NHRA issues updated “Medicine Renewal Guideline” (Version 2.1) & “Medicine Variations Guideline” (Version 3.1)

🔍 What’s new:

This updated documents provides clear instruction on the NHRA procedure for the renewal &Variations of a Marketing Authorization Product (MA).

💡 Key Points:

• Application submission must now be done through the NHRA online system “Adweya”.
• Renewal applications must be submitted 3 months prior to the MA expiry date ineCTD format.
• Variations are formally classified as Minor (Type IA: “Do and Tell” or Type IB: “Tell, Wait and Do”) and Major (Type II).
• For variations: Applicants must have Country of origin approval/proof of approval for the proposed variation for all relevant changes.
• The Manufacturing site License in NHRA must be valid before submitting the renewal or variation application.

Compounding variation applications with renewal applications is not accepted, although they can be submitted at the same time.

⏱️ Regulatory Timelines (Assessment Duration):

• Renewal Application: 30 working days
• Variation Application: 45 working days.
• Companies must implement approved variations within 12 months from the approval letter date.

📌 How ReguLinked can support you:

• Pathway Eligibility Assessment: Determine the correct classification (IA, IB, or II) for your proposed change.
• Dossier Mapping & Compilation: We specialize in compiling the renewal application into the mandatory eCTD format. This includes ensuring all required data is in accordance with NHRArequirements for Renewal or Variation application.
• Reference Agency Document Management: We manage the provision and validation of critical documentation, including ensuring copies of valid GMP certificates are provided for all manufacturers (finished product, bulk, primary, secondary, and API) and securing legalized Certificates of Pharmaceutical Product (CPP) according to WHO format.
• Manufacturing Site Compliance: We ensure the prerequisite of having a valid NHRA manufacturing site registration certificate is met before submitting the medicine Renewal or Site Variation application.
• 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.

📎PDF guide :
NHRA – Medicine Variation Guideline_V 3.1
NHRA – Medicine Renewal Guideline_V2.1

📎 Official Source:

NHRA Pharmacy & Pharmaceutical Product Regulation — Medicine Renewal Guideline (Version 2.1)

NHRA Pharmacy & Pharmaceutical Product Regulation — Medicine Variations Guideline (Version 3.1)

📨 Planning to Renew or Submit a Variation for your Marketing Authorization 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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