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MINISTRY OF HEALTH
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THE
SOCIALIST REPUBLIC OF VIETNAM
Independence– Freedom – Happiness
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No.:
06/2004/TT-BYT
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Hanoi,
May 28, 2004
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CIRCULAR
OF MINISTRY OF HEALTH NO.06/2004/TT-BYT DATED MAY 28, 2004
GUIDING THE OUTSOURCING PRODUCTION OF DRUGS
Pursuant to the Law on
Protection of People's Health dated July 11, 1989 and the Charter of drugs of
medical prevention and treatment issued together with the Decree No.23/HDBT dated
24/01/1991 of the Council of Ministers (now as the Government );
Pursuant to the Civil Code of
the Socialist Republic of Vietnam in 1995;
Pursuant to the Commercial
Law;
Pursuant to the Decree
No.57/1998/ND-CP dated 31/07/1998 of the Government detailing the
implementation of the Commercial Law regarding goods export, import,
outsourcing and agents of purchase and sale of goods with foreign parties;
Pursuant to the Decree No.44/2001/ND-CP dated 02/08/2001 of the Government
amending and supplementing some Articles of the Decree No.57/1998/ND-CP dated
31/07/1998 of the Government: detailing the implementation of the Commercial
Law regarding goods export, import, outsourcing and agents of purchase and sale
of goods with foreign parties;
To take
advantage of drugs production capacity of domestic enterprises, strengthen
production cooperation and improve the quality of drugs circulating in Vietnam,
better satisfy the needs of the people's drugs, the Ministry of Health guides
the outsourcing production of drugs as follows:
I. GENERAL PROVISIONS
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1.1. Subjects
of application:
-
Organizations, enterprises and individuals that produce pharmaceuticals, Legal
Institute, Center of Pharmaceutical Research under the provisions of the laws
of Vietnam.
- Foreign
manufacturers with licenses operating in the pharmaceuticals field in Vietnam
1.2. Scope of
governing:
- The
outsourcing production of the drugs having registration numbers for circulation
in Vietnam (except for the drug with active ingredients, dosage forms on the
list not receiving new registration and re-registration dossiers for foreign
drugs issued by the Health Ministry).
- The
outsourcing production of the drugs without registration numbers for circulation
in Vietnam: For foreign drugs, outsourcing ordering party must take back all
products after being processed; for domestic drugs, outsourcing ordering party
must export all products after outsourcing.
2.
Interpretation of terms
In this
Circular, the following terms are construed as follows:
2.1. Drug
outsourcing production means a manufacturer (outsourcing ordering party) owning
some drugs (with or without registration numbers in Vietnam) outsources another
manufacturer in Vietnam (outsourcing taking party) to manufacture those drugs.
The outsourcing taking party shall return the finished products to the
outsourcing ordering party to take an amount of remuneration as agreed in the
contract.
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2.3.
Outsourcing taking party means the party conducting the production and
receiving money of remuneration from the outsourcing ordering party.
2.4.
Production in this Circular shall be construed:
* For foreign
drugs:
- Outsourcing
all of the stages of the production process and are only be ordered at an
outsourcing taking party.
- Outsourcing
a stage of the production process and can only be ordered at an outsourcing
taking party applied to the particular dosage forms that Vietnam has not been
produced yet: lyophilized powder for injection, drug of slow effect, drug
releasing its active substance controlled, placing drug, special dosage forms
used for children.
* For
domestically-produced drug outsourcing one or all of the stages of the
production process and can only be ordered at an outsourcing taking party.
3. Grant of
registration numbers for circulation of drugs outsourced
3.1. Drug
ordered for outsourcing all of the stages of the production process will be
granted registration numbers for outsourcing, and allowed to circulate in
Vietnam. The registration numbers of the drugs produced by outsourcing takes
effect over 05 years from the date of issue, the validity of former
registration numbers will be terminated immediately after the registration
numbers of the drugs produced by outsourcing takes effect.
3.2. Drug
ordered for outsourcing one stage of the production process is continued for
production under the former registration number which has been issued and must
submit registration dossier as guided in this Circular.
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II. PROVISIONS FOR OUTSOURCING ORDERING PARTY OF DRUGS
PRODUCTION
1. Conditions
to be named the outsourcing ordering party:
The following
facilities are named in the outsourcing ordering party:
1.1. Lawful
drug production facilities in Vietnam having drugs granted valid registration
numbers or drugs having no registration numbers for circulation in Vietnam
receive outsourcing for export.
