioactive dust filter masks), overalls (protective work clothes), liquid proof aprons (protective aprons used against chemicals), glasses (protective glasses), and medical and surgical masks and medical sterile/nonsterile gloves placed onto the market within the scope of the Medical Device Regulation. This requirement concerning the preliminary approval of the TİTCK was abolished pursuant to the Communiqué published in the Official Gazette on 6 August 2021.

The Guideline on Use and Medicines Supply From Foreign Countries

Recent Development

The TİTCK published an announcement concerning an update to the Guideline on Use and Medicines Supply From Foreign Countries (“Guideline“). The update includes comprehensive explanations concerning drug supply processes and the institutions that manage them. The updated Guideline is available here.

What’s New?

The update in question includes detailed explanations concerning drugs: (i) that are not included in the Foreign Medicines List in Annex-1 of the Guideline; (ii) that are not licensed in Turkey and added to the Foreign Medicine List; and (iii) although licensed in Turkey, that are unavailable on the market for various reasons, but that are necessary for patients who tried all of the treatment options in Turkey or who have a condition that prevents them from being tried. Additionally, efficacy, safety and quality data for the supply of these medicines along with additional requirements are included in Annex-7 of the Guideline.

As an outcome of the update, the Uluslararası Sağlık Hizmetleri Anonim Şirketi (USHAŞ) will play an effective role in medicine supply processes. The USHAŞ, the Economic Enterprise of Turkish Pharmacists Association and the İbn-i Sina Social Security Center of the Social Security Institution are responsible for controlling the information and documentation regarding the active substances to be supplied from abroad and the supply of the products that are found adequate, and they are liable for compliance with good distribution practices.

Conclusion

The TİTCK continues to provide guidance for companies working in the medical industry. Companies should carefully review the TİTCK’s announcements and take the necessary actions to ensure compliance.