UAE Law and Practice Contributed by: Haykel Hajjaji, Julie Teperow, Robin Blaney and Winsome Cheung, Covington & Burling LLP
3.3 Period of Validity of Marketing Authorisations
3.4 Procedure for Obtaining a Marketing Authorisation An MA is obtained by applying to the EDE through its online portal, completing the application form, submit- ting the required documents, and paying the applica- ble fees. The applying entity must be registered with the EDE prior to registering its products. The application requirements are as follows. • A certificate of pharmaceutical product or a certifi- cate of free sale issued by the country of origin and certified by the UAE Embassy. The certificate must include the product brand name, and the name and address of the marketing or manufacturing company. • One sample of the product. • A registration certificate of the manufacturing com- pany issued by the EDE. • A Halal certificate. • A company statement confirming that the product is free of “hormones, heavy metals, antibiotics, steroids, pig derivatives, and any other natural or chemical substances that have a harmful impact on humans.” If the product contains substances derived from animals, the type of animal and the part from which the substance is extracted must be specified. The statement must also include the percentage of alcohol used, if any, and the justifi- cation for its use. • A certified copy of the contract between the mar- keting company and the local agent, indicating the products for which the agent is responsible. • A certified BS/TSE certificate from the country of origin. • A copy of the product’s cover and leaflet printed on the company’s letterhead, stamped by the com- pany, and signed by an authorised person. • A detailed composition certificate including the active and inactive ingredients and their quantities. • A Summary of Product Characteristics (SPC). The following circumstances constitute a variation to the MA that requires submitting a new MA application and results in the invalidation of the existing MA.
Marketing Authorisations are valid for five years and may be renewed through the EDE Portal for an addi- tional five years. An MA may be revoked under any of the following circumstances. • The medical product, if domestically manufactured, has not been placed on the market within two years; or, if imported, within one year. • A medical product granted an Emergency Use Authorisation or a Conditional Marketing Authorisa- tion has not been placed on the market within three months. • The medical product has not been available on the market for two consecutive years after it was initially placed on the market. • The MA was granted based on incorrect or mis- leading documents. • A decision has been issued to prohibit the manu- facture, distribution, or circulation of the medical product in either the UAE or any reference jurisdic- tion. • It is proven that a Medical Products Factory or a Contract Manufacturing Organisation failed to comply with Good Manufacturing Practice (GMP) or Good Storage and Distribution Practice (GDP) in a manner that affects the quality of the medical product. • The medical product is proven to be unsafe or has repeatedly failed to meet approved quality stand- ards when tested by the EDE’s Quality Control Laboratory. • The medical product is found to be unsafe or unreliable due to new safety concerns, or due to reports of adverse reactions or adverse medical events that require its withdrawal. • A decision has been issued prohibiting the activity of a Medical Products Factory, a Contract Manu- facturing Organisation, a Medical Warehouse in the State, or of the entity represented by the Market- ing Office in the country of origin or by any of the EDE’s accredited reference authorities.
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