Ministerial Decision No. 28/2018 On the Registration of Innovative and Orphan Drugs

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The Minister of Health and Prevention,

After perusal of Federal Law No. 1/1972 on the Competencies of the Ministries and Powers of the Ministers and its amendments;

Federal Law No. 4/1983 on the Profession of Pharmacy and Pharmaceutical Institutions;

Cabinet Decision No. 6/2013 on the organisational structure of the Ministry of Health, and

Cabinet Decision No. 7/2016 on the assignment of some competencies to some ministries;

Ministerial Decision No. 976/2009 on the formation of the Drug Registration Committee, as well as their companies and prices; and

Based on the public interest requirements;

Has decided the following:

Article 1

The following terms and expressions shall have the meanings assigned thereto unless the context requires otherwise:

State: United Arab Emirates

Ministry: Ministry of Health and Prevention

Minister: Minister of Health and Prevention

Innovative Drugs: Drugs that wholly or partly contain a new effective substance. Inventors thereof shall be granted patents.

Orphan Drugs: Drugs used for the treatment or diagnosis of orphan diseases or for the prevention therefrom.