DRUGS AND RELATED PRODUCTS (REGISTRATION, ETC.)
ACT 1996 (AS AMENDED)
Herbal Medicines and Related Products
(Labelling) Regulations 2005
Commencement:
In exercise of the powers conferred on the Governing Council of
the National Agency for Food and Drug Administration and Control
(NAFDAC) by Section 8 of the Drugs and Related Products
(Registration, Etc.) Act 1993, as amended, and of all the powers
enabling it in that behalf, THE GOVERNING COUNCIL OF THE
NATIONAL AGENCY FOR FOOD AND DRUG ADMINISTRATION AND
CONTROL with the approval of the Honourable Minister of Health
hereby makes the following Regulations:-
Scope. 1. These Regulations shall apply to all labeling of herbal medicines and related products used as
diagnostic, therapeutic or prophylactic agents.
Prohibition. 2. No person shall manufacture, import, export, distribute, advertise or sell any herbal medicine or
related product that is not labelled as required by the provisions of these Regulations.
Adequate and clear labelling information
3.(1) All information on a label shall be (a) clearly and prominently displayed thereon; and
(b) readily discernible to the consumer.
(2) All labelling information shall be in English language
and may include other languages.
(3) Herbal medicines and related products labeling shall
be informative and accurate and neither promotional
in tone nor false or misleading.
(4) The labeling shall be based whenever possible on data derived from human
experience.
(5) No implied claims or suggestions of herbal medicines or related products may be made, if there is inadequate evidence of safety or a lack of substantial evidence of effectiveness.
(6) Where a claim of effectiveness or therapeutic indication labelling is made by a herbal medicine or related
product, it shall carry boldly and in close proximity to the claim, a statement to the fact that such claim have not
been evaluated by the Agency, unless such claims has been clinically proven and deemed satisfactory by the
Agency.
Name and Address of Manufacturer, Packer or Distributor
4.(1) The label of herbal medicines and related products in package form shall specify conspicuously the name
and place of business of the manufacturer, and may
include the distributor or packer.
(2) Where a herbal medicine or related product is not manufactured by a person whose name appears on the
label, the name shall reveal the connection between the person and the manufacturer, such as "Manufactured for
_..__.", Distributed by____..", or any other wording that expresses the facts.