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THE
MINISTRY OF PUBLIC HEALTH
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SOCIALIST REPUBLIC OF VIET NAM
Independence - Freedom - Happiness
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No:
24/2006/QD-BYT
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Hanoi, August 14, 2006
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DECISION
ORGANIZING AND
GUIDING THE APPLICATION OF PRINCIPLES AND STANDARDS OF "GOOD MANUFACTURING
PRACTICES FOR COSMETICS" OF THE ASSOCIATION OF SOUTHEAST ASIAN NATIONS
THE MINISTER OF HEALTH
Pursuant to the December 24, 1999 Ordinance
on Goods Quality;
Pursuant to the Government's Decree No. 179/2004/ND-CP of October 21, 2004,
providing for the state management of product and goods quality;
Pursuant to the Government's Decree No. 49/2003/ND-CP of May 15, 2003, defining
the functions, tasks, powers and organizational structure of the Ministry of
Health;
At the proposal of the director of the Vietnam Drug Administration,
DECIDES:
Article 1.- To organize the application
of principles and standards of "Good Manufacturing Practices for
Cosmetics" of the Association of Southeast Asian Nations (CGMP-ASEAN) at cosmetics
manufacturing establishments in Vietnam.
Article 2.- To promulgate
together with this Decision the guidance on application of "Good
Manufacturing Practices for Cosmetics" of the Association of Southeast
Asian Nations.
Article 3.- This Decision
shall take effect 15 days after its publication in "CONG BAO."
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Article 5.- The director of
the Office and the chief inspector of the Inspectorate of the Health Ministry,
the director of the Vietnam Drug Administration, heads of units under the
Ministry, directors of provincial/municipal Health Services, and heads of
medical units in all branches shall have to implement this Decision.
MINISTER OF
HEALTH
Tran Thi Trung Chien
GUIDANCE
ON THE
APPLICATION OF "GOOD MANUFACTURING PRACTICES FOR COSMETICS" OF THE
ASSOCIATION OF SOUTHEAST ASIAN NATIONS (CGMP-ASEAN)
(Promulgated together with the Health Minister's Decision No. 24/2006/QD-BYT
of August 14, 2006)
I. GENERAL PROVISIONS:
1. Purposes:
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2. Interpretation of terms and abbreviations:
a/ Terms used in this guidance are construed as
follows:
- "Cosmetics manufacturing
establishments" means cosmetics business establishments which are
registered by organizations or individuals and have the function of
manufacturing cosmetics.
b/ Abbreviations:
- GMP stands for Good Manufacturing Practices.
- CGMP stands for Good Manufacturing Practices
for Cosmetics.
- ASEAN stands for the Association of Southeast
Asian Nations.
3. Subjects of application:
All cosmetics manufacturing establishments
operating in Vietnamese territory.
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a/ Guidance on the application of CGMP-ASEAN.
b/ ASEAN's latest documents on CGMP and the
Vietnamese Health Ministry's regulations on CGMP.
II. ORGANIZATION OF IMPLEMENTATION:
1. Dissemination and training:
1.1. The Vietnam Drug Administration shall
disseminate and provide training on CGMP-ASEAN contents and CGMP inspection for
provincial/municipal Health Services, medical units in all branches and
cosmetics manufacturing establishments.
1.2. Cosmetics manufacturing establishments
shall study, provide training on, and guide the application of, CGMP principles
and standards for their officials and employees.
2. Inspection registration procedures:
2.1. First-time inspection registration
dossiers:
Cosmetics manufacturing establishments applying
CGMP-ASEAN shall conduct self-inspection and -assessment according to the
CGMP-ASEAN principles and standards and prepare CGMP inspection registration
dossiers. Such a dossier shall comprise:
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- Enclosed documents:
a/ The business registration certificate or
enterprise establishment permit;
b/ The establishment's organization and
personnel plan (which should clearly state names, titles, professional or
technical qualifications of officials in charge of various sections), working
duration and relevant experience of officials in charge of various sections
(manufacture, quality control, quality assurance, warehousing);
c/ CGMP training programs and training-result
assessment at the establishment;
d/ The factory's location and design plans,
including the general plan; the plan of workers' paths; the plan of the course
of movement of raw materials, packings, semi-finished products and finished
products; and the plan of the waste treatment system;
e/ A list of the factory's existing equipment
(including cosmetics manufacture and quality control equipment: The name of
equipment, year of manufacture, country of manufacture, and state of equipment
should be indicated);
f/ A list of commodities being or planned to be
manufactured (clearly indicating the forms of preparation);
g/ A written certification or pre-acceptance
test record of fire prevention and fighting, issued by a competent agency in
the locality where the manufacturing establishment is located;
h/ The establishment's report environmental
impacts, enclosed with the dossier already evaluated and assessed by the
environmental state-management agency;
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A CGMP inspection registration dossier shall be
made in three sets and sent to the Vietnam Drug Administration - 138A Giang Vo street - Ba Dinh district - Hanoi.
