Page 65 - SAIT Compendium 2016 Volume2

Energy ef ciency INCOME TAX ACT: REGULATIONS ANd NOTICES General
published by Government Notice 721 of 5 August 2009 in respect of the IPP bid programme as de ned in those regulations, for any energy ef ciency savings or the sale and purchase of electricity constitutes a concurrent bene t. ‘.
Commencement
4. These regulations come into operation on 1 April 2015.
NOTICE IN TERMS OF SECTION 11D (6) (b) OF INCOME TAX ACT, 1962 (ACT 58 OF 1962), IN RESPECT OF CERTAIN CATEGORIES OF RESEARCH AND DEVELOPMENT DEEMED TO CONSTITUTE THE CARRYING ON OF RESEARCH AND DEVELOPMENT
Promulgated under
GN R343 in GG 38729 of 23 April 2015
I, Nhlanhla Musa Nene, Minister of Finance, hereby give notice in terms of section 11D(6)(b) of the Income Tax Act, 1962 (Act No. 58 of 1962), that–
(a) creating or developing a multisource pharmaceutical product, as de ned in the World Health Organisation Technical Report Series, No. 937, 2006 Annex 7 Multisource (generic) pharmaceutical products: guidelines on registration requirements to establish inter-changeability issued by the World Health Organisation, conforming to such requirements as must be prescribed by regulations made by the Minister of Finance after consultation with the Minister of Science and Technology; and
(b) conducting a clinical trial as de ned in Appendix F of the Guidelines for good practice in the conduct of clinical trials with human participants in South Africa issued by the Department of Health (2006), conforming to such requirements as must be prescribed by regulations made by the Minister of Finance after consultation with the Minister of Science and Technology, are deemed to constitute the carrying on of research and development for the purposes of section 11D of the Income Tax Act, 1962 (Act 58 of 1962).
Nhlanhla Musa Nene
Minister of Finance
REGULATIONS IN TERMS OF PARAGRAPH (e) OF DEFINITION OF ‘RESEARCH AND DEVELOPMENT’ IN SECTION 11D (1) OF THE INCOME TAX ACT, 1962, ON CRITERIA FOR CLINICAL TRIALS IN RESPECT OF DEDUCTION FOR RESEARCH AND DEVELOPMENT
Promulgated under
GN R344 in GG 38730 of 23 April 2015
I, Nhlanhla Musa Nene, Minister of Finance, in terms of paragraph (e) of the de nition of ‘research and development’ in section 11D(1) of the Income Tax Act, 1962 (Act No. 58 of 1962), in consultation with the Minister of Science and Technology, hereby make the regulations as set out in the Schedule hereto.
Nhlanhla Musa Nene, MP
Minister of Finance
De nitions
SCHEDULE
1. In these Regulations, unless the context indicates otherwise, any word or expression to which a meaning has been assigned in the Act bears the meaning so assigned, and—
‘clinical trial’ means a clinical trial as de ned in Appendix F to the Guidelines;
‘Guidelines’ means the Guidelines for God Practice in the Conduct of Clinical Trials with Human Participants in South Africa issued by the Department of Health (2006);
‘the Act’ means the Income Tax Act, 1962 (Act No 58 of 1962);
Criteria for deduction for research and development in respect of a clinical trial
2. Any research and development being carried on in respect of a clinical trial must, for the purposes of approval under
section 11D(9) of the Act, be carried on in accordance with the Guidelines.
Exclusions in respect of deduction for research and development in respect of a clinical trial
3. Despite regulation 2, the following activities do not qualify as research and development in respect of clinical trials being carried on for the purposes of section 11D of the Act:
(a) a phase IV clinical trial, as de ned in Appendix F to the Guidelines other than a clinical trial conducted for the
purpose of developing new indications, developing new methods of administration or developing new combinations
of pharmaceutical products;
(b) post-marketing research;
(c) cost-effectiveness research;
(d) an activity undertaken solely for the purpose of compliance with regulatory requirements;
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