Thông tư 20/2011/TT-BNNPTNT

CIRCULAR

ON AMENDMENTS TO AND ANNULMENT OF SOME REGULATIONS ADMINISTRATIVE PROCEDURES PERTAINING TO VETERINARY MEDICINE IN THE RESOLUTION NO. 57/NQ-CP DATED OCTOBER 15, 2010

Pursuant to the Government's Decree No. 01/2008/ND-CP on January 03, 2008, defining the functions, tasks, powers and organizational structure of the Ministry of Agriculture and Rural development; the Government's Decree No. 75/2009/ND-CP dated September 10, 2009 on amendments to Article 3 of the Government's Decree No. 01/2008/ND-CP on January 03, 2008, defining the functions, tasks, powers and organizational structure of the Ministry of Agriculture and Rural development;

Pursuant to the Government's Resolution No. 57/NQ-CP dated December 15, 2010 on simplification of administrative procedures under the management of the Ministry of Agriculture and Rural Development;

The Ministry of Agriculture and Rural Development issues a Circular on amendments, supplementation and annulment of some regulations on administrative procedures pertaining to veterinary medicine in the Resolution No. 57/NQ-CP dated October 15, as follows:

Article 1. Amendments to some Articles of the Decision No. 10/2006/QD-BNN dated February 10, 2006 of the Ministry of Agriculture and Rural Development

1. Article 1 is amended as follows:

Article 1. Scope of regulation

This Circular deals with the registration, import of veterinary drugs, veterinary ingredients, vaccines, bioproducts, microorganisms, chemicals used for animals and aquatic organisms (hereinafter referred to as veterinary drugs) in Vietnam.

2. Article 4b is amended as follows:

Article 4b. Conditions for registration of veterinary drugs

1. For veterinary drug manufacturers:

a) Every domestic veterinary drug manufacturer must have the Certificate of eligibility for medicine manufacture or the Certificate of Good medicine manufacturing practice (GMP) in accordance with the regulations of the Ministry of Agriculture and Rural Development;

b) Veterinary drug manufacturers must satisfy GMP standards;

c) Manufacturers of chemicals and preparations for in vitro diagnosis must satisfy GMP standards, ISO standards or equivalent standards.

2. For veterinary medicine importers:

Every veterinary medicine importers must have the Certificate of eligibility to sell veterinary drugs according to the Circular No. 51/2009/TT-BNNPTNT dated August 21, on inspection and certification of eligibility to manufacture and sell veterinary drugs, bioproducts, microorganisms, chemicals used for animals and aquatic organisms (hereinafter referred to as the Circular No. 51/2009/TT-BNNPTNT)

3. Article 5 is amended as follows:

Article 5. Labels of veterinary drugs

1. Veterinary drugs sold in the Vietnam's market must have labels. Veterinary drugs shall be labeled in accordance with the Government's Decree No. 89/2006/ND-CP dated August 30, 2006 on goods labels and the Circular No. 03/2009/TT-BNN dated January 14, 2009 of the Ministry of Agriculture and Rural Development on labeling veterinary drugs.

2. Labels of veterinary medicine being sold must comply with the label designs in the application for registration kept by the supervisory authority and the registry.

4. Article 6 is amended as follows:

Article 6. Registration of veterinary drugs

1. A new facility that registers veterinary drugs for the first time shall make an application that consists of:

a) The Certificate of eligibility to manufacture or import veterinary drugs as prescribed.

b) Copies of papers related to its establishment: Decision on Establishment, Certificate of Business registration, practice certificate conformable with its operation;

c) The application for registration of each drug prescribed in this Circular.

2. The facility is eligible to manufacture or import veterinary drugs when applying for registration according to Point c Clause 1 of this Article.

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

Article 7. Procedure for registering the import of veterinary drugs

1. Import of veterinary drugs in the List of approved veterinary drugs in Vietnam or issued with Certificate of free sale

The importer eligible to import veterinary drugs shall carry out the import as follows:

a) The procedure for importing drugs and ingredients of veterinary drugs shall be carried out at the customs of the checkpoint;

b) For vaccines, microorganisms: the importer shall make a manifest of imported goods under the form No. 2 in Appendix 3 (01 hard copy and 01 soft copy) and send it to the Department Of Animal Health.

