Circular No. 02/2009/TT-BNN guiding the procedures for withdrawal and disposal of veterinary drugs

Issue nos 01-D2IFebruary 2009 (Gong BaD nos 105-1lJ6fFebruary f,2009) OFFICIAL GAZETTE THE MINISTRY OF AGRICULTljRE AND RURAL DEVEWPMENT 27 Circular No. 02l2009/TT-BNN of January 14, 2009, guiding the procedures for withdrawal and disposal of veterinary drugs Pursuant to the Government's Decree No, 01/ 2008lND-CP of January 3, 2008, defining the functions, tasks, powers and organizational structure ofthe Ministry ofAgriculture and Rural Development; Pursuant to Novembe r 21, 2007 LawNo. 05/ 2007IQH12 on Product and Goods Quality; Pursuant to the April 29. 2()()4 Animal Health Ordinance; Pursuant to the Government's Decree No. 331 2005/ND-CP of March 15, 2005, detailing a number of articles of the Animal Health Ordinance; The Ministry of Agriculture and Rural Development guides the procedures for Withdrawal and disposal ofveterinary drugs and biological preparations, microorganisms and chemicals used in animal health (including aquatic veterinary drugs) as follows: @ VIETNAM LAW & LEGAL FORUM ' 28 OFFICIAL GAZETTE Issue nos01-02IFebruary 2009 (Gong BaD nos 105-10fIFebruary 1.2009) L GENERAL PROVISIONS 1. Scope of regula lion and subjects of application aJ This Circular applies to veterinary drugs and biological preparations. microorganisms and chemicals used in animal health. including aquatic veterinary drugs (below collectively referred to as veterinary drugs), specified in Article 50 of the Animal Health Ordinance and Article 62 of the Government's Decree No. 331 2005/ND-CP of March 15, 2005, detailing a n\lmber of <Irticlp.<: of thp. An i rna l Health Ordinance. bl State agencies, Vietnamese and foreign organizations and individuals engaged in veterinary drug production and trading activities in theVietnamese territory shallcomply withthis Circular. 2. Interpretatton of terms The terms referred to in this Circular are construedas follows: a/Use duration means the time limit rUi ueiug of a drug lot. Past this time limit, the drug may not be circulatedand used. hI Lot means a certain quantity of products which are manufactured in a given production cycleunder a specific production orderand have the samespecifications and quality. cI Poor quality drug means a drug failing to meetquality standards registered withtheAnimal Health Department. dI Fake veterinary drug means II veterinary drugwithout a production registration certificate granted by a competent agency, or a product in drug form falling under one of the following cases: Containing no or insufficiently containing pharmaceutical substances as registered; Containing pharmaceutical SUbstances other than those indicated on the label; Using the name, model or product circulation registration code of another manufacturer; Using the name or industrial design of another manufacturer's product already registered for industrial property protection. el Origin of a drug means the country or territory where such drug is manufactured, or processed at the final stage, for a drug manufactured through many stages in different countries or territories. fl Drugof unclear origin meansa drug whose original label fails to specify or insufficiently specifies the manufacturer's name and address; or fails to specify the country Of ten i lOI Y of manufacture, for an imported drug. gI Establishment responsible for veterinary drugs means a veterinary drug manufacturer, importeror trader. II. WITHDRAWAL OF VETERINARY DRUGS 1. Veterinary drugs subject to withdrawal include: atThoseon thelistof veterinary drugsbanned from circulation in Vietnam; bl Those not on the list of veterinary drugs penuiued fur circulation in Vietnam; cl Fake veterinary drugs, veterinary drugs of unclear origin or with expired use duration; d/ Unlabeled veterinary drugs or veterinary drugs improperly labeled under law; el Those with changing appearance (or properties). such as being curdled. turbid. discolored, sedimented, layeredor deformed. fI Those on the list of veterinary drugs permitted for circulation in Vietnam which are being circulated on the market, but detected @ VIETNAM LAW &lEGALFORUM : Issue nos 01·02lFebnla/y 2009 (Gong BaD nos 105-1I()f/February 1. 2009) OFFICIAL GAZETTE 29 through state inspection as failing to meet registered quality standards. 2.Procedures for veterinarydrug withdrawal: aJ When detecting veterinary drugs subject to withdrawalunder Points a, b,c,d ande, Clause 1,Part II, competent state agencies shall seal up those drugs and issue withdrawal decisions. blVeterinary drugs specifiedat Pointf, Clause 1, Pan II shall be withdrawII as follows: For a veterinary drug whose samples are taken at a manufacturer, exporter or importer: The Animal Health Department shall notify the drug owner of test results of drug samples and request it to immediately withdraw the lot of such drug by itself. Within 7 days, for a pharmaceutical product or chemical, or 45 days, for a vaccine or biological preparation, from the dateof receivingtheAnimalHealthDepartment's notice, the enterpriae may lodge a complaint about test results with the Animal Health Department. Past this time limit. if no complaint is lodged, the Animal Health Department shall issue a decision to withdraw such drug nationwide. When a complaint is lodged, the Animal Health Department shall take samples for re testing. If test results still showthat thedrug fails to meet quality standards, the Animal Health Department shall issue a decision to withdraw the drug nationwide. When test results showthat the drug meet quality standards, the lot of such drug may be circulated again on the market. For a veterinary drug whose samples are