Singapore legislation

Schedule 2

of Health Products Act 2007

Schedule 2

Matters for or in respect of which regulations may be made under section 72

SECOND 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:

(a)

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;

(b)

for prohibiting the manufacture, import, supply, possession, storage, transport, advertisement, administration and use of health products that are dangerous to human health;

(c)

for prescribing the standards for health products in relation to their composition, quality, efficacy and safety for use;

(d)

for prescribing the requirements and procedure for obtaining any licence under this Act;

(e)

for prescribing the requirements in accordance with which the manufacture, import, supply, storage and transport of active ingredients are to be carried out;

(f)

for prescribing the requirements and procedure for the registration of a health product;

(g)

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;

(h)

for prescribing the requirements for the presentation and advertisement of health products;

(i)

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 —

(i)

the persons who may so consent;

(ii)

the considerations which any such person must take into account before so consenting;

(iii)

the circumstances in which the consent of such person may be relied upon; and

(iv)

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;

(j)

for prescribing the procedure for the procurement, testing, examination or analysis of any sample under this Act;

(k)

for providing for the conduct by the Authority or an enforcement officer of routine inspections of —

(i)

premises that are being used for the manufacture, supply or storage of health products or active ingredients; or

(ii)

conveyances that are being used for the transport of health products or active ingredients;

(l)

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;

(m)

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;

(n)

for prescribing the offences that may be compounded under section 65; and

(o)

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 —

(a)

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;

(b)

restrict the classes of persons to whom and the circumstances under which any health product or active ingredient may be supplied;

(c)

restrict the places at which, the manner in which and the persons by whom any health product or active ingredient may be stored;

(d)

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;

(e)

make provisions for the regulation of places at which health products are supplied by retail;

(f)

restrict the classes of persons who may apply for a licence or registration under this Act;

(g)

prescribe the requirements which must be satisfied by any person before a licence or registration may be granted to the person;

(h)

prescribe the information, documents and samples that must be submitted by an applicant for any licence or registration; and

(i)

prescribe the types of assessment and evaluation to be made of any health product before it may be registered.[29/2015]

Read in full context — Health Products Act 2007 →