2. Import of veterinary drugs that are not in the List of approved veterinary drugs in Vietnam

a) Cases of permitted import:

- Veterinary drugs are non-commercial samples, exhibits;

- Veterinary drugs used for testing, experiments serving registration;

- Non-commercial proprietary veterinary drugs imported in small quantities used for diagnosis and prevention of diseases for rare animals and imported animals;

- Ingredients (pharmaceutical substances, excipients, solvents, chemicals, and other ancillary ingredients) used for manufacturing the products in the List of approved veterinary drugs in Vietnam.

b) An application for import of veterinary drugs that consists of:

- A manifest of imported goods under the form No. 1 in Appendix 3 to this Circular (01 hard copy and 01 soft copy);

- Certificates of GMP or ISO (of some common chemicals); Certificate of free sale for imported drugs;

- The Certificate of analysis of the manufacturer and competent authorities of the country of origin (of vaccines and bioproducts);

- Summary of characteristics (of new drugs).

c) The application for import of veterinary drugs shall be sent to the Department of Animal Health;

d) Within 07 working days from the day on which the application is received, the Department Of Animal Health shall verify the application and give a result.

6. Article 8 is replaced with Articles 8a, 8b, 8c and 8d below:

Article 8a. Application for registration of synthetic veterinary drugs:

1. For new veterinary drugs, the application consists of:

a) A written request for registration under the form No. 1 in Appendix 1 to this Circular;

b) Summary or characteristics of the products, including information about ingredients, contents, dosage form, packaging method, effects, indications, contraindications, instructions, guidance on preservation, notes for indicated animals and users, and other characteristics of the products under the form in Appendix 6 to this Circular;

c) Label design (03 copies) and an instruction sheet;

d) Certificates of GMP or ISO (of some common chemicals); Certificate of free sale issued by a competent authority of the country of origins (of imported drugs);

dd) Manufacture process;

e) Quality standards and testing methods (in detailed), the Certificate of analysis of the manufacturer;

g) Reports on the data proving the safety, including documents about the studies into toxicity (acute toxicity, semi-chronic toxicity, chronic toxicity, cytotoxicity, risk of cancer). Studies into residuals in indicated animals;

h) Reports proving the effects of products, including documents about studies into experimental pharmacology, pharmacodynamics, pharmacokinetics, and bioavailability of products;

i) Duration of interruption (if any);

k) Documents about studies into stability and shelf life of drugs;

m) Documents about studies into dosages and treatment regimens for indicated animals;

n) A Certificate of analysis issued by a competent authority of the country of origin (of imported products) and a Certificate of analysis issued by an agency specialized in testing veterinary drugs in Vietnam;

p) Experiment and test results;

q) A commitment to not violate the Law on Intellectual property under the form in Appendix 5 to this Circular;

r) Other technical information (if any).

2. For generic drugs, the application consists of:

a) The documents mentioned in Points a, b, c, d, dd, e, I, k, q, r Clause 1 of this Article;

b) The Certificate of analysis issued by an agency specialized in testing veterinary drugs in Vietnam;

c) Information about the innovator drugs (names of products, manufacturers, formulae, dosage forms, effects, indications, contraindications, dosages, interruption duration (if any), notes for indicated animals, users, and other characteristics of products).

3. An application for amendments consists of:

a) A written request for permission for amendments under the form No. 1 in Appendix 1 to this Circular;

b) The documents related to the amendments;

c) A photocopy of an unexpired Certificate of free sale for veterinary drugs;

d) The old label design (01 copy) and the new label design (03 copies);

dd) The old and new instructions sheets.

4. The application for re-registration consists of the documents in Clause 1 of this Article.

5. An application for extension of the Certificate of free sale for veterinary drugs consists of:

a) A written request for extension of the Certificate of free sale under the form No. 2 in Appendix 2 to this Circular;

b) A photocopy of an unexpired Certificate of free sale for veterinary drugs;

c) Certificates of GMP or ISO or Certificate of eligibility to manufacture veterinary drugs; Certificate of free sale for imported drugs;

d) The Certificate of analysis issued by the manufacturer or an agency specialized in testing veterinary drugs in Vietnam within 12 months;

dd) A report on stability of products in normal conditions;

e) Reports on drug sale under the form in Appendix 4 to this Circular.