2.2. Re-inspection registration dossiers:
Two months before the expiration of CGMP
certificates, cosmetics manufacturing establishments shall submit CGMP
re-inspection registration dossiers. Such a dossier shall comprise:
- A written CGMP re-inspection registration
(Form No. 02/CGMP-MP, not printed herein);
- Enclosed documents:
a/ A report on the establishment's changes in
two years' CGMP application;
b/ A report on the establishment's operation in
the past two years;
c/ A report on settlement of problems pointed
out in the previous inspection record;
d/ A summary on the establishment's training
activities in the past two years;
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2.3. Preparation and reporting upon inspection:
- Cosmetics manufacturing establishments shall,
upon CGMP inspection, report on their operation and application of CGMP
principles and standards through diagrams, graphs and summarized data.
- Upon CGMP inspection, cosmetics manufacturing
establishments must be in operation.
3. Inspection, and grant of certificates:
3.1. Criteria of officials conducting CGMP
inspection:
- Possessing a university or higher degree in
pharmacy, chemistry or biology; having been trained in CGMP; and possessing
knowledge about and experience in CGMP inspection.
- Being honest, accurate and impartial.
- Adopting scientific working methods; observing
regulations; being capable of rapidly detecting establishments' errors; and at
the same time, proposing persuasive measures for the establishments to rectify
their errors.
- Being physically fit, not suffering from
contagious diseases.
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The Vietnam Drug Administration shall receive
and evaluate inspection registration dossiers, set up inspection teams,
inspect, and grant certificates of satisfaction of CGMP standards to
establishments after the inspection shows that the establishments have
satisfied the CGMP requirements.
- Evaluation of CGMP inspection registration
dossiers:
After receiving establishments' complete CGMP
inspection registration dossiers as required in this guidance, the Vietnam Drug
Administration shall evaluate the dossiers. Within 30 days after receiving
complete and valid dossiers, the Vietnam Drug Administration shall decide to
set up inspection teams.
Where the dossiers are incomplete, the Vietnam
Drug Administration shall request in writing the establishments to supplement
them.
- Inspection, and handling of inspection
results:
+ Inspection:
* Members of an inspection team shall be decided
by the Vietnam Drug Administration.
* Contents of inspection: Inspection teams shall
inspect all activities of cosmetics manufacturing establishments according to
the CGMP-ASEAN principles and standards and current professional regulations.
* An inspection record shall be made in three
copies, one of them to be kept at the establishment and two others at the
Vietnam Drug Administration. Such a record must be signed and certified by the
person in charge of the establishment and the head of the inspection team. It
should also clearly indicate problems, recommendations and proposed solutions
for the CGMP application at the establishment (if any).
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+ Handling of inspection results:
* For first-time inspected establishments:
· If inspected establishments satisfy CGMP-ASEAN
principles and standards, the Vietnam Drug Administration shall grant
certificates of satisfaction of CGMP standards. Such certificates shall be
valid for 2 years.
· If inspected establishments basically
satisfy CGMP-ASEAN principles and standards and have several problems which do
not affect the quality of cosmetics and may be overcome in a short period,
inspection teams shall request the establishments to report on their solutions.
Within two months after the inspection, the establishments must overcome the
problems raised in the records made by the inspection teams and report the
results to the Vietnam Drug Administration. Heads of inspection teams shall
send sum-up reports thereon to the director of the Vietnam Drug Administration
for consideration and grant of CGMP certificates to the establishments.
· Inspected establishments which fail to
satisfy CGMP principles and standards must overcome their problems. After the
self-inspection and assessment of satisfaction of CGMP standards, the establishments
shall submit registration dossiers as required for first-time inspection
registration, enclosed with reports on the overcoming of the problems.
* For re-inspected establishments:
· Biennial inspections shall be
conducted, except cases of unexpected inspection at the proposal of
establishments or request of the Health Ministry (the Vietnam Drug
Administration).
· If the establishments still satisfy
CGMP-ASEAN principles and standards, the Vietnam Drug Administration shall
continue to grant CGMP certificates.
· Within 30 days after obtaining the
inspection results, which show the establishments' satisfaction of
requirements, the director of the Vietnam Drug Administration shall sign
decisions granting CGMP certificates to the establishments.
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4. Fee payment:
Cosmetics manufacturing establishments which
register for CGMP inspection at their establishments must pay a fee according
to the regulations of the Health Ministry and other provisions of law on
charges and fees.
III. IMPLEMENTATION PLAN:
1. From the effective date of this Decision to
December 31, 2007, the Health Ministry encourages establishments which have
applied GMP principles to register for inspection with the Health Ministry (the
Vietnam Drug Administration) in order to be inspected and granted CGMP-ASEAN
certificates.
2. From January 1, 2008, all cosmetics
manufacturing establishments must operate according to the CGMP-ASEAN
principles and standards.
In the course of implementation, organizations
and individuals should report any difficulties or problems to the Health
Ministry (the Vietnam Drug Administration) for consideration and solution.