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MINISTRY
OF HEALTH
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SOCIALIST
REPUBLIC OF VIETNAM
Independence - Freedom - Happiness
………….
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No.:
23/2013/TT-BYT
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Hanoi,
August 13, 2013
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GUIDANCE ON DRUG PROCESSING ACTIVITIES
Pursuant to the Law on Pharmacy No. 34/2005/QH11
dated June 14, 2005;
Pursuant to the Commercial Law No.36/2005/QH11
dated June 14, 2005;
Pursuant to Decree No. 12/2006/ND-CP dated
January 23, 2006 of the Government detailing the implementation of the
Commercial Law regarding international goods trading and activities of agents,
purchase, sale, processing and transit of goods with foreign countries;
Pursuant to Decree No. 79/2006/ND-CP dated
August 9, 2006 of the Government detailing the implementation of a number of
articles of the Law on Pharmacy;
Pursuant to Decree No. 89/2012/ND-CP dated
October 24, 2012 of the Government amending and supplementing a number of
articles of Decree No. 79/2006/ND-CP dated August 9, 2006 of the Government
detailing a number of articles of the Law on Pharmacy;
Pursuant to Decree No. 63/2012/ND-CP dated
August 31, 2012 of the Government stipulating the functions, tasks, powers and
structure of the Ministry of Health;
At the proposal of Director of
Drug Administration of Vietnam ;
The Minister of Health issues Circular guiding
activities of drug processing.
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GENERAL PROVISIONS
Article 1. Scope of regulation
and subject of application
1. This Circular provides for drug processing,
dossier to register drug processing, order and procedures for registration,
suspension and withdrawal of registration number of drug process.
2. This Circular applies to domestic and foreign
organizations and individuals having activities related to the drug processing
and registration for circulation of processed drug in Vietnam.
Article 2. Explanation of term
In this Circular, the terms below are construed as
follows:
1. Drug processing is that the processing Party
performs work to make products as required by the Ordering Party and the
Ordering Party receives products and makes payment of remuneration under the
agreement in accordance with the regulations of law.
The processing Party's job is to implement the
processing of one, a number or all stages of the drug manufacturing process
(receipt of raw materials, processing and packaging including packaging in the
final packing and labeling).
2. Drug ordered for processing is the drug issued
with Permit for circulation or product export by the pharmaceutical management
agency; issued with patent or researched by very ordering Party for drugs without
circulation registration number in Vietnam.
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4. Processing Party is the Party manufacturing and
receiving remuneration of manufacturing from the ordering Party. The processing
Party may consist of a lot of manufacturers and each manufacturer is involved
in one or a lot of stages of manufacturing.
5. Processing contract is the agreement between the
Parties, accordingly, the processing Parties perform work to make products as
required by the ordering Party which shall receive and make payment of
processing remuneration.
6. Transitional processing is the drug processing
in which there are a lot of processing parties, thus:
- The processed products of this processing
contract shall be used as processing materials for other processing contracts
in Vietnam;
- The processed products of processing contract of
previous stages shall be delivered to other manufacturers designated by the
ordering Party for the processing contract of the following stages.
Chapter II
REGULATIONS ON DRUG
PROCESSING
Article 3. Conditions for drug
processing
1. Conditions to be the name of the ordering Party
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2. Conditions to be the name of the processing
Party
a) For pharmaceutical chemical drugs, herbal drugs
(except for oriental drug), vaccines, sera containing antibodies, biomedical
products: manufacturing establishment in Vietnam with certificates of elibility
for drug business and certificate of standard satisfaction of "Good
manufacturing practice" (GMP) with the dosage form of suitable for drugs
intended for processing.
b) For in
vitro diagnostic biological products: manufacturing establishment in Vietnam
with certificate of eligibility for drug business and certificate of standard
satisfaction of "Good manufacturing practice" (GMP) or TCVN ISO 13485 or other equivalent standards with the
dosage form of suitable for drugs intended for processing.
