The Decision 4012/2003/qd-Byt: Regulation On Registration Of Vaccines, Medical Products

Original Language Title: Quyết định 4012/2003/QĐ-BYT: Về việc ban hành quy chế đăng ký vắc xin, sinh phẩm y tế

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Pursuant to the law on people's health protection 11/7/1989;

Pursuant to Decree No. 49/2003/ND-CP on 15/5/2003 of government functions, tasks, powers and organizational structure of the Ministry of health;

Base No. 2942/KGVX on 20/6/1996 of the Government Office reported comments by Deputy Prime Minister Nguyen Khanh agreed to the Ministry of Health issued the regulatory text for the vaccines and biological products;

At the suggestion of the Director of preventive medicine and HIV/AIDS? The Ministry of health, decision: article 1. Attached to this decision "vaccine registration regulation, medical products".

Article 2. This decision takes effect 15 days from the date the quote and replace decision No 2010/BYT-QĐ dated 28/10/1996 of the Minister of health on issuing "vaccine registration regulation, born immune products".

Article 3. The He, she: Chief, Chief Inspector, Chief of preventive medicine and HIV/AIDS; Director of the Service of the Ministry of health; Vietnam Pharmaceutical Management Bureau Chief; Director of quality management, sanitation, and food safety; Heads of subdivisions; The Director of the Health Department of the province, central cities; Organization, production and trading individual vaccines, medical products is responsible for the implementation of this decision.

  

 

The REGISTRATION REGULATION of VACCINES and medical PRODUCTS (attached to decision No 3922/2003/QD-BYT on July 30, 2003) To unify the administration of vaccines, medical products in circulation in Vietnam for the person to ensure the safety, effectiveness and quality of vaccines , medical products, Health Ministry issued the "regulation on registration of vaccines, medical products".

 

Chapter I GENERAL PROVISIONS Article 1 1. All the vaccines, health products used for prevention, diagnosis and treatment, for people to be the Ministry of Health issued a new registration number are allowed to circulate in Vietnam.

2. in special cases (vaccines, medical products not yet having the registration number issued to be used in emergency disaster prevention, disease, refers to a group of objects, ...), the Department of health will consider allowing for each particular case in accordance with circular No. 6/2003/TT-BYT on 15/5/2003 the Ministry of health guidelines on the management and use of the vaccine Please, not medical products have been circulating registration number in case of emergency aid or imported into Vietnam for use in special cases.

Article 2 Of this regulation, a number of terms below are interpreted as follows: 1. The vaccine Antigen-containing preparations is likely to make the body immune response, which is used for the purpose of prevention or with other purposes.

2. medical products (hereinafter referred to as products) are products of biological origin are used for prevention, diagnosis and cure for the people.

3. Vaccine products, biological products are intermediate products from which the anti-plague vaccines and biological products.

4. the finished vaccines, biological products are those products that eventually are used to people.

Article 3 1. The production base, domestic businesses have production function, business, imported vaccines, products are allowed to register vaccines, biological.

2. the foreign facility has been the Ministry of health to license the operation of foreign companies in the field of vaccines, medical products in Vietnam are allowed to register vaccines, biological.

3. The scientific research base of Vietnam when a successful vaccine research, new products, while waiting for the technology transfer of the base functions to produce vaccines, biological research facility, if it is eligible and vaccine production standards, products prescribed by the Ministry of health shall be the registration of vaccines , biological research was successful. The Health Ministry will review and grant of registration under this regulation.

Article 4 The vaccines, products must register is: 1. The vaccines, biological production in the country and abroad have not been granted registration but named in the list of medical products, vaccines are the Ministry of health to review the registration number issued by the Minister of Health issued annually.

2. The vaccines, products have been given the registration number but there is a change in the formula, composition, variable, specify a user, the road user, the form of finished products, quality standards, inspection method, method of production, manufacturing process, manufacturing base.

