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THE MINISTRY OF HEALTH
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SOCIALIST
REPUBLIC OF VIET NAM
Independence - Freedom - Happiness
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No.: 10/2013/TT-BYT
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Hanoi, March
29, 2013
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CIRCULAR
AMENDING AND SUPPLEMENTING A NUMBER OF ARTICLES
OF THE CIRCULAR NO. 02/2007/TT-BYT, OF JANUARY 24, 2007, OF THE MINISTER OF
HEALTH GUIDING IN DETAIL THE IMPLEMENTATION OF A
NUMBER OF ARTICLES ON DRUG-DEALING CONDITIONS PRESCRIBED BY THE PHARMACY LAW
AND THE GOVERNMENT'S DECREE NO. 79/2006/ND-CP OF AUGUST 09, 2006, DETAILING THE
IMPLEMENTATION OF A NUMBER OF ARTICLES OF THE PHARMACY LAW
Pursuant to Pharmacy Law No. 34/2005/QH11 of June 14, 2005;
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;
Pursuant to the Government’s
Decree No. 89/2012/ND-CP, of October 24, 2012, amending and supplementing a
number of articles of the Decree No. 79/2006/ND-CP of August 09, 2006,
detailing the implementation of a number of articles of the Pharmacy Law;
At the proposal of the Director
of Drug administration of Vietnam,
The Minister of Health
promulgates the Circular amending and supplementing a number of articles of the
Circular no. 02/2007/TT-BYT, of January 24, 2007, of the Minister of Health
guiding in detail the implementation of a number of articles on drug-dealing
conditions prescribed by the Pharmacy Law and the Government's Decree No.
79/2006/ND-CP of August 09, 2006, detailing the implementation of a number of
articles of the Pharmacy Law.
Article 1. To amend and supplement
a number of articles of the Circular No. 02/2007/TT-BYT, of January 24, 2007,
of the Minister of Health guiding in detail the implementation of a number of
articles on drug-dealing conditions prescribed by the Pharmacy Law and the Government's
Decree No. 79/2006/ND-CP of August 09, 2006, detailing the implementation of a
number of articles of the Pharmacy Law (hereinafter abbreviated to the Circular
No. 02/2007/TT-BYT) as follows:
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“9. Dossiers
for grant or re-grant of pharmaceutical practice certificates
Dossiers for
grant or re-grant of pharmaceutical practice certificates shall comply with
clause 2 Article 1 of the Government’s Decree No. 89/2012/ND-CP, of October 24,
2012 amending and supplementing a number of articles of the Government’s Decree
No. 79/2006/ND-CP, of August 09, 2006 detailing the
implementation of a number of articles of the Pharmacy Law (hereinafter
abbreviated to the Decree No. 89/2012/ND-CP).
2. Clause 10 section II is
amended and supplemented as follows:
“10. Dossiers
for grant, re-grant, extension, business scope supplementation of certificates
of full satisfaction of drug-dealing conditions
a. Dossiers for grant, re-grant, extension, business scope
supplementation of certificates of full satisfaction of drug-dealing conditions
shall comply with clause 6 Article 1 of Decree No. 89/2012/ND-CP.
b. In case of grant, re-grant,
extension, business scope supplementation of
certificates of full satisfaction of drug-dealing conditions, if the
drug-dealing facilities have been issued the certificate of well practicing (GMP,
GSP, GLP, GDP, GPP) in conformity with business form
and scope, the respective technical documents as prescribed in clause 6 Article
1 of the Decree No. 89/2012/ND-CP are required authenticated copy or
copy of the well practicing certificate with signature of owner or head of
facility and seal for confirmation (for enterprise).
c. In case of grant, re-grant,
extension, business scope supplementation of certificates of full satisfaction
of drug-dealing conditions (inter-issuance), if the drug-dealing facilities
have not yet been issued the certificate of well practicing (GMP, GSP, GLP,
GDP, GPP) in conformity with business form and scope, the technical documents
as prescribed in clause 6 Article 1 of the Decree No. 89/2012/ND-CP shall
perform as follows:
- For drug production facilities:
Dossier of inspection on Good manufacturing practice (GMP) shall comply with
guides in the Decision No. 3886/2004/QD-BYT, of November 13, 2004, of the
Minister of Health on application of principle, standard on “Good manufacturing
practice” according to the recommendations of the World Health organization and
the relevant documents guiding, amending and supplementing.
