Procedures for Registration of Veterinary Biologics (Excluding Vaccines)/ Diagnostic Test Kits for Animal Use in Malaysia

1 PROCEDURES FOR REGISTRATION OF VETERINARY BIOLOGICS (EXCLUDING VACCINES)/ DIAGNOSTIC TEST KITS FOR ANIMAL USE IN MALAYSIA Key word: biologic registration, diagnostic test kits registration, animal use Copyright 2016 DEPARTMENT OF VETERINARY SERVICES MINISTRY OF AGRICULTURE AND AGR0-BASED INDUSTRY 2 ABBREVIATIONS COA COO DVS Certificate of Analysis Certificate of Origin Department of Veterinary Services GMP Good Manufacturing Practice GQC Good Quality Control TACB MAQIS Technical and Advisory Committee on Biologics Department Of Quarantine And Inspection Services Malaysia 3 PROCEDURES FOR REGISTRATION OF VETERINARY BIOLOGICS (EXCLUDING VACCINES) / DIAGNOSTIC TEST KITS IN MALAYSIA 1. INTRODUCTION Section 84, Animal Act 1953, requires a person to get a written permission from the Director General to import any living disease germ or virus or any bacterial culture or part of them used for diagnosis, treatment, research and control or prevention of disease. Section 30, Animal Act 1953, requires licenses to possess live cultures or vaccines and to inoculate animals or birds with such culture or vaccine. (Living culture???) There are many types of biologics available, each with different function and purpose such as vaccines, antibody products, and in vitro diagnostic test kits. Veterinary biologicals must meet certain basic criteria, include: • Safety: the product must be safe in the target species and, if live, in species exposed to shed organisms; • Efficacy: the product should be effective according to claims indicated on the label; • Quality: includes purity, potency and consistency; • Purity: the product must be free from contaminating agents; • Potency: each batch of product should be formulated, and tested, to ensure effectiveness and reproducibility of activity as demonstrated in the registration data The objective of this registration is to regulate the importation of veterinary biologic (including domestic livestock, poultry, companion animals, wildlife, and aquatic species) and thus as well as to safeguard veterinary public health and food safety by controlling indigenous animal disease and preventing the introduction and dissemination of foreign animal diseases. As the regulatory agency to enforce legislative requirements, Department of Veterinary Services (DVS) has set down specific procedures for registration of veterinary biologics in Malaysia with regards to production, importation, distribution, sale and use. The purpose of this guideline is to provide information to the applicant regarding the preparation and submission of documents for the registration of veterinary biologics in Malaysia. The Biosecurity and SPS Management Division is responsible for registration of veterinary biologics, manufactured and/or distributed in Malaysia. The related official form for submission of dossier / dossier check list for registration as well as the appropriate veterinary biologics procedures, should be submitted when preparing a new product submission for registration. 4 A new product submission should be submitted to DVS after the licensing process is complete in the country of manufacture. All documents pertinent to product registration must be submitted at the same time. All documents, including study reports and labels must be reviewed and approved by the Technical and Advisory Committee on Biologics (TACB) prior to the product registration. 2. SCOPE 2.1 The procedures shall apply to registration of veterinary biologics/ diagnostic test kits other than vaccines. 2.2 Veterinary biologics products that are required for registration under DVS are following: i. Diagnostics test kit are products used to determine the health status of an animal or diagnosis of animal disease. ii. Bacterins, bacterial extracts, toxoid are made from viruses, bacteria, spores or other disease-causing organisms; may contain whole organisms or selected portions of an organism. iii. Immunomodulators are products used to stimulate or suppress the immune system and to treat certain types of tumors or infection. iv. Immunological products including antigen, antisera, antitoxins, monoclonal antibodies, specific immunoglobulins are products containing protective antibodies against a particular organism or a toxic substance that the organism produces. v. Biotechnology products including rDNA products, recombinant antibodies, monoclonal antibodies and derivatives, gene therapy products vi. Blood products including plasma, albumin, clotting factors, fibrinogens, immunoglobulin vii. Hormone, enzyme, probiotic, yeast and yeast extract, viii. Microorganism either live, killed or attenuated Microscopic or sub-microscopic organisms, which are sometimes referred to as organisms, which may introduce or disseminate disease of animal ix. Live culture x. Primer xi. Allergenic extract (please check USDA:FDA) manufactured from microorganisms, animals (such as molds, insects, insect venoms, and animal hair) known to elicit allergic reactions 5 2.3 Veterinary biologics for research purpose is not be subjected to registration procedures but shall have written permission from DVS prior to importation. (Please refer to Guidelines of Veterinary Biologics for Research Use) 2.4 This procedure shall apply to Peninsular Malaysia and Federal Territory of Labuan. 3. PURPOSE OF PROCEDURES 3.1 To provide the local manufacturer, importer and distributor with guidelines on preparing submissions for registration of veterinary biologics/ diagnostic test kits of animal origin and/or for animal use in Peninsular Malaysia and Federal Territory of Labuan. 