On the 4^th of September 2023, the UAE President issued Federal Decree Law no. 11 of 2023 (“Amendment”), amending certain provisions of Federal Law no. 8 of 2019 concerning Medical Products, Pharmacy Profession and Pharmaceutical Establishments (“Law”).

The Amendment introduces few changes, which can be summarised, as follows:

1. Replaces the definition of the holder of the medical product marketing right.

“Holder of the medical product marketing right” is now defined as the holder of a license to market one or more medical products in the UAE in accordance with the provisions of the Law, its Executive Regulations and any relevant resolutions as opposed to the juristic person licensed to market one or more medicinal products. This Amendment removes the condition;being a corporate person to become a holder of the said right.

2. Introduces the concept of exclusive marketing.

“Exclusive Marketing” is defined as the authorization to market specific medicinal products for specific entities within the UAE, without being required to obtain a marketing authorization.

3. Replaces few of the provisions related to marketing of medical products, virtually maintaining the current licensing regime for marketing of medical products.

1. 1. The Amendment provides a limitation in applying the text of Article 3 of the Law, to exclude applicable legislation regarding veterinary preparations in case of any discrepancy with the Law by adding the following language:
      
      Without prejudice to the applicable legislation regarding veterinary preparations, any medical product may only be put into circulation in the UAE after obtaining from the Ministry of Health and Prevention a marketing authorization or authorization for exclusive marketing in accordance with the controls and conditions specified by the minister.

   2. Additionally, Article 7(2) of the Law has been amended to read: “For the purpose of marketing medical products, the license applicant shall: […] Provide two or more pharmaceutical establishments to carry out all activities related to the import and marketing of licensed medical products”. As opposed to the previous text that required the applicant to provide one or more medical warehouses for the purpose of that Article.

      A similar amendment was also instated for Article 27 of the Law which now reads: “The holder of the medical product marketing right shall designate at least two pharmaceutical establishments licensed to import medical products into the State, as importers of the medical product for which he has obtained the marketing right, and shall appoint one or more pharmaceutical establishments licensed in the State to distribute the medical product for which he has obtained the marketing right, in accordance with the controls, conditions and standards determined by a resolution of the Minister”.

It should be noted that for the purpose of Article 3 of the Law, there are no currently observable requirements or mechanics for the granting of Exclusive Marketing licenses, which suggests that further amendments by the federal government of the UAE to the Law will be introduced or issuance of additional implementing regulations in order to maximize its business potential.

Additionally, while the Law, as amended, does not specify the requirements or specifications of the said “pharmaceutical establishment” for the purpose of Article 7 upon this alteration of their text, the scope of pharmaceutical establishments captures the warehouses, pharmacies and chain of pharmacies amongst other establishments, which would ultimately provide more options to applicants of marketing authorizations.

The Amendment also serves as a step towards securing the importation of medicinal products by obliging the marketing authorization holder to procure two pharmaceutical establishments to import the medicinal products to which a marketing license is held, which effectively safeguard the availability of medicinal products in the UAE.

How can we help?

Our GLA team would be delighted to assist companies obtain marketing authorization to market for any medicinal products. Feel free to reach out to Alex Saleh (alex.saleh@glaco.com), and Yousef Alamly (y.alamly@glaco.com) if you have any queries.

Authors: Hegui Taha, Partner, Maha El Meihy, Legal Director, and Khaled Al Khashab, Associate.