Health Products Act 2007 · 2020 Revised Edition · Schedules
Schedule 2 · Matters for or in respect of which regulations may be made under section 72
Feedback & supportSECOND SCHEDULESection 72(2) and (4)Matters for or in respect of which regulations may be made under section 721. The matters in respect of which regulations may be made under section 72 are as follows:
for prescribing the requirements in accordance with which the manufacture, import, supply, storage, transport, presentation, advertisement, administration and use of health products are to be carried out;
manufacture
“manufacture”, in relation to a health product, means to make, fabricate, produce or process the health product and includes —(a)any process carried out in the course of so making, fabricating, producing or processing the health product; and(b)the packaging and labelling of the health product before it is supplied;
for prohibiting the manufacture, import, supply, possession, storage, transport, advertisement, administration and use of health products that are dangerous to human health;
supply
“supply”, in relation to a health product, means to transfer possession of the health product by any means whether or not for reward, and includes the following:(a)to sell the health product, whether by retail, wholesale or auction;(b)to expose or display the health product as an invitation to treat;(c)to transfer possession of the health product by exchange, gift, lease, loan, hire or hire-purchase;(d)to supply the health product in connection with —(i)a contract for the provision of any goods or the performance of any service; or(ii)any advertising, sponsorship or promotional activity;(e)to supply the health product by way of administration to or application in any person in the course of any diagnosis, treatment or test;(f)to offer, agree or attempt to supply the health product in any of the ways described in paragraphs (a) to (e) or to cause or permit the health product to be so supplied;(g)to keep or possess the health product for the purpose of supplying it in any of the ways described in paragraphs (a) to (f);
for prescribing the standards for health products in relation to their composition, quality, efficacy and safety for use;
efficacy
“efficacy”, in relation to a health product that is a device, includes the ability of the device to properly carry out its intended purpose;
for prescribing the requirements and procedure for obtaining any licence under this Act;
for prescribing the requirements in accordance with which the manufacture, import, supply, storage and transport of active ingredients are to be carried out;
for prescribing the requirements and procedure for the registration of a health product;
health product
“health product” means any substance, preparation or device —(a)that —(i)is represented for use by humans;(ii)whether because of its presentation or otherwise, is likely to be taken for use by humans; or(iii)is included in a class of substances, preparations or devices which are or are ordinarily intended for use by humans,solely or principally for a health-related purpose; and(b)that falls within any of the categories of health products specified in the First Schedule;
for prescribing the duties and obligations of a person to whom any licence or registration is issued or granted under this Act, and the duties and obligation of the person upon the suspension, revocation or cancellation of the licence or registration;
for prescribing the requirements for the presentation and advertisement of health products;
presentation
“presentation”, in relation to a health product, means the way in which the health product is presented for supply, and includes matters relating to the name of the health product, the packaging and labelling of the health product and any other informational material associated with the health product;
for regulating the conduct of clinical trials of health products, and prescribing the matters relating to any consent for a subject to participate in such a trial, including —
the persons who may so consent;
the considerations which any such person must take into account before so consenting;
the circumstances in which the consent of such person may be relied upon; and
the circumstances in which no consent of any person is required for the subject’s participation in the trial,and whether any matter so prescribed has effect in addition to or despite any other written law or rule of law;
for prescribing the procedure for the procurement, testing, examination or analysis of any sample under this Act;
sample
“sample”, in relation to a health product or an active ingredient, includes a sample of the packaging of the health product or active ingredient;
for providing for the conduct by the Authority or an enforcement officer of routine inspections of —
premises that are being used for the manufacture, supply or storage of health products or active ingredients; or
conveyances that are being used for the transport of health products or active ingredients;
for implementing any international agreement to which Singapore is a party that concerns the regulation of the manufacture, import, supply, possession, storage, transport, presentation, advertisement, administration and use of health products and active ingredients;
advertisement
“advertisement”, in relation to a health product, means the publication, dissemination or conveyance of any information for the purpose of promoting, whether directly or indirectly, the sale or use of that health product by any means or in any form, including the following:(a)publication in a newspaper, magazine, journal or other periodical;(b)display of posters or notices;(c)circulars, handbills, brochures, pamphlets, books or other documents;(d)letters addressed to individuals or bodies corporate or unincorporate;(e)photographs or cinematograph films;(f)sound broadcasting, television, the Internet or other media;(g)public demonstration of the use of the health product;(h)offer of trials of the health product to members of the public;
for providing for the protection of any confidential information that relates to any health product and that is received by the Authority or any enforcement officer in the course of administering and enforcing this Act, and for prescribing the purposes for which such confidential information may be disclosed to any specified person;
enforcement officer
“enforcement officer” means —(a)the Chief Executive; or(b)any officer of the Authority or any other person who is appointed by the Chief Executive under section 7 to be an enforcement officer;
for prescribing the offences that may be compounded under section 65; and
for prescribing any other matter that is necessary to be prescribed for the administration and enforcement of this Act.
2. Regulations made under paragraph 1 may —
restrict the classes of persons by whom and the circumstances under which any health product or active ingredient may be manufactured, imported, supplied, kept in possession, stored, transported or used;
active ingredient
“active ingredient” means any substance or compound that is usable in the manufacture of a health product as a pharmacologically active constituent;
restrict the classes of persons to whom and the circumstances under which any health product or active ingredient may be supplied;
restrict the places at which, the manner in which and the persons by whom any health product or active ingredient may be stored;
require records to be kept or submitted to the Authority in relation to the manufacture, import, supply, possession, storage, transport or use of any health product or active ingredient;
make provisions for the regulation of places at which health products are supplied by retail;
restrict the classes of persons who may apply for a licence or registration under this Act;
prescribe the requirements which must be satisfied by any person before a licence or registration may be granted to the person;
prescribe the information, documents and samples that must be submitted by an applicant for any licence or registration; and
prescribe the types of assessment and evaluation to be made of any health product before it may be registered.[29/2015]