Hong Kong Regulations

CHINESE MEDICINES REGULATION - SECT 15

Particulars to be registered for proprietary Chinese medicines

PART 5

REGISTRATION OF PROPRIETARY CHINESE MEDICINES

For the purposes of section 121(1)(b) of the Ordinance, the following
particulars are required to be registered for a proprietary Chinese medicine-

   (a)  its Chinese and English name;

   (b)  its dose form;

   (c)  the name and quantity of each of its active ingredient;

   (d)  the name and quantity of each of its excipient (if any);

   (e)  its specification;

   (f)  its indication (if any);

   (g)  its dosage and method of usage;

   (h)  each of its labels to be attached or printed on its package;

   (i)  the package insert to be supplied for its sales inside Hong Kong;

   (j)  each of the package inserts to be supplied for its sales outside Hong
        Kong (if any);

   (k)  the name and address of each of its manufacturer; and

   (l)  its function or pharmacological action.