Jon Parker
Partner
Article
The healthcare industry is a priority sector for the UAE government, which continues to increase its spending in the development of high standard healthcare services in the country, notwithstanding the bearish oil market.
Likewise, the UAE's pharmaceutical market is rapidly expanding. The prevalence of chronic lifestyle diseases in the region such as obesity and diabetes, and the development of medical tourism, contribute to this continuing growth, and the UAE currently imports between 85% and 90% of its pharmaceutical products. The value of the pharmaceutical market in the UAE is projected to reach around 3.7 billion USD by 2020 (i.e. an 8.2% growth per year).
The healthcare industry is strictly regulated at both the Federal and Emirate level. International (i.e. non-UAE) pharmaceutical companies seeking to import and distribute pharmaceutical products in the UAE require considered local advice to navigate the regulatory paths.
In this article, we examine what "medicines" fall under the auspice of the Pharmaceuticals Law, how to register medicinal products with the MoH, how and to whom a Pharmaceutical Import Licence and distribution registration may be awarded, and the key considerations regarding promotion (including packaging, labelling and advertising) of medicines that stakeholders should be aware of.
Federal Law No. 4/1983 on the Pharmaceutical Professions and Establishments and the Import, Manufacture and Distribution of Pharmaceutical Products (the Pharmaceuticals Law)[1] mandates that:
In this respect, one should note that a distributor of medicines in the UAE must also be registered with the Ministry of Economy as a commercial agent[3].
In this article, we examine what "medicines" fall under the auspice of the Pharmaceuticals Law, how to register medicinal products with the MoH, how and to whom a Pharmaceutical Import Licence and distribution registration may be awarded, and the key considerations regarding promotion (including packaging, labelling and advertising) of medicines that stakeholders should be aware of.
The Pharmaceuticals Law regulates the import, storage, distribution, sale, marketing and export of all medicines for humans and animals, being understood as any chemical substance intended for use in medical diagnosis, cure, treatment, or prevention of disease (further detail available in the Dubai Health Authority's Community Pharmacy Licensure and Pharmaceutical Practices Guide of February 2013 (the Pharmacy Guide)). Its scope extends to antiseptics and disinfectants, medicated cosmetics, dietary supplements, and miscellaneous products which contain pharmaceutical ingredients and/or a medical claim and cannot be classified as medicines (MoH's Circular Number 20 of 2001).
The Committee of Drug Pricing of the Ministry of Health is responsible for overseeing the award of Medicines Registrations (and also for determining the pricing of medicines).
The application for registration of the product should be filed jointly by the product marketing authorisation holder from the home country and its local authorised representative in the UAE.
The local authorised representative is the local entity/person appointed by the marketing authorisation holder to be responsible for monitoring the safety and effectiveness of the product once launched on the UAE market, and for any product recall or complaint. It must be registered with the Ministry of Health and may be the local distributor of the products (see further details below).
Registration requirements vary depending upon the classification of the relevant product, as determined by the Classification Committee of the MoH (e.g. as General Sale[4], herbal, homeopathic, conventional or veterinary).
As a general rule, the application form must be accompanied by the following supporting documents:
However, for those registered products to be imported into the UAE, the importing company first needs to get registered with the MoH as an authorised importer of pharmaceutical products.
Only a company registered with the MoH with a valid Pharmaceutical Importation License issued by the MoH is permitted to import pharmaceutical products into the UAE.
But, in order to be registered with the Ministry of Health as an authorised importer and distributor of pharmaceuticals in the UAE, the importing company must first obtain from the MoH a medical store license. A medical store is defined as an establishment within the UAE, the business purpose of which is the import, storage and wholesale distribution of medicine.
As a result, where a pharmaceutical company seeking to market its products in the UAE is based outside the country, it must choose one of the following approaches:
As detailed below, the Pharmaceutical Law governs the requirements that must be met before a Pharmaceutical Importation Licence will be granted to an importing company, and include the establishment of a medical store meeting specified storage as detailed below.
Which approach is most suited to the requirements of any particular pharmaceutical company will depend upon the circumstances. It will of course, be paramount to obtain experienced local advice before a distribution strategy for the Middle East region is settled upon and executed.
The Pharmaceuticals Law contains mandatory labelling requirements and regulates aspects of promotion of medicines and pharmaceutical products in the UAE.
Where the distributor is also in charge of the promotion of the products, its trade license shall expressly list promotion and marketing activities amongst the authorised commercial activities of the company.
Any medical representative(s) hired by the distributor to promote the products in the UAE will only be authorised to carry out promotional activities within the Emirate in which the distributing company is incorporated. In other words, a distributor incorporated in Dubai is only permitted to carry out the activities specified in its trade license in the Emirate of Dubai, so the scope of action of its medical representatives will also be restricted to Dubai.
As a result, if an international pharmaceutical company wishes to promote and distribute its products across the territory of the UAE, on a regular and continuous basis, it is recommended to establish branches of the local distributing company in each Emirates, to hold trade licenses in the relevant geographical areas.
Also, the promotion of pharmaceutical products in the UAE requires the establishment of a scientific office (which may be located onshore or in a free zone) composed of qualified pharmacologists.
The Pharmaceuticals Law requires that leaflets and containers of medicines and pharmaceutical products feature the following information in both Arabic and English:
Under the Pharmaceuticals Law, the MoH shall approve the publication of any advertising material (printed or broadcast) for any medicine or pharmaceutical preparation.
Other regulations and legislations must be considered when it comes to the promotion of pharmaceutical products in the UAE, such as Regulation 430 of 2007 on Health Advertisement and the Federal Law no 15 of 1980 on printed matters and publications.
Gowling WLG has a wealth of life sciences experience, with 200 experts around the world available to advise on all legal matters affecting your business.
Written by Vanessa Delnaud.
Footnotes:
[1] UAE Federal Law N°4 of 1983 on the pharmaceutical profession and industry should be updated by the end of this year to introduce new seizure procedures for suspicious shipments, and to strengthen penalties against individuals and companies dealing with counterfeit drugs, in accordance with international best practices. The amendments are currently under discussion at the Federal National Council.
[2] Although there is a limited number of exceptions under which the importation of unregistered drugs is permitted by hospitals – but we will not deal with such exceptions in this article.
[3] Under Federal Law Number 18 of 1981 concerning organising of trade agencies.
[4] The General Sale List lists all the registered pharmaceutical substances in the UAE.
[5] Foreign companies willing to incorporate a UAE structure must be aware that a company incorporated in Dubai is only permitted to carry out its activities as set forth in its trade licence in the Emirate of Dubai. If the UAE entity is incorporated in a free zone, its trade license would only permit activities within such free zone.
[6] The UAE Commercial Companies Law requires companies incorporated under such law to have at least 51% of its share capital to be owned by UAE nationals. As a result, any company established in the UAE onshore is required to have one or more UAE partners holding at least 51% of the share capital of the company.
[7] The officials of the UAE Ministry of Economy and the Ministry of Health have confirmed orally, when preparing this article, that this requirement is still in force.
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