3.2 To regulate use of veterinary biologics/ diagnostic test kits for animal use in Peninsular Malaysia and Federal Territory of Labuan. 4. DEFINITION 4.1 “animal” includes horses, cattle, sheep, goats, swine, dogs, cats and any four-footed beast kept in captivity or under control, of any age or sex. 4.2 “Director-General” means the Director General of Veterinary Services appointed under section 3 of Animal Act 1953 and includes the Deputy Director-General under the same section. 4.3 “diagnostic test kit” is a product that is used in the course of a chemical or analytical procedure for laboratory, industrial, educational, or research purposes, used to determine the health status of an animal. 4.4 “importer” includes any person who, whether as owner, consignor, consignee, agent or broker, is in possession of, or is otherwise entit led in the custody or control, of the imported biologics/ diagnostic test kits , bring or cause to be brought into Malaysia by land, water or air 4.5 “Immunomodulators” includes any products used to stimulate or suppress the immune system and to treat certain types of tumors or infections. 4.6 “live culture” includes live cell culture, live microorganism which is grown under controlled condition, generally outside of their natural environment. 4.7 “local agent” means any person or organization that has been appointed and authorized by the manufacturer to import and distribute the product. 4.8 “manufacturer” includes any person who, formulates, prepares, compounds, mixes, makes, packs or labels any veterinary biologics product with a view to its sale or for own use but does not include a bona fide research or experiment relating to biologics/ diagnostic test 6 kits and any action forming part of or incidental to such research or experiment. 4.9 “premises” includes farm, any house, slaughterhouse, plant processing, feed mills, animal clinic, animal shop, wet market, stores, booths, cubicles, sheltered place, rooms or building is open or enclosed or area can be delimited where animals or animal products placed or placed temporarily or permanently and any related services to animal, and animal products 4.10 “Sole agent” is the only person or organization who appointed as agent or representative. 4.10 “veterinary biologics” means any viruses, serums, toxins, and analogous products of natural or synthetic origin, including genet ically modified organism, diagnostics, antitoxins, vaccines, live microorganisms, killed micro-organisms, and the antigenic or immunizing component of micro-organisms intended for use in the diagnosis, treatment, or prevention of diseases of animals or birds, for the purposes of research in animals or birds 4.11 “Feed additives” means any added ingredient including microorganism and enzyme not normally consumed as feed by itself, whether or not it has nutritive value, which affects the characteristics of feed or animal products 5. REGISTRATION OF VETERINARY BIOLOGICS/ DIAGNOSTIC TEST KIT 5.1. Registration will be based on evaluation of technical information and complete supporting documents provided in the registration a) Applicat ions shall be made local agent b) TACB 9 form should be completed and submitted by applicants. c) Please use an appropriate checklist: i . Test kit i i . Animal feed product i i i . Enzyme and hormone d) Authorized English translation must accompany any material not published in English. e) For each product, please submitted applicat ion separately 5.2. General criteria for product acceptability a) The product must be pure, safe, potent and eff icacious. b) The product must be l icensed by, or have the approval of, the regulatory authorit ies in the country of manufacture. 7 c) Each biologically active component must be relevant to infect ious animal diseases condit ions and animal genetic in Malaysia. d) The product must be manufactured in a GMP facil ity. 6. REGISTRATION OF FEED AND FEED ADDITIVES CONTAINING VETERINARY BIOLOGICAL SUBSTANCE 6.1. Feed and feed additives either single or multiple material whether processed, semi-processed or raw, which is intended to be fed to animals are subject to the Feed Act 2009. 6.2. Feed and feed additives containing veterinary biological substance have to refer “Senarai Bahan-bahan Biologik Dalam Kategori Umumnya Diiktiraf Sebagai Selamat” (GRAS List) 6.3. If the biologic substances are not in the list, the applicant is required to submit an application to list the biologic substance in the list of biologic substance in the category of generally recognized as safe (GRAS) 6.4. This GRAS list will be updated from time to time 7. CERTIFICATE OF PRODUCT REGISTRATION 7.1 A cert if icate of registration shall be issued for a period of 5 years from the date of approval and not transferable to other company. 8. LOCAL AGENT/LOCAL MANUFACTURER 8.1 The local agent/local manufacturer must provide detail information and complete documentation. 8.2 Local agent shall be responsible to import the product. 8.3 Local agent shall provide confirmation of appointment as a local agent by manufacturer. 8.4 Local manufacturer shall submit business license that issued by Local Authority 8.5 Application must include the following details for DVS evaluation: i. Name and address of company (must be a Malaysian registered company – with document evidence) ii. Copy of registration certificate (ROC) of the company iii. Copy of memorandum and articles of association of the company iv. Letter of attorney/authorization letter by the manufacturer as a sole agent v. Standard operating procedures (SOPs) for handling and disposal of bio hazardous materials. 