- For facilities doing business on
drug testing service: Dossier of inspection on Good laboratory practice (GLP)
shall comply with guides in the Decision No. 1570/2000/QD-BYT, of May 22, 2000,
of the Minister of Health on application of principle on “Good laboratory
practice” and the relevant documents guiding, amending and supplementing.
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- For drug import facilities:
Dossier of inspection on Good storage practice (GSP) shall comply with guides
in the Decision No. 2701/2001/QD-BYT, of June 29, 2001, of the Minister of
Health on application of principle on “Good storage practice” and the relevant
documents guiding, amending and supplementing (Facilities with foreign direct
investment capital shall comply with the separate guiding documents).
- For drug wholesale facilities:
Dossier of inspection on Good distribution practice (GDP) shall comply with
guides in the Circular No. 48/2011/TT-BYT, of December 21, 2011, of the
Minister of Health on promulgating principles of good distribution practice.
- For drug retail facilities:
Dossier of inspection on Good pharmacy practice (GPP) shall comply with guides
in the Circular No. 46/2011/TT-BYT, of December 21, 2011, of the Minister of
Health on promulgating principles and standard of good pharmacy practice.
- For facilities producing
medicines from pharmaceutical ingredients: Dossier of grant of certificate of
egibility for medicine production shall comply with guides in the Circular No.
16/2011/TT-BYT, of April 19, 2011, of the Minister of Health on the principles
of producing medicines from pharmaceutical ingredients and the roadmap for
application of principles, standards on the good manufacturing practice (GMP)
to facilities producing medicines from phamaceutical ingredients (hereinafter abbreviated
to the Circular No. 16/2011/TT-BYT).
- For medicine retail facilities
that have not yet performed GPP under the roadmap in application of priciples,
standards on Good pharmacy practice (GPP) provided by the Ministry of Health,
the technical documents include: Declaration of locations and equipment of
business facilities (Form No. 07/KKDD-TTB); declaration on list of personnel
and professional degrees (Form No. 06/KKNS).”
3. Clause 11 section II is
amended and supplemented as follows:
“11. Procedures
and competence for grant, re-grant of pharmaceutical practice certificates
a. The
procedures for grant, re-grant of pharmaceutical practice certificates shall
comply with Clause 4, Article 1 of the Decree No. 89/2012/ND-CP.
b. The
Health Ministry shall authorize for the Provincial
Health Services to grant, re-grant or
withdraw pharmaceutical practice certificates to individuals who register for
pharmaceutical practice with foreign investment capital for business forms
including: Medicine production, service of medicine
storage, service of medicine testing, medicine import.
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4. To supplement Clause 11b
to section II as follows:
“11b. Order of and procedures for
returning the pharmaceutical practice certificates to individuals registering
for pharmaceutical practice
The state management agencies
competent to grant of certificate of drug business eligibility (hereinafter
referred to as competent agencies) shall return the original of pharmaceutical
practice certificates of the specialized manager of the drug-dealing facilities
in the following cases:
a. When the drug-dealing facility
changes the pharmaceutical manager:
- If the head of facility requests
for re-grant of the certificate of drug business eligibility as prescribed in
clause 6 Article 1 of the Decree No. 89/2012/ND-CP because change of the
pharmaceutical manager, the competent agency shall return the original of
pharmaceutical practice certificate of the old specialized manager for the
facilities together with the new certificate of drug business eligibility that
have been re-granted.
- If the pharmaceutical manager
unilaterally files application for receiving back the original of
pharmaceutical practice certificate, he/she must notify the request for change
of professional manager for the head of drug-dealing facility. Within 05
working days after receiving the request of pharmaceutical manager, the
competent agency shall notify for the head of drug-dealing facility to have to
change professional manager. Within 30 working days after being notified by the
competent agency, if the business facility fail to do procedures for change of
the professional manager, the competent agency shall return the original of the
practice certificate for the professional manager and carry out procedures for
withdrawal of certificate of eligibility for medicine business.
b. When the drug-dealing facility
terminates business operation:
Within 05 working days after
receiving notice of operation termination of the drug-dealing facility or after
the drug-dealing facility is withdrawn certificate of eligibility for drug
business as prescribed in Article 31 of the Government’s Decree No.
