Table Of Contents (TOC) for VENEZUELA

VENEZUELA

Authority

ministerio de salud y Desarrollo social

website

www.msds.gov.ve

if any

DOSSIER REQUIRMENTS

S.No.:

INDEX

Page.No.:

1

CPP.  Certified of Pharmaceutical Product including:

the complete quali-quantitative formula--------------------------------------- 

2

10 samples of the finish product as it is sold in the origin country, including the pack, etc----------------------------------------------------------------------------

3

Certificate of analysis of the finish product (of the samples you send) including all the specifications and analysis. The methods must inlcude the specifications--------------------------------------------------------------------------

4

Complete method of analysis of the finish product and raw material (only active ingredient), including the bibliografy-------------------------------------

5

Complete quali-quantitative formula including all the raw materials of the product and the cap or the coated, etc--------------------------------------------

6

Sample of the active ingredient (secondary standard) with its certificate of analysis compared with a reference standard when it is necessary, depending of the method of analysis. 3 samples in small bottles (the Ministery doesn´t acept bags) ------------------------------------------------------

7

Certificate of analysis of the active ingredient you used to manufacture the samples of the product you send----------------------------------------------------

8

Specifications of all the raw material, including the specifications of all the components that doesn´t remain in the final product:  alcohol, nitrogen, solvents, etc----------------------------------------------------------------------------

9

Method of manufacturing of the product including the equipments, size batch, industrial formula, in process controls, all the manufacturing instructions, precautions and warnings during the manufacturing process, packing, etc.----------------------------------------------------------------------------

10

Protocol for stability studies including stability data: ---------------------------

11

Dissolution studies including methods of analysis, apparatus and results. The dissolution protocol must be compared with777666 the original product.  If you include graphic, much better. This protocol must be done to 12 tablets or capsules------------------------------------------------------------------------------

12

Pharmacological data including method of action, pharmacokinetics, excretion, distribution, toxicology, indications, contraindications, adverse effects, precautions, warnings, drugs interactions, recommended dosage,  indications for administration--------------------------------------------------------

13

Bioequivalence for some products, such as controlled release, anti neoplastics and others. I will tell you when we need bioequivalence----------