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THE MINISTRY
OF HEALTH
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SOCIALIST
REPUBLIC OF VIETNAM
Independence - Freedom - Happiness
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No.
12/2013/TT-BYT
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Hanoi, April
12, 2013
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CIRCULAR
GUIDING IN DETAILS IMPLEMENTATION OF A NUMBER OF
ARTICLES OF THE GOVERNMENT’S DECREE NO. 96/2012/ND-CP, OF NOVEMBER 15, 2012, ON
ADDICTION TREATMENT FOR SUBSTANCES OF OPIUM BY USE OF THE ALTERNATIVE MEDICINES
Pursuant to the Law on Hiv/Aids prevention and control;
Pursuant to the Government’s Decree
No. 96/2012/ND-CP, of November 15, 2012, on addiction treatment for substances
of opium by use of the alternative medicines;
Pursuant to the Government’s
Decree No. 63/2012/ND-CP, of August 31, 2012, defining the functions, tasks,
powers and organizational structure of the Ministry of Health;
At the proposal of Director of
the Vietnam Administration of HIV/AIDS Control;
The Minister of Health
promulgates the Circular guiding in details implementation of a number of
articles of the Government’s Decree No. 96/2012/ND-CP, of November 15, 2012, on
addiction treatment for substances of opium by use of the alternative medicines.
Chapter 1
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Article 1.
Scope of regulation
This Circular guides on:
1. The operation conditions of an
establishment of addiction treatment for substances of opium by use of the
alternative medicines (hereinafter abbreviated to the addiction treatment
establishment)
2. Dossier of, procedures for
grant, re-grant of operation permit for the addiction treatment establishments.
3. Procedures for suspension of
operation and withdrawal of an operation permit for a treatment establishment.
4. Guide on registration for
treatment participation and forwarding for treatment participation for
substances of opium by use of the alternative medicines.
Article 2. The
principle of addiction treatment for substances of opium by use of the
alternative medicines
1. Only the addiction treatment
establishments which are eligible as prescribed in this Circular may perform
addiction treatment for substances of opium by use of the alternative
medicines.
2. The professional guides on
addiction treatment for substances of opium by use of the alternative medicines
as prescribed by the Minister of Health must be abided.
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THE OPERATION
CONDITIONS OF TREATMENT ESTABLISHMENTS
Section 1. THE OPERATION
CONDITIONS OF TREATMENT ESTABLISHMENTS BY USE OF ALTERNATIVE MEDICINES
Article 3. Conditions of
material facilities
Apart from satisfaction of
conditions specified in clause 1 Article 12 of the Government’s Decree No.
96/2012/ND-CP, of November 15, 2012, on addiction treatment for substances of
opium by use of the alternative medicines (hereinafter abbreviated to the
Decree No.96/2012/ND-CP), a treatment establishment by use of alternative
medicines must satisfy the following conditions:
1. Its rooms must be built firmly,
have enough light, anti-dust ceilings, wall and floor made of materials that
are easy to erase, clean, reliable doors and windows with locks.
2. Laboratories must meet the
folowing conditions:
a. Walls of the laboratory areas
and desks must be flat, waterproof, heat and corrosive chemical resistant;
b. There are wash basins and
emergency taps for eyewash, first-aid kit.
Article 4.
Conditions on equipment
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a. humidity measure;
b. Thermometer to measure room
temperature;
c. Air conditioner;
d. 02 cabinets with locks, of
which: 01 cabinet for containing medicines of daily allocation and 01 cabinet
for medicine preservation;
dd. Instruments for medicine
allocation;
e. Cabinet or shelves to contain
files, books, treatment records.
2. Clinics:
a. Thermometer to measure body
heat;
b. Stethoscope;
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d. Blood pressure meter;
dd. Set of first-aid equipment;
e. Ambulance Stretchers and
trolleys;
g. Beds of medical examination;
h. Weight -height healthy scale.
3. Laboratories:
a. Set of instruments to test
urine and blood;
b. Refrigerator to preserve
patient specimens and biological substances.
4. Place for taking urine of
patient:
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b. Wall is sticked with colored
glass of one direction from outside and officer of the addiction treatment
establishment may observe while patient self-collect his/her urine.
