Transcript Slide 1

MANAGEMENT OF VETERINARY DRUGS
IN VIETNAM
Dr. Nguyen Cong Dan
Department of Animal Health (DAH)
Ministry of Agriculture and Rural Development (MARD)
CONTENTS
1. Background.
2. Structure of veterinary system in Vietnam.
3. Key legislation on veterinary drugs
management/administration.
4. Registration of veterinary drugs and vaccines.
5. System of veterinary drugs distribution.
6. Quality management system of vet drugs and vaccines.
I. Background
Map of Vietnam
1.1 Introduction
• Located in South-East Asian with extremely long borders to
China, Laos and Cambodia.
• Total area: 330,000 square kilometres
• Population: 85.79 million (~ 60.42 million live in rural areas
- GSO, 2009).
• Has seven agro-ecological regions.
• Divided into 63 provinces and cities.
• Warm and humid climate.
• An average yearly rainfall: ~ 1,600 to 2,500 mm, from April to
October.
• Two main seasons in the year: monthly temperature ranges
between 16 oC – 25 oC in winter and 28 oC – 36 oC in summer.
• Average monthly humidity: 80-88 % all year round except in
the South.
Livestock Production in 2009
Name of Animals
Number (million)
• Pig
27.3
• Poultry (chicken, duck)
285
• Cattle (cow, buffalo)
9.2 (115.000 dairy)
• There were 20,000 livestock farms and 10 millions farmer
households involved in livestock (small scale)
• Value of animal products shared 30 % of total agriculture
production
Important Diseases in Livestock Production
• Avian Influenza (AI; especially HPAI)
• Porcine Reproductive and Respiratory Syndrome (PRRS)
• Food and Mouth Disease (FMD)
• Estimation cost of veterinary drugs used in livestock
production accounted for:
- For pig:
1.45 % of production costs
- For poultry:
3.15 % of production costs
- For dairy:
0.66% of production costs
Aquaculture Production in 2009
Aquaculture species
Area (ha)
Production (tonne)
• Mekong river catfish
6,500
1,200,000
(Pangasius hypothalmus)
• Brackish water shrimp
330,000
380,000
750,000
1,100,000
(P. monodon, P. vannamei)
• Carps and tilapias
• Marine fish (cage culture
on the sea)
100,000
Total: 2,400,000 tonnes (fish), 380,000 tonnes (shrimp),
sharing 52 % of total fish production (capture and aquaculture)
Important Diseases in Aquaculture
• In Mekong river catfish: Liver and kidney white spot disease
(Edwardsilla ictaluri)
• In brackish water shrimp: White spot disease, Yellow head
disease, Taura syndrome
• In carps and tilapias:
Haemorrhagic disease, Epizootic
ulcerative syndrome and Saprolenosis
• Marine fish and lobster: Viral nervous necrosis (VNN)
Lobster milky disease.
• Lost due to diseases: 3 – 5 % of total aquaculture production.
• Chemicals/drugs used in aquaculture: 2 % of production costs
1.2. Veterinary drug production in Vietnam
• 2008: 90 local & 197 foreign veterinary drug companies,
manufacturing and trading around 6,676 different kinds of
veterinary products.
• Among 6,676 veterinary products:
 4,886 products produced by Vietnamese enterprises;
 1,790 products registered by foreign companies from 35
countries around the world. (see Table 2).
•
Drugs manufactured outside imported into Vietnam,
includes:
- Premixes and
- Materials used in the manufacture of veterinary drugs
and feed additive as well as finished products.
1.2. Veterinary drug production in Vietnam
(cont)
- Micro-organisms may also be imported for vaccine
production. In addition, registration is required for
products bought in bulk and repackaged into smaller
containers.
• Department of Animal Health [DAH] under MARD:
government agency directly managing the registration,
import and circulation of veterinary drugs and vaccines in
Vietnam.
Table 2
Domestic produced
Year
Total
Imported
Number of Number of
Number of Number of
Total
Total
producers Re-packagers
producer countries
Restricted
use
2007 6,423 4,671
87
12
1,752
190
35
16
2008 6,676 4,886
90
13
1,790
197
35
16
Trend + 253 +215
+3
+1
+ 38
+7
-
-
1.3. Top companies
• National Veterinary Company (Navetco)
• Veterinary Medicine Import Export Joint Stock Company
(Vemedim)
• Bio-Pharmachemie Joint Venture Company Limited
• Anova Joint Venture Company Limited
• Minh Dung Veterinary-Aquaculture Medicine Company
Ltd
• Pharmaceutical and Veterinary Material Company
(Hanvet)
• Virbac Vietnam Company Limited
• Bayer Vietnam Company Limited.
II. Structure of Veterinary System in
Vietnam
2.1. Structure of Veterinary Services
Figure 1
MINISTRY OF AGRICULTURE
AND RURAL DEVELOPMENT
