Article 1(Purpose) #
The purpose of this Decree is to prescribe the facility standards for the animal pharmacies and for the manufacturers, importers, and distributors of veterinary pharmaceuticals, etc. categorized as medicinal products and quasi-drugs under Article 20 (3), Article 31 (1) and (4), Article 42 (3), and Article 45 (2) of the Pharmaceutical Affairs Act, in accordance with Article 85 of that Act.
Article 2(Definitions) #
The terms used in this Decree shall be defined as follows:
1. The term "veterinary pharmaceuticals, etc." means veterinary medicinal products and veterinary quasi-drugs;
2. The term “partition” means a method of management of space divided by partitions or other similar means;
3. The term "separation" means a method of management of a room separated by a wall and having a different entrance;
4. The term "detachment" means a method of management in a state where the spaces are not adjoining but are physically separated from each other.
Article 3(Facility standards for animal pharmacies) #
An animal pharmacy that sells veterinary pharmaceuticals shall be equipped with the following facilities and equipment:
1. Facilities for low-temperature storage and light shielding;
2. Waterworks and other facilities necessary for water supply;
3. Equipment necessary for dispensing.
Article 4(Facility standards for manufacturing plants of veterinary pharmaceuticals) #
(1) Veterinary pharmaceutical manufacturing plants shall be equipped with the following facilities and equipment:
1. A workplace where veterinary medicinal products are manufactured;
2. A storage facility for storing raw materials, packaging materials, and finished products;
3. A testing laboratory that manages the quality of raw materials, packaging materials, and finished products;
4. Facilities and equipment necessary for manufacturing and quality control.
(2) Where a person who has obtained a manufacturing license for pharmaceuticals under Article 31 (1) of the Pharmaceutical Affairs Act intends to manufacture veterinary pharmaceuticals intended solely for companion animals defined in Article 2 (7) of the Animal Protection Act, the veterinary pharmaceutical manufacturing plant facilities may be replaced by the facilities of such person's pharmaceutical manufacturing plant, provided that all of the following requirements are satisfied: <Added on Nov. 28, 2023>
1. The veterinary pharmaceuticals shall be manufactured with an effective ingredient specified in any of the following items:
a. Effective ingredients of medicinal products which have been granted permission by item under Article 31 (2) of the Pharmaceutical Affairs Act in the Republic of Korea, which have never been granted permission by item under Article 31 (2) of the Pharmaceutical Affairs Act for veterinary use in accordance with Article 85 of that Act before November 30, 2023;
b. Effective ingredients as specified in Appendix;
2. The pharmaceutical manufacturing plant facilities shall comply with each subparagraph of paragraph (1);
3. There shall be no risk of cross-contamination between medicinal products and veterinary pharmaceuticals.
(3) A person who has obtained a manufacturing license for veterinary pharmaceuticals may deem the manufacturing plant facilities for the particular veterinary pharmaceuticals as the manufacturing plant facilities for other veterinary pharmaceuticals, provided that there is no risk of cross-contamination between the products. <Amended on Nov. 28, 2023>
[Title Amended on Nov. 28, 2023]
Article 5(Facility standards for veterinary pharmaceutical workplaces) #
(1) A workplace for veterinary pharmaceuticals under Article 4 (1) 1 shall comply with the following standards: <Amended on Jul. 2, 2019; Jan. 5, 2021>
1. A workplace for sterile preparations (sterile preparations: injections, eye drops, and eye ointments; hereinafter the same shall apply), workplace for biological preparations, and workplace for other preparations shall be separated from each other;
2. A workplace for injections, eye drops, granules, powders, internal and external liquids, infusions, ointments, and other workplaces for formulations having different manufacturing processes shall be partitioned respectively.
(2) Notwithstanding paragraph (1), a workplace in which there is no risk of cross-contamination due to the installation of closed-type mechanical equipment or similar measures need not be separated or partitioned.
