- Herbal Medicines and Related Products (Labelling) Regulations 2005
- Scope
- Prohibition
- Adequate and clear labelling information
- Name and Address of Manufacturer, Packer or Distributor
- No reference to International Bodies etc.
- Declaration of ingredients
- Trade mark
- Identification Number assigned by the Agency
- Identification mark on tablets, capsules etc.
- Adequate Labelling for Herbal Medicines and Related Products
- Labelling of bulk package
- Labelling Information for Practitioners
- Adequate Information on the insert
- Prohibition of Labelling of Herbal Medicines or Related Products for certain treatments
- Penalty
- Forfeiture
- Herbal medicines and related products not for use in pregnancy
- Warning for Children
- Mis-leading and Misinformation
- Interpretation
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 in-adequate 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.
No reference to International Bodies etc.
5. No reference, direct or indirect to international bodies shall be made upon any label of herbal medicine or related product, except as prescribed by the Agency.
Declaration of ingredients
6.(1) Name or index number of colour used in the preparation shall be declared on the label.
(2) A quantitative list of ingredients of the herbal medicines by their botanical names or, by their common names, shall be declared quantitatively on the label.
Trade mark
7. (1) Where a herbal medicine or related product have a trade mark displayed on the
label, the trade mark shall not give a wrong impression of the nature, quality or substance of the herbal medicine or related product.
(2) Where the trade mark registration is in conflict with any regulations or requirements of the Agency, the latter shall supersede.
Identification Number assigned by the Agency
8. The inner and outer labels of a herbal medicine or related product shall show, in a clear terms, the Agency registration number (NAFDAC REG. NO.) assigned to it as
indicated on the certificate of registration in a manner prescribed by the Agency.
Identification mark on tablets, capsules etc.
9. (1) All tablets, capsule, caplets and similar dosage forms of herbal medicines and related products shall bear identification marks traceable to the manufacturer or holder of a certificate of registration of the herbal medicine or related product unless otherwise exempted by the Agency.
(2) Exemptions request shall be made in writing to the Agency giving reasons why a
waiver is justified.
Adequate Labelling for Herbal Medicines and Related Products
10. Herbal medicines and related products shall be properly labelled with the following information on the inner and outer labels:
(1) The brand name, botanical or common name if any shall be qualified as herbal,
homeopathic, animal or mineral medicinal product and or admixture there of.
(2) The name shall not be suggestive of therapeutic claim.
(3) Each product shall have a distinct design.
(4) A quantitative list of all ingredients of the product by their botanical or common
names.
(5) The net content of the product in terms of weight, measure, or numerical count
and shall be in metric unit.
(6) The name and address of the manufacturer.
(7) Adequate directions for safe use of the product, including amount for use in
specific age groups
(8) The lot or batch number of the product.
(9) The manufacture and expiration dates.
(10) The storage conditions.
(11) Dosage, route and frequency of administration.
(12) Indication for the product.
Labelling of bulk package
10. Where a herbal medicine or related product is sold in bulk for further manufacturing, provisions of this regulation shall not apply, provided that, the label of the bulk product contains the following information: