The batch of drugs that are exported from the port of the exporting country after the expiry date of the certificate of registration of circulation will not be cleared and circulated in Vietnam?
- What are the requirements for drugs circulating on the Vietnamese market?
- Customs clearance procedures for drugs to be exported in Vietnam before the expiry date of the circulation registration permit in Vietnam?
- Guidance of the Drug Administration of Vietnam on the clearance of drug shipments after the expiration date of the registration book?
What are the requirements for drugs circulating on the Vietnamese market?
Pursuant to Article 59 of the 2016 Pharmacy Law stipulates as follows:
“Article 59. Regulations on circulation of drugs and medicinal ingredients
1. Types of drugs and medicinal ingredients circulating on the market include:
a) Drugs and medicinal ingredients that have been granted circulation registration certificates;
b) Imported drugs and medicinal ingredients specified in Clauses 1, 2, 3 and 4, Article 60 of this Law;
c) Drugs specified at Point b, Clause 1, Article 47, Clauses 1 and 2, Article 70, and Clause 3, Article 85 of this Law;
d) Domestically produced drugs and medicinal ingredients may continue to be circulated until their expiry date in case they are manufactured before the expiry date of the circulation registration certificate;
dd) Imported drugs and medicinal ingredients may continue to be circulated until their expiry date in case they are delivered at the port of departure of the exporting country before the expiry date of the certificate of free sale;
e) Drugs, medicinal ingredients that are domestically produced or imported before the date of the registration of free sale are revoked according to the provisions of Article 58 of this Law, except for the cases where the drugs and medicinal ingredients are withdrawn according to the provisions of this Law. prescribed in Article 62 of this Law.
2. Drugs circulating on the market must satisfy the following requirements:
a) Meeting quality standards and ensuring safety and efficiency;
b) Satisfy the requirements on drug labels specified in Article 61 of this Law and other relevant provisions of law;
c) Packaging materials and packing forms must meet requirements for drug quality assurance.
3. Medicinal ingredients circulating on the market must satisfy the following requirements:
a) Meeting quality standards for drug production and ensuring safety and effectiveness;
b) Satisfy the requirements on drug labels as prescribed in Article 61 of this Law and other relevant laws;
c) Packaging materials and packing forms must meet the requirements to ensure the quality of medicinal ingredients.”
Thus, drugs circulating on the Vietnamese market must satisfy the conditions specified above. In case drugs imported into Vietnam are delivered at the port of departure before the expiry date of the circulation registration certificate, they will still be circulated in Vietnam until the expiry date of this drug.
The batch of drugs that are exported from the port of the exporting country after the expiry date of the certificate of registration of circulation will not be cleared and circulated in Vietnam?
Customs clearance procedures for drugs to be exported in Vietnam before the expiry date of the circulation registration permit in Vietnam?
Pursuant to Point dd Clause 2 Article 92 Decree 54/2017/ND-CP (amended by Point a Clause 49 Article 5 Decree 155/2018/ND-CP) stipulates as follows:
“Article 92. Regulations on specialized papers that pharmaceutical business establishments, organizations and individuals need to present and submit when customs clearance for export or import of drugs and medicinal ingredients
...
2. Customs clearance for import of drugs, medicinal ingredients with circulation registration certificates in Vietnam, medicinal ingredients on the list of active ingredients, excipients and semi-finished medicinal products for drug production according to the registered drug registration dossiers. have a certificate of registration for circulation of drugs in Vietnam, except for herbal ingredients:
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dd) In case of importing drugs and medicinal ingredients specified at Point dd, Clause 1, Article 59 of the Law on Pharmacy and not subject to the requirement for an import permit, the importing establishment shall present the bill of lading of the batch of drugs and ingredients. medicinal materials show that the goods are exported from the port of departure of the exporting country before the expiry date of the circulation registration certificate for customs clearance.
Thus, in case the drug is exported at the port of the exporting country before the expiry date of the marketing authorization and does not require an import permit, a bill of lading must be presented showing the batch of drugs being exported. from the port of exporting country before the expiry date of the circulation permit, the customs clearance will be granted.
Guidance of the Drug Administration of Vietnam on the clearance of drug shipments after the expiration date of the registration book?
Pursuant to Official Letter 4876/QLD-KD dated June 9, 2022 issued by the Drug Administration of Vietnam, there are instructions on the clearance of consignments to Vietnam after the expiry date of the Register. In this Official Letter, the Drug Administration of Vietnam made the following comments:
“Point d, Clause 1, Article 59 of the Law on Pharmacy stipulates: “Imported drugs and medicinal ingredients may continue to be circulated until their expiry date in case they are delivered at the port of departure of the exporting country prior to the date of registration for circulation. expires its validity period.”
Point dd, Clause 2, Article 92 of Decree No. 54/2017/ND-CP dated May 8, 2017 as amended and supplemented at Point a, Clause 49, Article 5 of Decree No. 155/2018/ND-CP stipulates: “Schools In case of import of drugs and medicinal ingredients specified at Point dd, Clause 1, Article 59 of the Law on Pharmacy and not subject to an import permit, the importer shall present the bill of lading of the batch of drugs or medicinal ingredients. the goods are exported from the port of departure of the exporting country before the expiry date of the circulation registration certificate in order to be granted customs clearance”.
The batches of FLAMIPIO drugs are mentioned in the Letter No. 0522/VPDD dated May 22, 2022 of the Representative Office of Flamingo Pharmaceuticals limited in Hanoi and Letter No. 42/DHT-XNK dated May 24, 2022 of the Joint Stock Company. Ha Tay Pharmaceuticals are exported from the port of departure of the exporting country on April 15, 2022 after the effective date of the Certificate of Free Sale (April 5, 2022).
Therefore, the above drug batches do not meet the requirements at Point dd, Clause 1, Article 59 of the Law on Pharmacy and point dd, Clause 2, Article 92 of Decree No. 54/2017/ND-CP dated May 8, 2017 as amended and supplemented. supplemented at point a, Clause 49, Article 5 of Decree No. 155/2018/ND-CP for customs clearance and circulation in Vietnam.
The Drug Administration of Vietnam shall notify the establishment to know and comply with current regulations./”
The above are the instructions of the Drug Administration of Vietnam on customs clearance procedures for drug shipments after the expiration date of the registration book. Organizations and individuals pay attention to comply with the law.
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