(3) A workplace shall be equipped with the facilities and equipment specified in the following subparagraphs; provided, if the Commissioner of the Animal and Plant Quarantine Agency (hereinafter referred to as the "Commissioner") or the Director General of the National Fishery Products Quality Management Service (limited to veterinary pharmaceuticals for aquatic animals; hereinafter the same shall apply) recognizes the relevant veterinary pharmaceuticals require special preparation methods such as synthesis of raw materials and publicly notifies it, appropriate safety measures to ensure safety may be implemented and part of such facilities may be located outside the workplace: <Amended on Jun. 7, 2011; Mar. 23, 2013; Jul. 2, 2019; Dec. 29, 2020>
1. Facilities and equipment necessary for manufacturing veterinary pharmaceuticals produced at the relevant manufacturing plants;
2. Water facilities necessary for manufacturing veterinary pharmaceuticals produced at the relevant manufacturing plants;
3. Sanitary toilets, changing rooms and washing facilities;
4. A workroom equipped with the facilities specified in the following items, in accordance with the type, formulation, manufacturing method, and manufacturing facilities of veterinary pharmaceuticals manufactured at the relevant manufacturing plants; provided, a raw material weight measurement workroom, product packaging workroom, or container washing workroom need not be established at each workplace, provided that it does not affect the quality of the veterinary pharmaceuticals, and if the Commissioner of the Animal and Plant Quarantine Agency or the Director General of the National Fisheries Quality Management Service recognizes and publicly notifies that the veterinary pharmaceuticals requires special preparation methods, such as raw material synthesis, a workroom need not be established:
a. Worktable; provided, an exception may be made in cases where the preparation poses no risk of contamination or pharmaceuticals are manufactured through a continuous process;
b. Facilities for preventing cross-contamination, or cleaning equipment such as high-pressure washers;
c. Facilities for removing powder (only applicable when powder is flying);
d. Facilities for humidity control (only applicable when handling hygroscopic preparations);
e. Facilities with automatic temperature control of drying equipment (only applicable where drying equipment is installed);
5. Facilities for handling toxic gases (only applicable to workplaces where toxic gases are generated during the manufacturing process);
6. Disinfection facilities (only applicable to workplaces for sterile preparations, oral liquid preparations, and ointments).
(4) A workplace for powder preparations equipped with a large-capacity mixer of 500 kilograms or more shall be separated from the facilities for other preparations, and within such facilities, those used for antibiotic preparations (including antimicrobial preparations) shall be detached.
Article 6(Facility standards for workplaces of finished products of veterinary pharmaceuticals) #
The facilities of a workplace for finished products of veterinary pharmaceuticals intended for direct administration to animals shall, in addition to meeting the standards under Article 5, comply with the following standards: <Amended on Jul. 2, 2019>
1. The entrances and windows of the workplace shall be capable of being completely sealed, and the workplace shall be equipped with the facilities specified in the following items:
a. Air conditioning equipment capable of preventing contamination and maintaining appropriate temperature and humidity levels, in accordance with the type, formulation, or manufacturing method of veterinary pharmaceuticals being manufactured;
b. Testing and inspection facilities or equipment necessary for the control of the manufacturing process;
c. Facilities for storing semi-finished products during the manufacturing process in a manner that does not affect their quality.
2. Workrooms where weighing of raw materials, preparation and filling of veterinary pharmaceuticals, or capping and sealing operations are performed shall comply with the standards specified in the following items:
a. The ceiling shall be finished in a manner that prevents dust from falling, and the floors and walls shall have smooth surfaces that allow for easy removal of dust and dirt;
b. Piping inside the workroom shall be easy to clean, and where piping passes through walls, it shall be finished without any gaps;
c. Entrances (excluding emergency exits) and windows shall not open directly to the outside;
d. The workroom shall not be designed to serve as a passageway for persons not engaged in the relevant operations.
[Title Amended on Jul. 2, 2019]
Article 7(Facility standards for workplaces for sterile preparations) #
The facilities of a workplace for sterile preparations shall, in addition to complying with the standards under Article 6, comply with the standards specified in the following subparagraphs: <Amended on Jul. 2, 2019>
1. The workplace for sterile preparations shall be equipped with the following facilities and equipment:
a. Sterilization or decontamination facilities in accordance with the type of sterile preparation (in the case of heat sterilization facilities, such facilities shall be capable of maintaining the required sterilization conditions in any section of the facilities during the sterilization process);
b. Facilities and equipment required for sterility testing;
c. Facilities and equipment necessary for foreign substances inspection;
d. Physicochemical testing facilities for raw materials, products, and containers, and equipment necessary for such testing;
e. Facilities for automatic washing and sealing of containers;
f. Facilities for preparation and filtration of medicinal substances;
g. Filling facilities capable of measuring the weight and volume of medicinal substances;
h. Water for injection production facilities (only applicable to cases of manufacturing injectable preparations that require distilled water);
i. Facilities and equipment necessary for seal integrity testing (applicable only when conducting inspections of sealed conditions);
j. Pyrogen testing facilities and equipment necessary for such testing (applicable only when pyrogen testing is required);
k. Biological testing facilities and equipment required for such testing (only applicable when biological testing is required);
2. Workrooms where weighing of raw materials and the preparation, filling, and sealing of veterinary pharmaceuticals are performed, as well as controlled areas such as corridors where aseptic operations are required, shall comply with the standards specified in the following subparagraphs:
a. Facilities for supplying sterilized air shall be provided;
b. The surfaces of the ceiling, floor, and walls shall be designed to withstand spray washing with disinfectant solution;
c. A work preparation room shall be provided for bringing raw materials and packaging materials into the workroom;
d. A dressing room and disinfection facilities exclusively for workers shall be provided, which is connected with the controlled area where aseptic operations are performed, to allow workers to enter the workroom.
