MEDICINES CONTROL COUNCIL - sahpra.org.za

1 Registration of MEDICINES Table of Contents: Guidelines and Forms May 2018 Page 1 of 7 GUIDELINES and FORMS TABLE OF CONTENTS 1 Guidelines and Forms Index to Guidelines and Forms 2 Human MEDICINES general information Pharmaceutical and Analytical Alcohol content of MEDICINES * Post-importation testing* Stability * Biostudies Dissolution* Amendments* Clinical Substitution of MEDICINES Adverse Drug Reactions Reporting Completing clinical trial applications (to be updated) Implementation of the post-registration amendments guideline Patient information Leaflet (PIL) Proprietary names for MEDICINES Package Inserts for human MEDICINES Safety-related Package Insert Notifications (SR-PINs)

2 Package Insert standardised texts ZA eCTD Module 1 Technical eCTD Validation Criteria Submission in eCTD format Guidance for the Submission of the ZA CTD / eCTD general & Module 1 Pharmaceutical &Analytical for CTD CTD Implementation Road Map eCTD Checksums eCTD Questions & Answers Biosimilars SAHPRA South African Health Products Regulatory Authority Registration of MEDICINES Table of Contents: Guidelines and Forms May 2018 Page 2 of 7 Fixed Dose Combination Products for HIV/Aids, Tuberculosis, and Malaria Wound Dressings Adverse Drug Reactions reporting post-marketing Labelling of MEDICINES containing sugars Scheduling of MEDICINES Scheduling of substances for prescribing by authorised prescribers SI International metric system Biological MEDICINES Pre-registration Consultation Meeting Multiple Applications of the same application with different proprietary names Emergency Procedures for Clinical Trial Sites Post Clinical Trial Drug Access for comment Oversight and Monitoring in Clinical

3 Trials Cultivation of Cannabis and manufacture for medicinal and research purposes for comment Borderline Products for comment Co-packaging of MEDICINES for comment Clinical Trial Investigators Exemptions for comment Capacity building & transformation in clinical trials research for comment MEDICINES & Human Reproduction for comment 3 Veterinary MEDICINES general information for Veterinary MEDICINES Bioavailability and bioequivalence Efficacy of and GCP for veterinary MEDICINES Pre-clinical safety for veterinary MEDICINES Efficacy of veterinary biological MEDICINES Maximum residue limits and withdrawal periods Safety of veterinary biological MEDICINES Reporting of adverse drug reactions Recall of veterinary MEDICINES Completing section 21 application form Veterinary Orphan Products- for comment Veterinary Antimastitis MEDICINES 4 Good Manufacturing Practice (GMP)* SA guide to Good manufacturing Practice (GMP)

4 SA Guide to Good Wholesaling Practice + amended for comment Aerosol manufacturing Isolator technology Cephalosporin manufacture Penicillin manufacture Radiopharmaceutical manufacture Site master file Inspections involving GMP Inspectors Exporting of MEDICINES by Wholesalers Registration of MEDICINES Table of Contents: Guidelines and Forms May 2018 Page 3 of 7 GCP guidelines 5 Miscellaneous Importation and exportation of MEDICINES * Parallel importation of MEDICINES (PIM) * Annual returns: international CONTROL * Destruction of schedule 5 MEDICINES * Destruction of schedule 6 MEDICINES * Recalls Recall / withdrawal of MEDICINES , medical devices and ivds - for comment Donations* Lodging a complaint on a medicine 6 Forms MRF1 Medicine Registration Application (Human)

5 - replaced by ZA-CTD MRF2 Screening of Application* MRF4 Package Insert Amendments* ARF1 Adverse Drug Reaction Reporting CTF1 Clinical Trial Application CTF2 Clinical Trial Protocol Amendments CTF3 Clinical Trial Investigators and Sites Amendments VMRF1 Veterinary Medicine Registration PIF1 Parallel Importation Amendments Licence application to manufacture, import or export* Licence application to act as wholesaler or distributor * Section 21 Application form Guideline comments form Application for the Donation of Medicine to South Africa Screening Template for New Applications for Registration Validation Template for eCTD Licence application for Wholesaler to export FPP record sheet API record sheet Pre-registration Consultation Meeting Check-list Licence application to manufacture, import.

6 Distribute or export medical devices Licence application to import, distribute or export medical devices Licence application to wholesale medical devices and ivds Licence application to cultivate, manufacture or import Cannabis for medicinal purposes Licence application to wholesale medical devices v2 CT Six monthly progress report form Module Application Form for ZA-CTD ZA-CTD ZA util Registration of MEDICINES Table of Contents: Guidelines and Forms May 2018 Page 4 of 7 7 Complementary MEDICINES (CAMs) Complementary MEDICINES Quality, Safety.

7 And Efficacy Roadmap for Complementary MEDICINES CAMs Use of ZACTD format in preparation of registration application Health Supplements Safety and Efficacy Health Supplements Safety and Efficacy Annexures for comment Complementary MEDICINES Registration Application ZA-CTD Quality Complementary MEDICINES Caffeine and Menthol for comment Government Gazette 38133 Vitamins and Minerals 8 Medical Devices and In Vitro Diagnostics general information Medical Devices and ivds for comment Medical Devices and ivds Essential Principles for comment Medical Devices and ivds Conformity Assessment Procedures for comment Adverse event and post-marketing vigilance reporting of medical devices and ivds for comment Classification of medical devices and ivds Access to and CONTROL of medical devices and ivds for comment Medical Device Quality Manual - for comment Medical device IVD technical dossier for comment Medical device non-IVD technical dossier for comment ZA.

8 Administrative information Application form Application for registration of a Medical Device 9 Communication with Industry / All Stakeholders Registration of antiretroviral MEDICINES ADR terminology used in package inserts Dear Healthcare Professional Letter (DHCPL) and MEDICINES Safety Alerts (MSA) Urgent Safety Restriction Notification (USRN) Regulation of Complementary MEDICINES Scheduling matters Meeting dates 2017 Scheduling Matters - Accessibility of Malaria Prophylaxis MEDICINES Screening Aug09 Enoxaparin Dec08 Cancellation or withdrawal Payments made to the Registrar of MEDICINES Implementation of CTD Changes during the Registration Process Important Medicine safety information withdrawal of dextropropoxyphene-containing MEDICINES Safety-related Package Insert Notification (SR-PINs)

9 Submission Dates for Pilot Phase eCTD Pilot Phase Scheduling of Meprobamate - for comment Audit of clinical package insert amendments Registration of MEDICINES Table of Contents: Guidelines and Forms May 2018 Page 5 of 7 Clinical Trial Committee meeting and submission dates 2017 Scheduling of Codeine Correction Notice to GG38133 on vitamins and minerals of Nov 2014 Process for implementation of amended Regulations 9 and 10 of Nov 2014 Electronic submission of clinical trial documents Scheduling of Aspirin Proposal to amend scheduling of codeine and dihydrocodeine - for comment Rejections and Comments on rejection Scheduling of Ibogaine Rescheduling of Diclofenac Expression of

10 Interest - API full assessment pilot Rescheduling of ephedrine, ephedra alkaloids and phenylpropanolamine ZA CTD implementation Expression of interest - Pilot for electronic submission of ADR reports Backlog action plan Position statement: Status of Disinfectants, Antiseptics and Germicides Medical Device Establishments: Licence requirements eCTD Go-live in South Africa Workshop re