Chapter II
DIVISION OF CONTRACT PACKAGES AND DRUGS
Article 7. Generic drug contract package
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:
a) Drugs manufactured entirely by a manufacturing line satisfying EU-GMP requirements or equivalent requirements in a country that is considered SRA;
b) 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;
c) 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:
a) Drugs manufactured entirely by a manufacturing line satisfying EU-GMP requirements or equivalent requirements and granted certificates by the drug authority of Vietnam.
b) 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.
Article 8. Contract package of proprietary drugs or equivalent drugs
1. Heads of health facilities shall make decision on procurement of proprietary drugs or equivalent drugs or reference biological on the basis of suggestions of Drug and Treatment Council.
2. A contract package of proprietary drugs or equivalent drugs may contain one or several proprietary drugs or equivalent drugs or reference biological, each drug is one part of the contract package. Drugs bidding for a contract package of proprietary drugs or equivalent drugs shall include drugs satisfying the two following criteria:
a) Drugs on the list of proprietary drugs or equivalent drugs and 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;
b) Drugs manufactured entirely in countries considered SRA, unless the health facility requests for evidence of proprietary drugs or reference biological marketing for the first time in countries not considered SRA or having at least one manufacturing stage in Vietnam
Article 9. Contract package of herbal drugs and traditional drugs (excluding traditional ingredients)
A contract package of herbal drugs and traditional drugs may contain one or several herbal and traditional drugs; each list of drugs must be sorted by category; each drug in each category is one part of the contract package. The contract package of herbal drugs and traditional drugs is divided into 3 categories and based on technical criteria as follows:
1. Category 1 includes drugs satisfying the two following criteria:
a) Drugs manufactured entirely from herbal ingredients planted and collected or naturally farmed satisfying GACP requirements and granted certificates by Ministry of Health of Vietnam;
b) Drugs manufactured entirely by a manufacturing line in Vietnam satisfying GMP requirements of herbal drugs and traditional drugs and granted certificates by Ministry of Health of Vietnam.
2. Category 2 includes herbal drugs and traditional drugs manufactured entirely by a manufacturing line in Vietnam satisfying GMP requirements of herbal drugs and traditional drugs and granted certificates by Ministry of Health of Vietnam.
3. Category 3 includes herbal drugs and traditional drugs not satisfying criteria specified in Clauses 1 and 2 of this Article.
Article 10. Contract package of traditional ingredients
A contract package of traditional ingredients may contain one or several traditional ingredients; each list of ingredient must be sorted by category; each ingredient in each category is one part of the contract package. The contract package of traditional ingredients is divided into 3 categories and based on technical criteria as follows:
1. Category 1 includes traditional ingredients satisfying the following two criteria:
a) Drugs manufactured from herbal ingredients planted and collected or naturally farmed satisfying GACP requirements and granted certificates by Ministry of Health of Vietnam;
b) Drugs manufactured entirely by a manufacturing line in Vietnam satisfying GMP requirements of traditional ingredients (including glue, granule, extract, essential oil, resin, gum, jelly) and granted certificates by Ministry of Health of Vietnam.
2. Category 2 includes traditional ingredients manufactured entirely by a manufacturing line in Vietnam satisfying GMP requirements of traditional ingredients (including glue, granule, extract, essential oil, resin, gum, jelly) and granted certificates by Ministry of Health of Vietnam.
3. Category 3 includes traditional ingredients not satisfying criteria specified in Clauses 1 and 2 of this Article.
Article 11. Contract package of herbal ingredients
A contract package of herbal ingredients may contain one or several herbal ingredients, each list of herbal ingredients shall be sorted by category; each ingredient in each category is one part of the contract package. The contract package of herbal ingredients is divided into 3 categories and based on technical criteria as follows:
1. Category 1 includes herbal ingredients planted and collected or naturally farmed satisfying GACP requirements and granted certificates by Ministry of Health of Vietnam.
2. Category 2 includes semi-finished herbal ingredients: glue, granule, extract, essential oil, resin, gum, jelly manufactured by a manufacturing line in Vietnam satisfying GMP requirements of herbal ingredients and granted certificates by Ministry of Health of Vietnam.
3. Category 3 includes herbal ingredients not satisfying criteria specified in Clauses 1 and 2 of this Article.
Article 12. Provisions on submission of bids of drug categories
1. Bidding principles of drug categories in a contract package.
a) Contractors shall be sorted according to technical criteria that their drugs satisfy. If a drug satisfies criteria of more than one category, its supplier may be divided into one or some categories corresponding to the technical criteria their drug satisfies, and provided the bid price for the same drugs in all categories participated by the contractor are consistent.
b) If an offered drug manufactured by several facilities, these facilities participated in production process shall satisfy technical criteria of the offered drug category.
