PRE-REGISTRATION

Dossier Preparation & Listing

Dossier Preparation

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1. Batch manufacturing formula
2. Product label
3. Manufacturing process
4. Certificate of analysis of finished product (2 batches)
5. Certificate of analysis of active ingredients
6. Product description (liquid colour, appearance)
7. Dosage
8. Packaging material (type of bottle)
9. For imported products:

Certificate of pharmaceutical product
Or
Certificate of free sale of product and GMP certificate of product manufacturer
10. Letter of authorization from product owner to product registration holder (PRH) (if product owner and PRH are different companies)
11. If contract manufacturer:
a) Letter of appointment of manufacturer from product owner
b) Letter of acceptance of manufacturer to product owner
12. Importer name and address (if applicable)
13. Store name and address
14. Stability study of the product (2 batches, minimum 6 months data)
15. If got bovine/ruminant ingredients - BSE/TSE free document

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Listing of new active ingredient, new excipient, new issuing body, new dosage form and new manufacturer

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If your active ingredient/excipient/issuing body/dosage form/manufacturer is not listed, click the `N/L` button in Quest button and send your request to list it. You will be provided further instructions by NPRA through email.