인허가(RA)정보
인허가(RA)정보
인허가(RA)정보
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2252 터키 Decree 14.0.732 of the Minister of Health: Presentation of the Dossier of Marketing Authorization Application for Medicinal Products, 18-Apr-2014 new 2017.10.18 첨부파일
2251 폴란드 Decree 14.0.679 of 12-May-2014: Variations to Marketing Authorizations and Dossier relating to the Marketing of the Medicinal Product new 2017.10.18 첨부파일
2250 폴란드 URPL Communication: Information of the President of the Office Concerning Official List of Medicinal Products, 25-Mar-2014 new 2017.10.18 첨부파일
2249 폴란드 Guideline: Requirements Regarding Documents to Be Joined to the Application for Waiving of Sunset Clause Provision, 17-Apr-2014 new 2017.10.18 첨부파일
2248 폴란드 Guideline: Requirements Regarding Documents to Be Joined to the Application for Withdrawal of Marketing Authorization for Medicinal Product in National Procedure, 2014 (Polish and English Version) new 2017.10.18 첨부파일
2247 폴란드 Decree 14.0.104 of 10-Jan-2014: Templates of Application Form for Marketing Authorization of Medicinal Products new 2017.10.18 첨부파일
2246 폴란드 URPL Communication: Information of the President of the Office Concerning Interpretation of Art. 12 of the Law Amending Pharmaceutical Law dated 27-Sep-2013, 08-Jan-2014 new 2017.10.18 첨부파일
2245 폴란드 Decree 14.0.10 of 12-Dec-2013: Templates of Application Form for Renewal or Shortening of the Validity Period of Marketing Authorisation new 2017.10.18 첨부파일
2244 폴란드 URPL Communication: Concerning Mode of Submission of Variation to Change Dispensing Classification of Medicinal Products authorized via MRP/DCP or National Procedure and falling under the Scope of Regulation 1234/2008 as amended by Regulation 712/2012, 11-Dec-2013 new 2017.10.18 첨부파일
2243 폴란드 Decree 13.0.1472 of 28-Nov-2013: Organizational Units which Conducts Quality Testing of Medicinal Products and Medicinal Products for Veterinary Use and Amount of Payments for Testing new 2017.10.18 첨부파일
2242 폴란드 Decree 13.0.1478 of 28-Nov-2013: Manner and Mode of Preparing and Agreeing upon Safety Communications on Medicinal Product Usage new 2017.10.18 첨부파일
2241 폴란드 URPL Communication: Information of the President of the Office on Launching of Internet Website concerning Pharmacovigilance in connection with coming into force of the Law dated 27-Sep-2013 amending Pharmaceutical Law and other Laws, 25-Nov-2013 new 2017.10.18 첨부파일
2240 폴란드 Decree 13.0.1292 of 05-Nov-2013: Amending Decree 09.39.321 of 20-Feb-2009 on Requirements Regarding Labelling of Medicinal Product and the Content of the Leaflet new 2017.10.18 첨부파일
2239 폴란드 Law 13.0.1245 of 27-Sep-2013: Amending Pharmaceutical Law and some other Laws new 2017.10.18 첨부파일
2238 폴란드 URPL Communication: on New Regulations Concerning Monitoring of Medicinal Products Safety in Force as of 01-Sep-2013, 02-Sep-2013 new 2017.10.18 첨부파일