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Name Importation of drugs and medicinal ingredients without the certificate of registration in Vietnam other than herbal ingredients
DescriptionA copy of the Certificate of eligibility for pharmacy business which bears the importer’s seal if the importer is a pharmacy business establishment (the original copy or certified true copy shall be produced for comparison)
CommentsA copy of the import license bearing the importer’s seal (the original copy or a certified true copy shall be produced for comparison); c) The original copy or a copy bearing the importer’s seal of the testing certificate of each batch of imported drug or medicinal ingredient in case of import of any of the drugs and medicinal ingredients specified in Articles 65, 66, 69, 71, 72, 79, 80, 84, 85, 86 and Clause 1a and Clause 1c Article 68 hereof (the original copy must be produced for comparison if a copy is submitted); d) Copies of the prescription and outpatient's medical record which is authenticated or bears the applicant’s signature (if the applicant is an individual) or seal (if the applicant is an organization) in any of the following cases: The quantity of drugs to be imported does not exceed 07 days’ dose for narcotic drugs or 10 days’ dose for psychotropic drugs and precursors according to the prescription; The drug is not a narcotic drug, psychotropic drug or precursor, the total customs value of a shipment does not exceed USD 200 according to the inter-bank exchange rate on the customs clearance date and not more than 03 shipments are received by an organization or individual in a year. If the drug is used for treatment of a disease on the list of fatal diseases in the Government's Decree No. 134/2016/ND-CP the customs value of a shipment must not exceed VND 10,000,000 and not more than 04 shipments are received by an individual in a year. The original copies the prescription and outpatient's medical record shall be produced upon customs clearance for comparison with the copies submitted. dd) A copy bearing the importer’s seal of the authorization letter or the seller’s license or certificate of partnership according to Clause 15dd Article 91 hereof, except for import of drugs specified in Articles 67, 70, 73 and Clause 1 of Article 74 hereof, primary packages of drugs, reference materials, medicinal ingredients granted the import license according to Articles 82, 83, 86 hereof and controlled medicinal ingredients that are imported for testing or research.
Validity From01-07-2017
Validity To31-12-9999
Reference
Technical Code
AgencyMinistry of Health
Created Date2018-01-18 09:57:26
Updated Date2018-01-18 10:00:05
StatusInactive
Measure TypeLicensing Requirement
Legal/RegulationDecree 54/2017/ND-CP dated May 08, 2017, guidelines for implementation of the Law on Pharmacy
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