Article 4. Rights and
obligations of the ordering Party and the processing Party
1. For ordering Party:
a) Owning registration number and processed
products;
b) Ordering the processing of one or a number of
manufacturing stage from the processing Party;
c) Receiving the processed products in accordance
with the method, time limit and terms agreed in the contract;
d) Taking responsibility for registration of
processed drug in accordance with the order and registration procedures
prescribed in Circular No. 22/2009/TT-BYT dated November 24, 2009 by the
Minister of Health stipulating drug registration (hereafter referred to as
Circular No. 22/2009/TT-BYT);
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e) Providing manufacturing processes, technical
standards and testing methods of original materials, semi-finished and finished
products, and other papers relating to the drug processing;
g) Making payment of processing remuneration as
agreed in the contract;
h) Taking responsibility for the quality, safety
and efficiency of processed and manufactured drugs during the course of drug
circulation;
i) Taking responsibility for issues relating to
intellectual property of drug registered for circulation and the other rights
and obligations under the provisions of law on commercial processing.
2. For processing Party:
a) Receiving remuneration as agreed in the
contract;
b) Having the right to require the ordering Party
to deliver materials with proper amount, quality, time limit and location as
agreed in the contract. If the processing Party itself may provide original
materials, it must ensure the quality of materials in accordance with the
ordering Party’s standards.
c) Having the right to refuse to receive the
processing if the ordering Party provide materials which do not meet quality
standard as stated in the signed contract;
d) Requiring the ordering Party to provide
manufacturing processes, technical standards and testing methods of original
materials, semi-finished and finished products, and other papers relating to
the drug processing.
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e) Keeping dossiers, materials and drug samples
related to drug manufacturing process and providing those dossiers to the
competent state agencies as required;
g) Taking responsibility for product quality
testing throughout the manufacturing process and product quality assurance
until delivering the processed products to the ordering Party;
h) Processed products, surplus materials, scrap,
waste products after completion of the processing contract as agreed by both
Parties in accordance with regulations of law;
i) Other rights and obligations as prescribed by
law on commercial processing.
Article 5. Drug processing
contract
1. Form of drug processing contract
The drug processing contract must be made in
writing and comply with regulations of Vietnam law on economic contract.
2. Mandatory contents in a drug processing
contract:
a) Agreement on provision of raw materials, provision
of manufacturing process, technical standards and testing methods of original
materials, semi-finished and finished products and other papers related to the
drug processing;
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c) Powers and responsibilities of each party for
the keeping of dossier on manufacturing, quality control, distribution and
circulation of drugs, the drug sample storage, settlement of problems related
to quality, complaints, product recalls on the market;
d) Responsibility of the ordering Party for issues
relating to intellectual property of the registered drugs;
dd) Process and procedures for inspecting the
processing Party’s manufacturing establishment;
e) Cases of annulment of contract;
g) There must be consent from the manufacturing
establishment to the drug processing whose registration number still valid by
Vietnam Ministry of Health (in case the registration establishment is different
from the manufacturing establishment).
Article 6. General regulation
on processed and manufactured drugs
1. Regulation on processed and manufactured drugs:
a) For drugs with circulation registration number
in Vietnam: Being manufactured and processed in one, a number or entire stage
of the manufacturing process at one or a number of processing manufacturers;
b) For drugs without circulation registration
number in Vietnam: Being manufactured and processed in the entire stage of the
manufacturing process and placed only at one processing manufacturer.
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a) First registration for processing;
b) Registration for major modification;
c) Registration for minor modification;
d) Re-registration;
dd) Other registration for modification;.
3. Requirements for clinical trials,
bioavailability and bioequivalence: The requirements for clinical trials
related to new drugs, bioavailability and bioequivalence for processed and
manufactured drugs for circulation in Vietnam shall comply with the provisions
of the Ministry of Health on clinical trials, bioavailability and
bioequivalence of drugs.
4. Production,
transportation, and circulation of processed drugs containing narcotic drugs,
psychotropic and precursor substances used as drugs (including pure in
combination form) shall comply with the provisions of the Ministry of Health on
management of narcotic drugs, psychotropic and precursor substances and other
regulations of the relevant laws.
