Circular No. 20/2011/TT-BNNPTNT amending, supplementing, and abolishing certain provisions on administrative procedures in the veterinary field pursuant to Resolution No. 57/NQ-CP dated October 15, 2010.

CIRCULAR

Amending, supplementing, and abolishing certain provisions on administrative procedures in the field of veterinary medicine

pursuant to Resolution No. 57/NQ-CP dated October 15, 2010

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On the basis of Decree No. 01/2008/NĐ-CP dated January 3, 2008 of the Government stipulating the functions, tasks, powers, and organizational structure of the Ministry of Agriculture and Rural Development; 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 stipulating the functions, tasks, powers, and organizational structure of the Ministry of Agriculture and Rural Development;

On the basis of Resolution No. 57/NQ-CP dated December 15, 2010 of the Government on simplifying administrative procedures within the scope of management functions of the Ministry of Agriculture and Rural Development;

The Ministry of Agriculture and Rural Development issues this Circular amending, supplementing, and abolishing certain provisions on administrative procedures in the field of veterinary medicine pursuant to Resolution No. 57/NQ-CP dated October 15, 2010 as follows:

1. Economic organizations conducting foreign exchange trading agency activities; economic organizations conducting foreign currency receipt and payment service provision activities; economic organizations conducting border country currency exchange agency activities.

"Article 1. Scope of Regulation

This Circular stipulates the registration for circulation and importation of veterinary drugs, raw materials for veterinary drugs, vaccines, biological preparations, microorganisms, chemicals used in veterinary medicine, and aquatic animal health products (hereinafter referred to as veterinary drugs) in Vietnam.”

2. Supplementing Clause 4b as follows:

“Clause 4b. Conditions for Registration for Circulation of Veterinary Drugs

1. For domestic production facilities

a) Domestic production facilities must have a Certificate of Compliance with Production Conditions for Drugs or a Certificate of Good Manufacturing Practice (GMP) compliance, in accordance with the regulations and the implementation schedule of GMP of the Ministry of Agriculture and Rural Development;

b) Foreign production facilities must meet GMP standards;

c) Facilities producing in vitro diagnostic chemicals and preparations must meet GMP, ISO, or equivalent standards.

2. For import facilities

Import facilities must have a Certificate of Compliance with Conditions for Veterinary Drug Business Operations according to Circular No. 51/2009/TT-BNNPTNT dated August 21, 2009 on Inspection and Certification of Compliance with Conditions for Production and Business Operations of Veterinary Drugs, Biological Preparations, Microorganisms, Chemicals Used in Veterinary Medicine, and Aquatic Animal Health Products (hereinafter referred to as Circular No. 51/2009/TT-BNNPTNT).”

3. Article 5 shall be amended and supplemented as follows:

"Article 5. Labels of Veterinary Drugs

1. Veterinary drugs circulating in the Vietnamese market must be labeled. Labeling of veterinary drugs shall comply with Decree No. 89/2006/NĐ-CP dated August 30, 2006 of the Government on Product Labels and Circular No. 03/2009/TT-BNN dated January 14, 2009 of the Ministry of Agriculture and Rural Development on Labeling of Veterinary Drugs.

2. The labels of veterinary drugs circulating in the market must match the label samples in the registration files at the management authority and at the registration facility.”

4. Article 6 is amended and supplemented as follows:

"Article 6. Registration for Circulation of Veterinary Drugs

1. New establishments registering for circulation of veterinary drugs for the first time must prepare a dossier including:

a) Certificates of Compliance with Conditions for Production, Business Operations, and Importation of Veterinary Drugs as prescribed;

b) Copies of relevant documents related to establishment: Establishment Decision, Business Registration Certificate, Professional Qualification Certificate corresponding to the type of production;

c) Registration dossiers for each product according to the provisions of this Circular.

2. Establishments already meeting conditions for production, business operations, and importation of veterinary drugs when registering for circulation shall follow point c of Clause 1 of this Article.”

