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LEBANON |
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Authority |
MOPH |
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website |
http://www.public-health.gov.lb/ |
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if any |
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DOSSIER REQUIRMENTS |
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S.No |
INDEX FinasterideTablets USP 1 mg for Lebanon |
Page No. |
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1 |
Questionnaire / a list of questions to be answered by you about your company & factory. (Legalized & certified) |
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2 |
Free sales certificate and Public price in country of origin. (CPP or CMP) |
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3 |
Price certificate in the country of origin |
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4 |
Export prices including export prices for neighboring countries. |
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5 |
Stability data file. |
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6 |
Complete technical file |
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Teratogenecity |
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Inhibition test for antibiotics |
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Bioavailability, Bibliography, Stability Data |
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Toxicology- Pharmacology- Clinical data |
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7 |
Certificate of analysis for each Batch. |
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8 |
Methods of analysis, mentioning the standard of reference |
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9 |
Packaging materials quality control. |
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10 |
Registration samples (6 units). |
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11 |
GMP certificate for the raw material supplier. |
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12 |
GMP certificate for the factory (manufacturer) |
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13 |
Bioequivalence study (original) |
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Additional Information |
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Master Formula |
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Manufacturing process with flow chart |
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N. B.: 1,2,3 have to be legalized from the following authorities: |
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MOH in country of origin or health authorities |
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Chamber of Industry & commerce |
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Ministry of Foreign Affairs in country of origin |
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Lebanese embassy at country of origin |
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Toc for lebanon, toc formate for dossier