5. Issuance of circulation registration number of
processed drugs:
a) The
processed drugs are issued with registration number which is valid for five
(05) years from the date of signing the decision on issuance of registration
number and must not be longer than the validity of registration number of drug
ordered for processing. The validity of registration number of transitional
processed drugs shall be equal to the remaning time of validity of registration
number of drug ordered in the previous stage. In special cases, the Advisory
Council shall issue the drug registration number – the Ministry of Health shall
consider and make proposal to the Minister of Health for decision.
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b) For drugs with circulation registration
number in Vietnam ordered for processing: the validity of old registration
number shall terminate after three (03) months from the date the processing
registration number takes effect; drugs ordered for processing before the
expiry of the old registration number shall be circulated to the expiration of
drug.
6. Import and export of processed drugs shall comply
with provisions of legal documents detailing the implementation of the
Commercial Law on international goods trading and activities of agents,
purchase, sale, processing and transit of goods with foreign countries; the
current regulations of the Ministry of Health
on the management of import and export of drugs and other relevant legal
documents.
Chapter III
DOSSIER
FOR PROCESSED DRUG REGISTRATION
Article 7. General provision on
dossier for processed drug registration
1. Language used in registration dossier:
Dossier for processed
drug registration must be written in Vietnamese (except for dossier for
bioequivalence testing report and clinical dossier).
2. Dossier for drug
registration shall be prepared on A4 size paper and firmly bound. Dossier shall
be arranged in the sequence of the catalog with the separation between
sections. The separated sections must be numbered for easy reference and
confirmed by registration establishment or drug manufacturing establishment in
the first page of each section of the entire dossier.
3. Each drug must have
separate registration dossier, except that the drug has the same factors likely
registered in the same dossier as follows:
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b) Dosage form;
c) Formula for a dose unit
(for drug form of single dose) or the same concentration levels (for multi-dose
drug);
d) Manufacturer;
4. General requirements for
materials to be submitted in the dossier for registration of processed
drug for the first time, re-registration and dossier to
request the other modifications as follows:
a) One (01) orginal including all
parts specified in Article 8 of this Circular;
b)
Two (02) copies of materials including application for drug registration and
standard of finished products;
c) Drug group: two (02) sample
sets of design label. These labels are mounted on A4 paper with the affixed
seal of the registration establishment;
d) Product information:
Instruction or information sheet for patient or Summary of product
characteristics as prescribed for each type of corresponding drug with the
affixed seal of the registration establishment;
dd) Drug sample:
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- For vaccines and sera containing
antibodies, the registration establishment shall send sample at the National
Institute for vaccines and biomedical products;
e) Summary of product.
5. Dossier for registration of major
modification, minor modification and other modifications ;
One (01) original with all materials
is required submitting as follows :
a) For pharmachemical drug, vaccines and sera containing antibodies, biomedical products:
Complying with provisions in Clause 4, 5 and 6, Article 17 of Circular No. 22/2009/TT-BYT;
b) For in vitro diagnostic
biological products: Complying with provisions in Clause 3 and
4, Article 22 of Circular No. 22/2009/TT-BYT;
c) For herbal drug (except for
oriental drug): Complying with provisions in Clause 3,
4 and 5, Article 26 of Circular No. 22/2009/TT-BYT;
6. Regulation on legal dossier
The legal dossier complies with the
provisions in Clause 6, Article 10 of Circular No. 22/2009/TT-BYT and Clause 1
and 2, Article 10 of Circular No. 45/2011/TT-BYT dated December 21, 2011 of the
Minister of Health amending and supplementing a number of articles of Decision
No. 1570/2000/QD-BYT dated May 22, 2000 of the Minister of Health on application of principle “Good
Laboratory Practice”; Decisison No. 2701/2001/QD-BYT dated June
29, 2001 of the Minister of Health on application of
principle “Good Storage Practice”; Circular No. 06/2004/TT-BYT
dated May 28. 2004 guiding the drug manufacturing and processing; Decision No.
3886/2004/QD-BYT dated November 13, 2004 of the Ministry of Health on
application of principle and standard ”Good Manufacturing Practice” as
recommended by the World Health Organization; Circular No. 13/2009/TT-BYT dated
September 01, 2009 of the Ministry of Health guiding activities of drug
advertising and information; Circular No. 22/2009/TT-BYT dated November 24,
2009 of the Ministry of Health on drug registration; Circular No.