Article 5 1. The vaccine, medical products have been given the registration number, the registration number within a period of validity if changes, additions to one of the following must apply for permission to the Ministry of health: a) to change the name of vaccines, biological b) dosage changes c) changing registered base d) change the name of the production facilities (production facility location does not change)) changed location of production (production base not changed) e) change or addition of contraindications to vaccines, biological g) change term used h) changes or additions packing i) change form label vaccines, biological Health Ministry review, retain the registration number and allows writing.

2. When changes or additions to one of the provisions in clause 1 of this profile, including: a) petition changes, supplements for vaccines, biological (form 8).

b) relevant documents about the problem please change or supplement.

For vaccines, foreign products: when changing location phảo production facilities have certificate of production facilities at the new location of GMP standards. When changing the name of the production facilities are certified production base with the new name of GMP standards.

Article 6 application of vaccines, products must be made in 3 sets, which have a set is the original (for the registration of births, vaccines abroad must be written in English for the original and Vietnamese for 2 sets left). The following documents must be the originals or copies of valid: a) the certificate of standard production facilities by the competent bodies of water in the level.

b) certificate of the competent authority country allows circulation or export of products of biological vaccines.

c) certificate of inspection results, vaccines, biological control center by country Vietnam medical products.

d) certificate of clinical trial results in quality, Vietnam.

DD) license issued vaccine, born by the competent authority.

The records must be clearly printed on A4 paper size, arranged in the correct sequence, are divided between sections, there are the cover and the list of documents.

All the materials in the record must be the basis of registration confirmation (signature, stamp). Sample case label vaccines, born in registration records are pasted on to A4 stamped up vaccine label, born.

Article 7 vaccine Label, products made in accordance with circular No. 14/2000/TT-BYT on 22/6/2000 of the Minister of health guidelines decision No 182/1999/QD-TTg dated 30/8/1999 of the Prime for labelling goods vaccines, born immune products and the other provisions of the current legislation on the labelling of goods circulation in the country import and export goods.

Information such as: barcode, code, medals, awards, signs of industrial property wanted to write on the label must have a copy of the legal documents pertaining to the above information.

Article 8 1. The registration number issued to print on the label, the vaccine products.

2. The registration number has the value of 5 years from the date of issue. The facility would like to sign back vaccines, biological to manufacturing, circulating in Vietnam, they must apply within 3 months before the registration number. After the registration number expire too 6 months that the basis has not filed registration documents, when want to continue to subscribe to the new registration records.

3. Term of use indicated on label vaccines, products must be in the same order: day, month, year.


4. for each of the vaccines, products of the same name, the Ministry of Health issued the registration number for each variable.

5. within 3 months from the receipt of completed as specified, the Health Ministry will issue the registration number. If not granted registration, the Ministry of health will clearly state the reason in writing.

Article 9 the base register circulation vaccines, products in Vietnam to pay fees in accordance with the law.

CHAPTER II REGISTRATION of VACCINES, PRODUCTS MANUFACTURED in the COUNTRY Article 10 1. Profile register vaccines, biological products for prevention and treatment, including: a) the registration application form (form 3).

b) certificate of standard production facility by the Health Ministry.

c) production processes, testing, d) quality standards and inspection) certificate of inspection results, vaccines, biological control center of national medical products for 3 consecutive batches.

e) A presentation Summary introducing the process and results of research with study materials on the following issues: composition, composition.

The effect, just use.

Contraindications.

Side effects, how to handle.

Stability and preserving.

Brief profile of production and testing of vaccines, products of three consecutive batches.

The material on made in the original strains of bacteria, viruses.

h) quality clinical results.

I) Label (designed or tied up model number 6) is the official form Please circulate, the label directly on the smallest packaging unit, the label on the package indirectly, attached to the sheet of directions for use.

k) vaccine, born: Save at the National Center for medical products.

2. birth registration records and products finished products to diagnose are: a) the application for registration (form 4) b) certificate of standard production facility by the Health Ministry.

c) production processes, testing.

d) quality standards and inspection) certificate of audit results of national accreditation centre for medical products.

e) A presentation Summary introducing the process and results of research with study materials on the following issues: composition, composition.

