Chapter VI
IMPLEMENTATION
Article 47. Effect
1. This Circular comes into force from October 1, 2019.
2. Circular No. 11/2016/TT-BYT dated May 11, 2016 of Minister of Health providing guidance on bidding for supply of drugs for public health facilities shall be annulled from the effective date of this Circular.
Article 48. Transitional provisions
1. The contract packages whose contractor selection plans are approved before the effective date of this Circular shall comply with the provisions of Circular No. 11/2016/TT-BYT dated May 11, 2016 of Minister of Health providing guidance on bidding for supply of drugs for public health facilities, unless the facilities specified in Article 2 of this Circular volunteer to follow this Circular's provisions from the issuance date.
2. For drug manufacturing facilities satisfying EU-GMP requirements or equivalent requirements and manufacturing facilities satisfying PIC/s-GMP requirements of the national drug authority of the country considered a member of PIC/s and ICH published by Drug Administration of Vietnam on its website before the effective date of this Circular; these manufacturing facilities shall not need to undergo evaluation of satisfying EU-GMP requirements or equivalent requirements or PIC/s-GMP requirements organized by the drug authority of Vietnam within months from the effective date of this Circular.
Article 49. Reference clause
In case any of the documents referred to in this Circular is replaced or amended, the newest document shall be applied.
Article 50. Organization and implementation
1. Heads of central authorities shall instruct affiliated health facilities to select contractors in accordance with this Circular and regulations of law on contractor selection.
2. Ministers, Heads of ministrial authorities shall assign tasks and inspect the assignment applied to some contract packages of health facilities under their management.
3. Chairperson of People’s Committee of each province shall:
a) Appoint a local centralized drug procurement unit to procure drugs on the local lists of drugs for centralized bidding procurement for health facilities participating in centralized procurement locally in accordance with this Circular;
a) Instruct health facilities to organize selection of suppliers of drugs on such list in accordance with this Circular;
c) Decide addition of other drugs to the local lists of drugs for centralized drug procurement (except for drugs on the list of drugs for price negotiation and for national centralized bidding) for use at local health facilities at the request of the Director of the Provincial Department of Health. Time limit for contract execution shall comply with Clause 4 Article 39 of this Circular.
If central health facilities, internal health departments and health facilities under the management of ministries and branches use the local lists of additional drugs (except for the local lists of drugs for centralized bidding procurement issued by Ministry of Health), health authorities of other sectors and internal health departments and supervisory authorities of health facilities under the management of ministries and branches shall sign agreement with Provincial Departments of Health to submit reports to People's Committees of provinces for contractor selection organization.
d) Decide and inspect task assignments to some contract packages of health facilities under their management at the request of the Director of the Provincial Department of Health.
4. Drug administration of Vietnam, Traditional Medicine Administration of Vietnam shall update the following information on their websites:
a) Lists serving contractor selection, including:
- The list of reference authorities;
- The list of drug authorities of SRA countries;
- The list of drug authorities of countries that are state members of PIC/s and ICH;
- The list of drug manufacturing facilities in Vietnam satisfying WHO-GMP requirements granted certificates by drug authority of Vietnam;
- The list of drug manufacturing facilities satisfying EU-GMP requirements or equivalent requirements ;
- The list of drug manufacturing facilities satisfying PIC/s-GMP requirements in a country that is a member state of PIC/s and ICH and granted certificates by drug authority of Vietnam.
- The list of drug manufacturing facilities that have herbal and traditional drugs satisfying GMP requirements granted certificates by Ministry of Health of Vietnam;
- The list of drug manufacturing facilities in Vietnam that have traditional ingredients satisfying GMP requirements granted certificates by Ministry of Health of Vietnam;
- The list of drug manufacturing facilities in Vietnam that have herbal ingredients satisfying GMP requirements granted certificates by Ministry of Health of Vietnam;
b) Lists of drugs serving contractor selection, including:
- List of drugs granted certificates of marketing authorization or import licences;
- List of proprietary drugs;
- List of reference bioequivalence;
- List of drugs whose therapeutic effects equivalent to those of proprietary drugs;
- List of drugs manufactured under a processing contract or technology transfer contract in Vietnam;
- List of proprietary drugs and reference bioequivalence manufactured under a processing contract or technology transfer contract in Vietnam;
- List of drugs having documents proving bioequivalence;
- List of drugs granted certificates of marketing authorization by one of reference authority;
- List of drugs granted certificates of marketing authorization by one of drug authority of SRA countries;
- List of drugs manufactured entirely in Vietnam satisfying criteria of Category 1 specified in point c Clause 1 Article 7 of this Circular;
- List of ingredients in dosage form of glue, granule, extract, essential oil, resin, gum, jelly in accordance with regulations of Ministry of Health on quality management of herbal ingredients and traditional drugs;
- List of semi-finished herbal ingredients: glue, granule, extract, essential oil, resin, gum, jelly in accordance with regulations of Ministry of Health on quality management of medicinal ingredients;
- List of drugs on the list of national products;
- List of drugs awarded the Ministry of Health's prize of “Star of Vietnamese medicines"
- List of herbal ingredients planted and collected or naturally farmed satisfying GACP requirements and granted certificates by Ministry of of Health of Vietnam;
- List of drugs manufactured in Vietnam satisfying requirements for treatment, price and supply capacity;
- List of herbal ingredients domestically planted and collected satisfying requirements for treatment, price and supply capacity;
- List of drugs manufactured from active ingredients in SRA countries or active ingredients granted CEP certificates;
- List of drugs and manufacturing facilities, suppliers failing to satisfy quality requirements or complying with regulations on bidding and drug supply;
c) Information on declared/re-declared drug price;
d) Information on drug price and successful bids of herbal ingredients for health facilities;
dd) List of capable, experienced and reputable drug manufacturers and suppliers to be invited to selective bidding.
