Effective 22 January 2018, the Ministry of Health and Prevention in the United Arab Emirates ('MOHAP') issued a Ministerial Resolution that provides for the fast-track registration of 1) 'drugs that contain an entirely or partially new active ingredient and whose owner holds a patent' ('Innovative Drugs') and 2) 'drugs that are used for treatment, diagnosis or prevention of rare diseases' ('Orphan Drugs').
An Innovative Drug or Orphan Drug can be included in the fast track process following a positive opinion issued by one of several specific accredited international regulatory bodies, even if final approval has not yet been granted by such regulatory body, provided, however, that the certificate of pharmaceutical product ('CPP') will be submitted to MOHAP once available.
The fast-track process states that the MOHAP Drug Registration Committee ('Committee') will evaluate the application of an Innovative Drug or Orphan Drug within 15 working days of submission, and approved or rejected within 10 working days from the date of evaluation of the registration file. Approval will require the approval of a majority of the members of the Committee. Once the Committee grants approval, the pricing will be determined and a certificate of registration and pricing of the drug will be issued.
The price of the drug is guided by the price in the country of origin, as well as the price in the Gulf countries, according to the pricing system implemented in the UAE. If the price in the country of origin is temporarily unavailable, the Committee will base the price on the price proposed by the marketing authorisation holder or importer; however, the product will be re-priced once the price in the country of origin or the prices in the Gulf Cooperation Council countries is available. In case that the market authorisation holder does not agree with the price set by MOHAP, it may apply for reconsideration of the price within one month of receiving the pricing certificate. Following receipt of a pricing dispute, the Committee will re-evaluate the same; in case of approval of a new price, a new pricing certificate will be issued.
In case an application for Innovative Drug or Orphan Drug registration is declined, the application may be presented again to the members of the Committee once further information about the product is available or after approval by one of the named accredited international bodies.
Should you require any advice concerning the registration of Innovative Drugs and Orphan Drugs, we would be happy to assist. In a forthcoming Law Update article, we will expand upon this development.
The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.