The effect, just use.

Stability and preserving.

The results of experiments.

h) Label (designed or tied up model number 6) was officially released, the label directly on the smallest packaging unit, the label on the package indirectly, attached to the sheet of directions for use.

I) vaccine, born: Save at the National Center for medical products.

3. the registration records of vaccine products, semi-finished products, including: a) the registration application form (form 3) b) certificate of standard production facility by the Health Ministry.

c) production processes, testing.

d) quality standards and inspection) of subscription license product e) certificate of inspection results, vaccines, biological control center of national medical products for 3 consecutive products batches.

h) A brief presentation introduces the process and results of research with study materials on the following issues: composition, composition.

Effects and specified use.

Contraindications.

Side effects, how to handle.

Stability and preserving.

Engineering, production processes and final products pulp forms.

Of the original strain origin i) is the official form Label Please circulate, the label directly on the smallest packaging unit, the label on the package indirectly, attached to the sheet of directions for use.

k) vaccine, born: Save at the National Center for medical products.

4. the registration records back vaccines, born: profile procedure as provided for in paragraph 1, item 2, paragraph 3 of this article, except item h item 1.

CHAPTER III REGISTRATION of VACCINES, PRODUCTS MANUFACTURED ABROAD Article 11 1. Profile register vaccines, biological products for prevention and treatment, including: a) the registration application form (form 3).

b) certificate of manufacturing GMP standard by the competent authority in the country.

c) certificate of the competent authority country allows circulation or export of products of biological vaccines.

d) certificate or a copy of the certificate of national auditing bodies in other countries in which vaccine products, please register đượn sold or distributed (case no auditing Agency in the country or is the vaccine, the first export products abroad, must also be specified).

DD) certificate of inspection results, vaccines, biological control center by country Vietnam medical products for 1 lot products.

e) clinical trial results with quality in Vietnam (the product was first used in Vietnam).

h) production processes, testing vaccines, products i) quality standards and accreditation k) materials: origin and history of the original strains of bacteria, viruses.

The relevant documents on copyright and the application of the certified production of vaccines, biological production situation report.

l) material about the stability of the vaccine, born: summary records of each batch produced 3 consecutive batches.

The licence issued by the competent authority country for each batch of 3 batches of vaccines, biological succession accompanied the audit results of the production control room.

m) Label (designed or tied up model number 6) is the official form Please circulate, the label directly on the smallest packaging unit, the label on the package indirectly, attached to the sheet of directions for use.

n) vaccine, born: Save at the National Center for medical products.

2. birth registration records and products finished products to diagnose: .2A) application for registration (form 4) b) certificate of standard production facilities by the competent bodies of water in the level.

c) certificate of the competent authority country allows circulation or export of products.

d) certificate of inspection results by the national accreditation centre of biological medicine, Vietnam.

DD) production process and inspection.

e) quality standards and accreditation h) A brief presentation introduces the process and results of research with study materials on the following issues: composition, composition.

The effect, just use.

Stability and preserving.

The results of experiments.

I) Label (designed or tied up model number 6) was officially released, the label directly on the smallest packaging unit, the label on the package indirectly, attached to the sheet of directions for use.

k) vaccine, born: Save at the National Center for medical products 3. Registration documents of vaccine products, biological products include: a) the application for registration (form 3).

b) certificate of manufacturing GMP standard by the competent authority in the country.

c) certificate of the competent authority country allows circulation or export finished products.

d) certificate or a copy of the certificate of national auditing bodies in other countries in which the registration please đượn products for sale or distribution. Case no auditing Agency in the country or was first published product abroad, must also clearly.

d) certificate of inspection results, vaccines, biological products by the national accreditation centre of biological medicine, Vietnam.

e) manufacturing process, inspection.

h) quality standards and inspection i): origin and history of the original strains of bacteria, viruses.