47/2010/TT-BYT dated December 29, 2009 guiding the import and export of drug
and packaging in direct contact with the drug (hereinafter referred to as
Circular No. 45/2011/TT- BYT).
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a) Application for registration must
be directly signed and sealed (if any) by the Director of drug registration
establishment or its authorized representative. The stamp signature is not
acceptable;
b) Power-of-attorney is required in
the following cases:
- Authorized to sign dossier for drug
registration when director of drug registration establishment authorizes the
Head of representative of drug registration establishment in Vietnam;
- Authorized to use drug name the
drug name registered as a trademark when the owner of trademark is not the drug
registration establishment.
Each dossier must have one (01)
original or certified copy of power-of-attorney of the registration
establishment or representative office in Vietnam.
8.
Provision on quality dossier, pre-clinical and clinical dossier :
a) Quality dossier : applies
with the ASEAN Common Technical Dossier (ACTD) and technical guidelines as
prescribed in Circular No. 22/2009/TT-BYT, particluarly :
- Technical standards and
methods of drug testing, drug manufacturing process provided by the ordering
Party;
- Drug testing slip of
processed drug provided by the processing Party.
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c) For
drugs processed for export (no domestic circulation):
- Quality dossier consists of :
Technical standards, methods of drug testing, drug manufacturing
process, materials of stabilit research (acceptable research result in terms of
speed aging of extrapolated life expectancy) provided by the ordering Party;
processed drug testing slip provided by the processing Party.
- The
report on bioequivalence research data, the pre-clinical and clinical dossier
are not required submitting.
9. Provision on drug group and
product information :
a) Processed drugs in domestic
circulation: the content of drug group and product information comply with the
provisions of Clause 8, Article 10 of Circular No. 22/2009/TT-BYT.
b) Drugs processed for export : The
content of drug label and product information comply with regulations of
importing country. The procesing establishment and ordering Party are
responsible for the contents on drug label and product information.
10. Provision on charges
The
drug registration establishment shall make payment of charges relating to the
drug registration and circulation as prescribed by law on fees and charges.
11.
Provisions on processed drug naming: complies with provisions on drug naming in
Article 11 of Circular No. 22/2009/TT-BYT.
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1. Dossier for registration of
processed drug of the drug with valid circulation registration number
a) Administrative dossier and
product information:
- Cover page - (Form 1/GC)
- Table of Contents;
- Application for registration
specifying each stage of production, including processing stages with names and
addresses of respective manufacturers (01 original + 02 copies)- (Form 2a/GC);
- Power-of-attorney (if any) -
(Form 3a/GC) or (Form 3b/GC);
- Certificate of eligibility
for drug trading if being Vietnamese drug business establishment (copy with
certification of establishment):
- Drug group (03 originals) ;
- Product information : (03
originals) ;
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- Summary of product (Form 7a/GC);
- Certificate, title of
protection, transfer contract of related objects of industrial property rights
(if any);
- Other legal papers (if any).
b) Quality dossier (including
technical standards and methods of drug testing: 01 original + 02 copies).
- For pharmachemical finished
drugs, vaccines, sera containing antibodies, biomedical products: complying
with the provisions of Clause 1, 2, 3 and 4, Article 19 of Circular No.
22/2009/TT-BYT.
- For diagnostic biological products:
complying with provisions in Article 24 of Circular No. 22/2009/TT-BYT.
- For herbal drugs (except for
oriental drugs) : complying with the provisions in Article 28 of Circular
No. 22/2009/TT-BYT.
- For drugs on the list of drugs
locally manufactured: submitting registration dossier at the local Service of
Health: complying with the provisions of Annex V of the Circular No.
22/2009/TT-BYT.
c) Drug processing contract :
complying with provisions in Article 5 of this Circular.