5. When purchasing drugs funded by health insurance, the social insurance shall send officials to participate in:
a) Making, appraising the contractor selection plan;
b) Making, appraising the bidding documents;
c) Evaluating the bid and appraising the contractor selection result.
6. During the contractor selection process, the health facility or organizing unit shall send documents (except for confidential documents in accordance with Law on bidding) to members participating in the Council or Expert group specified in points a b c Clause 5 of this Article before meeting within 5 days (except for urgent drug procurement for treatment). After the above deadline, the health facility or organizing unit shall follow the steps in the process of contractor selection to hold meeting of Council or Expert Group. The members participating in the above-mentioned Councils or Expert Groups shall comply with regulations of these Councils or Expert Groups according to the Heads of Councils or Expert Groups.
Participants’ opinions shall be raised at the meeting. Any participant's opinion that is different from that of the others shall be specified in the report.
7. Procurement of health insurance drugs of private health facilities shall be based on the following principles:
a) Private health facilities may participate in centralized drug procurements (national procurements, local procurements, price negotiations) in their provinces. Such private health facilities shall formulate drug use plans and comply with regulations on local centralized bidding as if they are health facilities under the management of local authorities. Provincial Departments of Health and local centralized drug procurement units shall organize biddings for supply of drugs for private health facilities as if they are health facilities under the management of local authorities.
b) Private health facilities not participating in centralized drug procurements (national procurements, local procurements, price negotiations) may carry out contractor selection themselves in accordance with law on bidding, instructional documents and this Circular.
c) If a private health facility does not organize contractor selection as prescribed in points a and b of this Circular, the social insurance authority shall only pay according to the published result of local or national contractor selection or price negotiation result if the information such as trade name, number of marketing authorization certificate or number of import license, dosage form, content/concentration, route of administration, package contents, manufacturer, manufacturing country are correct.
If the drug is not included in the local or national-level concentrated procurement plan or price negotiation plan, it shall be paid for according to successful bids of public health facilities of the same districts which are published by Social Insurance Office in accordance with Point b Clause 3 Article 77 of Decree No. 63/2014/ND-CP.
8. Health facilities requesting for announcement of information specified in Clause 1 Article 7 of this Circular shall provide the following documents and be legally responsible for their precision:
a) Certificates of free sale granted by drug authority of SRA countries and consular legalization (original copies or certified true copies).
b) List of information proving drugs sold in Vietnam and drugs granted certificates of free sale by SRA countries having the same dosage form, manufacturing process, quality standard, verifying method; active ingredient and excipient having the same quality standard, manufacturing facility and manufacturing place specified in Appendix 13 enclosed herewith.
9. Health facilities requesting for evidence of proprietary drugs or reference bioequivalence sold for the first time in countries not on the SRA list specified in point b Clause 2 Article 8 of this Circular shall provide the following documents and be legally responsible for their precision:
a) Patents for modern medicines granted by one of competent intellectual property authority. A patent for the active ingredient (if the drug has only one active ingredient) or the mixture of active ingredients (if the drug has more than one active ingredients) enclosed with the request for protection of the corresponding drug (original copy or certified true copy).
b) International birth date of drugs shall be expressed in periodic safety update reports;
c) Other evidence (if any).
Article 51. Responsibility for implementation
Director of Drug administration of Vietnam, Director of Traditional Medicine Administration of Vietnam, Director of Planning – Finance Department, Chief of the Ministry Office, Ministrial Chief Inspector, Director of the National Centralized Drug Procurement Center, Heads of units affiliated to Ministry of Health, Director of Departments of Health of provinces, drug business facilities and other relevant organizations/individuals/authorities shall implement this Circular.
Difficulties that arise during the implementation of this Circular should be reported to the Ministry of Health for consideration./.
Tìm kiếm
Thông tư 15/2019/TT-BYT (Bản Word)
Thông tư 15/2019/TT-BYT (Bản Pdf)