National Institute of
Veterinary Research
Regional Animal Health
Offices (RAHOs)
 No. 1
 No. 2
 No. 3
 No. 4
 No. 5
 No. 6
 No. 7
DEPARTMENT OF ANIMAL HEALTH
Functional Divisions:
- Personnel and Administration
- Epidemiology (Terrestrial)
- Aquatic Animal Health
- Inspection & Quarantine
- Drug & Vaccine Management
- Legislation & Inspection
- Plan (Inter. Cooperation & Sciences)
- Finance
Veterinary Drug and
Vaccine Company
Professional Centers
The National Center
for Vet. Diagnosis
 The National Centers
for Examination of
Vet. Drugs and
Vaccines No. 1, 2
Provincial Sub-Departments of Animal Health
Regional Sub
Departments of
Animal Quarantine
and Inspection in
Lang Son, Lao Cai
and Quang Ninh
District Veterinary
Stations
Communal Veterinary
Team
Domestic Inspection
Stations
 The National Centers
for Vet. Hygiene
Inspection No.1, 2
2.2. Main Duties of DAH regard to
Drug & Vaccine Management
•
•
•
•
•
•
•
•
Assessment of registration dossiers. Provide free sell
certificate (market authorisation);
Preparation of “List of veterinary drugs licensed to be
produced in, exported from, imported into, circulated and
used in Vietnam”;
Authorisation of veterinary products for use in field trials;
Control of local production, trading, import-export of
veterinary drugs and vaccines;
Setting procedures on management of veterinary drugs
and vaccines in Vietnam;
Formulation and implementation of veterinary legislation;
Setting additional national technical standards for
veterinary drugs and vaccines;
Dealing with complaints about veterinary drugs and
vaccines.
2.3. Main Duties of National Centre for Examination
of Veterinary drugs and Vaccines (NCEVDV)
•
Analysis of veterinary products and imported materials for
both registration and quality control;
•
Supervision and implementing the field trial process of
veterinary drug and vaccines;
•
Setting additional National Technical Standards for
analysis of veterinary drugs and vaccines.
•
Maintenance of reference strains of virus and bacteria.
III. Key legislation on veterinary drug
management
• Veterinary Ordinance 18/2004/PL-UBTVQH11 promulgated
on 29 April 2004 by National Assembly of The Socialist
Republic of Vietnam.
•
Government Decree 33/2005/ND-CP dated 15 March 2005
stipulating implementation of a numbers of articles of the
Veterinary Ordinance 18/2004/PL-UBTVQH11.
• Decision No 51/2009/TT-BNNPTNT dated 21 August 2009 of
MARD regulating on Veterinary Hygiene Conditions for
Veterinary Drug Production and Trading Enterprises.
• Decision No 03 /2009/TT-BNN dated 14/01/2009 of
MARD regulating “Labeling of Veterinary Products”
• Decision No 10/2006/QD-BNN dated 10 February 2006 of
MARD regulating “ Procedures for Production,
Registration, Import and Circulation of Veterinary Drugs,
Materials for Veterinary Drug Production, Biological
Products (pro-biotics), Micro-organisms and Chemicals”.
• Decision No 71/ 2007/QĐ-BNN dated 06 August 2007 of
MARD regulating “Procedures for Laboratory Test and
Field Trial of Veterinary Drug and Vaccines”.
• Decision No 72/ 2007/QĐ-BNN of MARD dated 06
August 2007 regulating “Procedures for Quality Control
of Vet. Drugs, Vaccines, Biological Products (pro-biotics)
and Chemicals”.
The following lists are issued annually
by MARD:
• List of Veterinary drugs permitted for circulation in
Vietnam.
• List of veterinary vaccines, biological products (pro-biotics),
microorganisms, chemicals permitted for circulation in
Vietnam.
• List of prohibited and restricted veterinary drugs in Vietnam
IV. Registration of Veterinary Drugs
According to Decision No 10/2006/QĐ-BNN
of MARD dated 10 February 2006,
registration of all veterinary products as
follow:
Local manufacturers
i.
The production plant must firstly be registered and
certificated.
ii.
A registration dossier, come with the application form for
sample permit should be submitted to DAH
iii.
Samples of products should be sent to the National Centre
for Examination of Veterinary Drugs for analysis.
iv.
When the results of this analysis are known and the
dossier assessed, then consideration can be made for
approval.
Foreign manufacturers
• Brief guidelines are available to applicants on the
requirements for registration.
•
Follows step ii, iii, iv as mentioned above
The Committee of Science and Technology under the DAH
deals with registration matters in general and with specific
points on individual products.
• Criteria for approval

