RegulinkedNHRA issues updated “International Manufacturing Site Licensing Procedure” Guideline (Version 1.6)
🔍 What’s new:
This document defines the procedure for the licensing of international manufacturing sites by the NHRA. The updated guideline clarifies that manufacturing site licensing is mandatory with NHRA prior to submission of an application for new product registration or a variation application pertaining to relevant site transfer.
It also outlines the required documentation, including valid GHC or GMP certificates from one of the recognized competent authorities (e.g., US FDA, EMA, TGA).
💡 Key point:
✅ Mandatory prerequisite for product registration and site transfer variations.
✅ Defines the specific requirement for licensing of batch releasers and bulk manufacturers of sterile formulations.
✅ A site license is valid for 5 years.
✅ Companies must register products after site licensing; failure to do so within 3 years will result in license cancellation without notification.
⏱️ Regulatory Timelines:• Application assessment is expected to be completed within ~30 working days by designated NHRA staff.
📌 How ReguLinked can support you:
• Pathway Eligibility Assessment: Ensuring your manufacturing site activities (e.g., bulk manufacturing, batch release) meet the required licensing criteria.
• Dossier Mapping & Compilation: Assistance in preparing and uploading all necessary documents through the NHRA online system “Adweya”.
• Manufacturing Site Compliance: Guidance on mandatory site licensing, which must precede finished product registration in the Kingdom of Bahrain.
📎PDF guide : NHRA_Guideline_International Manufacturing Site Licensing Procedure V1.6_20251020
📎 Official Source: NHRA Pharmacy & Pharmaceutical Product Regulation — International Manufacturing Site Licensing Procedure (Version 1.6)
📨 Planning to register a pharmaceutical product or Site Variation:
Let ReguLinked accelerate your site licensing submissions with a fully compliant NHRA strategy.
“Book your complimentary consultation today”
📧 bd@regulinked.com 🌐 www.regulinked.com
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