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a) Administrative dossier and product
information:
- Cover page – (Form 1/GC)
- Table of contents;
- Application for registration
(01 original + 02 copies) - (Form 2b/GC);
- Power of attorney (if any) -
(Form 3a/GC) or (Form 3b/GC);
- Certificate of eligibility
for drug trading if being Vietnamese drug business establishment (copy with
certification of establishment):
- Certificate of
Pharmaceutical Product (CPP) or Certificate of Free Sale (FSC) (if without
CPP);
- Drug label (03 originals);
- Product information: (03
originals);
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- Summary of product (Form 7b/GC);
- Patent or drug research materials
at the ordering establishment ;
- Certificate, title of
protection, transfer contract of related objects of industrial property rights
(if any);
- Other legal papers (if any).
b) Quality dossier : (technical
standards, methods of drug testing : 01 original + 02 copies).
- For pharmachemical finished
drugs, vaccines, sera containing antibodies, biomedical products: complying
with the provisions of Clause 1, 2, 3 and 4, Article 19 of Circular No.
22/2009/TT-BYT.
- For diagnostic biological
products: complying with provisions in Article 24 of Circular No. 22/2009/TT-BYT.
- For herbal drugs (except for
oriental drugs) : complying with the provisions in Article 28 of Circular
No. 22/2009/TT-BYT.
- For drugs on the list of
drugs locally manufactured: submitting registration dossier at the local Service
of Health: complying with the provisions of Annex V of the Circular No.
22/2009/TT-BYT.
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d) Pre-clinical
and clinical dossier (if new drug) ;
- For pharmachemical finished
drugs, vaccines, sera containing antibodies, biomedical products: complying
with the provisions of Article 20 and 21 of Circular No. 22/2009/TT-BYT.
- For in vitro diagnostic
biological products: Complying with provisions in Article 25
of Circular No. 22/2009/TT-BYT;
- For herbal drugs (except for
oriental drugs) : complying with the provisions in Article 29 of Circular
No. 22/2009/TT-BYT.
3. Dossier for re-registration of
processed drugs :
a) Administrative dossier and product
information :
- Cover pate (Form 1/GC);
- Table of contents;
- Application for registration (01
original + 02 copies) (Form 2c/GC);
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- Certificate of eligibility
for drug trading if being Vietnamese drug business establishment (copy with
certification of establishment):
- Drug label (03 originals);
- Product information: (03
originals);
- Drug sample;
- Summary of product (Form 7c/GC);
Certificate, title of protection, transfer contract
of related objects of industrial property rights (if any);
- Other legal papers (if any).
b) Quality dossier (including
technical standards and methods of drug testing: 01 original + 02 copies).
- For pharmachemical finished
drugs, vaccines, sera containing antibodies, biomedical products: complying
with the provisions of Clause 1, 2, 3 and 4, Article 19 of Circular No.
22/2009/TT-BYT.
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- For diagnostic biological
products: complying with provisions in Article 24 of Circular No. 22/2009/TT-BYT.
- For herbal drugs (except for
oriental drugs) : complying with the provisions in Article 28 of Circular
No. 22/2009/TT-BYT.
- For drugs on the list of
drugs locally manufactured: submitting registration dossier at the local
Service of Health: complying with the provisions of Annex V of the Circular No.
22/2009/TT-BYT.
c) Drug processing contract :
complying with provisions in Article 5 of this Circular.
d) Report on drug circulation (Form
5/GC).
Article 9.
Provision on dossier for registration of processed drug for export (No
circulation in Vietnam)
1.
Dossier for registration of processed drug for the first time not circulating
in Vietnam:
a) Administrative dossier and
product information:
- Cover page - (Form 1/GC)
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- Application for registration
(01 original + 02 copies) (Form 4a/GC);
- Power-of-attorney (if any) -
(Form 3a/GC) or (Form 3b/GC);
- Certificate of eligibility
for drug trading if being Vietnamese drug business establishment (copy with
certification of establishment):
- Drug label (03 original);
- Product information: (03
original);
- Drug sample;
- Summary of product (Form 7b/GC);
- Certificate, title of
protection, transfer contract of related objects of industrial property rights
(if any);
- Other legal papers (if any).
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c) Drug processing and manufacturing
contract : complying with provisions in Article 5 of this Circular.
d) Undertaking that drugs
manufactured under processing contract shall not be circulated in Vietnam (Form
6/GC).
