Secondary Pharmaceutical Repackaging

On 17 October 2014, the Drug Office of the Department of Health, the Government of Hong Kong Special Administrative Region briefed licensed pharmaceutical manufacturers on the new licensing condition. It is confirmed that a full compliance with the PIC/S GMP Guide is required for all licensed pharmaceutical manufacturers, with effect from 1 October 2015. The Hong Kong Guide to GMP for the Secondary Packaging applies to any company carrying out the secondary packaging of pharmaceutical products in Hong Kong. 

Secondary packaging operations involving the application of a supplementary label that does not obliterate, change nor display information relating to the original name, list of ingredients, dosage instructions, batch number or expiry date of the pharmaceutical products are exempted from the requirements of the Hong Kong Guide to GMP for the Secondary Packaging of Pharmaceutical Products. 

A manufacturing step involving the labelling, re-labelling, cartoning, re-cartoning or adding additional information (including inserts) to pharmaceutical products which are already enclosed in the container in which they are to be sold or supplied. 

Our management and staff are knowledgeable in their functions and are capable to ensure interpretation, implementation and compliance to the international standard requirements.

Label Express could fulfill the requirements per the industry guidance from Hong Kong Department of Health on GMP for the Secondary Packaging of Pharmaceutical Products and is considered as a qualified packaging materials supplier without any CAPAs needed.

Secondary Pharmaceutical Repackaging

 

Secondary Pharmaceutical Repackaging