MANAGEMENT OF VETERINARY DRUGS IN VIETNAM
I.System of veterinary authority agencies
1.Department of Animal Health under the Ministry of Agriculture and Rural Development, government agency directly managing the registration, import and circulation of veterinary drugs and vaccines in Vietnam
2.Veterinary divisions affiliated to Services of Agriculture and Rural development of provinces (hereinafter referred to as provincial veterinary authorities);
3.Veterinary stations of districts, city affiliated to provinces and equivalent administrative units (hereinafter referred to as veterinary authorities of districts).
II. General provisions on management of veterinary drugs
1.Veterinary drug shall undergo quality management according to the technical standards.
2.Veterinary drugs satisfying the requirements for quality according to the technical standards shall be granted marketing authorizations of veterinary drugs in Vietnam.
3.The Minister of Agriculture and Rural development shall promulgate:
a) The technical standards for veterinary drugs
b) The List of veterinary drugs permissible for sale in Vietnam
c) List of prohibited and restricted veterinary drugs in Vietnam
d) Regulations on label, documents about field trials, production, trade, import and sale of veterinary drugs.
4.The Government shall detail the requirements for productions, trade, import, analysis and field trial of veterinary drugs.
III. Registration for sale of veterinary drugs
1.Any organization/individual producing or importing veterinary drugs shall register with Department of Animal Health for sale in any of the following cases:
a) Such veterinary drugs are newly produced in Vietnam;
b) Such veterinary drugs are initially imported into Vietnam for trading and producing.
2.An application for marketing authorizations of veterinary drugs shall include:
a) An application form
b) Technical documents, sample of the label of drug;
c) Reports on results of the analysis of product quality made by manufacturer; results of the testing of quality of veterinary drugs made by a laboratory in Vietnam that is appointed; results of the field trials of the effect and safeness of veterinary drugs, applicable to drugs subject to trial;
d) The GMP Certificates or the Certificate of eligibility for producing veterinary drugs or the Certificate of eligibility for importing veterinary drugs; the marketing authorizations of veterinary drugs granted by a competent agency of the producing country, applicable to imported drugs.
3.Procedures for the granting of the marketing authorizations of veterinary drugs:
a) Organizations/individuals shall submit the application to Department of Animal Health.
b) Within 06 months from the day on which the satisfactory application is received, Department of Animal Health shall examine the documents and grant the marketing authorizations of veterinary drugs; if the application is rejected, Department of Animal Health shall make a written response containing the explanation.
4.Effective duration of a marketing authorization of a veterinary drug is 05 years.
Note: 03 months before the expiration of the marketing authorizations of veterinary drugs, organizations/individuals wishing to extend the effect of the marketing authorizations shall submit the application for extension.
IV.Requirements for production of veterinary drugs
a) Having the certificate of enterprise registration.
b) Location, workshops, drug warehouses shall be designed with area and distance ensuring the safety for human, animals and the environmental protection.
c) Provided with equipment appropriate to the scale of production and quality inspection of each type of veterinary drug.
d) There is a quality control room for veterinary medicinal products.
e) Sewage treatment system shall be equipped according to veterinary hygiene standards and the law provisions on environmental protection.
f) People who directly manage the production, quality control of veterinary drugs shall have a veterinary practice certificate about manufacturing and testing of veterinary medicinal products.
h) Having the Certificate of eligibility for producing veterinary drugs.
Requirements for manufacturers of veterinary drugs in form of medicinal products or vaccines
Each manufacturer of veterinary drugs in form of medicinal products or vaccines must apply the GMP guidelines of Association of South East Asian Nations ASEAN – GMP or WHO – GMP or a GMP at least equivalent to ASEAN – GMP.
Entitlements to inspect and issue certificates
– Department of Animal Health shall receive applications for GMP inspection, establish inspection team, carry out inspections and issue GMP certificates to satisfactory facilities.
– A GMP certificate is valid for a period of 2 years from the date of issue.
Note: 03 months before the GMP certificate expires, the manufacturing facility must make and send 03 packages of application for GMP reinspection to Department of Animal Health.
V. Requirements for import of veterinary drugs
Organizations/individuals importing veterinary drugs shall satisfy the following conditions:
- There is adequate all requirements for trade in veterinary drugs;
- There is a warehouse that has adequate all requirements to preserve of drugs;
- Having the marketing authorizations of veterinary drugs in Vietnam or the License to import veterinary drugs according to the regulations;
- Having documents on quality control and follow up release/ receipt of each product;
- Having the Certificate of eligibility for importing veterinary drugs.