SUMMARY OF REQUIREMENTS FOR SANITARY REGISTRATION

ACCORDING TO BOLIVIA'S NEW REGULATIONS ISSUED BY THE MINISTRY OF HEALTH, THE SUPPLIER MUST SEND THE DOSSIER CONTAINING THE NEXT DOCUMENTS IN ORDER TO OBTAIN A SANITARY REGISTRATION NUMBER FOR ANY GIVEN MEDICATION OF HUMAN USE:

General documents about the product

ü      Pharmaceutical technical director's certificate (letter that certifies that such person is works for your company)

ü      Good Manufacture Practice Certificate

ü      Pharmaceutical Product Certificate

Technical information of the active ingredient

ü      Photocopy of the certificate of analysis of the raw material

ü      Generic name (DCI)

ü      Chemical name, structural formula, molecular formula, molecular weight.

ü      Physical and chemical characteristics of the active ingredient

ü      Organoleptic characteristics

ü      Routes of synthesis or obtaining of biological products (only for biological products).

ü      Degradation products and impurities 

ü      Active ingredient stability

ü      Analytical methodology

ü      Validation of the Analytical methodology (only when the product does not belong to any pharmacopeias).  

Technical information of the finished product

ü      Physician development of the product

ü      Quali -quantitative  formula

ü      Photocopy of the certificate of analysis of the finished product.

ü      Physiochemical characteristics of the excipients.

ü      Manufacturing methods (summary or flow chart).

ü      Validation of the Analytical method (only when the product does not belong to any pharmacopeias or for new associations). 

ü      Finished product liberation

ü      Storage conditions

ü      Package (can or pack) material characteristics

ü      Batch codification

ü      Secondary Standards of three batches