The Pharmaceutical Sector in Jordan: What is Involved in Changing a Marketing Authorisation Holder?
Type
E-journal
Date
25 Jan 2017
Jurisdiction
Jordan
Taxonomy
Pharmacy, Drugs & Medicinal Products
Copyright
LexisNexis
Relevant company
Al Tamimi & Company
Legal reference
Jordan Medicine and Pharmacy Law No. 12/2013, Jordan Regulation No. 19/2015
Analysis
The pharmaceutical industry in Jordan is regulated by the Ministry of Health (‘MoH'), and supervised by the Jordanian Food and Drug Association (‘JFDA'). Under the auspices of the MoH and the JFDA, a myriad of local laws regulate the pharmaceutical sector, including those governing the import of medical products and registration requirements. In this article, we examine the impact of transferring the marketing authorisation holder (‘MAH') status to a new legal entity.
The process for transferring or changing the MAH begins with the submission of an application to the JFDA, together with all the required documents explaining the justification and scientific basis for the change.
The detailed requirements for the submission of documents are beyond the scope of this article, accordingly, we focus on the overall process and key points of interest only.
Change of MAH