Egyptian Drug Authority (EDA)

Issuing of final Registration & Re-registration License for Human Pharmaceuticals quality
Procedure
Code:QP.CAPP.012
Issue/Rev No.:2/0 Issue Date:26/7/2022 Rev Date:--/--/---- Page | 1 of 3
Annex I
New Under-Registration Products
(296/2009-425/2015-820/2016-645/2018)
Please arrange the file to contain the following folders
1. Company commitments
 Application form & Commitment
 Letter of attorney for company representative
 Any required declarations
 Fast track payment receipt according to EDA chairman decision on 27/9/2021 (If required)
2. EDA Approvals
 Action letter
 Naming approval (optional in case of export only)
 Pricing license (Not required in tender and export)
 Pharmacovigilance approval (Not required in:" Export only and ministerial decree 296/2009")
 Importation approval for each API(Not required in export only)
 Pilot batch samples withdrawal record (Not required in export only)
 Any other approvals (e.g. Fast track, Technical committee approval, …….)
3. Imported / Under license documents
 Certificate of Pharmaceutical Product (CPP)*
 Certificate of the Good Manufacturing Practice (GMP)
 Technical Committee approval on Inspection Report (in case of products imported from non-
reference countries& not marketed in any reference country).
 List of Countries in which the product is registered & marketed
4. Committees' approvals, Leaflet and Lay Out
 Stability approval
 Bioequivalence Approval/Decision (If applicable) (not required in export only)
 Quality committee approval (module 3 S&P part) (If Required)
 Approved leaflet*(+ original leaflet in case of Under license, Imported products)
 Approved layout (+ original pack (outer &inner) In case of Under license, Imported products)
5. Reference
 The reference & Leaflet of the reference Product
 Specialized committee and (pharmacology or non-reference committee) approvals (in case
of non-reference products)
6. Product certificates
 EDA Labs certificate + EDA Labs composition
 Composition certificate (on company's head letter)
 Certificate of analysis of finished product
7. API Documents & Specifications
 Issuing of final Registration & Re-registration License for Human Pharmaceuticals quality Procedure
Code:QP.CAPP.012
Issue/Rev No.:2/0 Issue Date: 26/7/2022 Rev Date:--/--/---- Page | 2 of 3

 Certificate of analysis of active substance

 GMP of the manufacturer
 Recent edition of specifications (pharmacopeias) and/or in-house of all active ingredients.
 In house specification of all inactive ingredients.
8. Company documents & agreements
 According to the submission guidance
9. Any other documents or special requirements
N.B:
 Each document should be uploaded as separate PDF.
 (*) Document should be searchable PDF.
 Issuing of final Registration & Re-registration License for Human Pharmaceuticals quality Procedure
Code:QP.CAPP.012
Issue/Rev No.:2/0 Issue Date: 26/7/2022 Rev Date:--/--/---- Page | 3 of 3

Re-Registration Products
(150/2022)
Please arrange the file to contain the following folders:
1. Company commitments
 Application form & Commitment
 Letter of attorney for company representative
 Any required declarations
 Fees payment receipt
 Fast track payment receipt according to EDA chairman decision on 27/9/2021 (If Required)
2. EDA Approvals
 Registration license
 Preliminary approval for the re-registration
 Pricing license(Not required in tender and export)
 Pharmacovigilance approval(Not required in:" Export only ")
 Any Pre-approved letters from different EDA administration concerning product during
previous registration period (e.g. Variation approval, Technical committee decisions…)
 Production/Importation status report(Not required in export only)
 Importation approval / plan of each API. (Not required in export only)
3. Imported / Under license documents
 Certificate of Pharmaceutical Product (CPP)*
 Certificate of the Good Manufacturing Practice (GMP)
 Technical committee approval on Inspection Report (in case of products imported from non-
reference countries& not marketed in any reference country).
 List of Countries in which the product is registered & marketed.
4. Committees' approvals, Leaflet and Lay Out
 Stability approval
 Bioequivalence Approval /Decision (If applicable)
 Quality committee approval (module 3 S&P part) (If Required)
 Approved leaflet* (+ original leaflet marketed in Egypt)
 Approved layout (+ original layout marketed in Egypt)
5. Reference
 The reference & Leaflet of the reference Product
 Non-Reference committee and pharmacology committee approvals (in case of non-reference
products)
6. Product certificates
 EDA Labs certificate + EDA Labs Composition
 Composition certificate (on company's head letter)
 Certificate of analysis of finished product
7. API Documents & Specifications
 Certificate of analysis of active substance
 GMP of the manufacturer
 Recent edition of specifications (pharmacopeias) and/or in-house of all active ingredients.
 In house specification of all inactive ingredients.
8. Company documents & agreements
 According to the submission guidance
9. Any other documents or special requirements
N.B:
 Each document should be uploaded as separate PDF.
 (*) Document should be searchable PDF.