Công văn 6068/TCHQ-GSQL năm 2020 về tăng cường kiểm tra thuốc, nguyên liệu làm thuốc nhập khẩu do Tổng cục Hải quan ban hành

To: Provincial Customs Departments.

During the collection of information on import of goods that are drugs and medicinal ingredients, there are still difficulties arising when following customs procedures. In order to manage these imports in accordance with regulations and laws, pursuant to the Law on Customs and its guiding documents, and the Government's Decree No. 54/2017/ND-CP dated May 08, 2017 providing guidelines for implementation of the Law on Pharmacy (as amended in the Government’s Decree No. 155/2018/ND-CP dated November 12, 2018), when carrying out customs procedures, Provincial Customs Departments are requested to pay attention to the following inspection contents:

1. Registration of customs declarations.

Customs authorities shall only accept registration of customs declarations of drugs and medicinal ingredients that have been granted registration numbers by the Ministry of Health or are imported under an unexpired import license.

2. Customs dossier.

In addition to the documents prescribed in Article 16 of the Circular No. 38/2015/TT-BTC (as amended in the Circular No. 39/2018/TT-BTC), the declarant is required to submit the following documents to the customs authority:

2.1. The commercial invoice issued by the supplier of drugs/medicinal ingredients as prescribed in Clause 15 Article 91 of Decree No. 54/2017/ND-CP (as amended in Decree No. 155/2018/ND-CP): 01 photocopy;

2.2. The commercial contract signed with the supplier of drugs/medicinal ingredients as prescribed in Clause 15 Article 91 of Decree No. 54/2017/ND-CP (as amended in Decree No. 155/2018/ND-CP): 01 photocopy;

2.3. The business license as prescribed in Decree No. 09/2018/ND-CP if the importer is a FDI enterprise: 01 photocopy;

2.4. Certificate of registration of right to export or import if the supplier of drugs/medicinal ingredients that is a foreign trader without a commercial presence in Vietnam authorizes a customs brokerage agent or its representative in Vietnam whose name is specified in the certificate of registration of right to export or import to follow import procedures: 01 photocopy;

2.5. Documents for import of drugs as prescribed in Article 92 of Decree No. 54/2017/ND-CP (as amended in Decree No. 155/2018/ND-CP). To be specific:

a) Regarding import of drugs/medicinal ingredients having the certificate of registration in Vietnam, medicinal ingredients included in the list of active ingredients, excipients, medicinal semi-finished products used for drug production having the certificate of registration in Vietnam, except for herbal ingredients, the import documents shall comply with the provisions in Clause 2 Article 92 of Decree No. 54/2017/ND-CP (as amended in Decree No. 155/2018/ND-CP), including:

 “a) A copy bearing the importer’s seal of the certificate of eligibility for pharmacy business if the importer is a pharmacy business establishment (the original copy or certified true copy shall be presented for verification purpose);

b) A copy of the import license bearing the importer’s seal in case of import of controlled drugs (the original copy or certified true copy shall be presented for verification purpose);

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; the original copy must be presented for verification purpose if a copy is submitted;

d) A copy bearing the importer’s seal of the authorization letter or the seller’s license or certificate of partnership according to Point d Clause 2 Article 92, in case of import of drugs as emergency aid or humanitarian aid;

dd) In case of import of a drug or medicinal ingredient specified in Point dd Clause 1 Article 59 of the Law on Pharmacy, which does not require the import license, the importer shall present the bill of lading proving that the shipment is sent from the exporting country’s port before the expiration date of the certificate of registration.”

b) Regarding import of herbal ingredients and semi-finished herbal ingredients, regardless of availability of the certificate of registration in Vietnam, the import documents shall comply with the provisions in Clause 3 Article 92 of Decree No. 54/2017/ND-CP (as amended in Decree No. 155/2018/ND-CP), including:

 “a) A copy bearing the importer’s seal of the certificate of eligibility for pharmacy business if the importer is a pharmacy business establishment (the original copy or certified true copy shall be presented for verification purpose);

b) Regarding herbal ingredients and semi-finished herbal ingredients having the certificate of registration in Vietnam, a copy of the certificate of registration bearing the importer’s seal (the original copy or certified true copy shall be presented for verification purpose);

c) Regarding herbal ingredients and semi-finished herbal ingredients without the certificate of registration in Vietnam, a copy bearing the importer’s seal of the license to import herbal ingredients (the original copy or certified true copy shall be presented for verification purpose);

d) A copy bearing the importer’s seal of the manufacturer’s document authorizing the foreign exporter to export herbal ingredients, unless the manufacturer is also the exporter. The content of such document is specified in Point dd Clause 15 Article 91 of this Decree;

dd) The original copy or a copy bearing the importer’s seal of the testing certificate of each batch of the imported herbal ingredient or semi-finished herbal ingredients; the original copy must be presented for verification purpose if a copy is submitted;

e) In case of import of a herbal ingredient or semi-finished herbal ingredient mentioned in Point dd Clause 1 Article 59 of the Law on Pharmacy, which does not require the import license, the bill of lading proving that the shipment is sent from the exporting country’s port before the expiration date of the certificate of registration;

g) In case of import of herbal ingredients and semi-finished herbal ingredients specified in Article 82 and Article 83 of this Decree, the documents specified in Points b, d, dd and e of this Clause are not required.

