As enacted

Contents

National Medicines Regulatory Authority Act 2015 · As enacted · Part IV · General

50. Labelling, &c.,to be in conformity with the prescribed standards

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

(1)

Where the standard is prescribed for any medicine, no person shall label, package, sell, exhibit, distribute or advertise any medicine which does not conform to such standard or in such manner as is likely to be mistaken for the medicine for which the standard has been prescribed.

(2)

Where the standard has not been prescribed for any medicine, but a standard for that medicine is contained in any prescribed publication, no person shall label, package, sell, exhibit, distribute or advertise any medicine which does not conform to the standard contained in that publication in such a manner as is likely to be mistaken for the medicine which the standard is contained in that publication.

(3)

Where a standard has not been prescribed for any medicine, or a standard for that medicine is not contained in any prescribed publication, no person shall sell, exhibit or distribute such medicine –

(a)

unless it is in conformity with the standard set out in the label accompanying the medicine; or

(b)

in such a manner as is likely to be mistaken for a medicine for which a standard has been prescribed or for which a standard is contained in any prescribed publication.

(4)

No person shall label, package, re-pack, treat, process, sell, distribute, exhibit or advertise any medicine in a manner that is false, misleading, deceptive or likely to create an erroneous impression regarding efficacy, quality, composition or safety.

(5)

A medicine that is not labeled or packaged in a manner as may be prescribed shall be deemed to be labeled or packaged contrary to subsection (1).

Read on from s 51

Part V