FNC approves draft law on medical products

ABU DHABI, The Federal National Council, FNC, today approved, during the 12th meeting of the fourth ordinary session of its 16th legislative chapter, a draft law for 2019 related to medical products, the pharmacy profession and pharmaceutical establishments, after creating and amending several articles and clauses.

The session was chaired by Dr. Amal Abdullah Al Qubaisi, Speaker of Federal National Council, FNC, and attended by Abdul Rahman bin Mohammad bin Nasser Al Owais, Minister of Health and Prevention, and Minister of State for Federal National Council Affairs.

The FNC stated that this law is part of key legislations related to the development of the UAE’s health and medical system, to achieve the goals of the national agenda of the UAE Vision 2021.

According to the draft law, which also applies in the country’s free zones, the sale of any medical product in the country is prohibited until the Ministry of Health and Prevention has issued a marketing approval or approval for exclusive marketing, based on rules, conditions and procedures determined by a resolution from the Minister of Health and Prevention, without prejudice to the current legislation related to veterinary products.

Marketing approval for a new medical product and approval for use will be issued by the ministry, based on an evaluation of a product’s effectiveness and safety, and whether it meets the required standards. Those issuing the request will have the right to market a product, according to intellectual property and trademark laws.

Source: Emirates News Agency