Pharmacy & Pharmaceutical Product Regulation

Manufacturers & Distributors

In Bahrain, the Pharmaceutical Products Regulation Department (PPR) of the National Health Regulatory Authority (NHRA) ensures in so far as possible, in consistent with current medical and scientific knowledge, the quality, safety and efficacy of pharmaceutical products, including medicines, health products, and alternative/complementary medicines in the Kingdom of Bahrain. 

Before a pharmaceutical product can be sold in Bahrain, an application must be made to the NHRA and this must contain all of the necessary data supporting its quality, safety and efficacy, based on the current guidelines and procedures. PPR members review the scientific aspects of each application and reach a conclusion on the likely balance of any benefits versus risk before arriving at a decision.

  •  New license application for Bahrainis
  •  License Transfer
  •  License Re-Categorization
  •  New license application for Non-Bahrainis
  •  License Renewal
  •  License Examination
  •  Gap of practicen
  •  Visiting Physicians
  •  Good standing certificate
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  •  Guideline Labeling and Package Leaflet Information
  •  Medicine Variations Guideline
  •  Medicine Licensing Guideline
  •  Medicines Barcoding and Serialization Guideline
  •  Medicines Renewals Guideline
  •  Pricing Guideline
  •  List of Bioequivalence Centers Approved by GCC
  •  Procedure for Pharmaceutical Preparation at Healthcare Facilities
  •  Procedure for Pharmaceutical Product Recall
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Product Classification

Before a pharmaceutical product can be placed on the market in the Kingdom of Bahrain, an application must be made for a license to the NHRA. Such applications should contain the data necessary to support the quality, safety, and efficacy for the product. These data are reviewed by the NHRA, and a conclusion reached based upon the likely balance of the benefits versus risks associated with the product. The license must be granted prior to the product being placed on the market. The NHRA requires that the interests of consumers and users of pharmaceutical products.

To view more details, see classifcation section in left menu.

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Alternative & Complementary Medicines

  •    Alternative and Complementary Medicine Application Form
  •    Alternative and Complementary Medicinal Product Checklist
  •    Approved Alternative and Complementary Medicine List
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Important Links

Important Links