Circular No. 08/2012/TT-BNNPTNT on procedures for registering the production and processing of veterinary drugs

CIRCULAR

Regulations on the registration procedures for the production and processing of veterinary drugs

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On the basis of the Veterinary Law April 29, 2004;

Decree No. Decree No. 33/2005/NĐ-CP dated March 15, 2005 of the Government detailing the implementation of certain provisions of the Veterinary Law;

Pursuant to Decree No. 119/2008/NĐ-CP dated November 28, 2008 of the Prime Minister amending and supplementing some articles of Decree No. 33/2005/NĐ-CP;

Pursuant to Decree No. 01/2008/NĐ-CP dated January 3, 2008 of the Government stipulating the functions, tasks, and organizational structure of the Ministry of Agriculture and Rural Development and Decree No. 75/2009/NĐ-CP dated September 10, 2009 of the Government amending Article 3 of Decree No. 01/2008/NĐ-CP dated January 3, 2008 of the Government;

The Ministry of Agriculture and Rural Development issues this Circular on the registration procedures for the production and processing of veterinary drugs.

PART I

GENERAL PROVISIONS

Article 1. Scope of Regulation and Applicability

1. This Circular stipulates the registration procedures for the production and processing of veterinary drugs (including aquatic animal health products).

2. This Circular applies to organizations within and outside Vietnam involved in the production and processing of veterinary drugs in Vietnam.

Article 2. Interpretation of Terms

In this Circular, the following terms are understood as follows:

1. Processing production of veterinary drugs refers to a manufacturer (the party requesting processing) owning one or more veterinary drugs (with or without a Certificate of Registration in Vietnam) entrusting another manufacturer (the processing party) in Vietnam to produce such drugs. The processing party returns the finished product to the requesting party.

The party requesting processing is the manufacturer owning the drug that is being processed.

2. The processing party is the entity undertaking the production of the drug according to a contract with the party requesting processing.

Article 3. Contract for the Production and Processing of Veterinary Drugs

The contract for the production and processing of veterinary drugs must be in writing and comply with current Vietnamese laws, and must include the following contents:

1. Agreement on the supply of raw materials and auxiliary materials, provision of production processes, technical standards, and testing methods for initial raw materials, semi-finished products, finished products, and other relevant documents related to the processing of veterinary drugs.

2. Rights and responsibilities of each party regarding the quality inspection of raw materials, auxiliary materials, semi-finished products, finished products, packaging procedures, and labeling of the product, and clearly defining the signing of test certificates for each batch of finished products and dispatch certificates for the product.

3. Rights and responsibilities of each party concerning the retention of records on production, quality inspection, distribution, circulation of drugs, sample retention, resolution of issues related to quality, complaints, and market recall of products.

Article 4. Conditions for Registering the Production and Processing of Veterinary Drugs

1. The product registered for processing must be a veterinary drug with a valid Certificate of Registration in Vietnam or a veterinary drug without a Certificate of Registration in Vietnam produced solely for export.

2. The processing facility must be a production facility certified by the Department of Animal Health with Good Manufacturing Practice (GMP) certification suitable for the veterinary drug being registered for processing.

3. The processing must encompass all stages of the production process and can only be carried out at one processing facility.

Article 5. Fees and Charges

The processing production registration facility must pay fees and charges for the examination of the application dossier and issuance of the Certificate of Registration

in accordance with current legal regulations. REGISTRATION FOR THE PRODUCTION AND PROCESSING OF VETERINARY DRUGS

Chapter II

REGISTRATION FOR THE PRODUCTION AND PROCESSING OF VETERINARY DRUGS

Article 6. Language and Form of Documents

1. Languages used in the application dossier:

The application for registration of domestic veterinary drug manufacturing and processing must be

written in Vietnamese, and the names of the drug components in the application must be the original name or commonly used name both domestically and internationally;

2. The application for registration of veterinary drug manufacturing and processing must be prepared on A4 paper size, securely bound. The application must have a cover page and table of contents, arranged in accordance with the correct sequence of the table of contents, with clear separation between sections. Each section must be numbered in order for easy reference and must have confirmation from the party placing the order or the party undertaking the processing at the beginning of each section throughout the entire application. Each veterinary drug must have its own separate registration application.

3. Drug labels and usage instructions:

Implement labeling of veterinary drugs according to current regulations on labeling guidelines and product trademarks.

On the outer packaging label and usage instruction sheet, the phrase "Produced at: (Name and address of the processing party) under contract with: (Name and address of the ordering party)" must be printed in the same font size. For labels on vials (syringes) or bottles (containers) of injectable or oral solutions where the surface area is too small, only the name of the ordering party should be printed, but all information must be fully recorded on the Usage Instruction Sheet.