The relevant documents on copyright and the application of the production certificate statement production situation.

k) The material about the stability of test results: test production base for 3 consecutive products batches.

l) label is the official form of circulation, the label directly on the smallest packaging unit, the label on the package indirectly, attached to the sheet of directions for use.

m) vaccine, born: Save at the National Center for medical products.


4. the registration records back vaccines, born: profile procedure as provided for in paragraph 1, item 2, paragraph 3, of this article, except section e account 1.

 

CHAPTER IV RULES REGARDING CLINICAL TRIALS of VACCINES, BIOLOGICAL health article 12 all vaccines, new products are domestic or research have been used in the water but was first used in Vietnam to be the clinical trial in accordance with the Ministry of health before the grant of the registration number.

 

Chapter V HANDLE VIOLATION of article 13.

Vaccines, products have been given the registration number, in the longer term effect will be suspended in circulation or withdraw the registration number if a breach in the following cases: a) suspended from circulation for batches of vaccine, born not of standard quality as signed.

b) Withdrawal of registered products, vaccines circulating on the market is not properly registered profile; vaccines, biological production in 3 batches of substandard quality in 1 year or 1 time but seriously.

c) Clinical Trials of vaccines, biological permission in writing of the Ministry of health shall be processed under the provisions of the law.

d) vaccines, products in breach of industrial property will be handled according to the regulations.

Article 14.

1. The Ministry of Health announced suspension of circulation of vaccines, biological, withdrawal of registration and revocation of vaccines, poor quality products, vaccines, biological products not properly registered profile on a national scope.

2. When the decision to suspend and revoke the vaccines, the Agency checks, processing and sanctioning the violations as stipulated by the current legislation.

Article 15.

1. Upon receipt of the decision, suspending and revoking, the production base, business, imported vaccines, products must carry the following regulations: a) urgently implement measures to withdraw, notify authorities and customers know.

b) Created the recovery profile.

c) reports results recovered, causes, consequences and developments by vaccines, products withdrawn.

d) Established a process and proceed to handle vaccines, products withdrawn under current rules.

2. The basis of vaccines, products withdrawn must be responsible about vaccines, and products subject to all forms of handling in accordance with the law.

Article 16.

1. Who would violate this policy, depending on the level of violation will be disciplined, handling administrative violations or criminal processing, if damage to compensation under the provisions of the law.

2. The sanctioning of administrative violations in the field of administration of vaccines, products are made according to the current rules.

CHAPTER VI ORGANIZATION of the IMPLEMENTATION of article 17.

1. Authority to register vaccines, biological by the Minister of health decided, has the function to advise the Minister of health in the review and the level of registration of vaccines, born in Australia and overseas.

2. The Department of preventive medicine and HIV/AIDS is the permanent organ of the authority of registration of vaccines, biological Organization Mission of receiving the registration record of vaccines, biological, evaluation, organization of meetings of the Council and other relevant work.

3. On the basis of the conclusions and recommendations of the Board, the Minister of health will decide the level of registration, form processing for other types of vaccines, biological.

  

 

 

REGISTRATION form 1 vaccines, health PRODUCTS 1. Facility name and address: 2. Name Server registration Base: 3. name and address of the manufacturing facility: 4. Name Server production base: 5. name of vaccines, born: 6. vaccine Form sin, born: 7. Intended use: model 2 CATEGORY APPROVALS VACCINES PRODUCTS, PREVENTION And Treatment Of DOMESTIC PRODUCTION Of 1. Đơn xin đăng ký (mẫu 3)

 

 






 











 






2. Certificate of standard production facility by the Health Ministry. Production process, testing 4. Quality and inspection standards 5. Certificate of inspection results, vaccines, biological control center of national medical products for 3 consecutive batches 6. A summary presentation introducing the process and results of research with study materials on the following issues: a) the composition, structure, composition.

b) effects and specified use.

c) contraindications.

d) side effects, how to handle.

DD) stability and preserving.

