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ECUADOR |
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Authority |
ministerio de salud publica del Ecuador |
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website |
www.msp.gov.ec/ |
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if any |
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DOSSIER REQUIRMENTS |
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S.No.: |
INDEX |
Page No. |
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I |
LEGAL DOCUMENTS |
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1. |
Free Sale Certificate |
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2. |
GMP certificate issued by the relevant health authorities, in original, updated and legalized. |
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3. |
Legalized authorization/power of attorney from manufacturer. |
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II |
TECHNICAL DOCUMENTS |
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1. |
Composition Formula: C omplete Qualitative-quantitative formula. |
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2. |
Interpretation of the Batch code (original). |
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3. |
Stability studies chemical and/or microbiological (original) |
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4. |
Certificate of Analysis of quality control of the batch sent (original signed) |
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5. |
Standard Certificate of Analysis (original signed by Technician) |
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6. |
Analytical, chemical, biological, microbiological and/or pharmacological methodology of finished product (original) Complete quail-quantitative formula. Indentification of the active principles of the finished product. Weight, weight variation, uniformity of content, fusion temperature and others according to pharmaceutical form. And/or dissolution in case of tablets, coated tablets/caps or capsules Complete description of the method use for physical/chemical valuation of active principles in the finished products. En delayed release pharmaceutical form, prolonged action/release, or coated, these conditions and techniques must be stated in order to be proved. Biopharma studies : (Bioequivalence test and dissolution) for pertinent products. |
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7. |
Specifications on finished product (original ) |
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8. |
Specifications of the prime materials (original) |
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9. |
Specifications on materials sued for bottling and packaging (original ) |
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10. |
Description of the manufacturing procedure (original) |
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11. |
Justification of the composition formula (original) |
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12. |
Format/Design of external and internal side of labels (original) |
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13. |
Monography Clinical Pharmacological (Copy) |
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III |
OTHERS |
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1. |
Samples in its original package (200 tablet/capsules) |
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2. |
Standard of reference (2 or 3 g) |
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Toc for ecuador, toc formate for dossier