2. Dossier for re-registration of
processed drugs not circulating in Vietnam:
a) Administrative dossier and product
information :
- Cover page - (Form 1/GC)
- Table of Contents;
- Application for registration
(01 original + 02 copies) (Form 4a/GC);
- Power-of-attorney (if any) -
(Form 3a/GC) or (Form 3b/GC);
- Certificate of eligibility
for drug trading if being Vietnamese drug business establishment (copy with
certification of establishment):
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- Product information: (03
original);
- Drug sample;
- Summary of product (Form 7b/GC);
- Certificate, title of
protection, transfer contract of related objects of industrial property rights
(if any);
- Other legal papers (if any).
b) Quality dossier : complying
with the provisions at Point c, Clause 8, Article 7 of this Circular (technical
standard and methods of drug testing : 01 original + 02 copies).
c) Drug processing and manufacturing
contract : complying with provisions in Article 5 of this Circular.
d) Undertaking that drugs
manufactured under processing contract shall not be circulated in Vietnam (Form
6/GC).
Chapter IV
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Article 10.
Order, procedures for registration of processed drugs
1. The order, procedures for domestic registration of processed drugs
(excluding drugs specified in Annex V of Circular No. 22/2009/TT-BYT) and registration for modification.
a) Receipt : The Drug
Administration of Vietnam – Ministry of Health shall receive dossiers for
registration of processed drugs directly submitted or sent via post for the
following cases :
- Dossier for first registration,
re-registration concerning dossiers for registration of processed drugs
- Dossier for registration of major
modification, minor modification and other modifications during the time
the registration number of processed drug is still valid for all drugs with
registration number.
b) Appraisal and approval:
- The Drug Administration of
Vietnam shall appraise and request the Advisory Council to issue
the circulation registration number of drug – Ministry of Health (hereafter
referred to as Advisory Council) for:
+ Processed drugs of the drugs
ordered for processing without circulation registration number
+ Processed drugs of the drugs
ordered for processing with valid circulation registration number but
their registration dossiers have not followed the ASEAN Common
Technical Dossier (ACTD) ;
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- The Drug Administration of Vietnam shall
appraise to issue registration number (without submission to the Advisory
Council) for:
+ Processed drug re-registered
but their dossiers for registration of processed drug for the
first time have followed the ASEAN Common Technical
Dossier (ACTD);
+ Drugs processed for the first time of the drugs
ordered for processing already have their valid circulation registration number
but their dossiers for registration have followed the ASEAN Common Technical Dossier (ACTD);
+ Drugs processed for export
2. Order and procedures for registration of drugs
used other than domestic processing are specified in Annex V of Circular
No.22/2009/TT-BYT.
a) Service of Health of provinces and
centrally-affiliated cities where the manufacturing establishments are located
shall receive dossiers for first registration, re-registration submitted
directly or via post.
b) Within three (03) months after
receiving valid dossiers, the Service of Health shall appraise and send the
Ministry of Health (Drug Administration of Vietnam) official dispatch together
with list of drugs to propose the issuance of registration number for processed
drugs whose dossiers have been received by the Service of Health so that the
Ministry of Health may review and issue registration numbers. If there is not
sufficient grounds to propose the issuance of registration numbers, the Service
of Health shall reply in writing to the registration establishment stating the
reasons
3. Competence to issue registration
number of processed drugs :
a) The Minister of Health shall
authorize the Director of Drug Administration of Vietnam to sign the decision
on issuance of list of drugs to be issued with processing registration number
for drugs detailed in Paragraph 1, Point b, Clause 1 and 2 of this Article;
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c) The Drug Administration of Vietnam
shall respond in writing to the proposed modification for valid processed drugs
and settle issues relating to the manufacturing, registration and circulation
of processed drugs.
