Circular No. 02/2009/TT-BNN guiding procedures for recalling and handling veterinary drugs

CIRCULAR

HGuidelines for the procedures for recalling and handling veterinary drugs

Pursuant to 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;
Pursuant to the Law on Product Quality and Commodities No. 05/2007/QH12, November 21, 2007;
Pursuant to the Veterinary Law dated April 29, 2004;
Pursuant to Decree No. 33/2005/NĐ-CP dated March 15, 2005 of the Government detailing the implementation of certain Articles of the Ordinance on Veterinary Medicine;
The Ministry of Agriculture and Rural Development issues guidelines for the procedures for recalling and handling veterinary drugs, biological preparations, microorganisms, chemicals used in veterinary medicine (including aquatic veterinary drugs) as follows:

I. GENERAL PROVISIONS

1. Scope of Regulation and Applicability

a) These Guidelines apply to veterinary drugs, biological preparations, microorganisms, chemicals used in veterinary medicine including aquatic veterinary drugs (hereinafter referred to as veterinary drugs) as specified in Article 50 of the Ordinance on Veterinary Medicine and Article 62 of Decree No. 33/2005/NĐ-CP dated March 15, 2005 of the Government detailing the implementation of certain Articles of the Ordinance on Veterinary Medicine.

b) State agencies, organizations, individuals in Vietnam, foreign organizations, and individuals engaged in the production and business of veterinary drugs within the territory of Vietnam must comply with these Guidelines.

2. Definitions

The terms used in this Circular are understood as follows:

a) Shelf life of drugs is the time limit set for a batch of drugs beyond which the drugs may not be circulated or used.

b) Lot of Product is a quantity of product produced during a specific production cycle and according to a specific production order, uniform in characteristics and quality.

c) Substandard drugs are drugs that do not meet the registered quality standards with the Department of Animal Health.

d) Counterfeit veterinary drugs are products that have not been registered for production by the competent authority or are products produced under the guise of a drug belonging to one of the following categories:

- Not containing or not containing sufficient types of active ingredients as registered;

- Containing different active ingredients from those listed on the label;

- Imitating the name, model, registration number of another entity's product;

- Imitating the trademark or design of a product already protected by industrial property rights of another entity.

đ) Country of origin of drugs is the country or territory where the entire drug was manufactured or where the final basic processing stage was carried out in cases where multiple countries or territories were involved in the manufacturing process.

e) Drugs of unknown origin or source are drugs whose original labels do not indicate or do not fully indicate the name and address of the manufacturer; for imported drugs, they do not clearly state "produced in" or "origin" followed by the name of the country or territory where the drug was manufactured.

Policy Bureau, General Political Department Entities responsible for veterinary drugs include manufacturers, importers, and businesses dealing in veterinary drugs.

II. RECALL OF VETERINARY DRUGS

1. Veterinary drugs subject to recall include:

a) Veterinary drugs listed in the Catalogue of Prohibited Veterinary Drugs in Vietnam;

b) Veterinary drugs not included in the Catalogue of Permitted Veterinary Drugs in Vietnam;

c) Counterfeit veterinary drugs, veterinary drugs of unknown origin, expired veterinary drugs;

d) Veterinary drugs without labels or with labels that do not conform to legal requirements;

đ) Veterinary drugs that have changed in form (characteristics): clumping, turbidity, color change, sedimentation, layering, deformation;

e) Veterinary drugs listed in the Catalogue of Permitted Veterinary Drugs in Vietnam currently circulating in the market and found through national inspection to not meet the registered quality standards.

2. Procedures for recalling veterinary drugs:

a) Competent state authorities upon discovering veterinary drugs subject to recall as specified in points a, b, c, d, đ, Clause 1, Part II, shall immediately seal them and issue a decision to recall.

b) The recall of veterinary drugs specified in point e, Clause 1, Part II shall be conducted as follows:

- In the case where samples of veterinary drugs are taken from the place of manufacture or import/export:

The Department of Animal Health will notify the enterprise concerned about the results of the sample testing and request the enterprise to immediately recall the batch of drugs. Within seven days for pharmaceuticals and chemicals and forty-five days for vaccines and biological preparations, from the date of receipt of the notification from the Department of Animal Health, the enterprise has the right to appeal to the Department of Animal Health regarding the test results of the sample. If the enterprise does not appeal within this period, the Department of Animal Health will issue a nationwide recall decision.

In the event of an appeal, the Department of Animal Health will take new samples for retesting. If the retest results still do not meet the quality standards, the Department of Animal Health will issue a nationwide recall decision; if the retest results conclude that the batch of drugs meets the quality standards, the batch of drugs will continue to circulate in the market.