 






 






e) material about the origin of the original strains of bacteria, viruses, 7. Clinical trial results in quality Vietnam 8. The label and instructions for use 9. Model vaccines, biological SAMPLES 3 REGISTERED vaccines, BIOLOGICAL PREVENTION, healing dear: the Ministry of Health Department of preventive medicine and HIV/AIDS 138A Giang Vo, Hanoi 1. Commercial name: Common Name: 2. name the production base: production Director: address: phone: Fax: 3. Sale Price: 4. The form of the vaccine, born: 5. Unit: 6. Use: 7. Specify, dosage: 8. Roads: 9. Stability and storage: 10. Expiration: 11. Contraindications, side effects,: 12. The original strains used to produce vaccines, born: 13. Package: Director production facilities (signed and stamped) on ...., ..... 200 years Director of the registered facility (signed and stamped) model 4 REGISTERED DIAGNOSTIC PRODUCTS Dear Health Ministry Directorate of preventive medicine and HIV/AIDS 138A Giang Vo, Hanoi 1. Commercial name: Common Name: 2. name the production base: production Director: address: phone: Fax: 3. Sale Price: 4. The form born: 5. Unit: 6. Use: 7. Specify, dosage: 8. Usage: 9. Stability and preservation conditions: 10. Expiration: 11. Package: Director production facilities (signed and stamped) on ...., ..... 200 years Director of the registered facility (signed and stamped) form 5 register records list biological products for diagnosis 1. Đơn xin đăng ký (mẫu 4)                                                                  

 






 






2. Certificate of standard production facilities by the competent authority. Production process, testing 4. Standard of quality inspection, 5. Certificate of inspection results by the national accreditation Center for medical-grade products 6. A summary presentation introducing the process and results of research with study materials on the following issues: a) the composition, structure, composition.

b) effects and specified use.

c) stability and preserving.

d) results 7. The label sheet with instructions for use 8. The SAMPLE products form 6 LABEL TEMPLATE CONTENT 1. Vaccine name, b.: the registration number:....................

2. Where production: 3. Number of series production: 4. number of units: 5. Date of manufacture: 6. Expires: 7. Usage: 8. Storage: Director production facilities (signed and stamped) Form 7


REGISTRATION LIST Of VACCINES, BIOLOGICAL PREVENTION And Treatment ABROAD 1. Đơn vị đăng ký (mẫu 3)

 



 





 






 





2. Certificate of manufacturing GMP standard by the competent authority in the country.

 



 





 






 





3. A certificate of the competent authority country allows circulation or export 4. The certificate or a copy of the certificate of national auditing bodies in other countries in which vaccines, products registered that are sold or distributed 5. Certificate of inspection results, vaccines, biological control center of the national supply medical products 6. Kết quả thử lâm sàng tại Việt Nam

 



 





 






 





7. Quy trình sản xuất, kiểm định

 



 





 






 





8. Tiêu chuẩn chất lượng và kiểm định

 



 





 






 





9. The: a) the origin and history of the original strains of bacteria, virus b) related documents on copyright and produced certificates application c) situation report produced recently for 10. The material on the vaccine's stability, b.: a) summary records of each production series of 3 finished product batches in a row.

b) licence issued by the competent national authority for each series of 3 batches of vaccines, biological succession accompanied the audit results of the production control room 11. Nhãn kèm tờ hướng dẫn sử dụng

 



 





 






 





12. Model vaccines, biological SAMPLES 8 PROPOSED CHANGES and supplements for medical PRODUCTS, VACCINE dear: the Ministry of Health Department of preventive medicine and HIV/AIDS 138A Giang Vo, Hanoi 1. Commercial name: Common Name: 2. name: a. production base address: b. phone: Fax: 3. Name of the registered establishments: a. address: b. phone: Fax: 4. The form of the vaccine, born: 5. Unit of force: 6. Use: 7. Specify, dosage, usage: 8. Roads: 9. Stability and preservation conditions : 10. Expiration: 11. Contraindications, side effects,: 12. The original vaccine strains, born: 13. Suggested content changes, additional: Director production facilities (signed and stamped) on ...., ..... 200 years Director of the registered facility (signed and stamped)