NHRA issues updated “Health Products Licensing Guideline” (V 3.0)

🔍 What’s new:
This guideline provides clear instruction on the NHRA procedures for the licensing, Variation and Renwak of health products in the Kingdom of Bahrain. The updated guideline clarifies that all applications (New, Variation Renewal of Health Product Licenses) must be submitted through the NHRA online system “Adweya”. In addition, Samples analysis by NHRA-authorized laboratories for new registration applications of product is mandatory prior to the first importation of the product.

⏱️ Regulatory Timelines (Assessment Duration):
• New Application: 15 Working Days
• Renewal & Variation Applications: 30 Working Days 

📌 How ReguLinked can support you:

• Adweya System Submission Management: We help clients navigate the NHRA’s mandatory online system “Adweya”, ensuring all required documentation and fee payments are submitted correctly for new registrations, variations, and renewals.
• Dossier Compilation and Checklist Adherence: We ensure that your application includes all necessary data and documentation to facilitate efficient and timely assessment. This includes ensuring all required data is in accordance with NHRA requirements for New, Renewal or Variation application.
• Reference Agency Document Management:We manage the provision and validation of critical documentation, including ensuring copies of valid GMP certificates and FSC are provided.
• Pathway Eligibility Assessment:Determine the correct classification for your proposed change.
• Renewal & Variation Strategy:We help structure your submissions, ensuring that while variations and renewals can be submitted concurrently, they are not compounded within the same application sequence. We also provide strategic advice on addressing any post-approval changes.

📎 Official Source: NHRA Pharmacy & Pharmaceutical Product Regulation — Health Products Licensing Guideline (Version 3.0)

📨 Planning to Submit New, Renewal or Variation application in Bahrain? Let ReguLinked accelerate your submissions with a fully compliant NHRA strategy.

“Book your complimentary consultation today”

📧 bd@regulinked.com 🌐 www.regulinked.com

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