Pharmaceutical Registration in Hong Kong: An Update

When applying for a Certificate for Clinical Trial/Medicinal Test in Hong Kong, a summary of the pre-clinical studies (or alternate similar information) is now required as part of the application packet. The registration and payment may be submitted Monday through Friday, between the hours of 9:00am and 1:00pm or 2:00pm and 5:00pm. The office is also open on Saturday between 9:00am and 1:00pm. To receive an application, a written request must be submitted to the following updated address: Pharmaceutical Registration and Import/Export Control Section, Pharmaceutical Service, Department of Health, 3/F Public Health Laboratory Center, 382 Nam Cheong Street, Shek Kip Mei, Kowloon.

In addition, as of February 2004, the labels of all medicines dispensed by a pharmacy or medical practitioner should include the following information: (a) name of the patient, (b) date of dispensing, (c) name and address of the pharmacy or medical practitioner, (d) trade name or common name of the medicine, (e) dosage per unit, (f) method and dosage of administration, and (g) a precaution where applicable.