Hong Kong Regulations

CHINESE MEDICINES REGULATION - SECT 5

Licensing requirements in respect of applications made under section 132 of the Ordinance

For the purposes of section 132(2) of the Ordinance, the following are the
prescribed licensing requirements in respect of an application for a
manufacturer licence-

   (a)  the premises to which the application relates are in sanitary
        condition;

   (b)  where ingredients or packing materials, or both, used for
        manufacturing proprietary Chinese medicines are to be stored in the
        premises-

        (i)    adequate space; and

        (ii)   adequate and suitable facilities, for storing the ingredients
               or packing materials, or both, as the case may be, are provided
               in the premises;

   (c)  where any Schedule 1 medicine is to be stored in the same premises
        with any Schedule 2 medicine or material of herbal, animal or mineral
        origin customarily used by the Chinese for medicinal purpose,
        arrangements are made so that the Schedule 1 medicine can be stored
        effectively separated from the Schedule 2 medicine or material;

   (d)  fittings and equipment suitable for use in the manufacturing  process
        specified in the application are provided in the premises;

   (e)  where intermediate products generated or proprietary Chinese medicines
        manufactured in the course of manufacture, or both, are to be stored
        in the premises-

        (i)    adequate space; and

        (ii)   adequate and suitable facilities, for storing the products or
               medicines, or both, as the case may be, are provided in the
               premises;

   (f)  the humidity, lighting, temperature and ventilation of the part of the
        premises provided for-

        (i)    storing ingredients or packing materials;

        (ii)   manufacturing proprietary Chinese medicines; or

        (iii)  storing intermediate products or proprietary Chinese medicines,
               are suitable for their respective purposes;

   (g)  the premises are in all other respects suitable for carrying on a
        business in the manufacture of proprietary Chinese medicines; and

   (h)  each responsible person nominated in the application complies with the
        minimum requirements regarding knowledge and experience as set out in
        section 2 of Schedule 1.