قرار وزارى رقم 244 لسنه 2013 بمد مهلة تقديم ملف التسجيل بعد التسعيرة اضغط هنا
Tuesday, December 31, 2013
Monday, January 7, 2013
Veterinary Technical Committee Decisions
Technical Committee Decisions - Click Here Technical & Scientific Committees decisions concerning Veterinary Products until Feb. 2014.
Veterinary Re-Reg Check-list
Re-Reg Check-list - Click Here Documents required for veterinary product re- registration (Arabic version)
New Vet. Check-list
New Vet. Check-list - Click Here Documents required for veterinary product registration.
Veterinary Scientific Insert
Scientific Insert - Click Here Template for of scientific Insert main items.
Veterinary Leaflet References
Leaflet References List of latest edition of references of product insert or leaflet.
Veterinary Work Flow
Veterinary Work Flow - Click Here Veterinary product registrations steps from A-Z.
Veterinary product sheet
Veterinary product sheet - Click Here An essential document for product's hard file?
Veterinary Submission Request
Submission Request - Click Here How to submit registration of new veterinary product?
Agent Company Profile
Agent Company Profile - Click here Application of Agent Company profile (Under license products)
Factories Company Profile
Factories Company Profile - Click Here Application of Factories Company profile
Toll Card
Toll Card - Click Here Toll Company Profile application For Toll Cosmo-Pharmaceutical Manufacturer.
Dosage Tests Required
Dosage Tests Required - Click Here Check List for required Tests for each Dosage Form.
Stability Submission Rules
Stability Submission Rules - Click Here How to submit new / old studies and needed study technical templates.
Check Lists
Check Lists - Click Here Check List for Stability Study of Human Drug Product In All Regulatory Cases.
Study File Contents
Study File Contents - Click Here Stability Study File Contents in case of:Human Drug Product (OLDSYSTEM) &FoodSupplement & Vet. ...
Stability Summary Sheet
Stability Summary Sheet - Click Here Stability Summary Sheet (5 original Copies) within file.
Follow-Up Request
Follow-Up Request - Click Here submission request to follow-up of submitted Stability study (Monday requests at reception - Window 6 fro...
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Stability-Comment Application
Stability-Comment Application - Click Here For re-submission of rejected studies with comments, email: stability.comment@eda.mohealth.go...
Stability Study Submission Request
Stability Study Submission Request - Click Here New Stability Study Submission Request, email: stability@eda.mohealth.gov.eg, only on (o...
Appendix-E
Appendix-E - Click Here Company Declaration of Patency, Good Manufacturing, Submitted Studies, Storage, NODCAR file.
Sunday, January 6, 2013
Declarations Of License
Declarations Of License - Click Here Required Signed and Stamped Declarations to get marketing license.
List of Countries Prices
List of Countries Prices Declaration for the brand prices around the world, required for imported pricing files.
Imported cost sheet
Imported cost sheet - Click Here excel sheet calculating finished imported product cost that required for pricing file.
Local cost sheet
Local cost sheet - Click Here excel sheet calculating finished product cost that required for pricing file.
Naming List
Naming List - Click Here Recommend 20 Names for your product and apply it to CAPA to get approval for the 1st applicable name.
Hard File Application Form
Hard File Application Form - Click Here Print application after filing and signed by company to be submitted within human medicinal prod...
PRE-SUBMISSION REQUEST INQUIRY FORM
PRE-SUBMISSION REQUEST INQUIRY FORM - Click Here For Re-reg, export filing request.
Submission Request
Submission Request - Click Here New e-Human Drug Submission Request, complete required items and send it within attached company papers ...
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