Quality

Safety

Efficacy

Stable of product
Veterinary Drug Registration Certificate
•
The certificate of registration is issued and attached to
this is a list of products that may be produced or imported
in accordance with the registration dossier.
•
The certificates must be signed by the Director of DAH
and validated for two years from the date of issue and for
five years with the re-registration.
Requirements for Registration dossiers
• Apply for the permission to manufacture (or circulation in
case of import drug)
• Name of product;
• Formula (name and amount of active ingredients);
• Summary of product characteristics (SPC);
•
•
•
•
Dosage determination procedure (in case of new drugs);
Labeling and packaging;
Report of pharmacokinetics research (in case of new drugs);
Residual substances
• Report of field trials (in case of new drugs);
Registration dossiers (cont)
• Report of pharmacodynamics (in case of new drugs);
• Toxicology (in case of new drugs);
• Certificate of sample analysis of (NCEVDV);
• Certificate of analysis of manufacturer
• Raw material specification and control method in-process
control;
• Manufacturing process;
• Finished product specification and control method;
• Quality and analytical method;
• Safety & efficacy;
Registration dossiers (cont)
•
Stability studies and report;
•
Withdraw time;
•
•
Storage condition;
Name and address of manufacturer;
In case of imported drug registration should have:
•
Free sale certificate (FSC or MA) from the country of
origin
•
Certificate of analysis (CA);
•
GMP certificate from the country of origin;
•
The appointment letter from manufacturer.
Re-registration
• The registers should carry our re-registration after two years.
• A re-registration dossier, consist of: Application, copy of
certificates and report of circulating process of the product
(for the second re-registration). The certificates of reregistration are validated for five years.
• Registration fee:
- First registration: 700.000 VND
- Re-registration: 350.000 VND
V. System of veterinary drug
distribution
Authority to issue Certificates of eligibility
for trading of Veterinary Drugs:
1. DAH is responsible for:
• Inspecting vet. hygiene conditions and
• Issuing certificates for trading, storage and
transportation of veterinary drugs at the national
level; foreign joint ventures.
2. SDAH's are responsible for:
• Inspecting vet. hygiene conditions and
• Issuing certificates for local organisations and
individuals who register for local trading, storage
and transportation of veterinary drugs.
• A system/network of veterinary drug trading stores has been
established in all 63 provinces in Vietnam.
• In average, there are 50-65 vet. drug shops in a province.
• This system, so far, has met increasing demands in
veterinary drugs for prevention and control of animal and
poultry diseases in the country.
• People who own a veterinary drug shop or engage in trading
of such products must be trained and have a license in
veterinary drug trading.
• Parallel to the above system, a chain of direct supply of
veterinary drugs from factories to farms has been formed to
meet the demand of the commercialized farming system.
• This chain of supply is based on contracting agreement
between drug producers and farmers. With a contract, vet.
drug producers deliver their products directly at site.
VI. Quality management system
The Quality management system of vet drugs
The First: MARD
 Manage a sectoral system of vet. drugs and vaccines quality
control from central (DAH) to local (Provincial Subdepartment of Animal Health –Sub DAH) level
 Supply the fund to set up national technical standards
 Decide to apply Vietnam and international technical standards
for quality control of vet. drugs and vaccines, for example
standard of safety and efficacy and potency test evaluation,
ISO, GMP…
 Approve the annual plant for sampling vet drugs and vaccines
for quality control of DAH and supply the fund for analysis
samples.
The second : DAH
 Assessment of registration dossiers for approval
 Post-market surveillance assay (drugs and vaccines)
 Consultation of veterinary drug development and quality
control.
 Establishing and implementing the annual plan for sampling
vet. drugs and vaccines for the purposes of quality control.
 Establishing and implementing the annual plan for
inspection and monitoring of establishments producing
veterinary drugs, import-export veterinary drugs and
vaccines in Vietnam.
 Directing two National Centre for Examination of
Veterinary Drugs and Vaccines to receive and analyzing
sample of vet. drugs and vaccines for quality control.
 Dealing with complaints about the quality of veterinary
drugs and vaccines.
The third: SDAH
• Provincial Sub-department of Animal Health (SDAH)
responsible for inspection activities and monitoring the drug
and vaccines shops in their area.
• Inspection activities cover a sampling to check quality,
monitoring veterinary hygiene conditions and the use of
veterinary drugs with particular attention paid to the use of
antibiotics and chemical. Special inspection schedule is
worked out for prohibited and non-approved vet drugs…
• National Centre for Examination of Veterinary Drugs and
Vaccines carry out analysis all samples sent by SDAH and
report results to DAH.
Application of GMP in Vietnam
•
At the present, there are 08 veterinary drugs making
establishments complying with GMP standards.
•
According to Decision No 08 dated 30/3/2004 of MARD,
at the end of 2012, all veterinary drugs making
establishments in Vietnam must fully comply with GMP
standards.
Thank you
for your attention
!