3. Workrooms for weighing and preparing aseptic raw materials requiring aseptic manipulation, and workrooms for filling and sealing sterile preparations shall be equipped with aseptic rooms or aseptic facilities with aseptic conditions in addition to the standards under subparagraph 2.
Article 8(Facility standards for workplaces of biological preparations) #
In addition to the standards provided in Article 6, the facilities of a biological preparation workplace shall comply with the following standards: <Amended on Jun. 7, 2011; Mar. 23, 2013; Dec. 29, 2020; Jan. 5, 2021>
1. The workplace shall be equipped with the following facilities; provided, in accordance with the type and manufacturing method of the biological preparation, facilities that are not necessary for manufacturing the preparation need not be equipped:
a. Storage facilities for microorganisms;
b. Facilities for managing animals inoculated with microorganisms among animals used in manufacturing or testing;
c. Facilities for treating animals used in manufacturing or testing;
d. Facilities for transplanting microorganisms into a medium (referring to a liquid or solid containing nutrients necessary for cultivating living things; hereinafter the same shall apply);
e. Facilities for culturing microorganisms;
f. Facilities for collecting, inactivating, sterilizing, or otherwise treating cultured microorganisms;
g. Facilities for preparing diluent for original solution;
h. Facilities for diluting and aliquoting original solution, and facilities for sealing containers;
i. Facilities for preparing diluents for original solution;
2. Workrooms equipped with the facilities under subparagraph 1 shall have the ceilings, floors, and walls with surfaces resistant to washing and disinfection, and shall be separated or partitioned from other areas;
3. Where the facilities under items a, b, d, e, or i of subparagraph 1 are intended for handling variola virus, poliovirus, Clostridium botulinum, or Mycobacterium tuberculosis, the workrooms equipped with such facilities may be separated or partitioned and exclusively used according to the type of pathogen;
4. Controlled areas required for aseptic operations, where the facilities under items (d) and (f) through (h) of subparagraph 1 are located, shall comply with the standards set forth in subparagraphs 2 and 3 of Article 7;
5. In addition to the facilities under subparagraph 1, the workplace shall be equipped with the facilities specified in the following items, and the workroom in which such facilities are located shall comply with the standards under subparagraph 2 of Article 6:
a. Facilities for housing and managing animals used in manufacturing or testing; provided, such facilities need not be provided if animal testing is conducted using the facilities of an institution that meets the standards determined and publicly notified by the Commissioner of the Animal and Plant Quarantine Agency or the Director General of the National Fishery Products Quality Management Service;
b. Manufacturing facilities for preparing culture media and diluents;
c. Facilities for washing and sterilizing the equipment, containers, and other items used in manufacturing or testing;
d. Manufacturing facilities for distilled water required for manufacturing;
e. Incineration facilities for animal carcasses and other waste, and wastewater treatment facilities;
6. Storage facilities shall be equipped with temperature control devices, automatic temperature recorders, and other necessary measuring instruments.
Article 9(Facilities standards for workplaces of veterinary active pharmaceutical ingredient) #
In addition to the standards in Article 5, the facilities of workplaces for veterinary active pharmaceutical ingredients shall comply with the following standards:
1. Workplaces that perform filtration, crushing, refining, and filling operations within the workplaces for veterinary active pharmaceutical ingredients: Standards specified in each subparagraphs of Article 6;
2. Sterile preparation raw material veterinary drug production facility: Standards for each item of Article 7 (excluding items 1 and 2 of the same Article);
3. Workplaces of veterinary active pharmaceutical ingredient for biological preparations: Standards specified in each subparagraph of Article 8.
