Update on the Classification of Pharmaceutical Products in Bahrain

Analysis

The National Health Regulatory Authority in Bahrain (‘NHRA') was established in accordance with Federal Law No. 38 of 2009 and was granted the role of regulating healthcare in Bahrain. This was considered an important step towards achieving the goals of the Bahrain Government's Economic Vision 2030.

NHRA's scope includes regulating healthcare professionals, facilities, equipment, and pharmaceutical products, in addition to setting related guidelines in line with international standards.

According to Decree No. 9 of 2016 in relation to Classifying Pharmaceutical Products and Health Products (‘Decree 9 of 2016'), a pharmaceutical product is classified as either a health product or a medicine, based on the Pharmaceutical Product Classification Guideline annexed to the decree (‘PPC Guidelines'). Health products include: herbal products; products containing vitamins; products containing minerals; and other products that contain specific substances such as amino acids, charcoal lipids such as omega 3 and certain antiseptics (‘Health Products').

The PPC Guidelines attempt to provide clear definitions for what are considered Medicines (as defined herein) and Health Products, in addition to providing detailed information to be used as a basis for pharmaceutical products classification.