Decision No. 98/2007/QĐ-BNN Regarding the supplementation and amendment of Decision No. 71/2007/QĐ-BNN dated August 6, 2007 of the Minister of Agriculture and Rural Development on the procedures and formalities for testing and trial of veterinary drugs

Article 1. AMENDING AND COMPLETING ARTICLE 3, ARTICLE 4, AND CLAUSE 1 OF ARTICLE 8 AS FOLLOWS:

1. ADDING ARTICLE 3...

"6. ORIGINAL PRODUCT IS A PRODUCT THAT HAS BEEN GRANTED AN INVENTION PATENT, WITH A STABLE PRODUCTION PROCESS, AND HAS BEEN ISSUED A MARKET ENTRY PERMIT.

7. GENERIC VETERINARY DRUG IS A DRUG PRODUCED ACCORDING TO THE ORIGINAL PRODUCT, WITH THE SAME FORMULA, DOSAGE FORM, ROUTE OF ADMINISTRATION, INDICATIONS, DOSE, AND STOPPING TIME (IF ANY).

8. BRAND NAME VETERINARY DRUG IS A DRUG NAMED AFTER THE ACTIVE INGREDIENT.

9. VETERINARY DRUG TESTING IS THE ACT OF INSPECTING AND DETERMINING TECHNICAL STANDARDS AND QUALITY OF VETERINARY DRUGS."

2. AMENDING AND COMPLETING ARTICLE 4 ON THE CASES WHERE VETERINARY DRUGS MUST BE TESTED AND TRIALLED, AND THE CASES WHERE THEY ARE EXEMPT FROM TESTING AND TRIALING AS FOLLOWS:

"ARTICLE 4. CASES WHERE VETERINARY DRUGS MUST BE TESTED AND TRIALLED, AND CASES WHERE THEY ARE EXEMPT FROM TESTING AND TRIALING

1. CASES WHERE TESTING IS REQUIRED

NEWLY PRODUCED VETERINARY DRUGS IN VIETNAM WHEN REGISTERING FOR MARKET ENTRY OR VETERINARY DRUGS ALREADY LISTED IN THE REGISTER OF PERMITTED VETERINARY DRUGS IN VIETNAM BUT HAVE CHANGES AS PROVIDED FOR IN CLAUSE 1 OF ARTICLE 58 OF DECREE NO. 33/2005/NĐ-CP DATED MARCH 15, 2005 OF THE GOVERNMENT GUIDING THE IMPLEMENTATION OF CERTAIN PROVISIONS OF THE ANIMAL HEALTH ORDINANCE (HEREINAFTER REFERRED TO AS DECREE NO. 33).

2. CASES WHERE TRIALING IS REQUIRED

NEWLY IMPORTED VETERINARY DRUGS PRODUCED ABROAD WHEN REGISTERING FOR MARKET ENTRY OR VETERINARY DRUGS ALREADY LISTED IN THE REGISTER OF PERMITTED VETERINARY DRUGS IN VIETNAM BUT HAVE CHANGES AS PROVIDED FOR IN CLAUSE 1 OF ARTICLE 58 OF DECREE NO. 33.

3. CASES WHERE TESTING AND TRIALING ARE EXEMPT

VETERINARY DRUGS PRODUCED COMPLETELY ACCORDING TO THE ORIGINAL PRODUCT (GENERIC DRUGS); BRAND NAME DRUGS (FOR PHARMACEUTICAL CHEMICALS); NON-VACCINE VETERINARY DRUGS ALREADY PERMITTED FOR MARKET ENTRY IN EUROPE IMPORTED."

3. AMENDING CLAUSE 1 OF ARTICLE 8 AS FOLLOWS"

"WITHIN THIRTY WORKING DAYS FROM THE DATE OF RECEIVING A COMPLETE APPLICATION, THE ANIMAL HEALTH DEPARTMENT SHALL:

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Article 2. THIS DECISION SHALL TAKE EFFECT FIFTEEN DAYS FROM THE DATE OF PUBLICATION IN THE STATE GAZETTE.

Article 3. THE HEAD OF THE OFFICE, THE DIRECTOR OF THE ANIMAL HEALTH DEPARTMENT, THE HEADS OF THE UNITS, ORGANIZATIONS, AND INDIVIDUALS CONCERNED SHALL BE RESPONSIBLE FOR IMPLEMENTING THIS DECISION./.