4. Types of Good Manufacturing Practice (GMP) certificates, ISO certificates, Product Circulation Certificates (CFS, CPP, MA) included in the registration application may be submitted in one of the following forms:

- Original;

- Legal copy (certified copy);

- Photocopy, while presenting the original for verification if submitted directly;

For Product Quality Analysis Reports (CA), it must be the original.

Article 7. Registration of Veterinary Drug Manufacturing and Processing

1. Documents registration of veterinary drug manufacturing and processing shall be sent to the Department of Animal Health. Number of applications: one set.

2. For veterinary drugs that already have a Product Circulation Certificate in Vietnam, the application includes:

a) Application form for circulation of veterinary drugs produced through processing according to Appendix 1;

b) Summary of product information (name, ingredients, formulation type, packaging specifications, efficacy, usage method, expiration date);

c) Sample product label, Usage Instruction Sheet (registered label, processed label);

d) GMP certificate of the production facility undertaking the processing;

đ) Product Circulation Certificate issued by the Department of Animal Health for the party placing the order;

e) Contract for veterinary drug manufacturing and processing between the party placing the order and the party undertaking the processing (original);

g) Production process of the party placing the order;

h) Quality standards and testing methods for raw materials, intermediates, and finished products of the party placing the order;

i) Product quality analysis report of the processing facility.

3. For veterinary drugs without a Product Circulation Certificate from domestic manufacturers who place orders for export, the application includes:

a) Application form for exporting veterinary drugs through processing according to Appendix 2;

b) Summary of product characteristics including information on ingredients, quantitative composition, formulation type, packaging specifications, efficacy, indications, contraindications, usage instructions, storage instructions, precautions for animals designated, users, withdrawal period (if applicable), and other technical characteristics of the product;

c) Sample product label, Usage Instruction Sheet;

d) GMP or ISO certificates (for certain common chemicals) of the production facility undertaking the processing;

đ) Product Circulation Certificate issued by the regulatory authority of the foreign manufacturer's home country;

e) Contract for veterinary drug manufacturing and processing between the party placing the order and the party undertaking the processing;

g) Production process of the party placing the order;

h) Quality standards and testing methods for raw materials, intermediates, and finished products of the party placing the order;

i) Product quality analysis report of the processing facility;

k) Product quality analysis report issued by the designated veterinary drug testing agency in Vietnam;

l) Commitment statement that the manufactured drugs will not be sold in Vietnam;

m) Commitment not to violate intellectual property laws according to Appendix 4.

4. Time limit for resolution:

a) Within ten (10) working days from the date of receipt of the application for registration of manufacturing and processing, the Department of Animal Health is responsible for notifying the organization or individual applying to complete the application for those cases where the application does not meet requirements; b) Within twenty (20) working days from the date of receiving the completed application, the Department of Animal Health is responsible for reviewing the application and responding with the result.

5. Issuance of Certificates:

Veterinary drugs with a valid Product Circulation Certificate, which undergo full processing stages during production, will be issued a new Product Circulation Certificate for processed veterinary drugs.

a) b) Veterinary drugs without a Product Circulation Certificate in Vietnam, registered for processing and export, will be issued a Certificate of Free Sales (CFS) for export purposes only.

6. Validity of Certificates:

a) The Product Circulation Certificate for processed veterinary drugs

is valid for the duration of the Veterinary Drug Manufacturing and Processing Contract plus the product's shelf life, up to a maximum of five (5) years from the date of issuance. The validity of the old Product Circulation Certificate will terminate immediately when the Product Circulation Certificate for processed veterinary drugs becomes effective. b) Export Processing Certificate (CFS) is valid for two (2) years from the date of issuance.

b) The Certificate for Export Production Processing (CFS) is valid for two years from the date of issuance.

Article 8. Extension of the Veterinary Medicines Manufacturing Processing Circulation Certificate

1. Within three months before the Veterinary Medicines Manufacturing Processing Circulation Certificate expires, the commissioning entity shall submit one set of application documents for extending the Veterinary Medicines Manufacturing Processing Circulation Certificate to the Department of Animal Health. The documents include:

a) An extension application form for the Circulation Certificate according to Form 3 in the Appendix;

b) The Veterinary Medicines Manufacturing Processing Circulation Certificate;

c) The Good Manufacturing Practice (GMP) certificate of the processing entity;

d) A product quality analysis report from the processing entity producing veterinary medicines (for pharmaceutical and chemical products used in veterinary medicine) or from the designated veterinary drug testing agency in Vietnam (for vaccines and other forms) issued within twelve months;

d) A stability monitoring report under storage conditions stated on the label;

e) A circulation process report according to Form 5 in the Appendix;

g) A veterinary medicines manufacturing processing contract between the commissioning entity and the processing entity.

The processing time and validity period of the Certificate shall be governed by Clause 4 and Clause 6 of Article 7 of this Circular.