5. Clause 1 of Article 7 is amended and supplemented as follows:

"Article 7. Procedures for Importation of Veterinary Drugs

1. Importation of veterinary drugs listed in the Catalogue of Permitted Veterinary Drugs for Circulation in Vietnam or already granted a Circulation Permit

Establishments meeting the conditions for importation of veterinary drugs as prescribed shall carry out importation as follows:

a) For drugs and raw materials for veterinary drugs: Establishments handle importation procedures at the customs clearance gate;

b) For vaccines and microorganisms: Establishments submit import orders according to the form in Appendix 3, Form 2 (one copy with electronic file) to the Department of Animal Health.

2. Importation of veterinary drugs not listed in the Catalogue of Permitted Veterinary Drugs for Circulation in Vietnam

a) Cases permitted for importation:

- Sample veterinary drugs, goods for exhibitions without commercial value;

- Veterinary drugs for testing, trial, and evaluation purposes for registration for circulation;

- Special veterinary drugs imported in small quantities without commercial value for diagnosis, prevention, and treatment of rare animals and imported pets;

- Raw materials (active ingredients, excipients, solvents, chemicals, and other auxiliaries) for production of products already listed in the Catalogue of Permitted Veterinary Drugs for Circulation in Vietnam.

b) Importation dossier includes: One set

- Import order according to the form in Appendix 3, Form 1 issued together with this Circular (one copy with electronic file);

- Certificates of GMP or ISO (for certain common chemicals); Circulation Permit for imported drugs;

- Quality analysis certificates from the manufacturer and the competent authority of the producing country (for vaccines and biological preparations);

- Summary of product characteristics (for new drugs).

c) The importation registration dossier is submitted to the Department of Animal Health;

d) Response time: Within seven working days from the date of receipt of the registration dossier, the Department of Animal Health is responsible for reviewing the dossier and providing a response."

6. Article 8 is replaced by Articles 8a, 8b, 8c, and 8d as follows:

"Article 8a. Dossier for Registration for Circulation of Chemical Veterinary Drugs

1. For new veterinary drugs, the registration dossier includes: One set

a) Application for Registration for Circulation according to the form in Appendix 1, Form 1 issued together with this Circular;

b) Summary of product characteristics including information about components, quantitative components, dosage form, packaging specifications, indications, contraindications, usage instructions, storage instructions, special considerations for designated animals, users, and other technical characteristics of the product, according to the form in Appendix 6 issued together with this Circular;

c) Product label samples (three sets), Usage Instructions leaflet;

d) Certificates of GMP or ISO (for certain common chemicals); certificates of market authorization issued by the competent authority of the producing country (for imported drugs);

đ) Production process;

e) Quality standards and testing methods (complete and detailed), quality analysis reports of the production facility;

g) Reports on data proving safety including toxicity research materials (acute, subchronic, chronic, cellular, carcinogenicity); residue studies in all designated animal species;

h) Reports on data proving efficacy including experimental pharmacology research materials; pharmacodynamics, pharmacokinetics, and bioavailability studies;

i) Withdrawal period (if applicable);

k) Research materials on drug stability and shelf life;

m) Research materials on dosage and treatment regimen for each designated animal species;

n) Quality analysis reports of the product issued by the competent authority of the producing country (for imported products) and quality analysis reports of the product issued by the designated veterinary drug testing agency in Vietnam;

p) Test results or trial outcomes;

q) A commitment not to violate intellectual property laws according to the model at Appendix 5 issued together with this Circular;

r) Other technical information (if any).