Article 8b. Application for registration of veterinary drug ingredients and herbal drugs:

1. An application for registration of drug ingredients consists of:

a) The documents mentioned in Points a, b, c, d, dd, e, i, k, n, r Clause 1 Article 8a of this Circular;

b) Information about ingredients of innovator drugs after the patent expires (names of ingredients, manufacturers, formulae, dosage forms, and other characteristics of products).

2. Apart from the documents in Clause 1 of this Article, an application for registration of new ingredients must also have:

a) Reports on the data proving the safety, including documents about the study into toxicity (acute toxicity, semi-chronic toxicity, chronic toxicity, cytotoxicity). Studies into residuals in indicated animals;

b) Reports proving the effects of products, including documents about studies into experimental pharmacology, pharmacodynamics, pharmacokinetics, and bioavailability of products;

c) Reports on experiment or test results;

d) Documents about studies into stability of ingredients;

dd) Other technical information (documents about products approved in other countries).

3. The application for registration of herbal drugs consists of the documents in Clause 1 Article 8a of this Circular.

4. The application for amendments consists of the documents in Clause 3 Article 8a of this Circular.

5. The application for extension of the Certificate of free sale consists of the documents in Clause 5 Article 8a of this Circular.

Article 8c. Application for registration of vaccines and bioproducts

1. An application for registration of vaccines and bioproducts consists of:

a) A written request for registration under the form No. 2 in Appendix 1 to this Circular;

b) Summary or characteristics of the products, including information about ingredients, contents, dosage form, packaging method, indications, contraindications, instructions, guidance on preservation, notes for indicated animals and users, other technical characteristics;

c) Label design (03 copies) and an instruction sheet;

d) Certificate of GMP, Certificate of free sale issued by a competent authority of the country of origins (of imported products);

dd) Manufacture process;

e) Quality standards and testing methods, Certificate of analysis of the manufacturer;

g) Reports on the data proving the safety, including documents about the study into toxicity (acute toxicity, semi-chronic toxicity, chronic toxicity, cytotoxicity). Studies into residuals in indicated animals (if any);

h) Reports on the data proving the effects of products, including the documents about studies in amount of antibodies and duration of immunity (of vaccines);

i) Interruption duration (if any);

k) Documents about studies into stability, summaries of 03 consecutive batches and suggested shelf life;

m) Methods for determination of dosages and treatment regimens for indicated animals;

n) Certificates of analysis issued by a competent authority of the country of origin (of imported products) and an agency specialized in testing veterinary drugs in Vietnam;

p) Reports on test results (experiment result of imported products) including the reports on effects and safety of products to indicated animals, users and the environment);

q) Relevant documents including:

- Origins, history and stability of the microorganisms used for preparing vaccines and bioproducts;

- Documents related to patents and application of certificates of vaccine and bioproduct manufacture (if any);

r) Other technical information such as experiment and test result in laboratories, information about the products circulated in other countries (if any);

s) Epidemiological data proving the presence of pathogens in Vietnam (applicable to new bioproducts and vaccines).

2. An application for registration of diagnostic bioproducts consists of:

a) A written request for registration under the form No. 3 in Appendix 1 to this Circular;

b) Summary or characteristics of the products, including information about ingredients, contents, dosage form, packaging method, indications, contraindications, instructions, guidance on preservation, notes for indicated animals and users, other technical characteristics;

c) Label design (03 copies) and an instruction sheet;

d) Certificate of GMP, ISO or an equivalent certificate; the Certificate of free sale issued by a competent authority of the country of origins (of imported products);

dd) A Certificate of analysis issued by a competent authority of the country of origin (of imported products), a Certificate of analysis of bioproducts issued by an agency specialized in testing veterinary drugs in Vietnam;

e) Report on the data proving the safety;

g) Report on the data proving the effects of products;

h) The manufacture process;

i) Quality standards and bioproducts testing methods (in detailed), Certificate of analysis of bioproducts of the manufacturer;

k) Documents about studies into stability, summaries of 03 consecutive batches and suggested shelf life;

m) Reports on experiment and test result (including the tests on effects and safety or products);

n) Relevant documents including:

- Origins, history of original ingredients used for manufacturing the bioproducts;

- Documents related to patents and application of certificates of vaccine and bioproduct manufacture (if any);

p) Other technical information.

