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DECREE ON FACILITY STANDARDS FOR MANUFACTURING BUSINESS AND IMPORTERS OF DRUGS, ETC.

Wholly Amended by Presidential Decree No. 20432, Dec. 6, 2007

Amended by Presidential Decree No. 20679, Feb. 29, 2008

Presidential Decree No. 22075, Mar. 15, 2010

Presidential Decree No. 22498, Nov. 23, 2010

Presidential Decree No. 23248, Oct. 25, 2011

Presidential Decree No. 24479, Mar. 23, 2013

 Article 1 (Purpose)
The purpose of this Decree is to provide for matters concerning the facility standards for manufacturing businesses and importers of drugs, etc., pursuant to Article 31 (1) and (4) and Article 42 (3) of the Pharmaceutical Affairs Act. <Amended by Presidential Decree No. 22498, Nov. 19, 2010; Presidential Decree No. 24479, Mar. 23, 2013>
 Article 2 Deleted. <by Presidential Decree No. 24479, Mar. 23, 2013>
 Article 3 (Facility Standards, etc. for Factories of Drugs, etc.)
(1) A factory for manufacturing drugs or quasi-drugs (hereinafter referred to as “drugs, etc.”) shall have each of the following facilities and appliances:
1. A workroom for manufacturing work;
2. A laboratory to control the quality of raw materials, materials, and products;
3. A depository for keeping raw materials, materials, and products;
4. Facilities and appliances necessary for manufacturing and quality control.
(2) Where a person who manufactures articles, other than drugs, etc., intends to manufacture drugs, etc., and the facilities for manufacturing the relevant articles meet the following requirements, the facilities for manufacturing the relevant articles may be replaced by the facilities of the factory for manufacturing drugs, etc.:
1. Facilities for manufacturing articles, other than drugs, etc., shall comply with each subparagraph of paragraph (1);
2. There is no risk of cross-contamination between drugs, etc. and articles, other than drugs, etc.
(3) A person who has obtained permission for the business of manufacturing drugs or filed a report on the business of manufacturing quasi-drugs (hereinafter referred to as “manufacturer of drugs, etc.”) may use the facilities of the factory for manufacturing other drugs, etc. in place of the facilities of the factory for manufacturing the relevant drugs, etc. where there is no risk of cross-contamination between such drugs, etc.
 Article 4 (Use of Facilities and Appliances upon Outsourcing)
(1) Where a manufacturer of drugs, etc. outsources manufacturing or testing of drugs, etc. to a manufacturer, etc. of other drugs, etc., he/she need not have the facilities and appliances related to the outsourced manufacturing or testing among the facilities and appliances required under Article 3 (1). <Amended by Presidential Decree No. 22498, Nov. 19, 2010>
(2) Where a manufacturer of drugs, etc. outsources manufacturing or testing of drugs, etc. to a manufacturer, etc. of other drugs, etc. pursuant to paragraph (1), the scope of the contract accepter and the matters to be observed by the contract giver and the contract accepter shall be prescribed by Ordinance of the Prime Minister. <Amended by Presidential Decree No. 20679, Feb. 29, 2008; Presidential Decree No. 22075, Mar. 15, 2010; Presidential Decree No. 24479, Mar. 23, 2013>
 Article 5 (Use of Manufacturing Facilities and Appliances for Other Purposes)
A person who has obtained permission for or filed a report on the business of manufacturing or processing foods, business of manufacturing food additives, business of manufacturing functional health foods, medical devices, or cosmetics, together with the business of manufacturing drugs, etc. may use the manufacturing facilities and appliances for the relevant drugs, etc. for the purpose of manufacturing foods, food additives, functional health foods, medical devices, or cosmetics (hereinafter referred to as “foods, etc.”) where there is no risk of cross-contamination between the relevant drugs, etc. and the foods, etc. <Amended by Presidential Decree No. 22498, Nov. 19, 2010>
 Article 6 (Facility Standards for Importers of Drugs, etc.)
(1) Each importer of drugs, etc., shall install each of the following facilities and appliances: <Amended by Presidential Decree No. 20679, Feb. 29, 2008; Presidential Decree No. 22075, Mar. 15, 2010; Presidential Decree No. 24479, Mar. 23, 2013>
1. A business office and warehouse;
2. A laboratory, and facilities and appliances necessary for testing: Provided, That a laboratory or facilities and appliances necessary for testing need not be installed in cases prescribed by Ordinance of the Prime Minister.
(2) Notwithstanding paragraph (1), where a manufacturer of drugs, etc. or drug wholesaler who intends to import drugs, etc. has retained the facilities and appliances which the importer of drugs, etc. is required to install in compliance with each subparagraph of paragraph (1) or the detailed standards referred to in Article 9, the facilities and appliances classified as follows need not be installed separately:
1. Manufacturer of drugs, etc.: A business office, warehouse, laboratory, or facilities and appliances necessary for tests;
2. Wholesaler of drugs, etc.: A business office or warehouse.
 Articles 7 and 8 Deleted. <by Presidential Decree No. 24479, Mar. 23, 2013>
 Article 9 (Delegation of Formulating Detailed Standards for Facilities)
Detailed standards for the facilities provided for in this Decree shall be prescribed by Ordinance of the Prime Minister. <Amended by Presidential Decree No. 20679, Feb. 29, 2008; Presidential Decree No. 22075, Mar. 15, 2010; Presidential Decree No. 24479, Mar. 23, 2013>
ADDENDUM
This Decree shall enter into force on the date of its promulgation.
ADDENDA <Presidential Decree No. 20679, Feb. 29, 2008>
Article 1 (Enforcement Date)
This Decree shall enter into force on October 26, 2011.
Articles 2 through 9 Omitted.
ADDENDA <Presidential Decree No. 22075, Mar. 15, 2010>
Article 1 (Enforcement Date)
This Decree shall enter into force on March 19, 2010. (Proviso Omitted.)
Article 2 Omitted.
ADDENDUM <Presidential Decree No. 22498, Nov. 19, 2010>
This Decree shall enter into force six months after the date of its promulgation.
ADDENDA <Presidential Decree No. 23248, Oct. 25, 2011>
Article 1 (Enforcement Date)
This Decree shall enter into force on October 26, 2011.
Articles 2 through 4 Omitted.
ADDENDA <Presidential Decree No. 24479, Mar. 23, 2013>
Article 1 (Enforcement Date)
This Decree shall enter into force on the date of its promulgation.
Articles 2 through 7 Omitted.