1.2. Foreign
drug manufacturers having "operation license of foreign enterprises in
medicines and medicine materials in Vietnam," order outsourcing drugs
granted valid registration numbers for circulation by the Ministry of Health of
Vietnam or drugs having no registration numbers for circulation in Vietnam, but
outsourcing ordering party will get the entire products.
1.3. Institute,
Center of research having drugs granted valid registration numbers for
circulation by the Ministry of Health.
2.
Responsibility of the outsourcing ordering party
2.1. To
register drugs with the Drug Administration of Vietnam.
2.2. To
provide materials in accordance with the correct quantity, quality, duration,
location for the outsourcing taking party, or provide standards of materials in
which the outsourcing taking party themselves supply during the drug
manufacturing process.
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2.4. To keep
records and documents related to the distribution process to ensure quality of
drugs circulating in the market.
2.5. To be
responsible for the quality, safety and efficacy of drugs to consumers in the
process of distribution of drugs on the market.
2.6. To be
responsible for intellectual property for drugs ordered for outsourcing
production.
3. The right
of the outsourcing ordering party
3.1. To be
owned registration numbers and its products.
3.2. To be
received the processed products in accordance with the correct method, terms
and conditions agreed upon.
3.3. To be
refused to get outsourced products not meeting quality standards as stated in
the signed contract.
III. REGULATIONS FOR OUTSOURCING TAKING PARTY OF DRUGS
PRODUCTION
1. Conditions
to be named as outsourcing taking party.
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2.
Responsibilities of outsourcing taking party
2.1. To
conduct drug manufacturing according to the right process, technique and ensure
quality of drugs in accordance with records of drug registration and
requirements of the outsourcing ordering party specified in the signed
contract.
2.2. If the
outsourcing taking party self-supplies the original materials, it must ensure
the quality of raw materials according to the standards of the outsourcing
ordering party.
2.3. To
request outsourcing ordering party to provide the manufacturing process,
technical standards and methods for testing the initial materials,
semi-finished and finished products, and other papers relating to drug
outsourcing production.
2.4. To
maintain records, documents, drug samples related to drug manufacturing
process.
2.5. To be responsible
for product quality control during the manufacturing and ensure quality of the
products until handing over them to the outsourcing ordering party.
2.6. To
return outsourced products, surplus materials, scrap, defective products to the
outsourcing ordering party after completion of outsourcing contract as
prescribed.
3. The rights
of the outsourcing taking party
3.1. To be
received remuneration in accordance with the agreement.
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3.3. To be
entitled to refuse to accept outsourcing production if the outsourcing ordering
party supplies raw materials not meeting quality standards as stated in the
signed contract.
IV. CONTRACT FOR DRUG OUTSOURCING PRODUCTION
Contract for
drug outsourcing production must be made in writing and shall comply with the
current provisions of the law of Vietnam relating to contracts, in addition, it
must contain the following contents:
1. Agreement
for supply of raw materials, the supply of production process, technical
standards and testing methods of the initial materials, semi-finished products,
finished products and other papers relating to the manufacturing, outsourcing
of drugs.
2. Rights and
responsibilities of each party on the quality control of raw materials,
semi-finished products, finished products and packaging process, product labels
and clear rules for signature of testing slip for each batch of finished
products and manufacture slips of products.
3. Rights and
responsibilities of each party on the archives of records on production,
quality control, distribution and circulation of drugs, the storage of drug
samples, settlement of problems related to quality and complaints, recall of
products on the market.
4. Process
and procedures for inspection of the production facilities of the outsourcing
taking party.
5. The cases
of contract cancellation.
V. REGISTRATION OF DRUGS PRODUCED BY OUTSOURCING
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1.1.
Registration dossier of drug produced by outsourcing must be made in 3 sets,
including one original set. The following documents without the originals, they
must have a notarized copy:
- Permit for
the sale of drugs (FSC)
- Certificate
of satisfaction of standards of good manufacturing practice (GMP) or replaced
two above licenses by a certificate of pharmaceutical products (CPP).
Besides, it
is also required to have two more 02 original sets of drugs label accompanied
with the drug registration dossier. Dossier shall be printed on A4 size paper
and arranged in the correct order, with separates between the parts.
1.2. All
documents in the dossier must be certified by the outsourcing ordering party
(signature and seal), where label is pasted on an A4 size paper, it shall be
stamped on its label.
1.3. Drug
registration dossier must be written in Vietnamese. Names of components of the
drug in the dossier must be the original name or common name in general use
domestically and internationally. For herbal medicine, it must be written name
of drug together with the scientific name in Latin.