5. Other equipment in conformity
with functions and taks of each room.
Article 5.
Conditions on personnel
Apart from satisfaction of
conditions specified in clause 3 Article 12 of the Government’s Decree No.
96/2012/ND-CP, a treatment establishment by use of alternative medicines must
satisfy the following conditions:
1. A clinic has at least 03
officers with intermediate level qualification specialized
in medical field, of which at least 01 doctor in charge of technical operation
with time doing work of the medical examination and treatment from 18 months or
more.
2. The room of medicine allocation
and preservation has at least 02 officers with intermediate level qualification
specialized in pharmacy or intermediate level qualification specialized in
medical field or higher, of which the officer in charge of medicine
preservation must have intermediate level qualification specialized in pharmacy
or higher.
3. Advisory room has at least 01
officer with intermediate level qualification specialized in pharmacy or
intermediate level qualification specialized in medical or social field or
higher.
4. Laboratory has at least 01
officer with intermediate level qualification specialized in pharmacy or
medical, biological or chemical field or higher.
5. Administrative room has at
least 01 officer with intermediate level qualification or higher.
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Section 2. THE OPERATION
CONDITIONS OF MEDICINE ALLOCATION ESTABLISHMENTS
Article 6.
Conditions of material facilities
Apart from satisfaction of
conditions specified in clause 1 Article 13 of the Government’s Decree No.
96/2012/ND-CP, a medicine allocation establishment must satisfy conditions
specified in clause 1 Article 3 of this Circular.
Article 7.
Conditions on equipment
Meeting conditions specified in
clause 1 Article 4 of this Circular.
Article 8.
Conditions on personnel
Apart from satisfaction of
conditions specified in clause 3 Article 13 of the Government’s Decree No.
96/2012/ND-CP, a medicine allocation establishment must satisfy conditions
specified in clause 2 and clause 6 Article 5 of this Circular.
Chapter 3
DOSSIER OF,
PROCEDURES FOR GRANT, RE-GRANT OF OPERATION PERMIT FOR THE ADDICTION TREATMENT
ESTABLISHMENTS
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1. A dossier of application for
grant, re-grant of operation permit for the addiction
treatment establishments includes:
a. Application for grant of the
operation permit in according to form in the Annex 1 promulgated together with
this Circular;
b. authenticated copy of decision
on establishment issued by competent state agency of authenticated copy of
Certificate of Business registration or authenticated copy of investment
certificate;
c. List of staff of addiction
treatment establishment according to the form in the Annex 2 promulgated
together with this Circular and enclosed with authenticated copy of specialized
diplomas of each officer of the addiction treatment
establishment;
d. Diagram of premises of the
addiction treatment establishment;
e. Declaration of equipment of the
addiction treatment establishment made according to form in the Annex 3
promulgated together with this Circular;
2. A dossier of application for
re-grant of operation permit in case an addiction treatment establishment is
lost its operation permit or its operation permit is broken includes:
a. Application made according to
form in the Annex 1 promulgated together with this Circular;
b. Original of broken operation
permit (if any);
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3. A dossier of application for
re-grant of operation permit in case an addiction treatment establishment
changes its operation location or is withdrawn operation permit:
a. Papers as prescribed in clause
1 of this Article;
b. Operation report of the latest
6 months counted to time of applying for re-grant of operation permit.
Article 10.
Procedures for grant, re-grant of operation permit for the addiction treatment
establishments
1. Dossier of application for
grant, re-grant of operation permit for an addiction treatment establishment is
made into 01 set and send to the Department of Health of central-affiliated
cities and provinces (hereinafter abbreviated to province) where the addiction
treatment establishment places its head office.
2. Process for consideration of
application for grant, re-grant of operation permit for the addiction treatment
establishments:
a. After receiving a dossier of
application for grant, re-grant of the operation permit, the provincial Department of Health shall send a receipt of dossier made according
to the form in the Annex 4 promulgated together with this Circular to
applicant;
b. Within 20 working days, as from
fully receiving the valid dossiers, Director of provincial
Department of Health must organize appraisal for grant, re-grant of operation
permit;
c. In case dossier of application
for grant, re-grant of the operation permit is invalid, within 10 working days,
after day inscribed in the receipt of dossier, the provincial
Department of Health must have a written notice to applicant for amenment or
completion of dossier. The written notice must clearly state contents and
documents required for amendment and supplementation;
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e. In case an establishment
applying for grant, re-grant of the operation permit has amended and
supplemented dossier but it is inconsistent with request, the provincial
Department of Health shall notice in writing to that establishment for further
completion of dossier as prescribed in point c clause 2 of this Article.
