Registration of Proprietary Chinese Medicines > Proprietary Chinese medicines exempted from registration

According to the CMO and Chinese Medicines Regulation, the following pCms may be exempted from registration (the following interpretation is for reference only. In any case, the legislation should prevail);

  1. a pCm of a reasonable quantity that is manufactured by a manufacturer, or imported by a wholesaler of pCm, for the purposes of providing samples and seeking registration (Reference: section 119(3), CMO );

  2. a pCm that is required for the purposes of education or scientific research. The Chinese Medicines Board may exempt, with or without conditions or restrictions, a person or institution concerned with education or scientific research from the requirements for registration for the pCms in question (Reference: section 158(1), CMO ); such persons or institutions are required to apply to the Chinese Medicines Board for the exemption, the application form can be downloaded from this website;

  3. a pCm that is imported by a wholesaler of pCms for the purpose of re-exporting by the same wholesale dealer (Reference: section 158(5)(a), CMO );

  4. a pCm that is imported by a holder of a valid certificate for clinical trial and medicinal test and is to be used for the purposes of the clinical trial or medicinal test to which the certificate relates (Reference: section 158(5)(b), CMO );

  5. a pCm that is compounded by or under the supervision of a registered Chinese medicine practitioner or a listed Chinese medicine practitioner at the premises where he practises if, and only if, such pCm is being used for the purpose of administering or supplying to a patient under his direct care (Reference: section 158(6)(a), CMO );

  6. a pCm that is individually prepared or compounded for one patient

    1. by a person nominated under section 114(2)(b)(i) or (ii) of CMO; or
    2. under the supervision of such person,
      at the premises in respect of which a retailer licence is in force and in accordance with a prescription given by a registered Chinese medicine practitioner or a listed Chinese medicine practitioner (Reference: section 158(6)(b), CMO);
    1. a pCm that is manufactured in the premises in respect of which a manufacturer licence is in force and by or under the supervision of a responsible person in accordance with a prescription given by a registered Chinese medicine practitioner, or a listed Chinese medicine practitioner; and
    2. a pCm that is, in the case where the medicine is for internal application or both internal and external application, to be administered or supplied to the patient to whom the prescription is given and who is under the direct care of the Chinese medicine practitioner; or in the case where the medicine is for external application only, and is to be administered or supplied to a patient or patients under the direct care of the Chinese medicine practitioner (one patient for internal application, and several patients for external application); and
    3. The Chinese Medicines Board has received from the manufacturer, at least one working day before the day on which the manufacturing process of the medicine begins, a written notification including the particulars set out in section 37(2) of the Chinese Medicines Regulation and being accompanied by an undertaking referred to in section 37(3) of the Chinese Medicines Regulation (Reference: section 37(1), Chinese Medicines Regulation).

 

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