Posted 11 November 2013
The Medicines Control Council of the South African Department of Health has made available three documents as part of “Draft Administrative Guideline: Complementary Medicines – Quality, Safety, And Efficacy”.
Although the documents do not have a specific publication date, they are simply indicated as “November 2013”. Some indicate a very short comment period (22 November 2013)..
Interestingly, one of the documents indicate that this is not “new” draft, but had been first published for comment as far back as August 2011.
| Title | First publication for comment | Republished | Comment by |
| Complementary medicines – Quality, safety, and efficacy Version 1_5 draft – PDF | First publication released for comment August 2011 | November 2013 | Nil stated |
| Fees Payable to the Registrar for Complementary Medicines – PDF | November 2013 | | 22 November 2013 |
| Complementary Medicines -use of the ZA-CTD format in the preparation of a registration application – PDF | November 2013 | | 22 November 2013 |
Update: The CAMS Regulations have been published on the 15th November and can be downloaded from here or from the Government website. Note, These are “final” – no more comments allowed.
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[/note]
Please can you help me:
*has the registration documents for complementary medicines changed? If yes, where can I find them?
Thank you
@Roland,
The answer, as far as I know, is that the CTD form (or eCTD form) [common technical document] must now be filled in. The MRF1, again as far as I know, is no longer accepted – and also as far as I know – no more applications in terms of the 2002 “call-up” can be accepted.