Actions Taken by Pharmaceutical and Medical Device Institution in relation to COVID-19

Coronavirus (“COVID-19”), declared a pandemic by the World Health Organization, first emerged in Wuhan, China, on 31 December 2019 and rapidly spread globally. The first case in Turkey was reported on 11 March 2020. Following this, the Ministry of Health (the “Ministry”) and the Turkish Pharmaceutical and Medical Device Institution (the “Institution”) have taken various actions to prevent the spread of the virus, protect public health, and ensure market order. Significant actions taken include:

• Restrictions on promotional activities: According to the Institution’s announcement dated 19 March 2020, visits by product promotion representatives to all health institutions and organizations, including pharmacies, doctors, dentists, and pharmacists, have been suspended until further notice. However, promotional activities can be conducted electronically (via email or video conference) during this period.
• Export license requirement for medicinal products used against COVID-19: As per the “Communiqué Amending the Communiqué Regarding Products Subject to Export Prohibition and Pre-Authorization (Export: 96/31)” published in the Official Gazette numbered 31058 dated 4 March 2020, the export of protective masks, jumpsuits, liquid-proof aprons, goggles, medical and surgery masks, and medical sterilized/non-sterilized gloves now requires pre-authorization from the Institution. Additionally, under the Amending Communiqué published in the Official Gazette numbered 31080 dated 26 March 2020, ventilators, oxygen concentrators, ventilation consumables, patient circuits, cannulas, intubation tubes, and intensive care monitors also require export pre-authorization. Information and documents required for obtaining export authorization are indicated in the Institution’s announcements dated 5 March 2020 and 6 March 2020. Products with export declarations registered before 4 March 2020 do not require authorization.
• Temporary license to produce disinfectants: Pursuant to Circular numbered 2020/1 dated 19 March 2020, pharmacies may be issued a temporary license for three months to produce hand sanitizers using a formula determined by the Institution, to meet the need for disinfectants due to the COVID-19 emergency.
• Measures regarding clinical research: Measures for clinical research in connection with COVID-19 were announced on 20 March 2020. Sponsors are reminded to conduct regular risk assessments, considering the safety of volunteers, reducing research centers’ workload, and ensuring compliance with social isolation rules. Clinical research may be temporarily suspended or terminated early if necessary. Emergency safety measures can be implemented without ethics committee approval. Deviations due to COVID-19 do not require notification to the ethics committee. Monitoring of clinical research should be postponed or rescheduled. If in-person monitoring is not possible, remote monitoring in compliance with data protection laws is allowed. Research products may be stocked up more than usual, research meetings will be held online, and face-to-face training and meetings on good clinical practices are not permitted.
• Postponement of scientific organizations: Based on Circular numbered 2020/3 published in the Official Gazette numbered 31074 dated 20 March 2020, all national and international scientific, cultural, artistic, and similar meetings or organizations in open or closed spaces are postponed until the end of April 2020.

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