S. I.
of 2005
DRUGS AD RELATED PRODUCTS(REGISTRATIO, ETC )
ACT 1999 (AS AMEMDED)
Drug Labelling Regulations 2005
Commencement:
In the exercise of the power conferred on the Governing Council of the ational
Agency for Food and Drug Administration and Control (AFDAC) by section 8 of the
Drug and Related Products (Registration, etc) Act 1999 (as amended) and all the powers
enabling it in that behalf, THE GOVERIG COUCIL OF THE ATIOAL AGECY
FOR FOOD AD DRUG ADMIISTRATIO AD COTROL with the approval of the
Honorable Minister of Health hereby makes the following Regulations:-
1.
Scope
These Regulations shall apply to all labelling of Drugs and Related Products.
2.
Prohibition
Except as provided in these Regulations, no person shall manufacture, import, export,
distribute, advertise, display for sale or sell any drug that is not adequately labelled.
3.
o reference to International bodies, etc.
No reference, direct or indirect to international bodies shall be made upon any label of a
drug, except as is prescribed by the Agency.
4.
Adequate and clear Labeling information
(1) All information required to be indicated on the label shall be prominent, legible and
distinct.
(2) All information shall be in English Language, and may include other languages.
(3) Labelling shall be informative and accurate.
(4) Labelling shall not be false or misleading.
5.
ame and Address of manufacturer, packer or distributor on label
(1) The label of a drug shall specify conspicuously the name and location address of the
manufacturer, and where applicable the name and address of the packer or distributor.
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