79/2006/ND-CP, of August 09, 2006, detailing the implementation of a number of
articles of the Pharmacy Law (hereinafter abbreviated to the Decree No.
79/2006/ND-CP), the competent agency shall withdraw certificate of eligibility
for drug business and returning the original of pharmaceutical practice
certificate for the professional manager (unless the professional manager is
withdrawn pharmaceutical practice certificate under Article 19 of the Pharmacy
Law).
c. When the facility submits
dossier of grant of certificate of eligibility for drug business but receives
reply in writing for grant refusal of the agency receiving dossier:
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d. When individual apply for
re-grant of pharmaceutical practice certificates
Not later than 60 days before the
pharmaceutical practice certificate of the professional manager is expired, the
drug-dealing facility must submit application for receipt of the original of
pharmaceutical practice certificate (Form No. 03/DDN-NCC) to the competent
agency.
Within 05 working days after
receiving request for receipt of pharmaceutical practice certificate from the
drug-dealing facility, the competent agency shall return the original of
pharmaceutical practice certificate for the drug-dealing facility, and notify
the facility which has been issued certificate of eligibility for information,
request the professional manager continue practice until past the time limit
inscribed in the pharmaceutical practice certificate. Before the old
pharmaceutical practice certificate is expired, the drug-dealing facility must
resubmit the newly-issued pharmaceutical practice certificate. If the pharmaceutical
practice certificate of the professional manager is expired but the facility
fail to resubmit a new pharmaceutical practice certificate or do procedures for
change of the professional manager, the competent agency shall withdraw
certificate of business eligibility as prescribed in point b clause 1 Article
31 of the Decree No. 79/2006/ND-CP.
5. Clause 12 section II is
amended and supplemented as follows:
“12. Procedures
and competence for grant, re-grant, extension, business scope supplementation
of certificates of full satisfaction of drug-dealing conditions
a. Procedures
and competence for grant, re-grant, extension, business scope supplementation
of certificates of full satisfaction of drug-dealing conditions shall comply
with clause 8 Article 1 of the Decree No. 89/2012/ND-CP.
b. For drug-dealing facilities
that have not yet issued the certificate of Good Practice (GMP, GSP, GLP, GDP,
GPP) in conformity with business form and scope, they shall be entitled to
apply the order of grant, re-grant, extension,
business scope supplementation of certificates of full satisfaction of
drug-dealing conditions as case of having to verify drug-dealing
facilities (inter-issuance).
c. In case where dossier of grant,
re-grant, extension, business scope supplementation of certificates of full
satisfaction of drug-dealing conditions have had valid certificate of
satisfying the Good pratice standard (GMP, GSP, GLP, GDP, GPP) in conformity
with business form and scope, the order of grant, re-grant, extension, business
scope supplementation of certificates of full satisfaction of drug-dealing
conditions without verification at business facilities as prescribed in clause
8 Article 1 of the Decree No. 89/2012/ND-CP shall be applied.
d. For re-grant of certificates of
full satisfaction of drug-dealing conditions specified in point 4 clause 6
Article 1 of the Decree No. 89/2012/ND-CP, it shall apply the order which not
require for verification at business facilities as prescribed in clause 8 of
the Decree No. 89/2012/ND-CP.
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e. Case of verification at
facilities, the Ministry of Health, the provincial Health Services shall
establish a delegation for verification at drug-dealing facilities. The
verification result shall be submited to leaders of the Ministry of Health or
the provincial Health Services to consider grant or refusal for certificate of
eligibility for medicine business without facility of A Advisory Council.”
6. To supplement Clause 13
to section II:
“13. To apply some content of
principle, standard of “Good Pharmacy Practice” for retail facilities in
roadmap of carrying out the Good practice (not yet compulsorily applied GPP)
The business conditions of agents,
medicine cabinet of medical stations, facilities retailing traditional
medicines, medicines from pharmaceutical ingredients shall comply with the
Circular No. 46/2011/TT-BYT, of December 21, 2011, of the Minister of Health,
on promulgating principles and standard of “good pharmacy practice”
(hereinafter abbreviated to the Circular No. 46/2011/TT-BYT), other than point
b, d clause 2; point b clause 3, point c clause 4 section II Chapter II and
point b, dd clause 1 section III Chapter II of principles and standard of “good
pharmacy practice” promulgated together with the Circular No. 46/2011/TT-BYT.