3. The application for amendments consists of the documents in Clause 3 Article 8a of this Circular.

4. The application for re-registration consists of the documents in Clause 1 of this Article.

5. An application for extension of the Certificate of free sale consists of:

a) A written request for extension of the Certificate of free sale under the form No. 2 in Appendix 2 to this Circular;

b) A photocopy of the issued Certificate of free sale;

c) The Certificate of GMP or Certificate of eligibility to manufacture veterinary drugs, Certificate of free sale issued by a competent authorities of the country of origins (of imported products);

d) Certificates of analysis issued by a competent authority of the country of origin (of imported products) and an agency specialized in testing veterinary drugs in Vietnam within the previous 12 months;

dd) A report on stability of products in the conditions written on the label;

e) Reports on product sale under the form in Appendix 4 to this Circular.

7. Clause 1 of Article 9 is amended as follows:

Article 9. Application for amendments to the Certificate of free sale for veterinary drugs:

1. The owner of veterinary drugs that are issued with Certificates of free sale and in the List of approved veterinary drugs in Vietnam must obtain the approval of the Department of Animal Health when making any of the changes below before the Certificates expire:

a) Change of product names;

b) Change of the applicant's name;

c) Change of the manufacturer's name;

d) Change of the packaging method;

dd) Change of the label design;

e) Change of the expiration date and interruption duration;

g) Change of dosages;

h) Change of contraindications;

h) Change of the treatment regimen;

k) Other changes that do not affect the quality, effect, and safety of drugs.

2. For imported drugs:

a) The change of drug names must be confirmed by the manufacturer;

b) If the factory location is changed, the factory at the new location must obtain a Certificate of GMP;

b) If the factory name is changed, the factory with the new name must obtain a Certificate of GMP.

8. Article 10 is amended as follows:

Article 10. Re-registration for veterinary drugs

1. The owner of veterinary medicines that are issued with Certificates of free sale and in the List of approved veterinary drugs in Vietnam must follow the procedure for re-registration when making any of the changes below before the Certificates expire:

a) Changes in the contents or formulae;

b) Changes in the dosage forms;

c) Changes in the administration routes;

d) Change in the manufacturer method or process that leads to a change in product quality;

dd) Reassessment of quality, effects, safety of veterinary drugs at the request of company;

e) Changes or addition of indicated animals.

2. Generic drugs may not apply for re-registration.

9. Article 11 is amended as follows:

Article 11. Receipt of application for registration, application for amendments, application for re-registration, application for extension of the certificate of free sale for veterinary medicine, and deadline for response

1. The application for the certificate of free sale, application for amendments, application for re-registration, application for extension of the Certificate of free sale shall be sent to the Department of Animal Health.

2. Deadline for response:

a) For the application for the certificate of free sale or re-registration:

- If the application is not valid, the Department Of Animal Health shall request the applicant to complete it within 15 working days from the day on which the application is received;

- Within 40 working days from the day on which the valid application is received, the Department Of Animal Health shall verify the application and establish a specialized council to examine the application and give a result.

b) For the application for amendments to the Certificate of free sale for veterinary drugs: Within 10 working days (for synthetic veterinary medicine) or 20 working days (for vaccines, bioproducts, microorganisms) from the day on which the valid application is received, the Department Of Animal Health shall verify the application and give a result;

c) For the application for extension of the certificate of free sale for veterinary drug:

- If the application is not valid, the Department Of Animal Health shall request the applicant to complete it within 10 working days from the day on which the application is received;

- Within 20 working days from the day on which the valid application is received, the Department Of Animal Health shall verify the application and issue a Certificate of free sale.

10. Article 12 is amended as follows:

Article 12. Validity period of the Certificate of free sale for veterinary drugs

A Certificate of free sale for veterinary drugs and registration number is valid for 5 years from the date of issue.

11. Article 13 is amended as follows:

Article 13. Extension of the Certificate of free sale for veterinary drugs

03 months before the expiration date written on the Certificate of free sale for veterinary drugs, an application for extension shall be sent to the Department Of Animal Health.

If the extension procedure is not followed after 01 month from the expiration date, it Certificate of free sale shall be invalidated.

