NATIONAL ASSEMBLY
FOR WRITTEN REPLY
QUESTION NO. 1220
DATE OF PUBLICATION IN INTERNAL QUESTION PAPER: 15 April 2011
(INTERNAL QUESTION PAPER NO. 11)
Mrs S V Kalyan (DA) to ask the Minister of Health:
Whether the Medicines Control Council has considered granting a special
exemption in terms of section 21 of the Medicines and Related Substances
Act, Act 101 of 1965, to allow patients with extensively drug-resistant
tuberculosis (XDR TB) to use TMC207; if not, what is the position in this
regard; if so, what are the relevant details?
NW1357E
REPLY:
No Section 21 application for TMC207 has been received to date. Should
there be an application for TMC207 to treat XDR-TB, it will follow the
standard Section 21 authorisation procedure.
END.