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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For further information, please feel free to contact one of the lawyers below or your usual Baker McKenzie contact.

Author

Hani Naja is a partner in the Corporate & Commercial practice of Baker McKenzie Habib Al Mulla. He has been practicing since 2007 with a focus on M&A, reorganizations and post-acquisition integration as well as corporate structuring in the Middle East, particularly in the UAE and Qatar. Hani also advises on general commercial, corporate governance and compliance matters, and has gained substantive experience in the technology, retail, defense and government sectors.

Author

Ghada El Ehwany is a partner in Baker McKenzie's Corporate Practice Group in Cairo. She has nearly 20 years’ experience in the Middle East, particularly in Egypt, Saudi Arabia and the UAE, focusing on corporate and commercial transactions. Ghada also advises on healthcare regulatory, structuring, insolvency, employment and compliance matters.

Author

Els Janssens is a counsel in Baker McKenzie's Brussels office, specializing in commercial law, litigation and healthcare regulatory issues. Els has been advising multinational pharmaceutical clients and investors on healthcare regulations in the EU and UAE. She has extensive industry experience having worked as senior regulatory legal counsel for Johnson & Johnson and as legal advisor in the European Medicines Agency, advising management, scientific committees, CMD(h) and the European Commission, on a wide variety of issues in the healthcare and pharmaceuticals sector.

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