NHRA issues updated “Medicine Licensing Guideline”  (Version 4.1)

🔍 What’s new:

This updates includes the addition of details regarding the fast-track registration pathway. Clarifies details for application submission through the NHRA online system “Adweya” and adds assessment durations for different pathways.
To be eligible for the fast-track pathway, the Product & Batch Releasing Site must be registered/approved in one of the listed reference authorities, including the SFDA, USFDA, EMA, SwissMedic, MHRA (UK), or GHC central.

⏱️ Regulatory Timelines (Assessment Duration):
• Fast track registration pathway: 10 Working Days
• Normal registration Pathway: 45 Working Days (subject to validation & eligibility)

📌 How ReguLinked can support you:

• Dossier Mapping & Compilation: Ensuring the mandatory eCTD format submission (Modules 1-5) aligns with GHC & ICH CTD guidelines, as required by NHRA.
• “Sameness” Declaration & Justification: Preparing declarations ensuring the SmPC is correct and similar to the one approved in the country of origin.
• Manufacturing Site Compliance: Verifying that the Batch Releaser and Bulk Manufacturer (for sterile formulation) have valid site licenses issued by NHRA, a vital instruction prior to submission.

• Submission & Validation Management: Guiding applicants through the required completion and payment via the ‘ADWEYA’ online portal for initial submission and validation.

📎PDF guide : NHRA – Medicine Licensing Guideline_V4.1

📎 Official Source: National Health Regulatory Authority (NHRA) — Medicine Licensing Guideline (Version 4.1)

📨 Planning to register a pharmaceutical product :

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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