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Renew registration of medicines by Aug. 31

Manufacturers or distributors of medicines whose registration has expired must approach the MoH to renew registration before end of August to continue their marketing in the country, said Dr Issa bin Jakka Al Mansoori, Director of the Drug Control Department at the MoH.

“Registration for such medicines will be automatically cancelled,” cautioned Dr Mansoori. “Distributors will not be allowed to import these medicines into the country any cancelled products,” he added.

He said the move aims to make sure pharmaceutical companies and distributors have not introduced any changes in the components or the basic medical information of the marketed products. “Companies and distributors have to fill a ‘Declaration Form’ pledging that they didn’t add or change the ingredients of medicines or information in the leaflet or the outside package,” said Dr Mansoori.

He stressed that pharmaceutical companies and distributors have to abide by the Decree No. 27 of 2006 on renewal of registration of pharmaceutical products, namely generics and innovators medicines enforced in the country.

“In case of adding any changes even if they were minor, the company has to approach the DCD for approval before renewing registration of marketed products,” said Dr Mansoori.

He added that the company had to attach the DCD’s certificate on approved changes or at least a receipt proving that it requested introducing minor variation upon renewal of registration.

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