Income Tax Act, 1962 (Act No. 58 of 1962)

Regulations

Purchase

[Regulation 2 heading substituted by Amendment Notice No. 4793, GG50642, dated 10 May 2024]

(1)	Any scientific or technological research and development being carried on in respect of multisource pharmaceutical products must, for the purposes of approval under section 11D(9) of the Act, constitute—

[Words preceding regulation 2(1)(a) substituted by Amendment Notice No. 4793, GG50642, dated 10 May 2024]

(a)

(i)

(aa)	any activity in respect of the analysis or characterisation of the properties of a pharmaceutical product with the purpose of determining the excipients and other ingredients to be utilised in the formulation of the multisource pharmaceutical product;

(bb)	compatibility tests between the active pharmaceutical ingredient, excipients and other ingredients; and

(cc)	dosage form design;

(ii)

(aa)	laboratory scale reformulation through experimentation on active pharmaceutical ingredient, excipients and other ingredients; and

(bb)	pilot plant scale reformulation; or

(iii)

the activities, tests, design and reformulation referred to in sub-subregulations (i) and (ii);

(b)	Determination of analytical and stability testing methods if those methods are determined in conjunction with—

(i)	the activities, tests and design referred to in subregulation (a)(i);

(ii)	the reformulation referred to in subregulation (a)(ii); or

(iii)

the activities tests and design referred to in subregulation (a)(i) and the reformulation referred to in subregulation (a)(ii).

(2)	For the purposes of this regulation "active pharmaceutical ingredient" carries the meaning ascribed thereto in Annex 4 of the WHO Technical Report Series, No 970, 2012 (WHO Expert Committee on Specifications for Pharmaceutical Preparations).