Thông tư liên tịch 36/2013/TTLT-BYT-BTC

JOINT CIRCULAR

AMENDING AND SUPPLEMENTING A NUMBER OF ARTICLES OF THE JOINT CIRCULAR NO. 01/2012/TTLT-BYT-BTC DATED JANUARY 19, 2012, OF THE MINISTRY OF HEALTH AND THE MINISTRY OF FINANCE GUIDING THE BIDDING FOR MEDICINE PURCHASE BY MEDICAL ESTABLISHMENTS

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

Pursuant to the Law on tendering No. 61/2005/QH11 dated November 29, 2005, Law amending and supplementing a number of articles of the laws concerning capital construction investment No. 38/2009/QH12  dated June 19, 2009;

Pursuant to the Government’s Decree No. 79/2006/ND-CP dated August 09, 2006, detailing implementation of a number of Articles of the Pharmacy Law, Government’s Decree No. 89/2012/ND-CP dated October 24, 2012, amending and supplementing a number of Articles of Government’s Decree No. 79/2006/ND-CP dated August 09, 2006, detailing implementation of a number of Articles of the Pharmacy Law;

Pursuant to the Government’s Decree No. 85/2009/ND-CP dated October 15, 2009, guiding implementation of Law on tendering and selection of the building contractors under construction law;

Pursuant to 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;

Pursuant to Government’s Decree No. 118/2008/ND-CP dated November 27, 2008, defining the functions, tasks, powers and organizational structure of the Ministry of Finance,

The Minister of Health, the Minister of Finance promulgate the Joint Circular amending and supplementing a number of articles of the Joint Circular No. 01/2012/TTLT-BYT-BTC dated January 19, 2012, of the Ministry of Health and the Ministry of Finance guiding the bidding for medicine purchase by medical establishments as follows:

Article 1. To supplement point d into Clause 2 Article 2 as follows:

“d) Medical oxygen.”

Article 2. To supplement Clauses 6 and 7 into Article 3 as follows:

“6. Establishments producing medicines satisfying EU-GMP or PIC/s-GMP standard mean medicine producers granted certificate of satisfying EU-GMP or PIC/s-GMP standard or equivalent by competent management agencies of countries participating in EMA or ICH or PIC/s and published on website of the Drug Administration of Vietnam by the Ministry of Health (Drug Administration of Vietnam).

7. Countries participating in ICH include EU countries, Japan, American and countries which are observers of ICH and associated members of ICH’s members, as announced by the Ministry of Health (Drug Administration of Vietnam) based on the list updated by ICH.”

Article 3. To amend and supplement Clauses 1 and 3 of Article 7 as follows:

“1. Bidding package for medicines under generic name:

Bidding package for medicines under generic name may have one or many medicines under generic name. Each generic under generic name is divided into group based on technical criteria and technological standards licensed as follows:

a) Group 1:

- Drugs produced at production establishments satisfying EU-GMP or PIC/s-GMP standard of countries participating in ICH;

- Drugs produced at establishments producing medicines which satisfy WHO-GMP standard and granted certificate by Vietnam Ministry of Health (the Drug Administration of Vietnam) and licensed for circulation by competent management agencies of countries participating in ICH.

b) Group 2:

- Drugs produced at production establishments satisfying EU-GMP or PIC/s-GMP standard but not being countries participating in ICH;

- Drugs franchised by production establishments satisfying EU-GMP or PIC/s-GMP standard of countries participating in ICH and produced at medicine production establishments subject to grant of certificate of satisfying WHO-GMP standard by Vietnam Ministry of Health (the Drug Administration of Vietnam).

c) Group 3: Drugs produced at establishments producing medicines which satisfy WHO-GMP standard and granted certificate by Vietnam Ministry of Health (the Drug Administration of Vietnam).

d) Group 4: Drugs having bioequivalence proof announced by the Ministry of Health.

dd) Group 5: Drugs failing to satisfy criteria of classification specified at points a, b, c and d Clause 1 this Article.”

“3. Bidding packages of oriental medicines, medicines from materia medica.

Bidding packages of oriental medicines, medicines from materia medica are classified into groups based on technical criteria and technological standards licensed as follows:

a) Group 1: oriental drugs, drugs from materia medica produced at establishments which satisfy WHO-GMP standard and granted certificate by Vietnam Ministry of Health (the Drug Administration of Vietnam).

b) Group 2: oriental drugs, drugs from materia medica produced at establishments which have not yet been granted certificate of satisfying WHO-GMP standard by Vietnam Ministry of Health (the Drug Administration of Vietnam).

