Do I need to apply for a license to import veterinary drugs for sale? What are the rights and obligations of importers of veterinary drugs in Vietnam?
Do I need to apply for a license to import veterinary drugs for sale?
Article 94 of the 2015 Law on Veterinary Medicine in Vietnam stipulates the requirements for import of veterinary drugs as follows:
Requirements for import of veterinary drugs
Organizations/individuals importing veterinary drugs shall satisfy the following conditions:
1. Satisfy the requirements for trade in veterinary drugs specified in clauses 1, 2 and 3 Article 92 of this Law;
2. Have warehouses satisfactory to the preservation of drugs;
3. Have the Certificate of sale of veterinary drugs in Vietnam or the License to import veterinary drugs according to the regulations;
4. Have documents on quality control and supervision of export/import of each type of drugs;
5. Having the Certificate of eligibility for importing veterinary drugs.
Thus, according to the above regulations, one of the requirements for individuals and organizations to import veterinary drugs is to have a Certificate of sale of veterinary drugs in Vietnam or the License to import veterinary drugs. Therefore, individuals and organizations that want to import veterinary drugs for sale must apply for one of the two papers above.
Do I need to apply for a license to import veterinary drugs for sale? What are the rights and obligations of importers of veterinary drugs in Vietnam? (Image from the internet)
What are the procedures for granting, re-granting, revocation of the Certificate of eligibility for importing veterinary drugs in Vietnam?
Pursuant to Article 98 of the 2015 Law on Veterinary Medicine in Vietnam, the procedures for granting, re-granting, revocation of the Certificate of eligibility for importing veterinary drugs are as follows:
Procedures for granting, re-granting, revocation of the Certificate of eligibility for importing veterinary drugs
1. An application for the Certificate of eligibility for importing veterinary drugs shall include:
a) An application form;
b) A detailed description of facilities of the establishment;
c) The Certificate of Enterprise registration or the Certificate of Business registration;
d) The veterinary practice certificate.
2. Procedures for granting of the Certificate of eligibility for importing veterinary drugs:
a) Organizations/individuals wishing to import veterinary drugs shall submit the application for the Certificate of eligibility for importing veterinary drugs to Department of Animal Health;
b) Within 10 days from the day on which the satisfactory application is received, Department of Animal Health shall conduct an inspection on site. If the establishment satisfies the requirements, within 03 working days from the day on which the inspection finishes, Department of Animal Health shall grant the Certificate of eligibility for importing veterinary drugs. If the application is rejected, a written response containing the explanation shall be made.
3. Documents and procedures for re-granting of the Certificate of eligibility for importing veterinary drugs in case the Certificate is lost, incorrect or damaged or the information about registered organization/individual is adjusted:
a) An application for re-granting shall include an application form; documents proving the adjusted contents, applicable to the case information relating to registered organization/individual is adjusted; The Certificate of eligibility for importing veterinary drugs that is granted, unless it is lost;
b) Organizations/individuals shall submit the application for re-granting of the Certificate of eligibility for importing veterinary drugs to Department of Animal Health. Within 05 working days from the day on which the satisfactory application is received, Department of Animal Health shall regrant the Certificate of eligibility for importing veterinary drugs. If the application is rejected, a written response containing the explanation shall be made.
4. Department of Animal Health shall revoke the Certificate of eligibility for importing veterinary drugs of an organization/individual importing veterinary drugs in any of the following cases:
a) The Certificate of eligibility for importing veterinary drugs is erased or adjusted;
b) The organization/individual commits violations against the legislation and incurs administrative penalties for at least three times a year or incurs administrative violations for 3 constant times for the same violation in the field of import of veterinary drug;
c) The organization/individual no longer performs the import of veterinary drugs;
d) The organization/individual commits another violation that is regulated to have the Certificate of eligibility for importing veterinary drugs revoked.
Thus, the procedures for granting of the Certificate of eligibility for importing veterinary drugs:
Step 1: Submit the application for the Certificate of eligibility for importing veterinary drugs to Department of Animal Health;
Step 2: Within 10 days from the day on which the satisfactory application is received, Department of Animal Health shall conduct an inspection on site.
Step 3: If the establishment satisfies the requirements, within 03 working days from the day on which the inspection finishes, Department of Animal Health shall grant the Certificate of eligibility for importing veterinary drugs. If the application is rejected, a written response containing the explanation shall be made.
What are the rights and obligations of importers of veterinary drugs in Vietnam?
Article 95 of the 2015 Law on Veterinary Medicine in Vietnam stipulates the rights and obligations of importers of veterinary drugs as follows:
- Rights of organizations/individuals importing veterinary drugs:
+ Organizations/individuals importing veterinary drugs shall be legally protected in terms of trademark;
+ Organizations/individuals importing veterinary drugs may make complaints and/or denunciation according to the law provisions;
+ Organizations/individuals importing veterinary drugs shall be provided with compensation for the damage according to the law provisions;
+ Other rights according to the relevant law provisions.
- Obligations of organizations/individuals importing veterinary drugs:
+ Provide the import documents according to the registered contents;
+ Comply with the regulations on conditions of preservation of drugs;
+ Provide conformable drugs according to the register contents;
+ Retain the documents relating to each batch of veterinary drugs for at least 06 months from the day on which such drugs expire;
+ Bear the management and supervision of regulatory agencies; provide sufficient documents relating to the harvest of specimens and inspection on request;
+ Pay the cost for the handling and compensate the damage from the violations against the law provisions on import of veterinary drugs according to the law provisions.
LawNet
