| (1) |
The organ of state or public entity may in terms of the Act, apply for exemption or deviation from applying the Codes of Good Practice, in writing, by— |
| (a) |
lodging an application with the Minister in the prescribed FORM B-BBEE 17; and |
| (b) |
providing a motivation setting out reasons or facts peculiar to the organ of state or public entity which necessitate an exemption or deviation as contemplated in section 10(2)(a) of the Act. |
| (2) |
In the case of an application for an exemption, the organ of state or public entity must in its application in terms of subregulation (1) above provide a plan indicating— |
| (a) |
the steps to be undertaken by the organ of state or public entity to comply with the Codes of Good Practice; and |
| (b) |
the time frame by when the organ of state or public entity will comply with the Code of Good Practice. |
| (3) |
In the case of an application for a deviation, the organ of state or public entity must in its application in terms of subregulation (1) above specify the element(s) of the Code of Good Practice the organ of state or public entity wishes to deviate from. |
| (4) |
The organ of state or public entity applying for exemption or deviation must— |
| (a) |
address the matters as specified in these Regulations above; and |
| (b) |
submit the application to the Minister at the following head office or postal address— |
| (i) |
delivered by hand at: |
Department of Trade and industry
77 Meintjies Street
Sunnyside
Pretoria
Republic of South Africa
| (ii) |
addressed by registered post to: |
Department of Trade and Industry
Private Bag X84
Pretoria 0002
Republic of South Africa
| (c) |
transmitted by Fax on 012 394 2577; or |
| (5) |
The Minister must, upon receipt of the application for exemption or deviation by the organ of state or public entity— |
| (a) |
provide the applicant with a written acknowledgement of receipt of the application within ten (10) days; |
| (b) |
inform the applicant in writing of any outstanding information or documents required within thirty (30) days of receipt of the application; |
| (c) |
assess the application to determine compliance with the requirements set out in these Regulations; |
| (d) |
consult with the relevant organ of state or public entity; and |
| (e) |
determine if particular objectively verifiable facts or circumstances applicable to the organ of state or public entity, as provided in the application, necessitate an exemption or deviation in terms of the Act. |
| (6) |
The Minister must, within ninety (90) days of receipt of application, decide whether or not to grant the exemption or deviation. |
| (7) |
Upon consideration of the application for an exemption or deviation, and after consulting the organ of state of public entity concerned, the Minister must— |
| (a) |
in writing either grant or refuse the application for an exemption or deviation; |
| (b) |
give written reasons for his or her decision; and |
| (c) |
publish the decision by notice in the Gazette. |
| (8) |
Where the Minister decides to grant the exemption or deviation in terms of the Act, the Minister must— |
| (a) |
issue a certificate of approval in the prescribed FORM B-BBEE 15; |
| (b) |
stipulate conditions, if necessary, and set time lines for the organ of state or public entity to comply with the Codes of Good Practice; and |
| (c) |
require the organ of state or public entity to submit a progress report, as may be necessary, for compliance with the Codes of Good Practice. |
| (9) |
The exemption or deviation granted by the Minister to the organ of state or public entity shall— |
| (a) |
become effective on the date of publication in the Gazette; and |
| (b) |
be valid for the period specified when granting the exemption or deviation, and shall not exceed ten (10) years. |
| (10) |
The organ of state or public entity that has been granted a deviation or exemption must submit a report to the Minister as follows: |
| (a) |
in the prescribed FORM B-BBEE 16; |
| (b) |
as may be set out in the certificate of approval, granted in terms of subregulation 8 above; |
| (c) |
with accurate disclosure of relevant information concerning— |
| (i) |
goals, programmes, finances for procurement and economic activities in place for accelerating transformation; |
| (ii) |
governance structure, management, capacity and skilled leadership for purposes of accelerating transformation; |
| (iii) |
analysis of business culture, level of diversity, responsibility and equal respect for cultural groups in accelerating transformation; |
| (iv) |
development policies in place for purposes of achieving these Regulations; and |
| (v) |
the impact of exceeding the qualification criteria on the targeted beneficiaries as identified in the Codes of Good Practice. |
| (11) |
The Minister shall, within thirty (30) days of making his or her decision to grant or refuse an exemption or deviation, notify the Commission of such decision in writing. |
| (12) |
Where the application for an exemption or deviation has been refused by the Minister, the applicant may re-apply. |
| (13) |
The exemption or deviation granted by the Minister to the organ of state or public entity cannot be assigned, ceded or transferred to another person. |
| (14) |
The Minister may withdraw the exemption or deviation if he or she is of the view that the organ of state or public entity has failed to comply with the conditions set out for the exemption or deviation, or the reasons for granting the exemption or deviation no longer prevail. |
| (15) |
Where the Minister is of the view that the organ of state or public entity has failed to comply with the conditions stipulated by the Minister for the exemption or deviation, the Minister must before making the decision to withdraw the exemption or deviation— |
| (a) |
notify the organ of state or public entity in writing of the apparent non-compliance, and |
| (b) |
give the organ of state or public entity thirty (30) days to remedy the non-compliance. |
| (16) |
Where the Minister decides to withdraw the exemption or deviation, the Minister shall— |
| (a) |
notify the organ of state or public entity in writing of the decision to withdraw the exemption or deviation; |
| (b) |
give the reasons for the decision to withdraw the exemption or deviation; and |
| (c) |
give the date on which the decision to withdraw the exemption or deviation becomes effective. |
| (17) |
The Minister shall, within thirty (30) days of making his or her decision to withdraw an exemption or deviation, notify the Commission of such decision in writing. |
Medicines and Related Substances Act, 1965