2. For generic drugs, the registration dossier includes:

a) The contents specified in points a, b, c, d, đ, e, i, k, q, r of Clause 1 of this Article;

b) Quality analysis reports of the product issued by the designated veterinary drug testing agency in Vietnam;

c) Information about the original drug (product name, manufacturer's name, formula, formulation, indications, contraindications, dosage, withdrawal period (if applicable), precautions for designated animals, users, and other technical characteristics of the product);

3. The registration dossier for changes and supplements includes: 01 set

a) An application for change and supplement according to the form at Form 1, Appendix 2 issued together with this Circular;

b) Related documents concerning the changes and supplements;

c) A copy of the valid veterinary drug market authorization certificate;

d) Old label samples (01 set), new label samples (03 sets);

đ) Old and new user guides;

4. The registration dossier for re-registration includes the contents specified in Clause 1 of this Article;

5. The registration dossier for extending the validity of the veterinary drug market authorization certificate includes: 01 set

a) An application for extension of the market authorization certificate according to the form at Form 2, Appendix 2 issued together with this Circular;

b) A copy of the valid veterinary drug market authorization certificate;

c) GMP or ISO certificates or certificates of compliance with conditions for veterinary drug production; market authorization certificates for imported drugs;

d) Quality analysis reports of the product issued by the production facility or by the designated veterinary drug testing agency in Vietnam within 12 months;

đ) Report on monitoring product stability under normal conditions;

e) Market circulation report according to the model at Appendix 4 issued together with this Circular.

Article 8b. Documents for registering the circulation of veterinary drug raw materials and herbal-based drugs

1. The documents for registering the circulation of drug raw materials include: 01 set

a) The contents prescribed in points a, b, c, d, đ, e, i, k, n, r of Clause 1 of Article 8a of this Circular;

b) Information about expired patent drug raw materials (name of raw material, name of manufacturer, formula, dosage form, and other technical characteristics of the product).

2. In addition to the provisions of Clause 1 of this Article, the documents for registering new raw materials must also include:

a) Reports on data proving safety including toxicity research data (acute toxicity, subchronic toxicity, chronic toxicity, cellular toxicity). Residue studies in all animal species designated for use;

b) Reports on data proving efficacy including pharmacological experimental research data; pharmacodynamics, pharmacokinetics, and bioavailability of the product;

c) Test results or trial reports;

d) Research data on raw material stability;

đ) Other technical information (data on the product's circulation in other countries around the world);

3. The documents for registering the circulation of herbal-based drugs include the contents prescribed in Clause 1 of Article 8a of this Circular;

4. The documents for registering changes and supplements include the contents prescribed in Clause 3 of Article 8a of this Circular;

5. The documents for extending the circulation certificate include the contents prescribed in Clause 5 of Article 8a of this Circular;

Article 8c. Documents for registering the circulation of vaccines and biological products

1. The documents for registering the circulation of vaccines and biological products include: 01 set

a) Application for circulation registration according to Form 2, Appendix 1 issued together with this Circular;

b) Summary of product characteristics including information on ingredients, quantitative components, dosage form, packaging specifications, indications, contraindications, usage instructions, storage instructions for vaccines and biological products, precautions for animals designated, users, and other technical characteristics of the product;

c) Product label samples (03 sets), Usage Instruction sheet;

d) Good Manufacturing Practice (GMP) Certificate; Product Circulation Permit issued by the competent authority of the producing country (for imported products);

đ) Production process;

e) Quality standards, testing methods for vaccines and biological products, Quality Analysis Report from the production facility;

g) Reports on data proving safety including toxicity research data (acute toxicity, subchronic toxicity, chronic toxicity, cellular toxicity). Residue studies in all animal species designated (if applicable);

h) Reports on data proving efficacy including antibody titer and duration of immunity research data (for vaccines);

i) Time of discontinuation (if applicable);

k) Research data on stability, batch summary of three consecutive batches and proposed shelf life;

m) Method for determining dosage and treatment regimen for each designated animal species;

n) Quality analysis report of the product issued by the competent authority of the producing country (for imported products) and by the designated veterinary drug testing agency in Vietnam;

p) Test result report (trial result report for imported products) including efficacy and safety of the product for target animals, users, and environment;

q) Related documents including:

