Table Of Contents (TOC) for COLOMBIA

COLOMBIA

Authority

Insitituto National de salude

Instituto Nacional de Vigilancia de Medicamentos y Alimentos

website

www.ins.gov.co/ ,    http://web.invima.gov.co/

if any

DOSSIER REQUIRMENTS

S.No.

Content Of The Common Parts

Page No.:

PART-I. TECHNICAL REQUIREMENTS

1.

It forms pharmacist and commercial presentation; specifying the container material and parking. -------------------------------------------------------------------

2.

Formula quali-quantitative of the product, expressing the active (with their generic name) principles and the same thing separately for the formulation assistants. ---------------------------------------------------------------------------------

3.

Formula of the standardized lot of production. -------------------------------------

4.

Description of the  process of production. -------------------------------------------

5.

Specifications of quality of active ingredients with certificate of analysis and Excipients monographs and specifications with certificate of analysis of Excipients and other inputs of the production process. ----------------------------

6.

Control carried out to the product during the production process.----------------

7.

Specifications of quality for the finished product. ----------------------------------

8.

Technique (s) of analysis of the product (if it corresponds one of the official pharmacopeias, it will be enough with indicating it, otherwise, to the procedure the documentation will be annexed that checks the respective validation. --------------------------------------------------------------------------------

9.

Protocol of stability according to the nature of the pharmacy and pharmaceutical form of the origin country and it copies from the study to Area IV (natural Aging) resolution 2514-.-------------------------------------------

10.

Period of validity of the product and storage conditions. --------------------------

11.

It copies for copy from the materials of primary and secondary acondicionamiento to color. -----------------------------------------------------------

12.

Pharmacological information the most complete and detailed thing possible, to attach copy of clinical studies yes they are had, and/or Bibliography. -------

13.

Countries where at the moment it is marketed. -------------------------------------

14.

Sale certificate free of the origin country. -------------------------------------------

15.

Certificate of quality for products object of international trade, sent by the sanitary authority of the country exporter, according to model promulgated by the world organization of the health  (OMS). ---------------------------------------

16.

Certificate of good practices of factory, where it points out THAT HAS SPECIAL AREAS FOR THE PRODUCTION OF ONCOLOGICAL. ---------

17.

Studies of Bioavailability. -------------------------------------------------------------

PART-II. LEGAL REQUIREMENTS.

1.

Certificate of Existence and Legal Representation of the manufacturing Company. --------------------------------------------------------------------------------

2.

Free sales certificate in the origin containing the complete quali - quantitative formula. -----------------------------------------------------------------------------------

3.

Certificate of Free Sale sent by sanitary authority of the origin country in which consists that the product is sold freely in this country. ---------------------

4.

Certificate of B.P.M. of the manufacturing Laboratory, sent by sanitary authority. (For production of oncological should clarify special area). ----------

5.

Authorization of the maker to the importer to care, to distribute, to market and to be the holder of the Sanitary Registration, of the product, in the Republic of Colombia. --------------------------------------------------------------------------------