Members of inspection delegation:
applying to Article 4 of the Circular No. 46/2011/TT-BYT.”
7. To supplement Clause 14
to section II:
“14. To promulgate together with
this Circular the following forms:
a. Application of grant, re-grant
of pharmaceutical practice certificates (Form No. 1a/DDN-CC, Form No.
1b/DDN-CLCC);
b. The request for receipt of
pharmaceutical practice certificates (Form No. 2a/DDN-LCC; 02b/DDN-LCC);
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d. Application of grant,
supplementation, extension, re-grant of certificates of full satisfaction of
drug-dealing conditions (Form No. 4a-4b-4c-4d/DDN-DDK);
dd. Form of recept for dossier of
grant of pharmaceutical practice certificate/ certificate of full satisfaction
of drug-dealing conditions (Form No. 5a/BNHS, 5b/BNHS);
e. Declaration of list of
personnel and professional degrees (Form No. 6/KKNS); declaration of locations
and equipment of business facilities (Form No. 7/KKDD-TTB)
g. List of individuals who are
granted, re-granted, withdrawn pharmaceutical practice certificate within state
management of the provincial Health Services (Form No. 8a/BC-CCHN); List of
drug-dealing facilities which are granted, re-granted, extended, supplied
business scope of certificates of full satisfaction of drug-dealing conditions
(Form 8b/BC-GCNDKKD).
h. The pharmaceutical practice
certificate (Form No. 9a/CCHN, 9b/CCHN-CL);
i. The certificate of full
satisfaction of drug-dealing conditions (Form No. 10a/GCN-DKKD,
10b/GCN-DKKD-CL, 10c/GCN-DKKD, 10d/GCN-DKKD-CL).”
Article 2.
Transitional provisions
1. Transitional provisions shall
comply with Article 2 of the Decree No. 89/2012/ND-CP.
2. The pharmaceutical practice
certificates, certificates of full satisfaction of drug-dealing conditions
which have been issued before the effective day of this Circular shall be valid
untill past the time limit inscribed in the pharmaceutical practice
certificates, certificates of full satisfaction of drug-dealing conditions.
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4. Individuals and facilities are
entitled to submit dossier of grant, re-grant, extension, business scope
supplementation of certificates of full satisfaction of drug-dealing
conditions, grant, and re-grant of pharmaceutical practice certificate as soon
as this Circular is promulgated.
The drug-dealing facilities and
drug manufacturing facilities which are operating and of which pharmaceutical
practice certificate, certificates of full satisfaction of drug-dealing
conditions are expired after December 10, 2012 (as guided in clause 1 of the
official dispatch No. 177/BYT-QLD, of January 09, 2013, of the Ministry of
Health, on carrying out the Decree No. 89/2012/ND-CP) shall further operate 45
days after this Circular takes effect.
Article 3.
The responsibility for implementation organization
1. Drug administration of Vietnam,
the provincial Health Services shall guide and implement this Circular.
2. Drug administration of Vietnam
shall summarize and announce information related to grant, re-grant, withdrawal
of pharmaceutical practice certificates, list of facilities which are granted,
re-granted, extended, supplied business scope in the certificates of full
satisfaction of drug-dealing conditions, withdrawal of certificates of full
satisfaction of drug-dealing conditions on its website in order to do as basis
for units to perform grant, re-grant of pharmaceutical practice certificates;
grant, re-grant, extension, business scope supplementation of certificates of
full satisfaction of drug-dealing conditions.
3. Monthly, the provincial Health
Services shall summarize and announce list of individuals who are granted,
re-granted, withdrawn pharmaceutical practice certificates, list of facilities
which are granted, re-granted, extended, supplied business scope in the
certificates of full satisfaction of drug-dealing conditions, cases of
withdrawal and termination of business activities within their management scope
on their websites and send data to Drug administration of Vietnam for updating
in the database of pharmaceutical practice.
Article 4.
Implementation provisions
1. This Circular takes effect on
May 14, 2013.
2. The clause 9, clause 10, clause
11, clause 12 section II of the Circular No. 02/2007/TT-BYT and the Form of
receipt of dossier, forms of pharmaceutical practice certificate, certificate
of full satisfaction of drug-dealing conditions promulgated together with the
Circular No. 02/2007/TT-BYT are repealed from the effective day of this
Circular.
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THE MINISTER
OF HEALTH
Nguyen Thi Kim Tien