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Pre - Registration

We support you in preparing a complete dossier and ensuring all documentation meets NPRA’s requirements.

01

Product Information

  • Batch manufacturing formula

  • Product label

  • Manufacturing process

  • Product description (liquid colour, appearance)

  • Dosage

  • Packaging material (e.g., bottle type)

02

Certificates of Analysis

  • Certificate of analysis – finished product (2 batches)​

  • Certificate of analysis – active ingredients

03

Regulatory & Authorization Documents

  • Letter of authorization (if Product Owner ≠ Product Registration Holder)

  • Importer name & address (if applicable)

  • Store name & address

04

Manufacturer & Import Requirements

  • Imported products: CPP or CFS, plus GMP certificate of manufacturer

  • Contract manufacturer:

    • Letter of appointment (owner → manufacturer)

    • Letter of acceptance (manufacturer → owner)

05

Additional Documentation

  • Stability study (minimum 6 months, 2 batches)
    •BSE/TSE-free document (if product contains bovine/ruminant ingredients)

For submissions with new active ingredient, excipient, issuing body, dosage form, or manufacturer:

  1. Click the “N/L” button in QUEST.

  2. Submit your request to NPRA for listing.

  3. Follow NPRA’s further instructions via email.

Product
Registration

Registration of a product requires an extensive knowledge on its requirements. The Authority ensures product safety, quality and efficacy (drugs). If you would like to know more about product registration or have a question, please send us an enquiry. We will do our best to assist you.

Variation & COS

Variation & Change of Manufacturing Site (COS)

Certain changes to a registered product is allowed. A variation or COS application must be submitted and approved by NPRA before the change can happen. ​ Variation and COS applications are regulated by its guidelines (link below).

Change of Holder (COH)

It is allowed to change the product registration holder of a registered product. The registered product will maintain its registration number and all other information. ​ COH application is regulated by its guidelines (link below).

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