Table Of Contents (TOC) for ECUADOR

ECUADOR

Authority

ministerio de salud publica del Ecuador

website

www.msp.gov.ec/ 

if any

DOSSIER REQUIRMENTS

S.No.:

INDEX

Page No.

I

LEGAL DOCUMENTS

1.

Free Sale Certificate

2.

GMP certificate issued by the relevant health authorities, in original, updated and legalized.

3.

Legalized authorization/power of attorney from manufacturer.

II

TECHNICAL DOCUMENTS

1.

Composition Formula: C omplete Qualitative-quantitative formula.

2.

Interpretation of the Batch code (original).

3.

Stability studies chemical and/or microbiological (original)

4.

Certificate of Analysis of quality control of the batch sent (original signed)

5.

Standard Certificate of Analysis (original signed by Technician)

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.

7.

Specifications on finished product (original )

8.

Specifications of the prime materials (original)

9.

Specifications on materials sued for bottling and packaging (original )

10.

Description of the manufacturing procedure (original)

11.

Justification of the composition formula (original)

12.

Format/Design of external and internal side of labels (original)

13.

Monography Clinical Pharmacological  (Copy)

III

OTHERS

1.

Samples in its original package (200 tablet/capsules)

2.

Standard of reference (2 or 3 g)