- Origin, history, and stability of the original microorganism strain used to produce vaccines and biological products;

- Documents related to copyright and application of vaccine and biological product manufacturing certificates (if applicable);

r) Other technical information such as laboratory test and trial results, data on the product's circulation in other countries around the world (if applicable);

s) Epidemiological data proving the presence of disease-causing agents in Vietnam (applicable to new vaccines and biological products);

2. The documents for registering the circulation of diagnostic biological products include: 01 set

a) Application for circulation registration according to Form 3, Appendix 1 issued together with this Circular;

b) Summary of product characteristics including information on ingredients, quantitative components, dosage form, packaging specifications, indications, usage instructions, storage instructions, user precautions, and other technical characteristics of the product;

c) Product label samples (03 samples); Usage Instruction sheet;

d) GMP Certificate, ISO Certificate, or equivalent certification; Product Circulation Permit (FSC) issued by the competent authority of the producing country (for imported products);

đ) Quality analysis report issued by the competent testing authority of the producing country (for imported products), Quality analysis report of biological products issued by the designated veterinary drug testing agency in Vietnam;

e) Reports on data proving safety;

g) Reports on data proving efficacy of the product;

h) Production process;

i) Quality standards, detailed testing methods for biological products, Quality analysis report of biological products from the production facility;

k) Research data on stability, batch summary of three consecutive batches and shelf life;

m) Test result report, trial report (including efficacy and safety test content of the product);

n) Related documents including:

- Origin, history of the original material used to produce biological products;

- Documents related to copyright and application of vaccine and biological product manufacturing certificates (if applicable);

p) Other technical information;

3. The documents for registering changes and supplements include the contents prescribed in Clause 3 of Article 8a of this Circular;

4. The registration dossier for re-registration includes the contents specified in Clause 1 of this Article;

5. The documents for extending the circulation certificate include: 01 set

a) Application for extending the Circulation Certificate according to Form 2, Appendix 2 issued together with this Circular;

b) Photocopy of the previously issued Circulation Certificate;

c) GMP Certificate or Certificate of Compliance for Veterinary Drug Production, Circulation Permit issued by the competent authority of the producing country (for imported products);

d) Quality analysis report of the product issued by the competent authority of the producing country (for imported products) and by the veterinary drug testing agency designated in Vietnam within twelve months;

đ) Report on product stability under storage conditions stated on the label;

e) Circulation process report of the product according to the model attached in Appendix 4 of this Circular.

7. Clause 1 of Article 9 shall be amended and supplemented as follows:

“Article 9. Registration for changes and supplements to the veterinary drug circulation certificate:

1. Organizations and individuals having veterinary drugs that have been granted a Circulation Certificate and listed in the Catalogue of Permitted Veterinary Drugs for Circulation in Vietnam, during the validity period of the certificate, when requesting to change or supplement any of the following contents must obtain the consent of the Department of Animal Health:

a) Changing the product name;

b) Changing the registration entity name;

c) Changing the production entity name;

d) Changing or supplementing packaging specifications;

đ) Changing the drug label format;

e) Changing the expiration date and discontinuation time of the drug;

g) Changing the dosage;

h) Changing or supplementing contraindications;

i) Changing or supplementing treatment regimens;

k) Other changes that do not affect the quality, efficacy, and safety of the drug.

2. For imported drugs:

a) Changing the drug name requires confirmation from the manufacturer;

b) Changing the production site requires a Production Facility Certificate at the new location meeting Good Manufacturing Practice (GMP) standards;

c) Changing the production entity name requires a Production Facility Certificate with the new name meeting GMP standards and related information.”

