Import Procedures For Pharmaceutical Materials

Import Procedures For Pharmaceutical Materials

 

Concept of pharmaceutical raw materials 

(Article 1, Clause 1, Decree No. 88/2023/NĐ-CP issued on December 11, 2023)

Pharmaceutical materials include active ingredients, excipients, capsule shells, semi-finished drug, and semi-finished herbal products without a Certificate of Registration for circulation to manufacture drugs according to the drug registration dossier that has been granted circulation in Vietnam and published on the Electronic Information Page of the licensing authority according to Form No. 46 in Appendix III issued with this Decree within 15 days from the date of issuance, renewal of the Certificate of Registration for circulation of drugs in Vietnam. Pharmaceutical raw materials listed in the published List are imported without the need for an import license, except for pharmaceutical materials subject to special control.”

Legal basis

  • Official Letter No. 6068/TCHQ-GSQL issued on September 16, 2020: Strengthening inspection of imported drugs, pharmaceutical materials.
  • Circular No. 39/2018/TT-BTC issued on April 20, 2018: Amendments to circular no. 38/2015/TT-BTC, dated March 25, 2015 dated March 25, 2015, On customs procedures, customs supervision and inspection, export duty, import duty, and tax administration applied to exports and imports.

Import procedures for pharmaceutical materials

Customs Declaration Registration

Customs authorities only register customs declaration for items such as drugs and pharmaceutical materials when they have been granted registration numbers for circulation by the Ministry of Health and the import license is still valid.

Customs Dossier

– Customs declaration according to the prescribed information in Form No. 01 in Appendix II issued with Circular No. 39/2018/TT-BYT.

– Bill of lading or other valid transport documents for goods transported by sea, air, rail, or multimodal transport according to legal regulations.

– Value declaration form.

– Certificate of origin of goods according to the regulations of the Minister of Finance on determining the origin of exported and imported goods.

– Entrusted Import Contract: 01 certified copy for cases of entrusted importation of items requiring an import license, specialized inspection certificate, or documents proving that the importing entity meets the conditions for importing goods according to investment laws, laws on inspection management, laws on foreign trade management that the Entrusters  uses the license or confirmation documents of the entruster.

– Commercial invoice from the entity supplying pharmaceutical materials according to the regulations in Article 91, Clause 15 of Decree No. 54/2017/NĐ-CP (amended and supplemented by Decree No. 155/2018/NĐ-CP): 01 certified copy.

– Commercial contract signed with the entity supplying pharmaceutical materials according to the regulations in Article 91, Clause 15 of Decree No. 54/2017/NĐ-CP (amended and supplemented by Decree No. 155/2018/NĐ-CP): 01 certified copy.

– Business license of the importing entity applying for an import license: 01 certified copy.

– Certificate of registration of import rights for cases where the entity supplying pharmaceutical materials is a foreign trader not present in Vietnam, authorizing an agent to perform customs procedures or a representative of the foreign trader in Vietnam whose name is on the Certificate of registration of export rights, import rights, performing import procedures: 01 certified copy.

– Import dossier for drugs according to the regulations in Article 92 of Decree No. 54/2017/NĐ-CP dated May 8, 2017, of the Government detailing a number of articles and measures for the implementation of the Drug Law (amended and supplemented by Decree No. 155/2018/NĐ-CP dated November 12, 2018, of the Government), as follows:

  1. a) For drugs, pharmaceutical materials with a registration certificate for circulation in Vietnam, pharmaceutical materials belonging to the list of active ingredients, excipients, semi-finished pharmaceutical products for drug production according to the drug registration dossier that has been granted circulation in Vietnam, except for herbal materials specified in Clause 2 of Article 92 of Decree No. 54/2017/NĐ-CP (amended and supplemented by Decree No. 155/2018/NĐ-CP), specifically:

“a) Presenting the original or a certified copy and submitting a copy with the confirmation stamp of the importing establishment’s Certificate of business conditions for pharmaceuticals for cases where the importing establishment is a pharmaceutical business;

  1. b) Submitting a certified copy with the confirmation stamp of the Import establishment and presenting the original or a certified copy for comparison in the case of importing drugs subject to special control;
  2. c) Submitting the original or a certified copy of the Test Report for each batch of imported drugs, pharmaceutical materials with the stamp of the importing establishment; in the case of a certified copy, the original must be presented for comparison during customs clearance;
  3. d) Submitting a certified copy with the confirmation stamp of the importing establishment for the authorization letter or sales permit or certificate of partner relations specified in point d of Clause 2 of Article 92 for supportive drugs, humanitarian aid;

đ) In the case of importing drugs, pharmaceutical raw materials specified in point d of Clause 1 of Article 59 of the Drug Law and not falling into cases requiring an import license, the importing establishment presents the transport document for the batch of drugs, pharmaceutical raw materials, indicating that the goods were exported from the departure port of the exporting country before the expiration date of the valid circulation registration certificate to be cleared.”

