Skip to content
As enacted
Contents

Part IV · General

49. Regulation of manufacture, importation, sale and distribution of medicine

Official English translation. Where it differs from the Sinhala or Tamil text, the Act itself says which text prevails.

(1)

No person shall import, distribute, exhibit or sell any medicine that-

(a)

is manufactured, prepared, preserved, packaged or stored under insanitary conditions;

(b)

consists in whole or in part any contaminant or decomposed substance or any foreign matter;

(c)

has in or upon it any deleterious substance that may cause injury to the health of the user; or

(d)

is adulterated.

(2)

No person shall manufacture, prepare, store, preserve, package or re-pack any medicine without adhering to Good

Manufacturing Practices (GMP) and any other prescribed guidelines or conditions.

(3)

No person shall import or distribute any medicine without adhering to Good Distribution Practices (GDP) and any other prescribed guidelines and conditions.

Part V

General

Part VI

Rules and Regulations

Part VII

Repeals and Transitional Provisions

Part VIII

Interpretation