[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]
| (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 |
| (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). |
