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Module 1 South Africa | |
1.0 | Correspondence |
1.0.1 | Letter of Application |
1.0.2 | Note to Evaluator |
1.0.3 | Correspondence from SAHPRA |
1.0.4 | Response to SAHPRA Request |
1.0.5 | Meeting Information |
1.2 | Application |
1.2.1 | Application Form |
1.2.2 | Annexes |
1.2.2.1 | Proof of Payment |
1.2.2.2 | Letter of Authorisation |
1.2.2.3 | Dossier Product Batch Information |
1.2.2.4 | Electronic Copy Declaration |
1.2.2.5 | Curriculum Vitae of the Person Responsible for Pharmacovigilance |
1.2.2.6 | API Change Control |
1.2.2.7 | EMA Certificate for a Vaccine Antigen Master File (VAMF) |
1.2.2.8 | EMA Certificate for a Plasma Master File (PMF) |
1.2.2.9 | Declaration of Sameness for Replicas and Clones |
1.2.2.10 | Letter of Permission from HCR for Replica |
1.2.2.A | Additional Annexes |
1.2.3 | Change in Applicant |
1.2.3.1 | Letter of Authorisation from Product Owner to New Registrant |
1.2.3.2 | Written Confirmation of Hand-over of Dossier |
1.2.4 | Patent Declaration |
1.2.5 | Checklists, Validation Templates |
1.2.A | Additional Administrative Information |
1.3 | South African Product Information |
1.3.1 | South African Professional Information |
1.3.1.1 | Professional Information (PI) |
1.3.1.1.1 | PI - Approved |
1.3.1.1.2 | PI - Clean |
1.3.1.1.3 | PI - Annotated |
1.3.1.2 | Standard References |
1.3.1.2.1 | Reference Product - Local |
1.3.1.2.2 | Other References |
1.3.2 | Patient Information Leaflet (PIL) |
1.3.2.1 | PIL - Approved |
1.3.2.2 | PIL - Clean |
1.3.2.3 | PIL - Annotated |
1.3.3 | Labels |
1.3.3.1 | Labels - Approved |
1.3.3.2 | Labels - Clean |
1.3.3.3 | Labels - Annotated |
1.3.4 | Braille |
1.3.5 | Foreign Prescribing and Patient Information |
1.3.6 | Artwork and Samples |
1.3.6.1 | Statement Confirming Submission of Samples |
1.3.6.2 | Artwork and Pictures of Samples |
1.3.6.3 | Batch Manufacturing Record of the Sample |
1.3.6.4 | CoA of the Sample |
1.4 | Information about the Experts |
1.4.1 | Quality |
1.4.2 | Nonclinical |
1.4.3 | Clinical |
1.5 | Specific Requirements for different Types of Applications |
1.5.1 | Literature Based Submissions |
1.5.2 | Amendments/Variations |
1.5.2.1 | Tabulated Schedule of Amendments |
1.5.2.2 | Medicines Register Details |
1.5.2.2.1 | Medicines Register Details |
1.5.2.2.2 | Registration Certificates |
1.5.2.3 | Affidavit by Responsible Pharmacist |
1.5.3 | Proprietary Name Applications and Changes |
1.5.4 | Genetically Modified Organisms |
1.5.6 | Generic Applications (BTIF) |
1.5.6.1 | Generic Applications (BTIF) |
1.5.6.2 | Biowaiver |
1.5.7 | Abridged Applications (Abridged/Verified Review Document) |
1.5.A | Additional Types of Applications Specific Requirements |
1.6 | Environmental Risk Assessment |
1.6.1 | Non-GMO (Genetically Modified Organisms) |
1.6.2 | GMO (Genetically Modified Organisms) |
1.7 | Good Manufacturing Practice |
1.7.1 | Date of Last Inspection of each Site |
1.7.2 | Inspection Reports or Equivalent Document |
1.7.3 | Latest GMP Certificate or a Copy of the Appropriate Licence |
1.7.4 | Release |
1.7.4.1 | API |
1.7.4.2 | IPIs |
1.7.4.3 | Finished Product Release Control (FPRC) Tests |
1.7.4.4 | Finished Product Release Responsibility (FPRR) Criteria |
1.7.5 | Confirmation of Contract |
1.7.7 | SAPC Registration |
1.7.8 | Registration with Registrar of Companies |
1.7.9 | Other Documents Relating to the Applicant/PHCR |
1.7.11 | Manufacturing Permits |
1.7.12 | Inspection Flow Diagram |
1.7.13 | Organogram |
1.7.14 | PQR |
1.7.A | Additional GMP Documents |
1.8 | Information Relating to Pharmacovigilance |
1.8.1 | Pharmacovigilance Systems |
1.8.2 | Risk Management Plan |
1.9 | Individual Patient Data - Statement of Availability |
1.10 | Foreign Regulatory Status |
1.10.1 | Tabulated List of Foreign Regulatory Status |
1.10.2 | Registration Certificate or Marketing Authorisation |
1.10.4 | Data Set Similarities |
1.10.4.1 | Data Set Similarities |
1.10.4.2 | Declaration of Sameness |
1.10.5 | RRA Reports |
1.10.6 | CPP (WHO certification scheme) |
1.12 | Paediatric Development Programme |
1.A | Additional Data |