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NHRA issues updated “Alternative and Complementary Medicines Guideline” (V 1.2)

🔍 What’s new:
This guideline provides clear instruction on the NHRA procedures and requirements for submitting an application to obtain approval for the import, distribution, and sale of alternative and complementary medicines which are not generally considered part of the conventional medicines. This includes (Homeopathic medicines, Ayurvedic medicines, Unani medicines, Traditional Chinese medicines) 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

📌 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.

📎 Official Source: NHRA Pharmacy & Pharmaceutical Product Regulation — Alternative and Complementary Medicines Guideline (Version 1.2)

📨 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

 

#ReguLinked #NHRA #Bahrain #GCC #AlternativeMedicine #ComplementaryMedicine #RegulatoryUpdate #ProductRegistration #MarketAccess #RegulatoryAffairs

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