Declaration of National Standard

2014 - September - 22

The Antigua and Barbuda Bureau of Standards (ABBS) wishes to advise the General Public and all stakeholder agencies that effective Monday 15 December, 2014 Labelling of Drugs (Pharmaceuticals) shall be declared to be a Standard and an Antigua and Barbuda Standard according to section 17 (1) and (3) of the Standards Act (411) of the revised laws of Antigua and Barbuda, 1992 edition, and section 3 (1) of the Standards Regulations 1998.

This standard describes general labelling requirements for drugs. It is applicable to all drugs which are manufactured, imported, sold or distributed within Antigua and Barbuda.

For the purposes of this standard a drug means any substance or mixture of substances manufactured, sold or represented for use in the:

  • the diagnosis, cure, treatment, mitigation or prevention of any disease, disorder, abnormal physical or mental state, or the symptoms thereof in human, animal or fowl;
  • the restoring, correcting or modifying of organic functions in human, animal or fowl;
  • any substance whether natural or synthetic with therapeutic or medical properties and chiefly used as medicines or ingredients in medicines.
  • any article other than food intended to affect the structure of any function of the body of man or animal.

The standard was prepared by the Labelling of Pharmaceuticals Technical Committee, and approved by the Antigua and Barbuda Standards Council on 26 March, 2014. It was circulated for public comment 14 April, 2014 to 13 June, 2014, and was the subject of two stakeholder consultations.

Interested persons can purchase copies of this specification from the

Antigua and Barbuda Bureau of Standards
Old Parham Road
Telephone 462 2424
Fax 562 0094
Email abbs@antigua.gov.ag

 

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  1. Standards Act
  2. Metrology Act
  3. Antigua and Barbuda Standards Regulations, 1998