Procedures for Pharmaceutical Registration in UAE

On one hand, it may seem to get over the counter medicines for headache, body ache, allergies, and stomach upset; whereas, on the other hand, it is difficult to avail yourself the antibiotics when you catch the flu or sore throat without a valid prescription from a licensed medical practitioner. However, irrespective of whether over-the-counter medicines are easily accessible to us when we need them, it still is not exempted from being duly registered with competent authorities in the United Arab Emirates (UAE). Having said that, it is mandatory for all kinds of pharmaceuticals products, which includes even non-medicinal products, like dietary supplements or cosmetics, to be registered with the Ministry of Health & Prevention (MOHAP) in UAE.  When it comes to the matters concerning the health and safety of the people of UAE, the UAE government takes all the necessary steps to ensure the safety standards and procedures are adopted in cases of import, export, trade, and sale of products, which are consumed or used by the people residing here. Hence, registration of all kinds of products, especially pharmaceutical products, is a way of regulating what products can be sold, imported, or exported within the UAE. This article shall briefly discuss the registration procedure in MOHAP for pharmaceutical products.

Federal Law Number 8 of 2019 on Medical Products, Profession of Pharmacy and Pharmaceutical Institutions (the Pharmacy Law), is the primary legislation that regulates all the aspects pertaining to the pharmaceuticals in UAE. Apart from the Pharmacy Law, there are other legislations like Federal Law Number 14 of 1995 on the Control of Narcotics and Psychotropic Substances (the Drugs Law), which governs the import, export, or sale of narcotics and psychotropic substances in UAE. As per the Pharmacy Law provisions, when it comes to the manufacture, export, import, trade, and sale of pharmaceutical products, obtaining prior approval from the Ministry of Health and Prevention is mandatory. However, in emergency cases, the MOHAP may permit the entry of certain pharmaceuticals without prior approval. Apart from MOHAP, the Dubai Health Authority (DHA) and Health Authority Abu Dhabi (HAAD) are also other regulatory authorities within their specific jurisdictions that govern the licenses, register various kinds of products, and formulate healthcare policies and guidelines for hospitals and pharmacies. Having said, the primary authority when it comes to healthcare and registration of medical products, MOHAP takes precedence over other regulatory, for without obtaining prior approval or license to carry out any kind of business with regards to any kind of products within UAE is unlawful.

Registration of Pharmaceutical Product for General Sale

This registration is for pharmaceutical products with less medicinal usage. Precisely, products like dietary supplements, disinfectants or antiseptics, cosmetics that are medicated, and all other such products contain some sort of medicinal substances but may not be classified as medicines. It is pertinent to note that, in UAE, the authority to sell these products can only be availed by companies or manufacturers that are registered with the Ministry of Health (MoH). Further, the applicant is required to have a medical warehouse that is licensed by MoH.  The application can be made either in English or Arabic. Below stated are the required documents for registration of general sale products:

1. A certificate of a pharmaceutical product in line with the World Health Organization (WHO) system and a certificate stating the free sale of the product issued by the competent authorities in the country where such product originated, along with a certificate from the Embassy of UAE. The certificate of pharmaceutical product and certificate of free sale shall contain the below-stated details:

• Name of the product’s brand, and in the case where the brand name for registration in UAE is not same as the brand name in the country of origin, then it shall be mentioned;
• The inactive and active substances and their quantities, with which the product has been created, further it shall also specify the functions of the inactive substances;
• Name and address of the company which is authorized to carry out the sale, manufacturing, and details of the subcontract manufacturers;
• The lifeline of the product and instructions regarding the storage of such products;
• Further, confirmation of the product being sold for a period of at least two (2) years in the country of origin.

2. Three samples of the product;
3. Product analysis certificate of the samples provided;
4. A certificate of halal as issued by competent authorities and organizations;
5. A document with the company’s letterhead and stamp and signature of the authorized person along with below stated information:

• A declaration by the company asserting that the following product is devoid of any hormones, antibiotics, steroids, substances from pig, heavy metals, or any other such chemical or innate substances which can threaten human being’s life, either psychologically or biologically;
• Further, if the product composes of any substances extracted from the animal, then the name and kind of the animal, along with from which part such substance has been extracted and the percentage of alcohol is used, and the reason for such use, shall be specified.

6. Further, an authenticated certificate issued by the competent authorities in the country of origin, declaring that the product is devoid of mad cow diseases;
7. A valid registration certificate of the company issued by MoH and also a copy of a valid license of the medical warehouse.
8. Name of the countries where else this product is registered.

Process of Registration

The application, along with the above-stated documents, may be submitted via electronic services available on the MOHAP website. Thereafter, an authorized technical committee will further the registration of products, and if any recommendations, it shall submit them to the relevant ministerial committee. Then, letters stating the committee’s decisions shall be dispatched to the companies. Then the applicant is required to check with the pharmacological analysis section at the department of the drug. Thereafter, it is necessary for the company to meet the requirements if any, and then submit them via electronic services. Then, the registration of the products hall is re-evaluated by the technical and ministerial committees. If all the required conditions are met, then the registration of the products shall be approved. The validity of the registration of the product shall be for a period of five (5) years, and the registration shall take effect from the date when the committee approves of such registration. Whereas, if the registration is approved for locally manufactured pharmaceutical products, then the validity shall be for a period of one (1) year. Likewise, registration for conventional pharmaceutical products and the pharmaceutical product originating from natural sources can be applied via electronic services provided by the MOHAP for the registration of different kinds of pharmaceutical products. However, the documents required for the registration process may differ depending upon the classification of pharmaceutical products as determined by the competent authorities. Having said, the common documents required for registration of any kind of pharmaceutical products are as follows:

• Certificate of a pharmaceutical product in line with the WHO system and a certificate of free sale as issued in the country of origin and further validated by the Embassy of UAE in the country of origin;
• Competent authorities issue a halal certificate;
• A declaration by the company on a document with its letterhead and stamp, and duly signed by the authorized person from the competent authority, stating that the product is devoid of any harmful substances, hormones, steroids, etc.;
• Product analysis certificate of the product;
• And a CD of the product specifying the relevant information related to the product, such as the expiry date, inner label, outer label, etc.;
• Valid registration certificate of the company by MOHAP and valid license certificate of the medical warehouse;
• Three samples of the product;
• The detailed composition of the product and the percentage of alcohol, if any, and why it is used.

The registration of pharmaceutical products in the UAE is strictly regulated to safeguard people’s life from being endangered because of the consumption of any kind of harmful products. If you need any legal assistance in any process you can reach out to well-known lawyers in UAE