Dear Colleagues, Clients and Friends,
Coronavirus (COVID-19), which has been declared a ‘pandemic’ by the World Health Organisation first emerged in Wuhan, China on 31 December 2019, and rapidly became a major topic by spreading across the globe. The first case in Turkey was seen on 11 March 2020, following which the Ministry of Health (the Ministry) and the Turkish Pharmaceutical and Medical Device Institution (the Institution) have taken various actions and steps to prevent the spread of the virus, protect the public health and ensure the market order. Some of the significant actions taken to date are as follows:
• Restrictions on promotional activities. According to the Institution’s announcement dated 19 March 2020, visits paid by product promotion representatives to all health institutions and organisations including pharmacies, doctors, dentists and pharmacists have been suspended until a further announcement. However, within this period, product promotion representatives can carry out promotional activities electronically (via e-mail or video conference).
• Export licence 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, export of protective masks (masks with gas, dust and radioactive dust filter), jump suits (protective work-clothes), liquid-proof aprons (protective aprons used against chemicals), goggles (protective goggles) supplied to the market within the scope of the Regulation on Personal Protective Equipment; as well as medical and surgery masks, and medical sterilised/ non-sterilised gloves supplied to the market within the scope of the Regulation on Medical Devices became subject to the pre-authorisation of 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 have also been made subject to export pre-authorisation. Information and documents required for obtaining export authorisation from the Institution of the relevant products are indicated in the announcements of the Institution dated 5 March 2020 and 6 March 2020. On the other hand, no authorisation is required for products, export declarations of which have been registered with the relevant Ministry before 4 March 2020.
• Temporary licence to produce disinfectants. Pursuant to the Circular numbered 2020/1 dated 19 March 2020, which regulates the procedures and principles regarding processes and operations related to biocidal products that are in direct contact with the human body, a temporary licence may be issued for a period of three months whereby pharmacies can be allowed to produce hand sanitisers using the formula determined by the Institution, for purposes of meeting the need for disinfectants due to the state of emergency caused by the COVID-19 outbreak.
• Measures regarding clinical research. Measures to be applied to clinical research in connection with COVID-19 have been determined with the announcement dated 20 March 2020. Firstly, sponsors have been reminded of the need to regularly conduct risk assessments by observing priorities and urgencies due to COVID-19 and to carry out and update research organisations on this basis. In terms of such risk assessments; protection of the safety of volunteers, reducing the workload of research centres and ensuring compliance with social isolation rules are essential. Pursuant to the regulation: (i) clinical researches may be temporarily suspended or terminated early if deemed necessary considering the nature of the research; (ii) in cases giving rise to safety concerns, emergency safety measures can be implemented without being subject to the approval of the ethics committee and the Institution; (iii) in case of deviation/breach of the protocol due to COVID-19 measures, such deviation or breach will not be required to be notified to the ethics committee and the Institution; (iv) postponing or re-scheduling of monitoring of clinical research will be the initial preference, but in case continuing of such monitoring activity is necessary due to the nature of the research, then timing of the visits will be coordinated with the research centre; (v) if monitoring at the research centre is not possible due to circumstances such as quarantine or isolation, clinical research may be remotely monitored in accordance with the Law on Protection of Personal Data and confidentiality principles applicable to clinical research; (vi) products subject to clinical research may be stocked up more than usual in order to ensure the sufficient amount of stock due to any potential quarantine or customs restrictions; (vii) research meetings will only be held online within this period; and (viii) training and meetings regarding good clinical practices and clinical research to be held face to face will not be allowed.
• Postponement of scientific organisations. Based on the 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 organisations to be held at open or closed spaces have been postponed until the end of April 2020.
Please do not hesitate to contact us for any further information on this briefing.
Elvan Aziz
Partner
eaziz@paksoy.av.tr
Nihan Bacanak
Counsel
nbacanak@paksoy.av.tr
Can Yasin Aksoy
Associate
caksoy@paksoy.av.tr
This briefing is for information purposes; it is not legal advice. If you have questions, please call us. All rights are reserved.
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