Bahrain Guide by UAE Experts
Explore Bahrain’s regulatory terrain with Product Registration UAE. Learn about NHRA’s role, registration steps, and more for a successful market entry
6/13/20243 min read
Mapping Out MENAT’s Regulatory Terrain
The Middle East, North Africa, and Turkey (MENAT) region presents a diverse and complex regulatory landscape.
Each country has its unique set of rules and requirements for product registration.
Local knowledge is key to successful market entry, particularly in Bahrain, which we will focus on in this blog.
Bahrain’s Health Vanguard: NHRA’s Commitment to Safety
The National Health Regulatory Authority (NHRA) of Bahrain is a beacon of safety in the healthcare sector.
Established in 2010 under Law No. 38 of 2009, the NHRA is committed to ensuring the appropriateness, continuity, efficiency, and safety of health services in both the governmental and private sectors.
The NHRA’s mission extends beyond regulation, It aims to foster a healthcare environment that is safe, trusted, high-quality, and effective.
This involves regulatory procedures related to licensing healthcare facilities, including hospitals, medical centers, private clinics, centers for allied health professionals, and pharmaceutical centers, as well as licensing healthcare professionals within these facilities.
The NHRA’s strategic goals include the regulation and accountability of all healthcare facilities to meet the required standards for licensing.
They continuously monitor the quality of health services to ensure compliance with evidence-based practices and accreditation standards.
Their commitment to preserving and protecting patients’ health rights, as well as the rights and safety of all people who use healthcare facilities, is unwavering.
A Comprehensive Guide to Product Registration in Bahrain
Navigating the regulatory environment in Bahrain is key to successful product registration.
The Bahrain Food and Drug Authority, also known as the NHRA, is instrumental in this process.
Before a pharmaceutical product can be sold in Bahrain, an application must be made to the NHRA.
This application must contain all of the necessary data supporting its quality, safety, and efficacy, based on the current guidelines and procedures.
The Pharmaceutical Products Regulation Department (PPR) of the NHRA reviews the scientific aspects of each application and concludes on the likely balance of any benefits versus risk before arriving at a decision.
The NHRA has developed and published licensing standards that set the criteria for all healthcare facilities in the Kingdom.
These licensing standards aim to provide a common set of requirements that will apply across all healthcare service providers to ensure that health services are both safe and of an acceptable quality.
In addition to registering with GS1, registration applications must be submitted and approved by the NHRA to permit pharmaceutical products to be sold in Bahrain.
Payment must be made to the NHRA at the time of registration. The NHRA registration process contains all of the necessary MAH location information.
Understanding these processes and regulations is crucial for successful product registration in Bahrain.
The NHRA plays a pivotal role in ensuring that all products meet the necessary safety and quality standards before they are allowed to be sold in the market.
The Registration Journey: Steps and Challenges
The process of registering a product with the NHRA involves several steps, from initial application to final approval.
This includes using the Sijilat portal for commercial registrations and understanding essential entrepreneurial concepts and tools for success, such as MVP creation and lean business canvas.
Businesses may encounter challenges such as comprehending regulatory requirements and ensuring product compliance.
However, these hurdles can be surmounted with meticulous planning and professional guidance.
Documentation and Compliance
The process of product registration necessitates a comprehensive list of documents.
These include product specifications, safety data, and evidence of compliance with international standards.
A Good Manufacturing Practice (GMP) certification is particularly crucial, as it attests that your product is consistently produced and controlled in accordance with quality standards.
The NHRA also requires all of the necessary data supporting its quality, safety, and efficacy, based on the current guidelines and procedures.
Fee Structure: What to Expect
The fee structure associated with product registration is variable, depending on the type of product.
Some fees are 'To Be Determined (TBD)', and businesses can procure this information directly from the NHRA. As per resolution 17 of 2016, application fees and service fees are chargeable for each new medicine application submitted to NHRA.
Navigating Bahrain’s regulatory environment can be intricate, but with a lucid understanding of the NHRA’s role and requirements, businesses can successfully register their products.
"Getting professional help can make the registration process more efficient, ensure compliance, and help avoid potential problems."
Are you in need of expert guidance on navigating the NHRA’s registration requirements?
Seek support from professionals who specialize in product registration.
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Further Readings:
Discover key insights in 2025 Trends & Compliance Tips for UAE product registration.