4. Time limit for issuance of
registration number or response to registrations dossiers :
a) Within six (06) months after fully
receiving valid dossiers, the Drug Administration of Vietnam shall issue
registration number or answer in writing specify the reasons if the dossiers do
not satisfy the conditions for issuance of registration number for the
drugs :
- Processed drugs of the drugs
ordered for processing without circulation registration number;
- Processed drugs of the drugs
ordered for processing with valid circulation registration number but
their registration dossiers have not followed the ASEAN Common
Technical Dossier (ACTD) ;
- Processed drugs are re-registered
but their dossiers for registration of processed drug for the first time have
not followed the ASEAN Common Technical Dossier (ACTD) ;
b) Within two (02) months after fully
receiving valid dossiers, the Drug Administration of Vietnam shall issue
registration number or respond in writing stating the reasons if the dossiers
have not met the conditions for issuance of registration number to the
following drugs :
- The processed drugs
re-registered whose dossiers for registration of processed drug for the first
time have followed the ASEAN Common Technical Dossier
(ACTD) ;
- The processed drugs
registered for the first time with their valid circulation registration number
but their dossiers have followed the ASEAN Common Technical
Dossier (ACTD);
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c) Within two (02) months after fully
receiving valid dossiers, the Drug Administration of Vietnam shall review and
respond to dossiers for registration of major modification, minor
modification ;
d) The time limit for issuing
registration number or responding to dossiers for other modifications shall
comply with the provisions specified at Point a, Clause 4 fo this Article.
dd) Within 20 working days after
receiving official dispatch from Service of Health, the Drug Administration of
Vietnam shall consider and issue circulation registration number. If there are
not sufficient grounds to issue the registration number, the Ministry of Health
shall respond in writing to the Service of Health clearly stating the reason.
Article 11.
Suspension and withdrawal of registration number of processed drugs
1. During the time the registration number
of processed drugs is valid, if both Parties terminate their contract , the
ordering Party shall report to the Drug Administration of Vietnam to withdraw
its circulation registration number in Vietnam.
2. Other cases of suspension and
withdrawal of registration number of processed drugs shall comply with the
provisions in Article 33, 34 of Circular No. 22/2009/TT-BYT.
Chapter V
IMPLEMENTATION
PROVISION
Article 12. Effect
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Annulling Circular No. 06/2004/TT-BYT
dated May 28, 2004 of the Minister of Health guiding the manufacturing and
processing of drugs and annulling Article 3 of Circular No. 45/2011/TT-BYT
dated December 21, 2011 of the Minister of Health amending and supplementing a
number of articles of Decision No. 1570/2000/QD-BYT dated May 22, 2000 of the
Minister of Health on application of principle “Good Laboratory
Practice”; Decision No. 2701/2001/QD-BYT dated June 29, 2001 of
the Minister of Health on application of principle “Good Storage Practice”;
Circular No. 06/2004/TT-BYT dated May 28, 2004 guiding the drug manufacturing and processing; Decision No. 3886/2004/QD-BYT
dated November 13, 2004 of the Ministry of Health on application of principle
and standard ”Good Manufacturing Practice” as recommended by the World Health
Organization; Circular No. 13/2009/TT-BYT dated September 01, 2009 of the
Ministry of Health guiding activities of drug advertising and information;
Circular No. 22/2009/TT-BYT dated November 24, 2009 of the Ministry of Health on
drug registration; Circular No. 47/2010/TT-BYT dated December 29, 2009 guiding
the import and export of drug and packaging in direct contact with the drug
from the effective date of this Circular.
Article 13. Transitional
provision
Dossiers for registration of
processed drugs submitted before the effective date of this Circular shall be
appraised and issued with registration number as prescribed in Circular No.
06/2004/TT-BYT dated May 28, 2004 of the Minister of Health guiding the
manufacturing and processing of drugs.
Article 14. Reference
provision
In case the legal normative documents and
provisions cited in this Circular have modifications, supplementation or
supersession, the new legal normative documents shall apply.
Article 15. Responsibility for
implementation
1. The Drug
Administration of Vietnam shall guide the implementation of provisions of this
Circular ; assume the prime responsibility for or coordinate with Ministry
of Health Inspector, Departments and Administrations to examine and inspect the
implementation of this Circular for pharmaceutical manufacturing and business
units nation-wide.
2.
Service of Health of provinces and centrally-affiliated cities are responsible
for examination and inspection of implementation of this Circular for pharmaceutical manufacturing and business
units under their management.
3. Units
directly under the Ministry of Health, Vietnam
Pharmaceutical Corporation, pharmaceutical
manufacturing and business units, foreign companies having Operation
Permit in pharmaceutical area are liable to execute this Circular.
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MINISTER
Nguyen Thi Kim Tien