Section 16: Regulations

(1) The Minister may make regulations for carrying out the purposes and provisions of this Act and with respect to any other matter connected with this Act.
[1999 No. 21.]
(2) Without prejudice to the generality of subsection (1) of this section the Minister may make regulations-
(a) for determining what constitutes the adulteration of any food or drug or class of food or drug and for determining what constitutes foreign matter in relations to any cosmetic or class of cosmetic;
(b) prescribing the type and level of food additive or contaminant that may be present in any food offered for sale;
(c) With respect to-
(i) the labelling and packaging and the offering or exposing in any manner for sale of any food, drug, cosmetic or device,
(ii) the specifications and fill of packages of food, drugs, cosmetics and devices and
(iii) the sale of any food, drug, cosmetic or device;
(d) with respect to the use of any substance as in ingredient in any food, drug, cosmetic or device, for the purpose of preventing consumers or purchasers thereof from being misled or deceived as to the quantity, character, value, composition, merit or safety of that substance when so used or of preventing injury to the health of consumers or users thereof;
(e) prescribing standards of composition, potency, purity or quality, or of any other property, for any article of food, drug, cosmetic or device;
(f) with respect to the importation of any food, drug, cosmetic or device for the purpose of ensuring compliance with the provisions of this Act and the regulations;
(g) with respect to the method of preparing, manufacturing, preserving, packaging, storing or testing of any food, drug, cosmetic or device, in the interests of, or for the prevention of injury to the health of, consumers or users thereof;
(h) requiring persons who sell food, drugs, cosmetics or devices to maintain and keep such books or records as may be prescribed;
(i) with respect to the form of certificate to be issued by the Minister for the purposes of section 7(1) of this Act, and the manner of application therefore including the fees payable therefore, and with respect to the premises or processes or conditions of manufacture, including the qualifications of technical staff, which purposes of that subsection;
(j) for requiring manufacturers of any drugs specified in the Forth Schedule to this Act to submit test portions of any batch of any such drug and with respect to the form of certificate to be issued by the Minister for the purposes of section 7(2) of this Act including the fees payable therefore;
(k) with respect to the manner of taking samples and the reporting of results of analysis or examination of samples;
(l) exempting any food, drug, cosmetic or device from all or any of the provisions of this Act or of the regulations whether unconditional or subject to prescribed conditions;
(m) prescribed forms for the purpose of this Act and the regulations
(n) providing for the analysis of food, drugs, or cosmetics otherwise than for the purpose of this Act and prescribing a tariff of fees to be paid for such analysis;
(o) with respect to the distribution of samples of any drug;
(p) with respect to any advertisement of drugs and cosmetics;
(q) amending the First to Fifth Schedule to this Act in the interests of, or for the prevention of injury to the health of consumers or users; and
(r) prescribing anything authorised or required by this Act to be prescribed.
Penalties and Legal Proceeding