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NEW rules have been introduced in Bahrain to register drugs and pharmaceutical products.
The regulations were issued by Supreme Council of Health (SCH) chairman Dr Shaikh Mohammed bin Abdulla Al Khalifa and published in the latest edition of the Official Gazette.
The drugs and pharmaceutical products will be registered within 10 days by the National Health Regulatory Authority (NHRA), after they have been registered with the Gulf Central Committee for Drug Registration, Saudi Food and Drug Authority, US Food and Drug Administration, European Medicines Agency, Swiss Medic, and the UK Medicines and Healthcare Products Regulatory Agency.
“All factories and producers have to be registered with one of the above-mentioned bodies,” said the notice. The fees have to be paid before any local registration is made.
“Any future imported drugs or medicines sought for registration have to be important and without any alternatives in Bahrain.”
The current list of emergency drugs and medicines will also have to meet the new conditions. However, registration without the new rules is allowed through an express licence issued within 20 days on the condition that the products comes from a permitted factory by the above-mentioned bodies, with a 12-month grace period being provided to complete all required documentation.
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