Article 11.
Holding appraisal for grant, re-grant of operation permit for the addiction
treatment establishments
Director of the provincial
Department of Health shall establish an appraisal delegation for grant,
re-grant of operation permit for the addiction treatment establishments.
Members of delagation include as follows:
1. A representative of leader of
the provincial Department of Health, as the chief.
2. A representative of leader of
the provincial HIV/AIDS Control Center, as a standing
deputy chief.
3. A representative of leader of
Division in charge of management of addiction treatment for substances of opium
by use of the alternative medicines - of the provincial Department of Health, as a deputy chief.
4. Representative of the pharmacy
operation division - of the provincial Department of Health, as member.
5. Doctor with experiences on
alternative treatment, as member.
6. Representative of the
provincial Public Security agency, as member.
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Article 12.
The process of appraisal for grant, re-grant of operation permit for the
addiction treatment establishments
1. The process of appraisal for
grant of operation permit for an addiction treatment establishment, re-grant of
operation permit in case an addiction treatment establishment changes its operation
location or is withdrawn operation permit:
a. Appraisal of legal dossier;
examining conditions on material facilities, medical equipment and instrument,
personnel of the addiction treatment establishment;
b. Making the appraisal minutes
according to form in the Annex 5 promulgated together with this Circular; The
appraisal minutes of addiction treatment establishment is made 02 copies: one
kept by the provincial of Department of health and 01 kept
by the appraised addiction treatment establishment;
c. Within 02 working days, after
the appraising day, the appraisal delegation must submit the appraisal minutes
to the Director of provincial Department of Health;
d. Within 03 working days, after
receiving the appraisal minutes, Director of provicical Department of Health
must consider and decide grant, re-grant of operation permit for the addiction
treatment establishment. In case refusal for grant of operation permit, it
should reply in writing and clearly state the reason thereof.
2. The process of appraisal for
re-grant of operation permit in case an addiction treatment establishment is
lost its operation permit or its operation permit is broken includes:
a. Within 05 working days, after
receiving dossier of applying for re-grant of operation permit (the time of
dossier receipt is counted according to receipt seal of the arriving official
dispatch of the provincial Department of Health), division in charge of
management of addiction treatment for substances of opium by use of the
alternative medicines of the provincial Department of Health must check dossier
of appraisal which is used in order to grant the previous operation permit for
the addiction treatment establishment and being kept by the provincial
Department of Health;
b. Within 10 working days, after
receiving dossier of applying for re-grant of operation permit (the time of
dossier receipt is counted according to receipt seal of the arriving official
dispatch of the provincial Department of Health), director of the provincial
Department of Health must consider and decide re-grant of operation permit. In
case refusal for grant of operation permit, it should reply in writing and
clearly state the reason thereof.
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1. Each addiction treatment
establishment is granted only one operation permit according to form in the
Annex 6 promulgated together with this Circular.
2. Copy of operation permit and
dossier of applying for grant, re-grant of operation permit are kept by the
provincial Department of Health.
Chapter 4
PROCEDURES FOR
SUSPENSION OF OPERATION AND WITHDRAWAL OF AN OPERATION PERMIT FOR AN ADDICTION
TREATMENT ESTABLISHMENT
Article 14.
Cases of being suspended operation permit
An addiction treatment
establishment may be suspended operation in the following cases:
1. Fail to abide by the treatment
process or have specialized mistakes in comparison with specialized guides
adopted by the Minister of Health.
2. The material facilities,
equipment and personnel fail to ensure conditions as prescribed by this
Circular.
3. Fail to perform report on
treatment and compliance of patients during treatment course to competent
agencies in accordance with regulation.
