Bolivia

Regulations &
Requirements

Agenda

Structure: Unidad de Medicamentos y Tecnologas en Salud

(UNIMED)
Applicable Regulations
Legal classification of medicinal products
Bolivia Regulatory Landscape
Submission Process
Topics Requirements: Phase I (Aval)
Topics Requirements: Phase II (Registration) or Renewal
Questions/Answers Bolivia

Structure : UNIMED (Resol. Min. N 447)

Ministerio de Salud

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

Legal classification of medicinal

products

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:

Governmental Priorities : Low prices/National Pharmaceutical Industry.

Marketing Authorization Holder is the manufacturer (bulk).

Resolutions can be used by different companies (LoA).

No specific regulation for bio similar products are available.

Importation must be approved by BoH for each batch.

Pharmacology Committe : Clinical/No Clinical Evaluation

References Countries: US and EMA

Dossier

Paper dossier is required. Clinical/No clinical information can be acceptable in CD.

CTD format is acceptable. No translation required

Several local forms is required.

Quality Control Activities:

Bolivia has PAHO recognition for Local Lab testing - INLASA

Local Testing Activities

Bolivia Regulatory
Enviroment (II)
New Products
2 Steps for
NCE/Biological/Vaccines

Manufacturing site
changes (PNS)

1 Phase: AVAL (Safety and

efficacy)

New Sanitary Registration

2 Phase: Quality / CPP /

GMP /Samples

Requirements: Quality
dossier / CPP / GMP/Samples

Approval Timelines: 912months

Approval Timelines: 69months

After approval a Local testing

must be performed (BoH
schedule prior renewal)

Submission: Two Parts / Two

Copies

Submission: Two Parts 8

copies
Samples

Samples

Renewals

Must be submitted 6 months

prior expiration until 1
month of license expired
Approval Timelines: 4months
Results of local testing must
be included
Submission: Two Parts / Two
Copies
Samples

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

Submission Process (I)

Lifecycle/
Regional
Growth

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

Submission Process (II)

Renewal :
4-6 months

Phase I : 2-4months

Phase II : 9- 12 months

Topics Requirements: Phase

I (Aval)

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

Topics Requirements: Phase

II (Registration) or Renewal
(I)
Submission consist in two parts

Part I : For UNIMED Evaluation

Part II: For CONCAMYT

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

Topics Requirements: Phase

II (Registration) or Renewal
(II)
CMC Documents

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.

Timepoints: 0, 3, 6, 9, 12, 18, 24, 36, 48, 60

3.2.R DP Cold Chain Transport Qualification (When applicable)

Letter signed by quality responsible to describe the expiration date format.

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

Questions and Answers