Article 4. To amend points b and c Clause 1 of Article 8 as follows:

“b) For a bidding package under proprietary medicine name, content of bidding package includes: Medicine name, name of active ingredients, concentration or content, dosage forms, calculation unit, quantity, tentative price as planned and inclusive of VAT, and must enclose with phrase “or equivalent treatment” If an active ingredient has various proprietary names already been announced by the Ministry of Health at list of original proprietary medicines or rare medicines, the proprietary name enclosed with phrase “or equivalent treatment” need be written in item of medicine name. Example: Proprietary name A or Proprietary name B or equivalent treatment.”

“c) For bidding packages of oriental medicines, medicines from materia medica, content of a bidding package includes medicine name, dosage form, calculation name, quantity, and tentative price as planned and inclusive of VAT.  Medicine names in bidding packages of oriental medicines, medicines from materia medica shall be written as follows:

- Only write name of components of medicine, not writing commercial name;

- If medicine has a same components, dosage form: Only write the concentration, content of medicine components when having differences of concentration, content that result the differences of dose, treatment indication of medicines. The Councils of medicines and treatment of medical examination and treatment establishments shall decide on the description of concentration, content of medicines in bidding packages for oriental medicines, medicines from materia medica in order to ensure the principles of competition and fairness between bidding packages for oriental medicines, medicines from materia medica.”

Article 5. To amend and supplement Clauses 2 and 3 of Article 16 as follows:

“2. For bidding packages for medicines under generic name, and bidding packages for oriental medicines, medicines from materia medica: Each medicine group only is considered for bid winning of 01 item of drug which meets technical and quality requirements specified in bidding dossier and has lowest price among such medicine group."

“3. For bidding packages for medicines under proprietary name: Each drug only is considered for bid winning of 01 item of drug which meets technical and quality requirements specified in bidding dossier and has lowest price among bidding packages."

Article 6. To amend and supplement point d Clause 1 Article 23 as follows:

“d) Medicines named in list of medicines under the approved bid plan, but in year, their use demand exceeds the plan approved by competent authorities.   Quantity of each item of drug allowed purchasing in excess of annual plan will not more than 20% of the quantity of that drug as winning bid. Total value of medicines allowed purchasing in excess of plan of unit in this case is not more than 02 (two) billion Vietnam dong/year.”

Article 7. To amend and supplement Clauses 1 and 4 of Article 26 as follows:

“1. The Ministry of Health shall announce, update list of countries participating in EMA, ICH, PIC/s; list of medicine production establishments satisfying EU-GMP or PIC/s-GMP standard; list of medicine producers satisfying WHO-GMP standard and granted certificate by Vietnam’s Ministry of Health (the Drug Administration of Vietnam); list of original proprietary medicines, medicines of equivalent treatment in comparison with the original proprietary medicines; medicines having documents to prove bioequivalence; list of medicines franchised from medicine production establishments satisfying EU-GMP or PIC/s-GMP standard of countries participating in ICH and produced at medicine production establishments granted certificate of satisfying WHO-GMP standard by Vietnam’s Ministry of Health (the Drug Administration of Vietnam); list of medicines produced at  medicine production establishments satisfying WHO-GMP standard and granted certificate by Vietnam’s Ministry of Health (the Drug Administration of Vietnam) and licensed for circulation by competent management agencies of countries participating in ICH.”

“4. Social insurance agencies shall appoint officers to participate in Council for appraising the bidding plan, group for elaboration of bidding dossier, group for bidding verification and group for appraising result of contractor selection in case of bidding for drug purchase from fund of medical insurance under decentralization of General Director of Vietnam Social Insurance.”

Article 8. Effect

1. This Circular takes effect on January 01, 2014.

2. Clauses 1, Clause 3 Article 7; points b and c Clause 1 Article 8; Clauses 2 and 3 Article 16; point d Clause 1 Article 23; Clauses 1 and 4 Article 26 of the Joint Circular No. 01/2012/TTLT-BYT-BTC dated January 19, 2012, of the Ministry of Health and the Ministry of Finance guiding the bidding for medicine purchase by medical establishments cease to be effective on the effective date of this Circular.

3. For bidding packages already been submitted for approval for bidding plan before the effective day of this Circular, further complying with the Joint Circular No. 01/2012/TTLT-BYT-BTC dated January 19, 2012, of the Ministry of Health and the Ministry of Finance guiding the bidding for medicine purchase by medical establishments.

Article 9. Organization of implementation

Chairpersons of provincial/municipal People’s Committees; Directors of provincial/municipal Services of Health; Directors of medical establishments and heads of relevant units shall implement this Circular.