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1. In the course of examination,
inspection over operation of an addiction treatment establishment, if detecting
that addiction treatment establishment commits one of violations specified in
Article 14 of this Circular, unit performing examination, inspection must make
a minutes on temporary operation suspension according to the form specified in
the Annex 7 promulgated together with this Circular and send it to the
provincial Department of Health.
2. Within 05 working days, after
receiving minutes on temporary operation suspension specified in clause 1 of
this article, director of the provincial Department of Health shall consider
and decide operation suspension. Decision on operation suspension have period
not exceeding 06 months from the day of signing, issuance and being sent to the
addiction treatment establishment suffered operation suspension, the provincial
HIV/AIDS control Center.
3. In case the addiction treatment
establishment suffered operation suspension has remedied violations, not later
than 30 days, before the suspension decision is expired, it must send report on
violation remedy to the provincial Department of Health where it places head
office. Time of receipt of report on violation remedy is counted under the
receipt seal of arriving official dispatch of the provincial Department of
Health.
4. Within 05 working days after
receiving report on remedying violations of the suspended establishment, the
provincial Department of Health must appoint a unit to check the remedy of that
establishment (hereinafter abbreviated to the appointed unit).
5. Within 10 working days after
receiving a written appointement from the provincial Department of Health, the
appointed unit must check and report the checking result to the provincial Department
of Health. Time of receipt of written appointement is counted under the receipt
seal of arriving official dispatch of the appointed unit.
6. If the suspended establishment
has remedied violations and met regulations of this Circular, within 05 working
days after receiving report from the appointed unit (Time of receipt of report
is counted under the receipt seal of arriving official dispatch of the
provincial Department of Health), director of the provincial Department of
Health must consider and decide to terminate the operation suspension. Decision
on terminating the operation suspension shall be sent to the addiction
treatment establishment suffered operation suspesion, the provincial HIV/AIDS
control Center.
7. In case the period of suspension
is expired but the establishment fails to remedy violation or has remedied
violation but still fail to meet regulations of this Circular, within 05
working days, after the expired day of the decision on suspension or after
receiving report of the appointed unit, director of the provincial Department
of Health must consider and decide the termination of treatment operation of
that establishment.
Article 16.
Withdrawal of operation permit of treatment establishment
An operation permit is withdrawn
in the following cases:
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2. 12 months after being granted
operation permit, the addiction treatment establishment has not operated.
3. The addiction treatment
establishment temporary stops operation during 12 consecutive months or it had
stopped operation.
4. Change its location.
5. In case prescribed in clause 7
Article 15 of this Circular.
Article 17.
Procedures for withdrawal of operation permit of treatment establishment
1. In the course of examination,
inspection over operation of an addiction treatment establishment which has
been licensed for operation, if detecting that addiction treatment
establishment commits one of violations specified in Article 16 of this
Circular, unit performing examination, inspection must make a minutes on
temporary operation suspension according to the form specified in the Annex 7
promulgated together with this Circular and send it to the provincial
Department of Health.
2. Within 05 working days, after
receiving minutes on temporary operation suspension specified in clause 1 of
this article, director of the provincial Department of Health shall consider
and decide withdrawal of operation permit. Decision on withdrawal of operation
permit shall be sent to the addiction treatment establishment withdrawn
operation permit, the provincial HIV/AIDS control Center.
Chapter 5
GUIDE ON
REGISTRATION FOR ALTERNATIVE TREATMENT PARTICIPATION AND FORWARDING FOR
TREATMENT TREATMENT
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1. Procedures for and dossier of
registration for the addiction treatment for substances of opium with respect
to addicts of substances of opium shall comply with the Decree No.
96/2012/ND-CP.
2. The application form of
participation in the addiction treatment for substances of opium is complied
with the form set in the Annex 8 promulgated together with this Circular.
Article 19.
Procedures for forwarding of addiction treatment for substances of opium
1. Procedures for forwarding of
addiction treatment for substances of opium:
a. Patient submits an application
for forwarding for treatment according to the form set in the Annex 9
promulgated together with this Circular to the head of the addiction treatment
establishment where he/she is participating in treatment;
b. Within 02 working days, after
receiving the application for forwarding for treatment of the patient, the head
of the medical treatment establishment where the patient has a wish to be forwarded shall make a copy of medical record and a
forwarding slip to send the patient for the addiction treatment of substances
of opium (hereinafter referred to as the forwarding slip for sending) according
to the form set in the Annex 10 promulgated together with this Circular;
c. Within 02 working days, after
receiving the medical record of patient who wishes to be
forwarded for the addiction treatment, the new addiction treatment
establishment shall receive and perform the treatment for the forwarded person.