1.4. Drug
labels, drug use instruction: strictly comply with current regulations on
labeling instructions and trademark of the drug. On the outer package label and
instruction sheet must include the words: "Made in: (name the outsourcing
taking party) under contract with: (name the outsourcing ordering party)"
with equal font size. Labels printed on the bottle (tube) of injections, vials
(tube) of oral solution with an area of the too small label, then allow only
printing in name of the outsourcing taking party.
1.5. Drug
registration dossier submitted to the Vietnam Drug Administration for assessment
and grant of registration numbers. Vietnam Drug Administration shall send
written notification of results no later than 30 days from the date of receipt
of valid dossiers.
1.6. Drug
registration facilities must pay registration fee in accordance with current
provisions.
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2.
Registration dossier of drug produced by outsourcing
2.1. Drug
registration dossiers of domestic production facilities, institutes, and
research centers ordering for outsourcing drug production having registration
numbers for circulation in Vietnam:
- Cover page
(Form No.1-DKT-SXGC).
- Contents of
documents (Form No.2-DKT-SXGC)
- Application
form (Form No.3A-DKT-SXGC) (In the application for registration, it must state
clearly the production stage of outsourcing).
- Drug labels
attached to Form No.4-DKT-SXGC (labels, instruction must be included full names
of manufacturers involved in the stages of the production process).
- Drug
testing slip produced at the outsourcing taking party.
- Sample of drug:
01 sample for one packing standard registered for circulation.
- Contract
manufacturing, outsourcing of drugs meeting the content as prescribed in this
Circular.
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- Cover page
(Form No.1-DKT-SXGC).
- Contents of
documents (Form No.2-DKT-SXGC)
- Application
form (Form No.3B-DKT-SXGC) (In the application for registration, it must state
clearly the production stage of outsourcing).
- Drug labels
attached to Form No.4-DKT-SXGC (labels, instruction must be included full names
of manufacturers involved in the stages of the production process).
- Drug
testing slip produced at the outsourcing taking party.
- Sample of
drug: 01 sample for one packing standard registered for circulation.
- GMP
certificate, permit for sale of drugs (FSC) or replaced two above licenses by
a valid certificate of pharmaceutical products (CPP) of the products
registered for outsourcing production granted by the competent agency (For
foreign drug).
- Contract of
outsourcing production of drugs to meet the contents as prescribed in this
Circular.
2.3.
Registration dossier of drug without registration number in Vietnam of the
domestic production facility ordering outsourcing for export, foreign
manufacturer ordering and receiving the entire processed products:
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- Contents of
documents (Form No.2-DKT-SXGC).
- Application
form (Form No.3A-DKT-SXGC or Form No.3B-DKT-SXGC) (In the application for
registration, it must state clearly the production stage of outsourcing).
- Drug labels
attached to Form No.4-DKT-SXGC (labels, instruction must be included full names
of manufacturers involved in the stages of the production process).
- GMP
certificate, permit for sale of drugs (FSC) or replaced two above licenses by
a valid certificate of pharmaceutical products (CPP) of the products
registered for outsourcing production granted by the competent agency (For
foreign drug).
- Technical
standards and methods of drug testing provided by the outsourcing ordering
party.
- The process
of drug production provided by the outsourcing ordering party.
- Drug
testing slip produced at the outsourcing taking party.
- Sample of drug:
01 sample for one packing standard registered for circulation.
- Contract of
outsourcing production of drugs to meet the contents as prescribed in this
Circular.
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VI. EXAMINATION, INSPECTION, AND HANDLING OF VIOLATIONS
1.
Examination – Inspection
1.1. Drug
Administration of Vietnam shall preside over and coordinate with the Health
Ministry Inspectorate, the departments of function to examine, inspect the
implementation of this Circular for the units manufacturing, trading
pharmaceutical products in the whole country.
1.2. Health
Departments of provinces, cities directly under the Central Government are
responsible for examining and inspecting the implementation of this Circular
for the units manufacturing, trading pharmaceutical products within their
respective local management.
2. Handling
of violations
Organizations
and individuals violating the provisions of this Circular, the current regulations
concerning the production and circulation of drugs and other concerned
provisions of law, depending on the seriousness of the violation will be
handled according to law provisions.
VII. IMPLEMENTATION PROVISIONS
1. This
Circular takes effect 15 days after its publication on the Official Gazette.
The previous regulations contrary to this Circular are hereby annulled.
2. Drug
Administration of Vietnam, the units under the Ministry of Health, Departments
of Health in provinces and cities directly under the Central Government, the
Vietnam Pharmaceutical Corporation, the pharmaceutical business enterprises,
foreign companies with operating license in pharmacy are responsible for
implementation of this Circular.
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Tran
Thi Trung Chien
(Signed)