How much is the fine for importing drugs without the import license or certificate of registration in Vietnam?
- What are the regulations on management of import of drugs without the certificate of drug registration in Vietnam?
- Drugs that do not have a certificate of free sale in Vietnam are allowed to be imported into Vietnam?
- How much is the fine for importing drugs without the import license or certificate of registration in Vietnam?
What are the regulations on management of import of drugs without the certificate of drug registration in Vietnam?
Pursuant to Article 78 of Decree No. 54/2017/ND-CP (some provisions have been annulled by Clause 43, Article 4 of Decree No. 155/2018/ND-CP and amended by Point a, Clause 44, Article 5 of Decree No. 155/2018/ND-CP), imported drugs without the certificate of drug registration in Vietnam must comply with the following regulations:
- The drug that contains an active ingredient that is not granted the certificate of drug registration or a herbal ingredient that is used in Vietnam for the first time or a drug licensed for import according to Article 65 and Article 69 of Decree No. 54/2017/ND-CP may only be supplied for health facilities.
- As for drugs used for emergency treatment and poison control, and vaccines used in some special cases with limited amounts and other drugs licensed for import according to Clause 1b and 1c, Article 68 of Decree No. 54/2017/ND-CP:
+ These drugs may only be supplied for health facilities and vaccination centers that wish to import them. The health facility or vaccination center shall inform the users, patients or their relatives of information about the drugs licensed for import without adequate legal and technical documents. The drug may only be used with the consent of the user, patient or patient’s relative.
+ The importer, health facility or vaccination center mentioned in Point a of this Clause may sell these drugs to other health facilities and vaccination centers. The buyer shall have adequate documents specified in Clause 3c and Clause 3d Article 68 hereof and take the responsibility specified in Point a of this Clause.
+ The regulations in clause 4, Article 103 of the Law on Pharmacy are not required to be implemented. The importer of drugs requiring cold or deep freezing storage shall retain the data sheets which record the storage conditions (cold chain) during the transport process of imported batch of drugs (bearing the seal of the importer). Such storage conditions are recorded by using the temperature data logger and from the freeze indicator (if any).
- Before being launch, a batch of drug that has the same trade name, active ingredients, concentration/content and dosage form as those of a proprietary drug having the certificate of drug registration in Vietnam, is manufactured by the same manufacturer of the proprietary drug or by an authorized manufacturer and is sold at a lower price than that of the proprietary drug sold in Vietnam specified in Article 70 of Decree No. 54/2017/ND-CP shall undergo quality inspection by an authority specialized in testing drugs and medicinal ingredients according to quality standards applied to proprietary drugs having the certificate of registration in Vietnam.
- Drugs licensed for import to serve health programs of the State, clinical trial, research or testing shall be used for intended purposes.
- Controlled drugs that are licensed for import to serve provision of humanitarian medical services and are not completely used shall be re-exported in accordance with Clause 5 Article 60 of Decree No. 54/2017/ND-CP and must not be used for any other purpose.
- Drugs licensed for import to be displayed at a medical, pharmaceutical or medical device fair according to Article 74 of Decree No. 54/2017/ND-CP shall be completely re-exported after the fair is ended and must not be used or sold in Vietnam.
- The applicant for permission for non-commercial import of drugs according to Article 75 of Decree No. 54/2017/ND-CP is responsible for their origin and quality.
How much is the fine for importing drugs without the import license or certificate of registration in Vietnam?
Drugs that do not have a certificate of free sale in Vietnam are allowed to be imported into Vietnam?
Pursuant to Clause 2, Article 60 of the 2016 Law on Pharmacy, a drug that does not have a certificate of free sale in Vietnam shall be licensed for import with a quantity not exceeding that written on the import license in the following cases:
- It contains an active ingredient that is not granted certificate of free sale or granted a certificate of free sale but the quantity is not sufficient for treatment;
- It contains an active ingredient that is medicinally used in Vietnam for the first time or was medicinally used in Vietnam but the quantity not sufficient for treatment;
- It serves purposes related to national defense and security, prevention and elimination of epidemics, disaster recovery, or need for special treatment;
- It is a rare drug;
- It has the same trade name, active ingredients, concentrations, dosage form as a original brand name drug which is granted a certificate of free sale in Vietnam, manufactured by the same manufacturer of the original brand name drug or an authorized manufacturer, and its price is lower than that of the original brand name drug being sold in Vietnam at the request of the Minister of Health;
- It serves a health program of the State;
- It serves as humanitarian aid;
- It is used for clinical trial, bioequivalence study, bioavailability assessment, as a sample for registration, testing, scientific research, or display at a fair or exhibition;
- It is used for other non-commercial purposes.
How much is the fine for importing drugs without the import license or certificate of registration in Vietnam?
Pursuant to Point c, Clause 5, Article 60 of Decree No. 117/2020/ND-CP:
Violations against regulations on import and export of drugs and medicinal ingredients
...
5. A fine ranging from VND 70.000.000 to VND 80.000.000 shall be imposed for commission of one of the following violations:
...
c) Importing drugs/pharmaceutical starting materials without the import license or certificate of registration, except drugs/pharmaceutical starting materials which are not required to be registered or do not require the import license;
Thus, importing drugs/pharmaceutical starting materials without the import license or certificate of registration, except drugs/pharmaceutical starting materials which are not required to be registered or do not require the import license shall be fined from VND 70.000.000 to VND 80.000.000.
Note: The above fine is imposed upon individuals. For organizations, it is equal to 02 times the fine imposed upon individuals (Clause 5, Article 4 of Decree No. 117/2020/ND-CP).
Nguyễn Thị Hồng Nhung