Total 46Articles, Present Page 4/5
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16(Common) Enforcement Regulation of the Enforcement Decree on the Standards of Facilities of Manufacturers and Importers of Medicinal products etcEnforcement Regulation of the Enforcement Decree on the Standards of Facilities of Manufacturers and Importers of Medicinal products etc.[Ordinance of the Prime Minister No. 1235, December 31, 2015]
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Enforcement_Regulation_of_the_Enforcement_Decree_on_the_Standards_of_Facilities_of_Manufacturers_and_Importers_of_Medicinal_Products_etc.pdf
2016-09-26 -
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15(Common) Enforcement Decree on the Standards of Facilities of Manufacturers and Importers of Medicinal products etcEnforcement Decree on the Standards of Facilities of Manufacturers and Importers of Medicinal products etc.[Presidential Decree No. 24479, March 23, 2013]
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Enforcement_Decree_on_the_Standards_of_Facilities_of_Manufacturers_and_Importers_of_Medicinalproducts_etc.pdf
2016-09-26 -
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14(Common) Regulation on Safety of Medicinal Products, etc.Regulation on Safety of Medicinal Products, etc. [Ordinance of the Prime Minister No.1089, Aug.21, 2014, Partially revised]
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Regulation_on_Safety_of_Medicinal_Products,_etc.pdf
2016-09-26 -
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13(Common) Enforcement Decree of the Pharmaceutical Affairs ActEnforcement Decree of the Pharmaceutical Affairs Act[Enforcement Date 30. Mar, 2016.] [Presidential Decree No.27048, 22. Mar, 2016., Partial Amendment]
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Enforcement_Decree_of_the_Pharmaceutical_Affairs_Act.pdf
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[Attachment_1-2]Conditions_for_the_Retail_or_Sale_Drugs_as_Apply_to_a_Person_Who_Has_Obtained_a_Drug_Product_License.pdf
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[Attachment_2]Guidelines_for_Calculating_Penalty_Surcharges.pdf
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[Attachment_2-2]Criteria_for_Imposing_Administrative_Fines.pdf
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[Attachment_3]Administrative_Fines_by_Violation.pdf
2016-09-26 -
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12(Common) Pharmaceutical Affairs ActPharmaceutical Affairs Act [Act No.11690, Mar.23, 2013, Other Laws and Regulations Amended]
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Pharmaceutical_Affairs_Act.pdf
2016-09-26 -
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11(Common) Korean Pharmacopeia (Tenth Edition)Korean Pharmacopoeia(Tenth Edition)[Notification 2012-9, 2012. 03. 26]
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01_Notification.pdf
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02_General_Notices.pdf
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03_General_Requirements.pdf
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04_Monographs_Part1_AtoI.pdf
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05_Monographs_Part1_JtoZ.pdf
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06_Monographs_Part2.pdf
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07_General_Tests.pdf
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08_General_Information.pdf
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09_Index.pdf
2016-09-26 -
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10(Quasi-drugs) Regulations on the Approval, Notification, and Evaluation of Quasi-DrugsRegulations on the Approval, Notification, and Evaluation of Quasi-Drugs
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Regulations on the Approval, Notification, and Evaluation of Quasi-Drugs.pdf
2016-07-13 -
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9(Quasi-Drugs) Guideline on Effectiveness Assessment of the Product for tooth whiteningGuideline on Effectiveness Assessment of the Product for tooth whitening (Quasi-Drug)
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Guideline on Effectiveness Assessment of the Product for tooth whitening (Quasi-Drug).pdf
2016-07-05 -
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8(Biological Products) Guideline on Tumorigenicity Assessment of Stem Cell Therapy ProductsGuideline on Tumorigenicity Assessment of Stem Cell Therapy Products
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Guideline on Tumorigenicity Assessment of Stem Cell Therapy Products.pdf
2016-05-31 -
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7(Biological Products) Standards for Breeding and Managing Animals Used in the Course of Manufacturing BiologicsStandards for Breeding and Managing Animals Used in the Course of Manufacturing Biologics
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Standards for Breeding and Managing Animals Used in the Course of Manufacturing Biologics.pdf
2016-05-31 -