2. Contract package of generic:
a) Drugs satisfying criteria of Category 1 may be sorted into Category 1, Category 2, Category 5;
b) Drugs satisfying criteria of Category 2 may be sorted into Category 2, Category 5;
c) Drugs satisfying criteria of Category 3 may be sorted into Category 3, Category 5;
d) Drugs satisfying criteria of Category 4 may be sorted into Category 4, Category 5;
dd) Drugs not satisfying criteria of Category 1, Category 2, Category 3 and Category 4 shall only be sorted into Category 5.
3. Contract package of herbal drugs and traditional drugs:
a) Drugs satisfying criteria of Category 1 may be sorted into Category 1, Category 2 and Category 3;
b) Drugs satisfying criteria of Category 2 may be sorted into Category 2 and Category 3;
c) Drugs not satisfying criteria of Category 1, Category 2 shall only be sorted into Category 3.
4. Contract package of traditional ingredients:
a) Traditional ingredients satisfying criteria of Category 1 may be sorted into Category 1, Category 2, Category 3;
b) Traditional ingredients satisfying criteria of Category 2 may be sorted into Category 2, Category 3;
c) Traditional ingredients not satisfying criteria of Category 1, Category 2 shall only be sorted into Category 3.
5. Contract package of herbal ingredients:
a) Herbal ingredients satisfying criteria of Category 1 may be sorted into Category 1 and Category 3;
b) Herbal ingredients satisfying criteria of Category 2 shall only be sorted into Category 2;
c) Herbal ingredients not satisfying criteria of Category 1, Category 2 shall only be sorted into Category 3.
6. Foreign drugs manufactured under a processing contract or technology transfer contract in Vietnam sorted into contract packages of generic drugs and proprietary drugs or equivalent drugs shall be implemented as follows:
a) Foreign drugs manufactured under a processing contract or technology transfer contract in Vietnam may be sorted into the drug categories specified in Point b of this Clause if satisfying the following criteria:
- There's a technology transfer contract with specific comprehensive technology transfer roadmap for the processor or technology transferee to prepare to manufacture finished drugs in Vietnam within 5 years from the date of certificate of marketing authorization is granted.
- Drugs manufactured under a processing contract or technology transfer contract and drugs manufactured without under a processing contract or technology transfer contract shall have the same dosage form, production process, quality criteria of ingredients and finished drugs;
- Drugs not on the List of domestically-manufactured drugs satisfying treatment, pricing and supply requirements issued by the Ministry of Health according to technique criteria (except for all manufacturing stages in Vietnam when the certificate of marketing authorization is granted in Vietnam).
b) The submission of bids for foreign drugs manufactured under a processing contract or technology transfer contract in Vietnam satisfying the provisions specified in Point a of this Clause if:
- Foreign drugs manufactured under a processing contract or technology transfer contract in Vietnam on the List of proprietary drugs or the List of reference bioequivalence and satisfying the provisions specified in Point b Clause 2 Article 8 of this Circular may be sorted into the contract package of proprietary drugs or equivalent drugs. Drugs on the List of drugs for procurement through price negotiation issued by Ministry of Health, procurement of these drugs shall be under price negotiation form;
- Foreign drugs specified in Point a Clause 1 Article 7 of this Circular manufactured under a processing contract or technology transfer contract in Vietnam by a manufacturing line satisfying EU-GMP requirements or equivalent requirements and granted certificates by the drug authority of Vietnam may be sorted into Category 1, Category 2, Category 4 and Category 5;
- Foreign drugs specified in Clause 2 Article7 of this Circular manufactured under a processing contract or technology transfer contract in Vietnam by a manufacturing line satisfying EU-GMP requirements or equivalent requirements and granted certificates by the drug authority of Vietnam may be sorted into Category 2, Category 4 and Category 5;
- Other drugs manufactured under a processing contract or technology transfer contract in Vietnam may be sorted into Category 4 and Category 5.
c) If foreign drugs manufactured under a processing contract or technology transfer contract do not satisfy criteria specified in Point 1 of this Clause, the submission of bids shall follow the provisions specified in Clauses 1 and 2 of this Article.
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Thông tư 15/2019/TT-BYT (Bản Word)
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