  1. b) For herbal materials, semi-finished herbal products with a registration certificate for circulation or without a registration certificate for circulation in Vietnam, following the regulations in Clause 3 of Article 92 of Decree No. 54/2017/NĐ-CP (amended and supplemented by Decree No. 155/2018/NĐ-CP), specifically:

“a) Submitting a certified copy with the confirmation stamp of the importing establishment and presenting the original or a certified copy the Certificate of business conditions for pharmaceuticals for cases where the importing establishment is a pharmaceutical business;

  1. b) For herbal materials, semi-finished herbal products with a circulation registration certificate in Vietnam, submitting a certified copy of the circulation registration certificate with the stamp of the importing establishment and presenting the original or a certified copy for comparison;
  2. c) For herbal materials, semi-finished herbal products without a circulation registration certificate in Vietnam, submitting a certified copy with the confirmation stamp of the importing establishment for herbal materials and presenting the original or a certified copy for comparison;
  3. d) A certified copy with the stamp of the importing establishment of the authorization letter of the manufacturing establishment for herbal materials, semi-finished herbal products for the foreign drug supplier, except in cases where the manufacturing facility is the supplying facility. The authorization letter shall be made according to the regulations in point d of Clause 15 of this Decree;

đ) Submitting the original or a certified copy of the Test Report of the manufacturing establishment for each batch of imported herbal materials, semi-finished herbal products with the stamp of the importing establishment; in the case of a certified copy, the original must be presented for comparison during customs clearance;

  1. e) In the case of importing herbal materials, semi-finished herbal products specified in point d of Clause 1 of Article 59 of the Drug Law and not falling into cases requiring an import license, the importing establishment presents the transport document for the batch of herbal materials, semi-finished herbal products, indicating that the goods were exported from the departure port of the exporting country before the expiration date of the valid circulation registration certificate to be cleared;
  2. g) For herbal materials, semi-finished herbal products imported according to the regulations in Article 82 and Article 83 of this Decree, no requirement to submit the documents specified in points b, d, đ, and e of this Clause.
  3. h) In the case of importing herbal materials, sem-finished herbal products specified in point d of Clause 1 of Article 59 of the Drug Law and falling into cases requiring an import license, the importing establishment presents the transport document for the batch of herbal materials, semi-finished herbal products, indicating that the goods were exported from the departure port of the exporting country before the expiration date of the valid circulation registration certificate and import license to be cleared.
  4. i) In the case of importing herbal materials, semi-finished herbal products according to the import license without a valid circulation registration certificate in Vietnam and at the time of customs clearance, the importing establishment presents the transport document for the batch of herbal materials, semi-finished herbal products, indicating that the goods were exported from the departure port of the exporting country before the expiration date of the import license to be cleared.”
  5. c) For drugs, pharmaceutical materials without a valid circulation registration certificate in Vietnam, except for herbal materials specified in Clause 4 of Article 92 of Decree No. 54/2017/NĐ-CP (amended and supplemented by Decree No. 155/2018/NĐ-CP), specifically:

“a) Presenting the original or a certified copy with authentication and submitting a certified copy with the confirmation stamp of the importing establishment for pharmaceuticals for cases where the importing establishment is a pharmaceutical business;

  1. b) Submitting a certified copy with the confirmation stamp of the importing establishment for drugs, pharmaceutical materials and presenting the original or a certified copy with authentication for comparison;
  2. c) Submitting the original or a certified copy with the confirmation stamp of the importing establishment of Test Report for each batch of drugs, pharmaceutical materials imported as specified in point c of Clause 4 of Article 92 in the case of importing drugs according to the regulations in point a, b of Clause 1 of Article 72.;
  3. d) Submitting a certified copy of the prescription, outpatient treatment record with authentication or the signature of the entry person or a certified copy with the seal of the importing organization for the quantity of imported drugs falling into one of the following cases:

Not exceeding the maximum usage for 07 days for addictive drugs or 10 days for psychotropic drugs, precursor drugs as prescribed in the prescription accompanying;

Imported drugs that are not addictive drugs, psychotropic drugs, precursor drugs, with a total customs value not exceeding 200 (two hundred) US dollars (calculated at the interbank exchange rate at the time of customs clearance) once, and the maximum number of drug receipts is not more than 03 times in 01 year for 01 organization, individual. In the case of drugs used for patients with diseases listed in the List of extremely difficult socio-economic conditions specified in Decree No. 134/2016/NĐ-CP dated September 1, 2016, of the Government detailing a number of articles and measures for the implementation of the Law on export tax, import tax, drugs with a total customs value not exceeding 10,000,000 (ten million) dong once, and the maximum number of drug receipts is not more than 04 times in 01 year for 01 individual.

In the case of submitting a certified copy with the signature of the entry person or a certified copy with the seal of the importing organization, the original prescription, outpatient treatment record must be presented for comparison during customs clearance.

đ) Submitting a certified copy with the confirmation stamp of the importing establishment for the authorization letter or sales permit or certificate of partner relations specified in

  1. e) In the case of importing pharmaceutical materials according to the import license without a valid circulation registration certificate in Vietnam and at the time of customs clearance, the importing establishment presents the transport document for the batch of pharmaceutical materials, indicating that the goods were exported from the departure port of the exporting country before the expiration date of the import license to be cleared.”

 

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