8 8.6 DVS may carry out inspection of the facilities of the local agent/ distributor/local manufacturer. 8.7 The local agent/local manufacturer may appoint local distributors and shall provide the DVS the list of distributors as and when necessary. 9. RENEWAL OF REGISTRATION 9.1 The local agent/local manufacturer is required to submit the official application for renewal of registration of veterinary biologics at least 3 months prior to the expiry of validity. 9.2 Letter of authorization from the foreign manufacturer to the appointed local agent for at least 5 years from the date of the renewal (for imported product) 9.3 Copy of business license from Local Council (for product manufactured in Malaysia) 9.4 A copy of present registration certificate and latest COA shall be submitted together. 9.5 Other new technical information or additional information if any must be provided. 9.6 Registered veterinary biologics which are not renewed will be automatically deregistered. 10. CHANGE OF LOCAL AGENT 10.1 Any change of local agent in Malaysia must be notified immediately to the DVS, in writing. 10.2 The newly appointed local agent must fulfill all the requirements in clause 8. 10.3 Letter of attorney/authorization letter to the newly appointed local agent must be issued by the foreign manufacturer. 10.4 Consent letter and acceptance letter from both companies; or Termination letter to the old local agent by the foreign manufacturer 10.5 Please attached together the registration certificates of the products to be transferred and latest COA. 10.6 Other new technical information or additional information if any must be provided 10.7 The application of change of local agent same as a new application 9 11. CHANGE/AMMEND OF PRODUCT INFORMATION The local agent must inform DVS for any changes of product information. It could be label, ingredient and manufacturer. Document needed: 11.1 Declaration letter from manufacturer. 11.2 Please attached together the registration certificates of the products. 11.3 Please attached together supportive document such a latest labeling, COA, COO or any related information subjected to amend. 11.4 Please attached together consent letter from manufacturer 12. DEREGISTRATION OF VETERINARY BIOLOGIC/ TEST KIT 12.1 TACB will, from time to time, advice the Director General of Veterinary Services (DGVS) Malaysia on the need for deregistration of any veterinary biologic/ diagnostic test kit. 12.2 DVS reserves the right to withdraw the registration in the event that there is non-compliance of the biologic to safety, potency, efficacy and purity standards or adverse reactions or health hazard to human or animals. 12.3 If the samples of product taken during DVS monitoring fail to meet the specifications, the registration of the product will be suspended. The distributor/ manufacturer have 30 days to identify the source/cause of quality defect and actions to be taken to improve quality. Failure to do so may effect in deregistration of the product. 13. OTHERS 13.1 Monitoring By DVS 13.1.1 The DVS has the right to inspect local manufacturer and importer premises, storage and transportation facilities without early noticed. 13.1.2 DVS may take samples of the biological products/ diagnostic test kit for the purpose of evaluation as when necessary. 13.1.3 In case of non-compliance to storage, handling and transportation facilities, the biologic/ diagnostic test kit may be placed under restriction until further evaluation and the non compliance corrected. 13.1.4 The manufacturer/importer/distributor is responsible to report any contamination associated with the use of the product in the field/ laboratory. 13.1.5 Manufacturer/Importer/distributor are also responsible to dispose the contaminated products in a proper way. 10 13.1.6 In the event that there is a consumer report or complaints, DVS may conduct an investigation and require the manufacturer/importer to provide data demonstrating the purity, safety, potency and efficacy of the product and submit samples to DVS’s laboratories for confirmatory testing. 13.2 Import of Biologics/ Diagnostic Test Kits 13.2.1 Veterinary Biologic/ diagnostic test kit products registered with DVS shall be imported for sale and use with an import permit issued by MAQIS. 13.2.2 Prior to importation of feed and feed additive containing biological substance, import licence under the Feed Act 20019 must be obtained. 13.2.3 Every consignment shall be accompanied by a declaration by the authorities or manufacturer regarding safety of the product. 13.3 Appeal Against TACB Decisions 13.3.1 Any applicants may make a written appeal to the DVS within fourteen (14) days from the day of the notification. 13.3.2 A period of 60 days is given for submission of any supporting data/ information. The appeal is considered closed if all the required information is not submitted within the stated time given without reasonable cause. A request for extension of this period will not be entertain. 13.3.3 The decision of the appeal is final. 14. APPLICATION AND ENQUIRY All applications and enquiries for registration of veterinary biologics for importation, production, sale and use in Malaysia must be made by writing direct to: Director General Department of Veterinary Services (DVS) Ministry of Agriculture and Agro-Based Industry, Wisma Tani, Blok Podium, Lot 4G1, Precinct 4, Federal Government Administration Centre, 62630 Putrajaya, Malaysia (Attn: TACB Secretary, Zoonosis and Public Health Section) Tel : 03 – 88702000/ 2099/ 2102 / 2105 Fax : 03 – 88886472