Abstract

REGULATORY PREREQUISITE FOR PHARMACEUTICAL PRODUCTS AS PER UAE GUIDELINES

J. Balasubramanian*, N. Radhika, G. Adinarayana, G.A. Nandhini, K. Jothi, K. Sai Sugathri

ABSTRACT

This contemplative approach on pharmaceutical product registration in UAE can be done only as per the regulatory guidelines of UAE. This retrospective approach provides the information on Roles and responsibilities of Health authorities as per UAE guidelines for export Application for registration of medicinal product, Drug application appointment sheet, checklist for conventional new drug application, Renewal of registration of conventional pharmaceutical product, Requirements of drug control lab, Registration of food supplement Requirements of Drug Registration in the United Arab Emirates, Receipt and checklist for receiving a conventional new drug application, Public healthcare services are administered by different regulatory authorities in the UAE. The Ministry of Health, HAAD, DHA and EHA are the main authorities. Despite the government’s efforts at modernizing the healthcare system by creating new authorities and issuing new regulations in the last decade, the division of powers and authorities among the various regulatory entities (between the Federal and Emirates levels and between different entities at each level). The main principle according to the UAE Regulation is implementing the registration of all medicines with the Ministry of Health (MOH) in order to be legally circulated in the UAE market. Any medical company which plans the marketing of its production in the country should be registered in the Ministry.

Keywords: Health Authority-Abu Dhabi (HAAD), the Dubai Health Authority (DHA), Emirates Health Authority (EHA), United Arab Emirates (UAE).