2. Procedures for change of the
addiction treatment establishment:
a. Patient submits an application
for forwarding for the treatment according to the form set in the Annex 9
promulgated together with this Circular to the head of the addiction treatment
establishment where he/she is participating in treatment;
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c. Within 02 working days, after
receiving the medical record of patient who wishes to be forwarded for the
addiction treatment, the new addiction treatment establishment shall receive
and perform the treatment for the forwarded person.
Chapter 6
RESPONSIBILITY
FOR REALIZATION
Article 20.
Responsibilities of the Ministry of Health
1. To direct, guide, check,
inspect implementation of this Circular nationwide.
2. To coordinate with relevant
units in formulation of education programs and documents on the alternative
treatment; study, apply science and technology in the alternative treatment.
3. To cooperate with experts,
perform the technical and new treatment method transfer, other international
cooperation activities related to the alternative treatment.
Article 21.
Responsibilities of the provincial Departments of Health
1. To assume the prime
responsibility for, and coordinate with relevant departments, sectors and units
in formulation and submission to the provincial People’s Committee for approval
of project on carrying out the alternative treatment in localities as
prescribed by law.
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3. To manage the grant of
operation permit for the local treatment establishment; publicize data involving
grant, re-grant, list of the addiction treatment establishments which have been
granted, re-granted, suspended or withdrawn the operation permit on their
websites.
4. To check, follow up operation
of the treatment establishment under their management; perform examination,
inspection and handling of violations involving activitied of the alternative
treatment in localities under their mamnagement as prescribed by law.
5. To perform the report regime of
grant, re-grant and withdrawal of operation permit for the addiction treatment
establishments as prescribed by law.
Article 22.
Responsibilities of the provincial HIV/AIDS control Centers
1. To consult for the provincial
Department of Health in formulation of the overall projects and carry out the
alternative treatment in localities.
2. To guide, technically support
for carrying out the alternative treatment of the addiction treatment
establishments in localities under their responsibility as prescribed by law.
3. To participate in examination,
supervision over activities of the treatment establishments under their
management.
Article 23.
Responsibilities of the adddiction treatment establishments
1. To hold the addiction treatment
for substances of opium by use of the alternative medicines according to specialized
guides as prescribed by the Minister of Health.
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3. Monthly report list of cured
persons, situation of treatment and compliance of patients during alternative
treatment course to competent agencies in accordance with regulation.
4. Suffer the examination and
supervision of the provincial Department of Health and the provincial HIV/AIDS
control Center.
Chapter 7
IMPLEMENTATION
PROVISIONS
Article 24.
Provisions of reference
In case the documents referred in
this Circular are replaced or amended, supplemented, the replacing documents or
amending and supplementing documents will be implemented.
Article 25.
Effect
This Circular takes effect on June
01, 2013.
Article 26.
Transitional provisions
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2. The treatment establishments
which have operated before January 01, 2013, are entitled to operate but not
later than July 30, 2014, they must send dossier of request for operation
permit as prescribed in clause 1 Article 9 of this Circular in order to perform
procedures for grant of operation permit.
Article 27.
Responsibility for implementation
The Director of the Vietnam
Administration of HIV/AIDS Control, director of the Legal Affair Department and
the Chief Inspector of Ministry shall, within their assigned functions, tasks
and powers, coordinate with relevant Departments, Directorates in examination,
inspection of grant, re-grant of operation permit, the implementation of
addiction treatment of substances of opium by use of the alternative medicines
and the law observance of the treatment establishments nationwide.
In the course of implementation,
any arising problems should be reported to the Ministry of Health (the Vietnam
Administration of HIV/AIDS Control) for study and settlement
FOR THE
MINISTER OF HEALTH
DEPUTY MINISTER
Nguyen Thanh Long