Zambia

Application for marketing authorisation of a medicine for human use 

Module1: Administrative documents 

1.0. Cover letter 

1.1. Comprehensive review 

1.2. Application Information 

1.2.1.  Application Form 

1.2.2.  Letter of authorisation for communication on behalf of the applicant  

1.2.3. Electronic copy declaration  

1.2.4. Copy of certificate for a Vaccine Antigen Master File (VAMF)  

1.2.5. Copy of certificate for a Plasma Master File (PMF) 

1.2.6.  Copy of certificate(s) of suitability of the European Pharmacopoeia (CEP)  

1.2.7. Confirmation of Prequalification (CPQ) of an API 

1.2.8. Letter of access from the APIMF holder, CEP holder or CPQ holder. 

1.3. Labelling and packaging 

1.3.1. Package Insert/SmPC 

1.3.2. Summary of product characteristics (SmPC) 

1.3.3. Patient Information Leaflet 

1.3.4. Label 

1.3.5. Braille 

1.4. Information about the experts 

1.4.1. Declaration signed by the expert – Quality 

           Information about the Expert – Quality 

1.4.2.  Declaration signed by the expert – non-clinical 

             Information about the Expert – Non-clinical  

1.4.3. Declaration signed by the expert – Clinical  

            Information about the Expert – Clinical 

1.5. Specific requirements for different types of applications. 

1.6. Enviornmental risk factors 

1.7. Good manufacturing practices 

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 license 

1.7.4. Registration of Responsible Pharmacist or Suitably Qualified Person, for local manufacturer. 

1.7.5. Certified copy of permit to manufacture specified controlled substances. 

1.8. Details of screening. (Screening checklist) 

1.9. Individual patient data- Statement of availability. 

1.10. Foreign regulatory status 

1.10.1. List of countries in which an application for the same product as being applied for has been submitted, approved, rejected or withdrawn 

1.10.2. WHO type Certificate of a Pharmaceutical Product 

1.10.3. Registration certificates or marketing authorisation 

1.10.4. Foreign prescribing and patient information 

1.10.5. Data set similarities 

1.11. Regional Summaries 

1.11.1. Summary of Bioequivalence Studies 

1.11.1.1 Study Title(s) (or brief description giving design, duration, and subject population of each study)  

1.11.1.2. Protocol and study numbers. 

1.11.1.3. Investigational products (test and reference) detalls in tabulated format, including 

active ingredient, strength, dosage form, manufacturer, batch no, expiry or retest date, country in which procured. 

1.11.1.4. Confirmation that the test product formulation and manufacturing process is that being applied for 

1.11.1.5. Name and address of the Research Organisation(s) / Contract Research Organisation(s) 

where the bioequivalence studies were conducted 

1.11.1.6. Sponsor and responsible sponsor representative: name and address, contact details 

1.11.1.7. Duration of Clinical phase: dates of dosing and last clinical procedure 

1.11.1.8. Date of final report 

1.11.2. Biostudy reference product confirmation 

1.11.3. Certificates of analysis of the test and reference products 

1.11.4. Bioequivalence trial information form (BTIF) 

1.11.5. Biowaiver requests in relation to conducting comparative bioavailability study Quality 

1.11.6. Information Summary (QS) 

1.12. Pediatric development program (reference to Pediatric development program) 

1.13. Information relating to pharmacovigilance 

1.13.1 Pharmacovigilance system 

1.13.2 Risk Management System 

 1.14 Electronic review documents (e.g. product information, BTIF, ZAMRA-QOS) 

1.15 Sample and Documents (e.g. FPP, device(s), certificates of analysis) 

1.15.1 Confirmation of submission of a sample 

1.15.2 CoA of the sample 

Module 2: Summary of the dossier 

 2.1. Table of contents of module 2 

2.2. Introduction 

2.3. Quality overall summary 

Module 3: quality 

Module 4: Non- Clinical study report 

Module 5: clinical study report