2. Article 9. Revocation of the Veterinary Medicines Manufacturing Processing Circulation Certificate

The Veterinary Medicines Manufacturing Processing Circulation Certificate will be revoked during its validity period in the following cases:

1. Veterinary medicines produced through processing do not meet quality standards after three consecutive regular or random inspections in one year by the competent authority, or if they violate regulations once but cause serious consequences; 2. Medicines infringe upon intellectual property rights laws;

3. Medicines have side effects that may harm human health, animals, or pose risks to humans, animals, and the environment;

4. Medicines contain active ingredients recommended by the World Health Organization, the World Organisation for Animal Health, or relevant authorities as unsafe for humans and animals;

5. Imported veterinary medicines registered for processing have had their circulation certificates revoked in their home country.

When the Veterinary Medicines Manufacturing Processing Circulation Certificate is revoked, the veterinary medicines listed in the certificate shall not be produced, circulated, or used. Produced and circulating medicines will be recalled and disposed of according to regulations.

Chapter III

Article 10. Responsibilities and Authorities of the Department of Animal Health

a) Receiving and reviewing applications for veterinary medicines manufacturing processing registration from organizations and individuals both domestically and internationally;

RESPONSIBILITIES AND LIMITATIONS

b) Issuing the Veterinary Medicines Manufacturing Processing Circulation Certificate;

1. Responsibilities

c) Organizing the dissemination and guidance on implementing this Regulation and related legal documents to units within the system and veterinary medicine production and trading enterprises nationwide;

d) Ensuring confidentiality of technical documents and data provided for manufacturing processing registration by the entities.

2. Authorities

a) Requesting manufacturing entities to provide documents and creating favorable conditions for inspecting compliance with this Circular and related legal documents concerning veterinary medicines manufacturing processing registration;

b) Suspending circulation and revoking the Veterinary Medicines Manufacturing Processing Circulation Certificate for cases stipulated in Article 9 of this Circular.

  a) Request the production facility to provide documentation and facilitate the inspection work to ensure compliance with the provisions of this Circular and other relevant regulatory documents concerning the registration for the production and processing of veterinary drugs;

  b) Suspend circulation and recall the Veterinary Drug Circulation Certificate for production processing in cases specified in Article 9 of this Circular.

Article 11. Rights and Obligations of the Party Commissioning Processing

1. Rights:

a) To be issued with a Veterinary Medicines Circulation Certificate for processed products, or a Processing Production Certificate for export (CFS);

b) To receive processed products according to the agreed method, time frame, and conditions with the party undertaking processing of veterinary medicines;

c) To have the right to refuse non-compliant processed products that do not meet the quality standards stipulated in the contract.

2. Obligations:

a) To register for the processing production of veterinary medicines with the Department of Animal Health;

b) To provide raw and auxiliary materials in accordance with the quantity, quality, time frame, and location agreed upon with the party undertaking processing, or to provide raw and auxiliary material standards so that the party undertaking processing can supply them during the production process of veterinary medicines;

c) To provide production procedures, technical standards, and testing methods for initial raw and auxiliary materials, semi-finished products, and finished products in accordance with the registration dossier at the Department of Animal Health and other documents related to the processing production of veterinary medicines;

d) To retain all relevant records and documents concerning the distribution process and the quality assurance of veterinary medicines circulating in the market;

đ) To be responsible for the quality, safety, and efficacy of veterinary medicines for consumers during their circulation on the market;

e) To be responsible for intellectual property rights regarding veterinary medicines commissioned for processing production.

Article 12. Rights and Obligations of the Party Undertaking Processing

1. Rights:

a) To receive processing fees as agreed;

b) To have the right to request the party commissioning processing to deliver raw and auxiliary materials in accordance with the quantity, quality, time frame, and location agreed upon in the contract;

c) To have the right to refuse to undertake processing if the party commissioning processing provides raw and auxiliary materials that do not meet the quality standards stipulated in the contract;

2. Obligations:

a) To carry out the production of veterinary medicines in accordance with the procedures, techniques, and ensure the quality of medicines as specified in the registered dossier and the requirements of the party commissioning processing as stipulated in the signed contract;

b) If the party undertaking processing supplies its own initial raw and auxiliary materials, it must ensure their quality in accordance with the standards of the party commissioning processing;

c) To request the party commissioning processing to provide production procedures, technical standards, and testing methods for initial raw and auxiliary materials, semi-finished products, and finished products, as well as other documents related to the processing production of veterinary medicines;

d) To retain all relevant records, documents, and samples of veterinary medicines concerning the production process;

đ) To be responsible for product quality inspection throughout the production process and ensure the quality of the product until it is returned to the party commissioning processing;

e) To return surplus raw and auxiliary materials, waste, and by-products to the party commissioning processing after completing the processing contract.

Chapter IV

IMPLEMENTING PROVISIONS

Article 13. Effectiveness

This Circular takes effect 45 days from the date of signature.

During implementation, if there are any issues, organizations and individuals should report to the Ministry of Agriculture and Rural Development (Department of Animal Health) for timely adjustment and supplementation./.