Professional Documents
Culture Documents
Regulations &
Requirements
Agenda
Viceministerio de
Salud y Promocin
Direccin General
de Servicios de
Salud
INLASA
CONCAMYT
UNIMED
rea de Suministro
y Uso Racional
rea de Evaluacin
y Registro
rea de Vigilancia
y Control
Comisin
Farmacolgica
Comisin
Nacional del
Sistema Nacional
de
Farmacovigilancia
Applicable Regulations
1996
Drugs Law
Law 1737
1998
Regulation for
Drug Law
D.S. 25235
and National
Pharmacology
Comitte R.M
0138
2003 National
Drug Policy RM0034; National
system for
Control and
Surveillance
Drugs R.M. 0250 and
Guidelines for
Vaccines
Registration
R.M. 0512
2004-Regulation
for Clinical
Studies R.M.
0834
2005
Guidelines for
Sanitary
RegistrationR.M. 0909
Generics Drugs
Brand Name Drugs
Homeopathic Drugs
Plants, animal and mineral source.
Special, biologic, blood, dietary, dental and radio pharmaceuticals
products
Vaccines and biologics
Cosmetics
Medical Devices
Reagents for diagnostic and clinical laboratory
No mutual recognition agreements for drugs registration process with
external agencies.
Bolivia - Regulatory
landscape (I)
Regulation:
Dossier
Bolivia Regulatory
Enviroment (II)
New Products
2 Steps for
NCE/Biological/Vaccines
Manufacturing site
changes (PNS)
Requirements: Quality
dossier / CPP / GMP/Samples
Samples
Renewals
Bolivia Regulatory
Landscape (III)
Post Approval Changes:
The following process can be change within the same license:
Shelf life extension
QQFMfg QQ Composition Change
LEN Changes
Packaging Site Change Secondary packaging
Packaging Component Change
Additional Presentation
SOS
Regulatory:
(La Paz Bolivia)
Legal Representative
(Santa Cruz Bolivia)
Build
Dossier
Dispatch
BoH Bolivia
(La Paz)
Dossier
permanece en
Santa Cruz por 5
das
2
days
PCO
Documents
1 day
Signature
Signature
1 day
Reception
Submission
Renewal :
4-6 months
Phase I : 2-4months
Phase II : 9- 12 months
PCO Documents
Local Form N 007
Local Form N 019
No CMC Documents
ClinicalStudies
No clinica Studies
Ancilliary Document
Approval Country of Origin
Worldwide Registration Status
References
PCO Documents:
Local Form N 005
Local Form N 007
Local Certifications
CPP
From manufacturing source country
Embassy Legalization
Expiration date: 2 years.
LoA :
Expiration date: 1 year
QQF :
Must present in detail the drug substances (salts and their corresponding
bases), excipients, sweeteners, colorants, preservatives, flavoring agents,
etc. The function of each component must be specified.
CoA :
Specification must be aligned to reference pharmacopeia.
Reference procedure, expiration date and manufacturing date is required.
Regulation detail mandatory tests for each dosage form.
Three consecutive batches
Stability:
If the stability data is not signed by the responsible, a cover letter is
required.
Topics Requirements:
Samples
Labels and Leaflet Samples
Physical Sample is required.
Two samples are required (Part 1 and
Part 2)
Artwork Mock is also submitted.
Product Sample
NCE : Must be labeled using the
artworks approved in the country of