8. Article 10 is amended and supplemented as follows:

“Article 10. Re-registration of veterinary drugs:

1. Entities having veterinary drugs that have been granted a Circulation Certificate and listed in the Catalogue of Permitted Veterinary Drugs for Circulation in Vietnam, during the validity period of the certificate, when requesting to change or supplement any of the following contents must go through the re-registration procedure:

a) Changing the composition or formula;

b) Changing the preparation form;

c) Changing the route of administration;

d) Changing the production method or process affecting the product quality;

đ) Re-evaluating the quality, efficacy, and safety of the veterinary drug upon request by the Department of Animal Health;

e) Changing or supplementing the species of animals indicated for treatment.

2. Re-registration does not apply to generic drugs.”

9. Article 11 shall be amended and supplemented as follows:

“Article 11. Acceptance of applications for circulation registration, applications for changes and supplements, applications for re-registration, and applications for extension of circulation of veterinary drugs and response deadlines:

1. Applications for circulation registration, applications for changes and supplements, applications for re-registration, and applications for extension of circulation of veterinary drugs shall be submitted to the Department of Animal Health.

2. Response deadlines:

a) In cases of circulation registration and re-registration of veterinary drugs:

- Within fifteen working days from the date of receipt of the application, the Department of Animal Health shall notify the organization or individual applying for registration to complete the application if it does not meet the requirements;

- Within forty working days from the date of receipt of a valid application, the Department of Animal Health shall review the application and establish a specialized scientific council to examine the application and provide a result.

b) In cases of changing or supplementing the Circulation Certificate of veterinary drugs: Within ten working days for chemical drugs and twenty working days for vaccines and biological preparations from the date of receipt of a valid application, the Department of Animal Health shall review the application and provide a result;

c) In cases of application for extension of circulation of veterinary drugs:

- Within ten working days from the date of receipt of the application, the Department of Animal Health shall notify the organization or individual applying for registration to complete the application if it does not meet the requirements;

- Within twenty working days from the date of receipt of a valid application, the Department of Animal Health shall review the application and issue the Circulation Certificate.”

10. Article 12 shall be amended and supplemented as follows:

"Article 12. Validity period of the veterinary drug circulation certificate

The veterinary drug circulation certificate and registration number have a validity period of five years from the date of issuance."

11. Article 13 shall be amended and supplemented as follows:

“Article 13. Extension of the veterinary drug circulation certificate

Three months before the expiry date stated on the circulation certificate, the registration entity must submit an extension application to the Department of Animal Health.

If the registration entity fails to extend the certificate within one month after its expiry date, the circulation certificate will be considered invalid.”

12. Add Article 13b as follows:

“Article 13b. Provisions on language, naming of drugs, and form of application:

1. Languages used in the application dossier:

a) Applications for registration of domestically produced veterinary drugs must be written in Vietnamese;

b) Applications for registration of foreign-produced veterinary drugs must be written in Vietnamese or English. In case the application is written in English, the information in the Drug Usage Guide and Product Summary Characteristics must be written in Vietnamese.

2. Applications for registration of veterinary drugs must be prepared on A4 paper, securely bound. The application must include a cover page and table of contents, arranged in accordance with the table of contents, with clear divisions between sections. Each section division must be numbered for easy reference and confirmed by the registration entity or the foreign drug production entity on the first page of each section throughout the application.

3. Each veterinary drug must have a separate registration application.

4. For domestically produced veterinary drugs, the naming of drugs must follow the following principles:

a) The registration entity may use the International Nonproprietary Name (INN) for the drug name;

b) In cases where the drug name is not based on the INN, the registration entity may use a trade name but must ensure compliance with the following principles:

- Not to overstate the therapeutic effects of the drug;

- Not to misrepresent the therapeutic effects of the drug, not to cause confusion about the pharmacological action group of the drug; drugs with different active ingredients must have different names;

- Not to violate Vietnamese customs, traditions, and morals;

- Not to conflict with intellectual property rights of other individuals or organizations that are protected;

- Not to duplicate the name of drugs already registered by other entities.”

