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Registration of Medicines Reporting of Adverse Drug Reactions 2.11_ADR_reporting_May03_v1_2.doc December 2012 Page 4 of 18 1 INTRODUCTION The following guidelines pertain to Regulations 34 and 37 of Act 90 of 1997 [the Medicines and Related
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MEDICINES CONTROL COUNCIL - mccza.com
www.mccza.comRegistration of Medicines CMs DS Safety & Efficacy 7.01_CMs_SE_DS_Jun16_v3.doc June 2016 Page 5 of 46 Back to ToC The CMs that will be the subject to these Guidelines are those associated with those disciplines as
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www.mccza.com1997 . Version 1 - Chapter 9 (Validation) reformatted : January 2004 . Version 2 - Sept 2005 adopted PIC/S GMP Guide of July 2004 - Implementation : January 2006
MEDICINES CONTROL COUNCIL - mccza.com
www.mccza.comImplementation. 1997 . Version 1 . Chapter 9 (Validation) reformatted : January 2004. Version 2 . Adoption of PIC/S GMP Guide of July 2004 : January 2006
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www.mccza.comRegistration of Medicines Table of Contents: Guidelines and Forms . 1.01_Contents_May18_v6.docx May 2018 . Page 2 of 7. 2.31 Fixed Dose Combination Products for HIV/Aids, Tuberculosis, and Malaria
MEDICINES CONTROL COUNCIL - mccza.com
www.mccza.comAdministration Notification of Registration of Medicines 12.52 Notification of Registration Apr10v1.doc May 2010 Page 1 of 4 MEDICINES CONTROL COUNCIL NOTIFICATION OF REGISTRATION OF MEDICINES BY THE
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MEDICINES CONTROL COUNCIL - mccza.com
www.mccza.comThis guideline is intended to provide to applicants on the scheduling of substances submitted for registration guidance as medicines. It represents the Medicines Control Council’s current thinking on the safety, quality and efficacy of medicines and
Medicines Control Council
www.mccza.comRegistration of Medicines Reporting of Post-Marketing ADRs 2.33_ADR_reporting_post-marketing_Jul16_v4.1_showing_changes.doc Nov 2016 Page 1 of 22 MEDICINES CONTROL COUNCIL
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