Article 10(Facility standards for storage of veterinary pharmaceuticals) #
The storage facilities referred to in Article 4 (1) 2 shall be maintained in a sanitary condition and shall be partitioned by the type of raw materials, packaging materials, and finished products so as not to affect their quality; provided, such partitioning may be omitted if the facilities are designed to prevent any risk of mixing among raw materials, packaging materials, and finished products.
Article 11(Facility standards for veterinary pharmaceutical laboratories) #
The testing laboratory referred to in Article 4 (1) 3 shall be equipped with the facilities and equipment necessary for quality control of raw materials, packaging materials, and finished products, as determined and publicly notified by the Commissioner of the Animal and Plant Quarantine Agency or the Director General of the National Fishery Products Quality Management Service; provided, if testing and inspection are conducted using the facilities and equipment of an institution that meets the standards determined and publicly notified by the Commissioner of the Animal and Plant Quarantine Agency or the Director General of the National Fishery Products Quality Management Service, a separate laboratory need not be established. <Amended on Jun. 7, 2011; Mar. 23, 2013; Dec. 29, 2020.>
Article 12(Facility standards for manufacturing plants of veterinary pharmaceuticals) #
The facility standards for veterinary pharmaceutical manufacturing plants shall be in compliance with Articles 4, 5, 10, and 11; provided, in cases where a person who has obtained a manufacturing license for veterinary pharmaceuticals intends to manufacture veterinary quasi-drugs in the same type of veterinary pharmaceuticals manufactured by the person, the facilities of the manufacturing plant may be substituted.
Article 13(Entrustment of manufacturing or testing of veterinary pharmaceuticals) #
(1) If a manufacturer of veterinary pharmaceuticals, etc. entrusts the manufacturing or testing of veterinary pharmaceuticals, etc. to other manufacturers, etc. of veterinary pharmaceuticals, etc., the facilities and equipment related to the manufacturing or testing of veterinary pharmaceuticals, etc. among the facilities and equipment stipulated in Articles 4 through 12 need not be equipped.
(2) Where a manufacturer of veterinary pharmaceuticals, etc. under paragraph (1) entrusts the manufacturing or testing of veterinary pharmaceuticals, etc. to other manufacturers, etc. of veterinary pharmaceuticals, etc., the scope of such trustee shall be as follows: <Amended on Jun. 7, 2011; Mar. 23, 2013; Jul. 2, 2019; Dec. 29, 2020; Jan. 5, 2021>
1. An entity entrusted with manufacturing:
a. A manufacturer of veterinary pharmaceuticals, etc.;
b. A manufacturer of goods other than veterinary pharmaceuticals, etc., who performs processes such as automatic aerosol filling, pencil manufacturing, gas injection, plating, casting, forging (referring to the process of shaping metal by hammering or pressing), sheet metal work, injection molding, printing, coating, painting, sterilization, weaving, non-woven fabric production, tenter (referring to the process of stretching materials to a specific mold), or design (applicable only in cases where the manufacturing of veterinary quasi-drugs is entrusted);
c. A manufacturer of goods other than veterinary pharmaceuticals, etc. who specializes in the production of parts or components (applicable only in cases where the manufacturing of veterinary quasi-drugs is entrusted);
2. An entity entrusted with testing:
a. A manufacturer of veterinary pharmaceuticals, etc.;
b. An institution that meets the standards determined and publicly notified by the Commissioner of Animal and Plant Quarantine Agency or the Director General of National Fishery Products Quality Management Service, in accordance with proviso of Article 11.