taken in a province or centrally run city: After having test results, the sample-taking agency shall immediately Se:1111p rhe lot of rln12" failing to meet quality standard and issue a decision to withdraw the drug in a province or centrallyruncity; and simultaneously notifysuch to the Animal Health Department and the manufacturer or importerof the drug lot. Within 7days, fora pharmaceutical productor chemical, or 45 days, for a vaccine or biological preparation, from the date of receiving the AnimalHealthDepartment'snotice,an enterprise may lodge a complaint about test results with the Animal Health Department. Past this time limit, if no complaint is lodged, the Animal Health Department shall issue a decision to withdraw the drug nationwide. When a complaint is lodged, the Animal Health Department shall take samples at the manufacturer or importer for re-testing. If lest results still show that the drug fails to meet quality standards,theAnimal Hea1thDepartment shall issue a decision to withdraw it nationwide. When test results show that the drug lot meets quality standards,theAnimal HealthDepartment will not issue a decision for withdrawal nationwide. cI A manufacturer, importer Of trader that has a drug subject to withdrawal shall withdraw the drugon its own underthe decisionof a competent agency. Upon completion. it shall report such to the agency which issues the withdrawaldecision. dI For a veterinarydrug subject to withdrawal nationwide. theAnimal HeanhDepartment shall issue a withdrawaldecision and publicize it on a central mass media. Provincial-level Sub Departments of Animal Health shall supervise the withdrawal in their localities. el For a veterinarydrug subject to withdrawal in a province or centrally run city, a Sub Department of Animal Health shall issue a withdrawal decision and publicize it on a local mass media. fI The Animal Health Department shall issue a decision for withdrawal nationwide, publicize it on a central mass media and withdraw the registration number for the following special cases of violation: e VIETNAM LAW &LEGAL FORUM 30 OFFICIAL GAZETTE Issue nos 01-o2IFebruary 2009 (eDna Baonos 105-10f1Februar; t 2(09) Veterinary drugs containing acti ve ingredients on the list of veterinarydrugs banned from circulation in Vietnam. Veterinarydrugs detected as failing to meet quality standards in three regular or random examinations in a year by a comperemagency. Veterinary drugs with unclear treatment effects or side effects that may harm human or animal health or pose. risks to humans, animals and the environment. III. DISPOSAL OF WITHDRAWN VETERINARY DRUGS 1. Provincial-level Sub-Departments of Animal Health shall destroy the following veterinarydrugs: alThose on the listof veterinary drugsbanned from circulation in Vietnam; bl .rnose not on the list of veterinary drugs permittee. for circulation in Vietnam; cl Fake veterinary drugs, veterinary drugs of unclear ongin or those with expired use duration; d1Veterinary drugs withchangingappearance (or properties), such as being curdled, turbid, discolored, scdimented, layered or deformed. e/ Unlabeled veterinary drugs. A Sub-Department of Animal Health shall issue a decision to set up a veterinary drug destruction council. Such a council must haveat least three members: a leader of the Sub Department of Animal Health, an inspector and a representative of the local environment agency. 2. For a veterinary drug on the list of veterinary drugs permitted for circulation in Vietnam, which is ),ping circnlared on rhe marker, but is improperly labeled under law or fails to meet registered quality standards, the establishment responsible for the drug shall promptly: aJ Withdraw and destroy veterinary drugs violatingquality regulations at level l, including: Erroneous contents that may cause serious consequences; Erroneous active ingredientsthatmay cause serious consequences; No active ingredients or lack of the main active element indicated on the label; Vaccines failing (Q meet one of the three criteria: sterility, safety and effect; Veterinary drugssubjectto urgentwithdrawal under decisions of foreign management agencies (for imported veterinary drugs). bl Withdraw and dispose of veterinary drugs violatingquality regulationsat level 2 according to manufacturers' regulations: Veterinary drugs that are improperly labeled under law; Veterinary drugs that tail to meet one at the registered quality indicators on appearance, physico-chemical properties; microorganisms; or have contents beyond the ± 10% limit for the contents indicated on the label; or net weight (actual volume) beyond the ±5% limit for the weight indicated on the label. 3. In case of destruction, an establishment responsible for the drug shall cover an expenses for destroying the drug and take responsibility for the consequences of such destruction under law. IV. ORGANIZATION OF IMPLEMENTATION 1. Responsibilities of competent agencies aITheAnimalHealth Department shallguide the destructionof veterinarydrugs, and forms of documentsrelatedto veterinary drug withdrawal. bl The Animal Health Department and provincial-level Sub-Departments of Animal VIETNAM LAW &LEGAL FORUM Issue nos 01.Q2JFebruary 2009 (r.IJng BaDnos 105-1061Februar; 1,2(09) Health shall organize the withdrawal and disposal of veterinary drugs under this Circular. 2. Effect This Circular takes effect 45 days from the date of its signing. In the course of implementation, any arising problems should be reported to the Ministry of Agriculture and Rural Development (the Animal Health Department) for timely adjustment and supplementation. For the Minister of Agriculture and Rural Development Vice Minister DIEP KINHTAN , , 31