New: Division of generic drug contract package in bidding for supply of drugs for public health facilities in Vietnam

According to Article 7 of Circular No. 15/2019/TT-BYT of the Ministry of Health of Vietnam, a generic drug contract package may contain one or several generic drugs; each list of generic drugs must be sorted by category; each generic drug in each category is one part of the contract package. A contract package of generic drugs is divided into 5 categories and based on technical criteria as follows:

1. Category 1 includes drugs satisfying one of the three following criteria:

- Drugs manufactured entirely by a manufacturing line satisfying EU-GMP requirements or equivalent requirements in a country that is considered SRA;

- Drugs on the list of proprietary drugs or reference biological announced by Ministry of Health, except for proprietary drugs on the list of drugs eligible for price negotiation issued by Ministry of Health and with announced price negotiation results;

- Drugs manufactured entirely in Vietnam and satisfy all following requirements:

+ Drugs manufactured by a manufacturing line satisfying EU-GMP requirements or equivalent requirements and certified by drug authority of Vietnam to satisfy EU-GMP requirements or equivalent requirements;

+ Drugs granted certificates of free sale by the national drug authority of a country that is considered SRA as specified in Clause 8 Article 50 of this Circular;

+ Drugs sold in Vietnam and drugs granted certificates of free sale by a country that is considered SRA shall have the same dosage form, production process, quality criterion, verification method; active ingredients, excipients shall have the same quality criterion, production facility and production place as specified in Clause 8 Article 50 of this Circular.

2. Category 2 includes drugs satisfying one of the two following criteria:

- Drugs manufactured entirely by a manufacturing line satisfying EU-GMP requirements or equivalent requirements and granted certificates by the drug authority of Vietnam.

- Drugs manufactured entirely by a manufacturing line in a country that is a member state of PIC/s and ICH, satisfying PIC/s-GMP requirements and granted certificates by the national drug authority of such country and the drug authority of Vietnam.

3. Category 3 includes drugs manufactured by a manufacturing line satisfying GMP requirements and granted certificates by the drug authority of Vietnam and having evidence of bioequivalence announced by the drug authority of Vietnam.

4. Category 4 includes drugs manufactured entirely by a manufacturing line in Vietnam satisfying WHO-GMP requirements and granted certificates by the drug authority of Vietnam.

5. Category 5 includes drugs manufactured by a manufacturing line satisfying WHO-GMP requirements and granted certificates by the drug authority of Vietnam and not included in provisions specified in Clauses 1, 2, 3 and 4 of this Article.

Other provisions can be found in Circular No. 15/2019/TT-BYT of the Ministry of Health of Vietnam, which takes effect from October 01, 2019.

Thu Ba

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