Quyết định 24/2006/QD-BYT

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."

Article 4.- The director of the Vietnam Drug Administration shall organize the application of "Good Manufacturing Practices for Cosmetics" of the Association of Southeast Asian Nations at cosmetics manufacturing establishments in Vietnam.

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.

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:

On September 2, 2003, the Minister of Trade, on behalf of the Government of the Socialist Republic of Vietnam, signed the Agreement on ASEAN Harmonized Cosmetic Regulatory Scheme (AHCRS), according to which, as from the member states of the Association of Southeast Asian Nations must apply principles and standards of "Good Manufacturing Practices for Cosmetics" of the Association of Southeast Asian Nations (CGMP-ASEAN).

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.

4. Applicable documents:

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:

- A written CGMP inspection registration (Form No. 01/CGMP-MP not printed herein);

- 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;

i/ The CGMP self-inspection record (which should clearly indicate the time of self-inspection, members of the self-inspection team, objectives of self-inspection, self-inspection results and proposals on the time and measures to deal with problems).

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;

e/ A report on the establishment's self-inspection and -assessment of CGMP application in the latest three months.

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.

3.2. Competence to inspect and grant certificates:

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).

Where an establishment disagrees with the inspection team's conclusions, all opinions of the establishment should be clearly stated in the record.

+ 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.

· In the course of inspection, if detecting establishments' violations, which seriously affect the quality of one or all cosmetics products, heads of inspection teams may make records thereon and report such to the director of the Vietnam Drug Administration for issuance of official handling decisions.

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.