Hong Kong Regulations

CHINESE MEDICINES REGULATION - SECT 28

Requirements for package inserts

not yet in operation PART 9

REQUIREMENTS FOR PACKAGE INSERTS

(1) For the purposes of section 144 of the Ordinance, no person shall sell in
Hong Kong or have in his possession for the purpose of selling in Hong Kong
any proprietary Chinese medicine without a package insert which-

   (a)  includes the particulars set out in subsection (2); and

   (b)  has the particulars being clearly and distinctly set out and not in
        any way obscured or obliterated.

(2) A package insert of a proprietary Chinese medicine to be sold in Hong Kong
shall include, at least in Chinese, the following particulars in respect of
the medicine-

   (a)  the name of the medicine;

   (b)  if-

        (i)    the medicine is composed of less than 3 kinds of active
               ingredients, the name of each kind of active ingredient and its
               quantity; or

        (ii)   the medicine is composed of 3 or more kinds of active
               ingredients, the names of more than half of the total number of
               kinds of active ingredients and their respective quantities;

   (c)  either the name of the holder of the certificate of registration of
        the medicine as specified in the certificate or the name of the
        manufacturer who produces the medicine;

   (d)  its dosage and method of usage;

   (e)  its functions or pharmacological action;

   (f)  its indications (if any);

   (g)  its contra-indications (if any);

   (h)  its side-effects (if any);

   (i)  its toxic effects (if any);

   (j)  the precautions to be taken regarding its use (if any);

   (k)  its storage instructions; and

   (l)  its packing specification.