Singapore legislation

Section 33

of Health Products Act 2007

Section 33

Evaluation of health products

(1)

In order to ascertain that a health product is suitable for registration under this Act or for registration under any particular category or class, the Authority may —

(a)

subject samples of the health product to an evaluation by an analyst;

(b)

require the applicant for the registration of the health product to send samples of the health product for evaluation by an analyst and then submit the evaluation report to the Authority; or

(c)

consider the evaluation report of any body or organisation, whether in Singapore or elsewhere, that has evaluated the health product.

(2)

The evaluation of a health product must include such tests and examination of the health product as the Authority thinks necessary to determine the following matters:

(a)

whether the quality, safety or efficacy of the health product for the purposes for which it is to be used has been satisfactorily established;

(b)

whether the presentation of the health product is appropriate, given its formulation, composition or design specification and intended purpose;

(c)

whether the health product complies with such requirements as may have been prescribed in relation to it;

(d)

any other matters relating to the health product as the Authority thinks relevant.

(3)

The requirements that may be prescribed for the purposes of subsection (2)(c) include the following:

(a)

that the health product should not have in its composition —

(i)

any prohibited substance; or

(ii)

any particular substance in excess of the prescribed permitted concentration;

(b)

that the manufacture of the health product —

(i)

if carried out in Singapore, should comply with such requirements as may be prescribed; and

(ii)

if carried out elsewhere, should comply with such standards that are acceptable to the Authority.

(4)

In determining whether a health product complies with the standards mentioned in subsection (3)(b)(ii), the Authority may consider such evidence as it thinks sufficient from a relevant overseas authority establishing that the manufacture of the health product is of the acceptable standard.

(5)

The costs of and incidental to the evaluation of a health product must be borne by the applicant for the registration of the health product.

Read in full context — Health Products Act 2007 →