- In the case where samples of veterinary drugs are taken from provincial or centrally-administered city areas:

After receiving the test results, the sampling agency will immediately seal the batch of drugs that do not meet the quality standards and issue a recall decision for the entire provincial or city area; at the same time, it will inform the Department of Animal Health and the producing or importing enterprise of the batch of drugs. Within seven days for pharmaceuticals and chemicals and forty-five days for vaccines and biological preparations, from the date of receipt of the notification, the enterprise has the right to appeal to the Department of Animal Health regarding the test results of the sample. If the enterprise does not appeal within this period, the Department of Animal Health will issue a nationwide recall decision.

In the event of an appeal, the Department of Animal Health will take new samples from the place of manufacture or import for retesting. If the retest results still do not meet the quality standards, the Department of Animal Health will issue a nationwide recall decision; if the retest results conclude that the batch of drugs meets the quality standards, the Department of Animal Health will not issue a nationwide recall decision for that batch of drugs.

c) Enterprises engaged in the production, import, and business of veterinary drugs subject to recall must take responsibility for recalling the drugs according to the recall decision of the competent authority. After completing the recall, the enterprise must report the results of the recall to the issuing authority.

d) For veterinary drugs that must be recalled nationwide, the Department of Animal Health shall issue a decision to recall and announce on central mass media. The provincial and centrally-administered city Animal Health Sub-departments shall supervise the recall within their jurisdiction.

đ) For veterinary drugs that must be recalled within the province or city, the Animal Health Sub-department shall issue a decision to recall and announce on local mass media.

e) The Department of Animal Health shall issue a notice to suspend circulation nationwide and announce on central mass media, withdraw registration numbers for the following special cases of violation:

- Veterinary drugs containing active ingredients listed in the Catalogue of Prohibited Veterinary Drugs in Vietnam.

- Veterinary drugs failing quality standards through three consecutive regular or random inspections within one year by the competent authority.

- Veterinary drugs with unclear therapeutic effects, having side effects that may harm human or animal health, or pose potential risks to humans, animals, and the environment.

III. HANDLING OF RECALLED VETERINARY DRUGS

1. The provincial Animal Health Sub-department shall be responsible for destroying the following types of veterinary drugs:

a) Veterinary drugs listed in the Catalogue of Prohibited Veterinary Drugs in Vietnam;

b) Veterinary drugs not included in the Catalogue of Permitted Veterinary Drugs in Vietnam;

c) Counterfeit veterinary drugs, veterinary drugs of unknown origin, expired veterinary drugs;

d) Veterinary drugs that have changed in form (characteristics): clumping, turbidity, color change, sedimentation, layering, deformation;

đ) Veterinary drugs without labels.

The Animal Health Sub-department shall issue a decision to establish a destruction committee for veterinary drugs. The committee must consist of at least three members, including one leader of the Animal Health Sub-department, one inspector, and one representative from the local environmental agency.

2. For veterinary drugs listed in the Catalogue of Permitted Veterinary Drugs in Vietnam currently circulating in the market but with labels not conforming to legal regulations or failing registered quality standards, the entity responsible for the drugs shall immediately carry out the recall and handling:

a) Recall and destroy veterinary drugs violating quality level 1, including:

- Mislabeling of dosage that could result in serious consequences;

- Mislabeling of active ingredients that could result in serious consequences;

- Drugs lacking the main active ingredient listed on the label;

- Vaccines failing one of the three criteria: sterility, safety, efficacy;

- Drugs subject to urgent recall according to decisions of foreign regulatory authorities (for imported drugs).

b) Recall and handle according to the manufacturer's regulations for veterinary drugs violating quality level 2:

- Veterinary drugs with labels not conforming to legal regulations;

- Drugs failing one of the quality standard criteria registered: sensory, physical and chemical, microbiological, drug content outside the permitted limit ±10% compared to the labeled content; net weight (actual volume) outside the permitted limit ±5% compared to the labeled weight.

3. In cases where drugs are destroyed, the entity responsible for the drugs must bear all costs for destruction and be liable for the consequences of drug destruction according to the law.

IV. IMPLEMENTATION

1. Responsibilities of competent authorities

a) The Department of Animal Health shall be responsible for guiding the destruction of veterinary drugs and the form of recall letters for veterinary drugs.

b) The Department of Animal Health and provincial Animal Health Sub-departments shall be responsible for organizing and implementing according to the guidance provided in this Circular.

2. Effective Date

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

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