Terms for registration of innovative drugs specified

ABU DAHBI - The Central Drug Control Department at the Ministry of Health has issued a circular specifying the conditions under which an innovative pharmaceutical product (innovator) will be protected from competitions of 'generic' medicines in the UAE market.

By Nada S. Mussallam

Published: Sun 12 Oct 2003, 12:18 PM

Last updated: Wed 1 Apr 2015, 11:33 PM

According to circular No. 34 of 2003, applicant must state clearly the market of origin and that the market of an innovator should be the same as that of the country issuing the certificate of pharmaceutical product (CPP).

Among many other requirements, the circular stated that registration of the innovator products depends upon the product having current marketing approval from the regulatory authority in the 'market of origin', and that the innovator product in the UAE must be the same as the innovator product in that market.

It also specified that exclusive UAE market authorisation will be given to an innovator medicine if there is current patent protection in the market of origin.

At the same time of application, the marketing authorisation holder of the innovator product will have to provide details of the patent protection for the product in the market of origin, according to the circular.

The circular also stated that in accordance with the federal law No. 12 of 2002 dealing with organisation and protection of the industrial property of patents, drawings and industrial models, these patents must be under registration with the Patent Directorate at the Ministry of Finance and Industry in the UAE.

It also stipulated that the protection for innovative drugs in the UAE will be provided as long as the patent is not rejected by the UAE Patent Directorate or the courts in the source market. This protection will be limited in the country while post-patent market exclusivity as provided in some markets will not be applied to the UAE market.

According to Dr Issa Jakka Al Mansouri, Director of the Department, an application to market a generic drug in the UAE will be accepted 12 months before the expiry of the UAE protection of the innovator. He said the generic drug applicants must state in their applications the name of the UAE innovator product.

Application for registering a generic drug must not contain any data relating to the innovator, which is protected under Article 39 of the TRIPS agreement on trade-related aspects of intellectual property rights, said Dr Mansouri.

He said marketing approval will not take effect until the UAE patent protection of the innovator has expired. Applicants, who wish to challenge the validity of a UAE patent protection, should make their appeal to the UAE Ministry of Finance and Industry, said Dr Mansouri.

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