12. Article 13b is amended as follows:

Article 13b. Languages, drug names, and presentation of the application

1. Languages in the application:

a) The application for registration of domestically produced veterinary medicine must be written in Vietnamese language;

b) The application for veterinary medicine produced overseas must be written in Vietnamese or English language. If the application is written in English language, the information in the instructions sheet, summary of product characteristics must be written in Vietnamese language.

2. A4 papers shall be used for the application for veterinary drug registration. The application must have a cover and table of contents. The parts must be separated. The separation must be numbered. The first page of every part must be certified by the applicant or manufacturer.

3. Each veterinary drug shall have a separate application.

4. The veterinary drugs produced domestically shall be named as follows:

a) The applicant may use international nonproprietary names;

b) If the drug is not so named, the applicant may choose a trade name, provided the following principles are adhered to:

- Do not exaggerate drug effects;

- Do not provide incorrect information about drug effects; do not cause confusion about pharmacological effects of drug; drugs that contain different substances must be named differently;

- Do not infringe Vietnam's native cultural tradition;

- Do not cause conflict with protected intellectual property of other organizations and individuals;

- The drug names must not be identical to those that are issued with registration numbers of other facilities.

5. The Certificate of GMP, Certificate of eligibility for manufacture, Certificate of ISO, Certificate of free sale (CFS, CPP, MA) enclosed with the application may be:

- Original copies;

- Authenticated copies (bearing the notary seal or authentication seal);

- Copies enclosed with the originals for comparison if the application is submitted directly;

- The Certificate of analysis must be an original.

13. Clause 2 of Article 14 is amended as follows:

Article 14. Considering the issuance of Certificates of free sale for veterinary drugs

2. The issuance of Certificates of free sale for veterinary drugs shall be considered as follows:

a) The Department Of Animal Health shall receive the application for registration, verify it, hold a consultation with the veterinary medicine council, issue the Certificate of free sale for veterinary drugs; request the Minister of Agriculture and Rural development to recognize them then add them to the List of approved veterinary drugs in Vietnam. For franchised and processed veterinary drugs, the Department Of Animal Health shall verify the application, issue the Certificate of free sale for veterinary drugs, request the Minister of Agriculture and Rural development to recognize them and add them to the List of approved veterinary drugs in Vietnam;

b) The Minister of Agriculture and Rural development shall delegate the Director of the Department Of Animal Health to establish the veterinary medicine council. The veterinary medicine council shall hold at least one meeting every 03 months to assess the result of application examination, test results, experiment results, and request the Minister of Agriculture and Rural development to recognize and add the registered veterinary drugs to the List of approved veterinary drugs in Vietnam;

c) The Ministry of Agriculture and Rural Development shall issue a list of veterinary drugs for aquatic organisms, a List of veterinary drugs, a List of vaccines, bioproducts, microorganisms and chemicals used for veterinary drugs that are approved in Vietnam.

Article 2. Annulment of some Articles of the Decision No. 03/2007/QD-BTS dated April 3, 2007 of the Ministry of Fishery on the promulgation of the Regulation on registration of veterinary drugs for aquatic organisms, products for improving fishery environments

1. Article 1 and Article 6 are annulled.

2. Clauses 1, 2, 3, 4 and 5 of Article 7 are annulled.

3. Clause 1 of Article 8 is annulled.

4. Clauses 1, 2, and 3 of Article 9 are annulled.

5. Articles 11, 12, 13, and 14 are annulled.

Article 3. Amendments to some Articles of the Decision No. 66/2008/QD-BNN dated May 26, 2008 of the Ministry of Agriculture and Rural Development on disease-free zones and facilities.

1. Article 11 is amended as follows:

Article 11. Registration of disease-free zones and facilities

1. Any People's Committee of districts, towns, and cities affiliated to provinces that wishes to establish a disease-free zone; any People's Committee of communes, any owner of breeding farms that wish to establish a disease-free facility shall send an application (as specified in Article 10 of the Regulation on disease-free zones and facilities promulgated together with the Decision No. 66/2008/QD-BNN dated May 26, 2008 of the Minister of Agriculture and Rural development) to the provincial Sub-department of Animal Health.

2. After the application for registration of disease-free zone is received, the provincial Sub-department of Animal Health shall examine the application and send it to the Department of Animal Health if it is satisfactory. Within 10 working days from the receipt of the application, the Department of Animal Health shall consider approving or disapproving of the establishment of the disease-free zone.

