Can a drug that does not have a certificate of free sale in Vietnam but contains an active ingredient that was medicinally used in Vietnam be licensed for import?
- Can a drug that does not have a certificate of free sale in Vietnam but contains an active ingredient that was medicinally used in Vietnam be licensed for import?
- Application for a license to import a drug that does not have a certificate of free sale in Vietnam but contains an active ingredient that was medicinally used in Vietnam?
- What are the procedures for licensing import of a drug that does not have a certificate of free sale in Vietnam but contains an active ingredient that was medicinally used in Vietnam?
Can a drug that does not have a certificate of free sale in Vietnam but contains an active ingredient that was medicinally used in Vietnam be licensed for import?
Pursuant to Point b, Clause 2, Article 60 of the 2016 Law on Pharmacy in Vietnam stipulating as follows:
Drugs/medicinal ingredients permitted for import and export
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2. 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:
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b) 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;
Thus, a drug that does not have a certificate of free sale in Vietnam but contains an active ingredient that was medicinally used in Vietnam but the quantity not sufficient for treatment shall not be licensed for import.
More specifically, according to Clause 1, Article 66 of Decree No. 54/2017/ND-CP stipulating as follows:
Requirements and application for licensing import of drugs containing active ingredients that already have the certificate of drug registration in Vietnam but are not available in sufficient quantity and drugs containing herbal ingredients that have already been used in Vietnam but are not available in sufficient quantity
1. The import of such a drug shall only be licensed when the following requirements are satisfied:
a) The drug is on the list of drugs not available in sufficient quantity published by the Minister of Health;
b) The drug is licensed in one of the following countries: the manufacturing country, a reference country that is a member state of the ICH or Australia.
Thus, a drug that does not have a certificate of free sale in Vietnam but contains an active ingredient that was medicinally used in Vietnam but the quantity not sufficient for treatment shall be licensed for import when meeting the following requirements:
- The drug is on the list of drugs not available in sufficient quantity published by the Minister of Health;
- The drug is licensed in one of the following countries: the manufacturing country, a reference country that is a member state of the ICH or Australia.
Can a drug that does not have a certificate of free sale in Vietnam but contains an active ingredient that was medicinally used in Vietnam be licensed for import?
Application for a license to import a drug that does not have a certificate of free sale in Vietnam but contains an active ingredient that was medicinally used in Vietnam?
Pursuant to Clause 2, Article 66 of Decree No. 54/2017/ND-CP (amended by Clause 36, Article 5 of Decree No. 155/2018/ND-CP) on the application for a license to import a drug that does not have a certificate of free sale in Vietnam but contains an active ingredient that was medicinally used in Vietnam but the quantity not sufficient for treatment:
- 03 copies of the purchase order according to Form No. 15, 16 or 17 in Appendix III enclosed with Decree No. 54/2017/ND-CP;
- The original copy or a certified true copy of the certificate of pharmaceutical product;
- Quality documents according to the regulations of the Minister of Health on the use of ASEAN Common Technical Dossier (ACTD) in drug registration or quality standards and results of bioequivalence study according to clause 7, Article 76 of Decree No. 54/2017/ND-CP.
- The original of 01 set of samples of the label and package insert from the drug production country or the exporting country, unless both of them or the summary of product characteristics are attached to the Certificate of Pharmaceutical Product.
- 02 sets of specimens of the labels intended to be used in Vietnam and the package insert in Vietnamese language which bear the importer’s seal;
- Clinical document if required by the regulations of the Minister of Health on drug registration.
Documents specified in this point are not required to be submitted in cases where the drug has been licensed for import according to the regulations in this Article and no changes have been made to the information about the indication, dosage and user.
- Regarding a traditional drug that contains an herbal ingredient that has been used in Vietnam as a medicinal ingredient, it is required to have a clinical document proving its safety and efficacy according to Article 89 of the Law on Pharmacy and documents proving the traditional concoction or combination method.
What are the procedures for licensing import of a drug that does not have a certificate of free sale in Vietnam but contains an active ingredient that was medicinally used in Vietnam?
Pursuant to Clause 1, Article 77 of Decree No. 54/2017/ND-CP (amended by Point a, Clause 43, Article 5 of Decree No. 155/2018/ND-CP), the procedures for licensing import of a drug that does not have a certificate of free sale in Vietnam but contains an active ingredient that was medicinally used in Vietnam are carried out as follows:
- The applicant shall submit an application to the Ministry of Health directly or by post;
- After receiving the application, the Ministry of Health shall give the applicant form No. 01 in Appendix I enclosed herewith;
- If the application is satisfactory, the Ministry of Health shall issue the import license within 60 days if clinical documents and documents proving equivalence to reference biologicals are not required, or within 90 days if clinical documents and documents proving equivalence to reference biological are required. The import license shall be issued on the basis of counsel given by the certification advisory council;
- If the application is not satisfactory, the Ministry of Health shall request the applicant in writing to complete it within 60 days if clinical documents and documents proving equivalence to reference biological are not required, or within 90 days if clinical documents and documents proving equivalence to reference biologicals are required;
- After receiving the supplemented application, the Ministry of Health shall give the applicant form No. 01 in Appendix I enclosed herewith. If the application is still unsatisfactory, the Ministry of Health shall request the applicant to complete it in accordance with Point d this Article. If the supplemented application is satisfactory, the Ministry of Health shall issue the import license in accordance with Point c Clause 1 Article 77 of Decree No. 54/2017/ND-CP;
- Within 06 months from the day on which additional documents are requested in writing by the Ministry of Health, the applicant shall submit additional documents as requested. If the applicant fails to satisfy such request by the aforementioned deadline or the application is not satisfactory within 12 months from the first time it is submitted, it will be rejected;
- In cases where drugs imported for provision of humanitarian medical services are approved by the competent authority and the documents specified in Points d, dd, e, g, h, i, clause 2, Article 72 of Decree No. 54/2017/ND-CP are not mentioned but the drugs are essential for the disease treatment, the Minister of Health shall consider approving the application on the basis of counsel given by the certification advisory council.
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