| Registering a New Pharmaceutical Product in Hong Kong
The following is a checklist of documents and information required for pharmaceutical product registration in Hong Kong:
1. Actual or prototype sales pack and sample.
(Including outer carton, container label and inserts if any)
2. Detailed qualitative and quantitative composition of the product, including information on both active and inactive ingredients.
(E.g. complete master formula.)
3. Evidence that the product is manufactured by a licensed manufacturer.
(Certified true copy of manufacturer's license and GMP certificate.)
4. Information on manufacturing facilities and practices of overseas manufacturers.
5. Evidence that the product is allowed for sale in the country of origin.
(E.g. certified true copy of Free Sale Certificate or Certificate of a Pharmaceutical Product)
6. Certificate of analysis of a representative batch of the product issued by the manufacturer.
7. Method of analysis of the product.
8. Specifications of the product.
(E.g. in the case of a tablet, physical description, uniformity of weight, disintegration time, identification and assay of active ingredients etc.)
9. Clinical papers if available.
(Especially in support of any new indications and claims that are not well documented in pharmacopoeias and for unusual combination of drug ingredients.)
10. Stability test data (real time/accelerated conditions) to substantiate the claimed shelf-life.