h) In case of import of a herbal ingredient or semi-finished herbal ingredient mentioned in Point dd Clause 1 Article 59 of the Law on Pharmacy, which requires the import license, the bill of lading proving that the shipment is sent from the exporting country’s port before the expiration date of the certificate of registration and the import license.

i) In case of import of a herbal ingredient or semi-finished herbal ingredient which is not granted the certificate of registration in Vietnam under the import license which has been expired when following customs clearance procedures, the bill of lading proving that the shipment is sent from the exporting country’s port before the expiration date of the import license.”

c) Regarding import of drugs and medicinal ingredients without the certificate of registration in Vietnam other than herbal ingredients, the import documents shall comply with the provisions in Clause 4 Article 92 of Decree No. 54/2017/ND-CP (as amended in Decree No. 155/2018/ND-CP), including:

 “a) A copy bearing the importer’s seal of the certificate of eligibility for pharmacy business if the importer is a pharmacy business establishment (the original copy or certified true copy shall be presented for verification purpose);

b) A copy bearing the importer’s seal of the import license (the original copy or certified true copy shall be presented for verification purpose);

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 as prescribed in Point c Clause 4 Article 92 in case of import of the drugs specified in Points a, b Clause 1 Article 72.;

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 (two hundred) 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 dated September 01, 2016,  the customs value of a shipment must not exceed VND 10.000.000 (ten million) and not more than 04 shipments are received by an individual in a year.

The original copies of the prescription and outpatient's medical record shall be presented with the copies submitted upon customs clearance for verification purpose.

dd) A copy bearing the importer’s seal of the authorization letter or the seller’s license or certificate of partnership according to Point dd Clause 4 Article 92, in case of import of drugs as prescribed in Articles 68, 72, controlled medicinal ingredients which are imported for production of exported drugs as prescribed in Article 80, and medicinal ingredients as prescribed in Articles 84 and 85.

e) In case of import of a drug or medicinal ingredient which is not granted the certificate of registration in Vietnam under the import license which has been expired when following customs clearance procedures, the bill of lading proving that the shipment is sent from the exporting country’s port before the expiration date of the import license.”

3. Detailed inspection of customs dossier.

Customs officials shall carry out detailed inspection of customs dossier in accordance with the provisions in the Circular No. 38/2015/TT-BTC (as amended in the Circular No. 39/2018/TT-BTC) and guidelines in Article 7 of the customs procedures for commercial imports and exports enclosed with the Decision No. 1966/QD-TCHQ dated July 10, 2016 of the General Department of Customs, check the validity and compare the information on the documents submitted by the declarant according to Point 2 hereof with other documents included in the customs dossier with paying attention to the following contents:

3.1. Check whether the exporter on the documents included in the customs dossier is the supplier of drugs/medicinal ingredients as prescribed in Clause 15 Article 91 of Decree No. 54/2017/ND-CP (as amended in Point dd Clause 48 Article 5 of Decree No. 155/2018/ND-CP). To be specific:

 “The supplier of drugs/medicinal ingredients is a foreign supplier that is allowed to sign a contract with the importer. The supplier of drugs/medicinal ingredients has to be either:

a) The manufacturer of the drug or medicinal ingredient to be imported;

b) The owner of the product or holder of the certificate of free sale of the drug or active ingredient written on the certificate of pharmaceutical product, whether or not the drug is granted the certificate of registration in Vietnam in accordance with the Law on Pharmacy;

c) The applicant for registration of the drug or medicinal ingredient having the certificate of drug registration in Vietnam which is unexpired when following customs clearance procedures other than the entities mentioned in Point a and Point b of this Clause;

d) An establishment granted the license to trade in drugs, medicinal ingredients, vaccines, biologicals or ingredients thereof in Vietnam;

dd) If the supplier is an entity prescribed in Point c, d or h of this Clause, it is required to be authorized in writing by the entity mentioned in Point a or b of this Clause to supply drugs in Vietnam, unless the entity prescribed in Point d or h of this Clause is also the one prescribed in Point a or b of this Clause.