5. The following types of Good Manufacturing Practice (GMP) certificates, certificates of production eligibility, ISO certificates, product circulation certificates (FSC, CPP, MA) included in the registration dossier may be submitted:

- Original copies;

- Legal copies (certified true copies);

- Copies must be accompanied by original copies for verification if submitted directly;

- Specifically, the Product Quality Analysis Report (CA) must be the original copy.”

13. Clause 2 of Article 14 shall be amended and supplemented as follows:

"Article 14. Examination and issuance of veterinary drug circulation certificates

2. The examination and issuance of veterinary drug circulation certificates shall be carried out as follows:

a) The Department of Animal Health receives the registration dossier for circulation, reviews the dossier, organizes meetings of the specialized scientific council on veterinary drugs, issues veterinary drug circulation certificates; reports to the Minister of Agriculture and Rural Development for recognition and inclusion in the list of veterinary drugs permitted for circulation in Vietnam. For authorized manufactured veterinary drugs and processed veterinary drugs, the Department of Animal Health reviews the registration dossiers for circulation, issues veterinary drug circulation certificates; reports to the Minister of Agriculture and Rural Development for recognition and inclusion in the list of veterinary drugs permitted for circulation in Vietnam;

b) The specialized scientific council on veterinary drugs, authorized by the Minister of Agriculture and Rural Development through the Director of the Department of Animal Health, decides to establish the council. The specialized scientific council on veterinary drugs meets at least once every three months to evaluate the results of dossier reviews, testing, trials, and field tests, and recommends to the Minister of Agriculture and Rural Development for recognition and inclusion of registered veterinary drugs in the list of veterinary drugs permitted for circulation in Vietnam;

c) The Ministry of Agriculture and Rural Development promulgates the list of aquatic veterinary drugs, the list of veterinary drugs, the list of vaccines, biological preparations, microorganisms, and chemicals used in veterinary medicine permitted for circulation in Vietnam".

Article 2. Repeal certain articles of Decision No. 03/2007/QĐ-BTS dated April 3, 2007 of the Ministry of Fisheries on the issuance of regulations for registering the circulation of veterinary drugs for aquatic animals; products for treating and improving aquaculture environments

1. Repeal Article 1, Article 6.

2. Repeal Clause 1, 2, 3, 4, 5 of Article 7.

3. Repeal Clause 1 of Article 8.

4. Repeal Clause 1, 2, 3 of Article 9.

5. Repeal Articles 11, 12, 13, 14.

1. Article 11 is amended and supplemented as follows:

"Article 11. Registration for establishing disease-free zones and safe premises

1. People's Committees of districts, counties, towns, cities under provinces register for establishing disease-free zones; People's Committees of communes, wards, towns (hereinafter referred to as People's Committees at commune level), owners of livestock farms register for establishing safe premises send one set of dossier according to Article 10 of the Provisions on Disease-Free Zones and Safe Premises for Livestock issued together with Decision No. 66/2008/QĐ-BNN dated May 26, 2008 of the Minister of Agriculture and Rural Development to the Provincial Animal Health Service (hereinafter referred to as the Provincial Animal Health Service).

2. After receiving the dossier for establishing a disease-free zone, the Provincial Animal Health Service checks the dossier and immediately forwards it to the Department of Animal Health. Within ten working days from the date of receipt of the dossier, the Department of Animal Health examines and responds in writing whether to accept or reject the establishment of a disease-free zone.

3. After receiving the dossier for establishing a safe premise from centrally-managed livestock farms and foreign-invested livestock farms, the Provincial Animal Health Service checks the dossier and immediately forwards it to the Regional Animal Health Office (Department of Animal Health) responsible for the area. Within ten days from the date of receipt of the dossier, the Regional Animal Health Office examines and responds in writing whether to accept or reject the establishment of a safe premise.

4. Within ten working days from the date of receipt of the dossier for establishing a safe premise from locally-managed livestock farms, the Provincial Animal Health Service examines the dossier of the People's Committee at commune level and responds in writing whether to accept or reject the establishment of a safe premise for the livestock farm and commune."

