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IRAN |
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Authority |
MOH & Medical Education, Deputy For Food & Drug |
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website |
www.fdo.ir/Uploadedfiles/gfiles/a727800514a4447 |
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if any |
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DOSSIER REQUIRMENTS |
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S.No |
INDEX LEVETIRACETAM TABLETS 250 mg |
Page No. |
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1. |
Certificate of Pharmaceutical Product CPP (According to the format recommended by WHO) |
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2. |
A list of the countries to which the product (s) is being exported /consumed |
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3. |
A list of other plants if the manufacturer has in other countries |
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4. |
Providing the following documents and Related Substances samples for Quality Assurance of MOH |
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4.1 |
Related Substances of Active ingredients along with Certificate of Analysis |
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4.2 |
Method of Analysis for finished products |
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4.3 |
Sample of all relevant excipients along with Certificate of Analysis |
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4.4 |
Registration Samples for Finished product along with Certificate of Analysis |
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5. |
Company General Information (Company Profile) |
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6. |
Providing relevant complete Registration documents of each importing pharmaceutical product which should contain the following data: |
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6.1 |
Name and Pharmaceutical form of the product |
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6.2 |
Name and address of the manufacturer |
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6.3 |
Exporting (Certifying) region |
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6.4 |
Composition |
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a |
Formula |
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b |
Packaging material |
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6.5 |
Method of preparation |
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a |
Manufacturing formula |
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b |
Manufacturing process |
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b-1 |
Equipment |
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b-2 |
Manufacturing procedure |
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b-3 |
In- process control |
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6.6 |
Control of starting materials |
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a |
Active ingredients |
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a-1 |
Specifications |
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a-2 |
Method of Analysis |
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a-3 |
Potential impurities and determination |
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a-4 |
Certificate of Analysis |
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b |
Other ingredients |
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b-1 |
Specifications |
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b-2 |
Method of Analysis |
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b-3 |
Certificate of Analysis |
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c |
Packaging materials |
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c-1 |
Specifications |
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c-2 |
Method of Analysis |
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c-3 |
Certificate of Analysis |
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6.7 |
Control tests on finished products |
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a |
Specifications |
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b |
Method of Analysis |
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c |
Certificate of Analysis |
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6.8 |
Stability |
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a |
Controlled batches |
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b |
Storage conditions |
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c |
Description of containers |
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d |
Analytical methods |
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e |
Stability schedule |
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f |
Results |
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g |
Shelf-life period |
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6.9 |
Pharmacology and Toxicology report |
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6.10 |
Clinical trials |
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6.11 |
Bio-equivalency |
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6.12 |
Patient information leaflet |
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6.13 |
Labels and Outer Carton Text |
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Toc for iran, toc formate for dossier