(3) In the case where a manufacturer of veterinary pharmaceuticals, etc. entrusts the manufacturing or testing of veterinary pharmaceuticals, etc. to other manufacturers, etc. of veterinary pharmaceuticals, etc. under paragraphs (1) and (2), matters to be observed by the consignor and the consignee shall be as follows:
1. The consignor of manufacturing or testing of veterinary pharmaceuticals, etc. shall thoroughly supervise and manage the consignee to ensure that the manufacturing or testing is properly conducted, and shall obtain from the consignee the documents related to manufacturing and quality control records and keep them for at least 3 years;
2. The consignor of manufacturing of veterinary pharmaceuticals, etc. shall prepare a product specification sheet and provide it to the consignee; and the consignee shall, based on the provided specification, prepare a manufacturing control standard and a quality control standard for each product and submit documents prepared in accordance with the standards to the consignor, and thoroughly control the quality of additives and containers used when manufacturing the veterinary pharmaceuticals, etc.;
3. The consignor of testing for veterinary pharmaceuticals, etc. shall provide the consignee with the testing standards and methods, as well as the test samples related to the consigned testing, and the consignee shall submit to the consignor the documents regarding the test records for each sample and shall ensure strict control over the reagents, reference standards, and other materials necessary for the consigned testing;
4. The consignee of manufacturing or testing of veterinary pharmaceuticals, etc. shall have the facilities and equipment necessary for manufacturing or testing according to the manufacturing process, and thoroughly manage the quality of the final product.
Article 14(Use of manufacturing facilities and equipment for other purposes) #
A person who has obtained a manufacturing license or submitted a notification for the manufacturing of veterinary pharmaceuticals, etc. and is registered as a manufacturer of livestock feed under the Control of Livestock and Fish Feed Act may use the manufacturing facilities and equipment for veterinary pharmaceuticals, etc. as facilities and equipment for manufacturing livestock feed, provided that there is no risk of cross-contamination between the veterinary pharmaceuticals, etc. and the livestock feed.
Article 15(Facilities standards for importers of veterinary pharmaceuticals) #
(1) The importers of veterinary pharmaceuticals, etc. shall be equipped with the facilities and equipment specified in each of the following subparagraphs: <Amended on Jun. 7, 2011; Mar. 23, 2013; Dec. 29, 2020.>
1. A business office and a warehouse. In such cases, if the business office and warehouse are located in the same building, they shall be partitioned from each other, and the warehouse shall be equipped with facilities that allow for the sanitary storage of veterinary pharmaceuticals, etc., and in cases of importing biological products, etc., storage facilities suitable for such products shall be equipped;
2. A testing laboratory and facilities and equipment necessary for testing; provided, if testing and inspection are conducted using the facilities and equipment of an institution that meets the standards determined and publicly notified by the Commissioner of the Animal and Plant Quarantine Agency or the Director General of the National Fishery Products Quality Management Service, the testing laboratory and testing-related facilities and equipment need not be equipped.
(2) Notwithstanding paragraph (1), if a manufacturer of veterinary pharmaceuticals, etc. or a wholesaler of veterinary pharmaceuticals, etc. who intend to import veterinary pharmaceuticals, etc. has the facilities and equipment required of the importers of veterinary pharmaceuticals, etc. under each subparagraph of paragraph (1) and Article 17, the following facilities and equipment need not be separately equipped:
1. A manufacturer of veterinary pharmaceuticals, etc.: Business offices, warehouses, laboratories, and facilities and equipment required for testing;
2. A wholesaler of veterinary pharmaceuticals: Business offices and warehouses.
Article 16(Facility standards for wholesalers of veterinary pharmaceuticals) #
(1) Veterinary pharmaceutical wholesalers shall have a business office and warehouse; provided, in the case of high-pressure gas for veterinary pharmaceuticals, the standards for high-pressure gas sales facilities under Article 4 (4) of the High-Pressure Gas Safety Control Act shall apply, and in the case of radioactive veterinary pharmaceuticals, the standards for radioisotope sales facilities under Article 55 (1) of the Nuclear Safety Act shall apply. <Amended on Apr. 6, 2011; Oct. 25, 2011>
(2) The warehouse of a veterinary pharmaceutical wholesaler under paragraph (1) shall be equipped with the following facilities:
1. Facilities for low-temperature storage and light shielding;
2. Storage facilities for biological products, etc.
(3) Notwithstanding paragraphs (1) and (2), if a manufacturer or importer of veterinary pharmaceuticals who intend to operate as a veterinary pharmaceutical wholesaler has the facilities required of veterinary pharmaceutical wholesalers under paragraphs (1) and (2), he or she need not have a separate business office and warehouse.
Article 17(Types of facilities and equipment) #
The types, specifications, and quantities of the facilities and equipment required under this Decree, as well as other necessary matters, shall be determined and publicly notified by the Commissioner of the Animal and Plant Quarantine Agency or the Director General of the National Fishery Products Quality Management Service.
<Amended on Jun. 7, 2011; Mar. 23, 2013; Dec. 29, 2020.>