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Healthcare & Lifesciences

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In brief To future-proof its regulatory system, the UAE cabinet has established the Emirates Drug Corporation (EDC) in September 2023. As a new independent regulator, the EDC will replace the Ministry of Health and Prevention (MOHAP) for the regulation of pharmaceuticals and medical devices. Besides medicines and medical devices the EDC will also be responsible for cosmetics, dietary supplements, GMOs, fertilizers, pesticides, agricultural conditioners and plant growth regulators. The EDC will also take over some…

Onshore healthcare legislation also applies to ADGM entities In brief On 11 January 2023, the Abu Dhabi Global Market (ADGM) published on its website the news about the issuance of the ADGM Healthcare Regulations 2022 (“Healthcare Regulations”). The Healthcare Regulations adopt the Abu Dhabi onshore healthcare legislation – including the regulations and circulars issued by the Department of Health Abu Dhabi (DoH) – into ADGM’s legislative framework. Key takeaways The Healthcare Regulations extend the scope…

In brief On 30 June 2022, the Government of Abu Dhabi Department of Health (DoH) issued Circular No. 147 of 2022 (“Circular”) requiring health and pharmaceutical facilities licensed by the DoH (“Licensed Entities”) to obtain a “secure” or “safe” certificate that certifies they operate in full compliance with the requirements of the Abu Dhabi Standard for Health Information Security and Cyber Security Standards (“Standards”). Licensed Entities have until the end of this year (i.e., by…

In brief On 10 March 2022 the National Data Management Office (the “NDMO”) published for consultation a draft of the executive regulations (the “Regulations”) to the Personal Data Protection Law, promulgated by Royal Decree No. M/19, dated 09/02/1443H (the “PDPL”). You can access our previous alert on the publication of the Law here. You can access the consultation and a full draft of the Regulations here. The consultation invites comments on the Regulations and will…

In brief The UAE’s Ministry of Health and Prevention (MoHAP) has issued a long awaited resolution setting out exceptions to Article 13 of Federal Law No. 2 of 2019 (“Health Data Law”), which by default prohibits the transfer, storage, generation or processing of health data that relates to health services provided in the UAE (“UAE Health Data”) outside of the UAE. Ministerial Resolution 51/2021 (“Resolution”) relaxes the data transfer restriction for certain types of processing…