Thông tư 31/2016/TT-BYT

CIRCULAR

ON GUILDELINES FOR BIDDING DOCUMENTS FOR PROCUREMENT OF HERBAL INGREDIENTS AND TRADITIONAL INGREDIENTS AT HEATH FACILITIES

Pursuant to the Law on Bidding No. 43/2013/QH13 dated November 26, 2013;

Pursuant to the Law on Pharmacy No. 34/2005/QH11 dated June 14, 2005;

Pursuant to Government's Decree No. 63/2014/ND-CP dated June 26, 2014 on guidelines for the Law on Bidding in terms of selection of bidders;

Pursuant to the Government's Decree No. 63/2012/ND-CP dated August 31, 2012 defining the functions, tasks, powers and organizational structure of the Ministry of Health;

At the request of Director of Traditional Medicine Administration of Vietnam,

The Minister of Health promulgates a Circular on guidelines for bidding documents for procurement of herbal ingredients and traditional ingredients at heath facilities.

Article 1. Scope and regulated entities

1. This Circular provides for forms of Bidding Documents for procurement of herbal ingredients and traditional ingredients at public health facility financed by state capital, health insurance fund, revenues derived from examination and treatment services and other legitimate revenues and at private health facilities financed by health insurance fund.

2. Apart from regulations of this Circular, agencies, organizations, and individuals engaging in or involving in bidding, procurement of herbal ingredients and traditional ingredients shall comply with Circular No. 11/2016/TT-BYT dated May 11, 2016 of the Minister of Health on medicine bidding in public health facilities (hereinafter referred to as Circular No. 11/2016/TT-BYT) and relevant legislative documents.

Article 2. Forms of Bidding Documents for procurement of herbal ingredients, traditional ingredients

Forms of Bidding Documents for procurement of herbal ingredients, traditional ingredients at heath facilities shall be issued herewith as follows:

1. Form 1: Bidding Documents for procurement of herbal ingredients applicable to open tender or national selective bidding with the single stage-one envelope bidding procedure.

2. Form 2: Bidding Documents for procurement of herbal ingredients applicable to open tender or national selective bidding with the single stage-two envelope bidding procedure.

Article 3. Implementation

1. Traditional Medicine Administration of Vietnam shall regularly keep the following up to date on its website:

a) The list of bidders satisfying requirements pertaining qualification and reputation in bidding of herbal ingredients, traditional ingredients announced by the Minister of Health;

b) The list of herbal ingredients issued with the receipt of publication of herbal ingredients produced under GACP-WHO;

c) The list of facilities obtaining herbal ingredient import licenses;

d) The list of facilities having storage of herbal ingredients meeting Good Store Practice in terms of herbal ingredients;

dd) The list of facilities meeting conditions for herbal ingredient processing;

e) The list of facilities and herbal ingredients, traditional ingredients marketing registration number or standard publication;

g) The list of facilities committing violations against quality of herbal ingredients, traditional ingredients prescribed in law on pharmacy and law on product quality;

h) The list of herbal ingredient samples announced by the Minister of Health.

2. Director of Traditional Medicine Administration of Vietnam shall initiate, provide guidelines for, make preliminary and final report on implementation of this Circular nationwide.

3. Directors of Services of Health of provinces and central-affiliated cities shall initiate, provide guidelines for, make preliminary and final report on implementation of this Circular in provinces/cities.

Article 4. Transitional provisions

1. Bidding Documents of procurement of which Bidding Documents or Request for Proposals are published before the effective date of this Circular shall keep being implemented as prescribed in the Law on Bidding, the Government's Decree No. 63/2014/ND-CP dated June 26, 2014 on guidelines for the Law on Bidding in terms of selection of bidders and Circular No. 58/2016/TT-BTC dated March 29, 2016 of the Minister of Finance on guidelines for using state capital for procurement to maintain regular operation of regulatory agencies, People’s armed forces, public service providers, political organizations, socio-political organizations, socio-political-professional organizations, social organization, social-professional organizations.

2. Bidding Documents of procurement of which Bidding Documents or Request for Proposals having not been published before the effective date of this Circular shall follow the procedures below:

a) Plan for selection of bidders approved by competent authorities before effective date of this Circular in accordance with Circular No. 11/2016/TT-BYT shall keep being implemented according to the approved plan concerned.

b) Plan for selection of bidders approved by competent authorities before effective date of this Circular not in accordance with Circular No. 11/2016/TT-BYT shall be amended in such manner in accordance with this Circular. The plan shall be submitted to the competent authorities hereafter prescribed in Article 9 of Circular No. 11/2016/TT-BYT for approval before initiation.

Article 5. Terms of reference

If any of the documents referred to in this Circular is replaced or amended, the new document shall prevail.

Article 6. Effect

This Circular comes into force from September 26, 2016.

Difficulties that arise during the implementation of this Circular should be reported to Traditional Medicine Administration of Vietnam of the Ministry of Health for consideration./.