GENERAL, ECTD & HUMAN MEDICINES GUIDELINES

Document NumberTitleCategoriesDate updatedVersionUnitsFile TypeLinkdoc_categories_hfilterdoc_tags_hfilter
Industry Communication on Interim Measures Pending Update of Variation Addendum,

2020 Sep

1pdfDownloadcommunication-to-industry guidelinegeneral-ectd-human-medicines-guidelines
2.01General information guideline

2019 Jul

10Downloadguidelinegeneral-ectd-human-medicines-guidelines
2.02Quality and Bioequivalence

2019 Jul

7Downloadguidelinegeneral-ectd-human-medicines-guidelines
SAHPGL-HPA-06Variations Addendum For Human And Veterinary Medicines

2022 Sep

6, pdfDownloadguidelinegeneral-ectd-human-medicines-guidelines veterinary-medicines
SAHPGL-CEM-01Clinical guideline

2022 Aug

3, pdfDownloadguidelineclinical-evaluations-management general-ectd-human-medicines-guidelines
SAHPGL-CEM-03Guideline for Patient Information Leaflet for Human Medicines (Categories A D)

2022 oct

7, , pdfDownloadguidelineclinical-evaluations-management general-ectd-human-medicines-guidelines health-products-authorisation
SAHPGL-CEM-02Guideline for Professional Information for Human Medicines (Categories A and D)

2022 Sept

5, , pdfDownloadguidelineclinical-evaluations-management general-ectd-human-medicines-guidelines health-products-authorisation
SAHGPL-HPA-03eCTD Validation Criteria

2022 Nov

4pdfDownloadguidelinegeneral-ectd-human-medicines-guidelines
2.23Guideline for submission in eCTD format

2019 Jul

3Downloadguidelinegeneral-ectd-human-medicines-guidelines
2.58Submission in eSubmission format

2019 Jul

1Downloadguidelinegeneral-ectd-human-medicines-guidelines
SAHPGL-PEM-03Guideline for the API Master File (APIMF) Procedure

2022 Nov

3, , pdfDownloadguidelinegeneral-ectd-human-medicines-guidelines pharmaceutical-evaluation-management pre-reg
SAHPGL-PEM-01Availability of medicines for use in a Public Health Emergency (PHE)

2022 Jun

2, , , pdfDownloadguidelineemergency-use general-ectd-human-medicines-guidelines section-21 unregistered-products
SAHPGL-INSP-02Guideline for Good Manufacturing Practice

2022 Sep

8, , pdfDownloadguidelinegeneral-ectd-human-medicines-guidelines inspectorate-and-good-manufacturing-practices licencing
5.08Reliance Guideline

2022 Mar

3Downloadguidelinegeneral-ectd-human-medicines-guidelines
SAHPGL-HPA-05BAU Variations Communication,

2022 Sep

4pdfDownloadcommunication-to-industry guidelinegeneral-ectd-human-medicines-guidelines
2.40Multiple submissions of the same application for registration with different proprietary names

2019 May

4Downloadguidelinegeneral-ectd-human-medicines-guidelines
SAHPGL-HPA-04Renewal of Human and Veterinary Medicines Requirements and Process

2022 Jun

1, pdfDownloadguidelinegeneral-ectd-human-medicines-guidelines veterinary-medicines
2.21South African Specification for eCTD Regional Module1

2019 May

3Downloadguidelinegeneral-ectd-human-medicines-guidelines