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On 19 December 2019, the UAE government adopted a new federal law which replaces Law No. 4 of 1983 on the Pharmacy Professional and Pharmaceutical Establishments and Law No. 20 of 1995 on the Drugs and Products. Law No. 8 of 2019 on Medical Products, Pharmacy Profession and Pharmaceutical Establishments (the new Law) aims to consolidate and modernise the legal framework under which medical products are placed on the UAE market. The new Law applies to medicines (both human and veterinary), medical devices and health related consumer goods.
Some of the key highlights are:
- The concept of marketing authorisation holder is defined and reinforced.
- The new Law suggests that a marketing authorisation holder must appoint one pharmaceutical establishment as an importer but can appoint one or more distributors to distribute the products within the UAE.
- The new Law explicitly provides that no person may start up a pharmaceutical establishment (such as for import, distribution and storage purposes) unless he is a UAE citizen.
- The new Law has not retained the concept of a scientific office and instead introduced marketing offices.
- The new Law includes provisions on the conduct of clinical trials largely codifying existing practices.
- Medical devices companies will need to monitor if under a ministerial resolution medical devices can remain outside the scope of products for which price controls are imposed.
- No discounts may be granted on medical products.
- Regulatory data protection for innovative medicines has not been introduced.
- The new Law provides a prohibition for the pharmacist to substitute or replace items that are prescribed unless the issuing person is consulted.
- Sanctions are substantially increased.
The new Law was published in the Official Gazette on 31 December 2019 and entered into force on 30 January 2020.
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