NATIONAL ASSEMBLY

FOR WRITTEN REPLY
QUESTION NO. 538
DATE OF PUBLICATION IN INTERNAL QUESTION PAPER: 22 MARCH 2013
(INTERNAL QUESTION PAPER NO. 9)

Mrs D Robinson (DA) to ask the Minister of Health:

What is the turnaround time by the Medicine Control Council for registrations of (a) pharmaceutical entities, (b) new clinical indications and (c) new doses of already existing registered molecules?

NW695E

REPLY:

The average turn-around times are as follows:

(a) New Chemical Entities: 39 months;

(b) New indications: 26 months;

(c) New doses of already existing registered molecules: 18 months.

END.

Issued by Parliament, April 29 2013

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