The authorization document may be an authorization letter, seller’s license or certificate of partnership. The authorization document shall be written in Vietnamese or English and contain: name and address of the authorizing party and authorized party; scope of supply of drugs/medicinal ingredients in Vietnam; authorization period; responsibilities of the parties for quality and origins of drugs/medicinal ingredients supplied in Vietnam; signatures of the parties;

e) Regulations of this Clause do not apply to suppliers of imported drugs specified in Article 67, 73 and Clause 1 Article 74 of this Decree.

g) Regulations of Point dd of this Clause do not apply to suppliers of imported drugs specified in Article 68 and 70 of this Decree;

h) An entity that is announced as prescribed in Clause 22 of this Article;”

3.2. Check whether the name of drug, ingredients and package contents specified in the customs declaration match with those in the certificate of registration/ import license, authorization letter or testing certificate of the manufacturer.

3.3. Inspect the remaining shelf life of imported drugs/medicinal ingredients when following customs clearance procedures in accordance with the provisions in Article 90 of Decree No. 54/2017/ND-CP. To be specific:

 “1. The minimum remaining shelf life of imported modern drugs, herbal drugs, traditional drugs, medicinal ingredients other than those specified in Clause 3 of this Article when customs clearance is granted:

a) 18 month if the official shelf life is longer than 24 months;

b) 1/2 of the official shelf life if it does not exceed 24 months.

2. The minimum remaining shelf life of imported vaccines and biologicals other than those specified in Clause 3 of this Article when customs clearance is granted is 1/2 of the official shelf life.

3. Imported drugs/medicinal ingredients specified in Articles 67, 73, 74, 75, 82, 83, 84, 85, 86 and Point b Clause 1 Article 68 hereof must be unexpired when customs clearance is granted.

4. The Minister of Health shall consider permitting import of drugs/medicinal ingredients whose remaining shelf life is shorter than those specified in Clause 1 or Clause 2 of this Article but they are essential for production, prevention and treatment of diseases.”

3.4. Inspect the testing certificate which must comply with the provisions in Clause 14 Article 91 of Decree No. 54/2017/ND-CP. To be specific:

 “a) The testing certificate shall be written in Vietnamese or English language. If it is written in a language other than Vietnamese or English language, a notarized Vietnamese or English translation shall be included;

b) If a batch is manufactured by more than 02 facilities or more, it is required to have the testing certificate of the final manufacturing, packaging or releasing facility;

c) The testing certificate shall contain: Administrative information (including name and address of the manufacturing facility, testing certificate number, name and signature of the responsible person, date of issue of the testing certificate) and information on drug or medicinal ingredient (including product name, batch number, shelf life, applied quality standards, criteria and requirements, testing results and conclusion).”

3.5. Inspect information on the validity of the certificate of registration/import license. Any changes in the certificate of registration/import license must be conformable with written certifications issued by the Drug Administration of Vietnam (if any). If the certificate of registration or import license expires as prescribed, the customs declaration shall be cancelled and handled in accordance with regulations and laws.

4. Physical inspection of goods (for customs declarations classified in red lane)

The physical inspection shall be carried out in accordance with the provisions in the Circular No. 38/2015/TT-BTC (as amended in the Circular No. 39/2018/TT-BTC) and guidelines in Article 8 of the customs procedures for commercial imports and exports enclosed with the Decision No. 1966/QD-TCHQ dated July 10, 2016 of the General Department of Customs, with paying attention to the following contents:

4.1. Inspect name of the drug/medicinal ingredient, ingredients and packaging contents which must match with those specified in the customs declarations and the package insert in Vietnamese language of the product.

4.2. Inspect the name and address of the manufacturing facility which must match with those specified in the certificate of registration and the package insert in Vietnamese language of the product.

4.3. Inspect the shelf life specified in the product's package which must comply with the provisions in Point 3.3 hereof.

5. Drugs/medicinal ingredients shall be only imported through international checkpoints, except for non-commercial import of drugs as prescribed in Clause 7 Article 91 of Decree No. 54/2017/ND-CP.

6. Further actions after inspection result is given:

6.1. If the inspection result indicates that the shipment of imported drugs/medicinal ingredients complies with the regulations of the Law on customs and the Law on pharmacy, customs procedures shall be continued as prescribed;

6.2. If the inspection result indicates that the shipment of imported drugs/medicinal ingredients does not comply with the regulations of the Law on customs and the Law on pharmacy, the shipment shall be handled in accordance with regulations.

Pursuant to the regulations referred herein, Provincial Customs Departments are requested to review and take actions against violations, and reorganize the performance of customs procedures; the Post-clearance Inspection Department is assigned to conduct assessment and post-clearance inspection of importers suspected of committing violations.

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This document is handled by Luật Dương Gia. Document reference purposes only. Any comments, please send to email: dichvu@luatduonggia.vn