3. Article 16 shall be amended and supplemented as follows:

"Article 12. Procedures for registering recognition of disease-free zones and safe premises

1. Organizations and individuals who register for establishing disease-free zones and safe premises according to Article 11 of this Circular, when applying for recognition of disease-free zones and safe premises, submit one set of dossier to the competent authority accepting the establishment of disease-free zones and safe premises as stipulated in Clauses 2, 3, and 4 of Article 11 of this Circular.

2. The dossier for recognition includes:

a) Application for recognition of disease-free zones and safe premises;

b) Report on conditions of established disease-free zones and safe premises;

c) Other relevant documents: vaccination results, post-vaccination surveillance results; hygiene inspection results; diagnostic results, animal quarantine certificates, issued by the Central Veterinary Diagnostic Center, Central Veterinary Inspection Centers I and II, and laboratories of Regional Animal Health Offices, Provincial Animal Health Services depending on the disease, diagnostic and testing levels of the Department of Animal Health.

3. Within fifteen working days from the date of receipt of a valid dossier, the receiving authority must conduct an assessment and respond with the result to the locality and the entity.

4. The competent authority receiving and assessing the dossier for recognition of disease-free zones and safe premises is responsible for retaining the dossier."

1. Criteria for evaluating managers who have excellently completed tasks Managers who are evaluated as having excellently completed tasks must meet all of the following criteria:

"Article 13. Establishment of inspection teams for disease-free zones and safe premises

1. Decision to establish inspection teams.

a) The Director of the Department of Animal Health issues a Decision to establish inspection teams for disease-free zones for livestock; the Director of the Regional Animal Health Office issues a Decision to establish inspection teams for safe premises for centrally-managed livestock farms and foreign-invested livestock farms;

b) The Director of the Animal Health Sub-department of the province or city issues a Decision to establish an assessment team for animal disease safety facilities for livestock farms managed by local authorities and disease-safe villages.

2. The assessment team shall include representatives from specialized departments such as Epidemiology or Technology, Inspection, Legal Affairs. In cases where necessary, representatives from specialized centers such as the Central Veterinary Diagnostic Center, the Veterinary Hygiene Inspection Center, or the Diagnostic Testing Laboratory may be added.

4. Article 16 shall be amended and supplemented as follows:

Article 16. Management of Disease-Safe Zones and Facilities

1. Certificates for disease-safe zones and facilities are valid for two years from the date of issuance for African Swine Fever and Pseudorabies; one year for Porcine Reproductive and Respiratory Syndrome (PRRS), Newcastle Disease, Duck Plague, Infectious Bursal Disease (Gumboro), Chronic Respiratory Disease (CRD), and White Scours; six months for Avian Influenza. The Department of Animal Health is responsible for announcing lists of recognized disease-safe zones and facilities; certificates will be revoked if conditions are not met as prescribed.

2. Procedures for extending the validity of disease-safe zone and facility certificates are as follows:

a) Two months before the certificate expires (for Avian Influenza safety certificates, fifteen days before expiration), the entity must submit an extension application to the Department of Animal Health.

b) The extension application includes: Request for Extension; Certificate for Disease-Safe Zone or Facility; other documents as stipulated in point c, Clause 2, Article 12 of this Circular.

3. Within fifteen working days from the receipt of a valid extension application for a disease-safe zone or facility certificate, the Department of Animal Health shall review and extend the certificate for zones and facilities that meet the prescribed conditions. If necessary, an assessment team may be established to re-examine and evaluate before extending the certificate.

4. The format of the animal disease safety certificate specified in Appendix 10 attached to this Circular."

Article 4. Implementation provisions

1. This Circular shall take effect 45 days from the date of signature.

2. The Director of the Department of Animal Health, the Head of the Ministry's Office, the Head of the Legal Affairs Department, the Heads of units under the Ministry, and related organizations and individuals are responsible for implementing this Circular./