3. After receiving the application for permission to establish a disease-free facility submitted by a breeding farm under the management of central agencies, breeding farms having foreign capital, the Sub-department Of Animal Health shall send it to a local Department Of Animal Health. Within 10 days from the receipt of the application, the Department of Animal Health shall consider giving an approval or disapproval of the establishment of the disease-free facility.

4. Within 10 working days from the receipt of the application for permission to establish a disease-free facility submitted by a breeding farm under the management of the local government, or the application submitted by the People's Committees of communes, the Sub-department of Animal Health shall consider giving an approval or disapproval of the establishment of the disease-free facility.

2. Article 12 is amended as follows:

Article 12. Application for recognition of disease-free zones and disease-free facilities

1. Every applicant that registered the establishment of a disease-free zone or facility as prescribed in Article 11 of this Circular shall send 01 application for recognition of the disease-free zone or facility to an authority competent to approve the establishment of disease-free zones or facilities according to Clauses 2, 3, and 4 Article 11 of this Circular.

2. An application for recognition consists of:

a) A written request for recognition of the disease-free zone or facility;

b) A report on the conditions of the disease-free zone or facility that was established;

c) Relevant documents: results of inoculation and post-inoculation supervision; results of veterinary sanitation inspection; result of animal quarantine diagnosis and certification given by the Central Veterinary Diagnosis Laboratory, the Central Veterinary Inspection I and II, Laboratories of Departments of Animal Health or Sub-department of Animal Health, depending on the diseases and responsibility for diagnosis and testing of the Department Of Animal Health.

3. Within 15 working days from the receipt of the valid application, the authority that receives the application shall verify it and give a result.

4. The competent authority competent to receive and verify applications for recognition of disease-free zones and facilities shall retain the applications.

3. Article 13 is amended as follows:

Article 13. Establishing a commission to assess the disease-free zone or facility (hereinafter referred to as assessing commission)

1. Decision to establish an assessing commission.

a) Directors of the Departments Of Animal Health shall issue decisions to establish commissions to assess disease-free zones; Directors of local veterinary authorities shall issue decisions to establish commissions to assess the disease-free status of the breeding farms under the management of central agencies and the breeding farms having foreign capital.

a) Directors of the Sub-departments Of Animal Health shall establish commissions to assess the disease-free status of breeding farms under the management of local governments and communes.

2. The assessing commission consists of representatives of specialized departments such as Epidemiology Department, Technical Department, Quarantine Department, Legal Department. Representatives of specialized agencies such as the Central Veterinary Diagnosis Laboratory, Veterinary Inspection Center, or Laboratories.

4. Article 16 is amended as follows:

Article 16. Management of disease-free zones and facilities

1. The certificate of disease-free zone or facility is valid for 02 years from its date of issue for foot-and-mouth disease (FMD) and hog cholera; 01 year for Porcine Reproductive & Respiratory Syndrome (PRRS), Newcastle, fowl cholera, Gumboro, CRD, pulorum disease; 06 months for avian influenza. Departments Of Animal Health shall announce the list of zones and facilities recognized as disease-free; revoke the Certificates of disease-free zone or facility if the conditions are not satisfied.

2. Applying for extension of the Certificate of disease-free zone or facility:

a) 02 months before the Certificate expires (15 days for avian influenza), an application for extension shall be sent to the Department Of Animal Health;

b) The application consists of: a written request for extension, the Certificate of disease-free zone or facility, other documents mentioned in Point c Clause 2 Article 12 of this Circular.

3. Within 15 working days from the day on which the valid application for extension of the Certificate of disease-free zone or facility, the Department Of Animal Health shall consider extending the Certificate if the prescribed conditions are satisfied. A commission shall be establish to re-inspect or re-assess before extension if necessary.

4. The form of the Certificate of disease-free status is provided in Appendix 10 to this Circular.

Article 4. Implementation

1. This Circular takes effect after 45 days from the day on which it is signed.

2. Directors of Departments Of Animal Health, Chief of the Ministry Office, the Director of the Legal Department, heads of units affiliated to Ministries, relevant organizations and individuals are responsible for the implementation of this Circular./.