인허가(RA)정보
인허가(RA)정보
인허가(RA)정보
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2293 폴란드 Decree 15.0.393 of 10-Mar-2015: Fee Amount and the Mode of Covering for the Cost of Inspection of Manufacturer or Importer by Manufacturing Responsible Inspectors of Main Pharmaceutical Inspectorate new 2017.12.12 첨부파일
2292 폴란드 URPL Communication: Guideline on Bank Transfer Description, 15-Apr-2017 (English and Polish Versions) new 2017.12.06 첨부파일
2291 폴란드 Guideline: Requirements Regarding Documents to Be Joined to the Application for Renewal of Marketing Authorization for Medicinal Product in Mutual Recognition/Decentralized Procedure with Poland as CMS, Apr-2017 new 2017.12.06 첨부파일
2290 폴란드 Guideline: Requirements Regarding Documents to Be Joined to the Application for Renewal of Marketing Authorization for Medicinal Product in National Procedure and in European Procedure where Poland acts as RMS, Apr-2017 new 2017.12.06 첨부파일
2289 폴란드 Guideline: Requirements Regarding Documents to Be Joined to the Application for Marketing Authorization for Medicinal Product in Mutual Recognition/Decentralized Procedure with Poland as RMS or CMS new 2017.12.06 첨부파일
2288 폴란드 Guideline: Requirements Regarding Documents to be Joined to the Application for Marketing Authorization of Medicinal Product in National Procedure, 10-Nov-2015 new 2017.12.06 첨부파일
2287 폴란드 URPL Communication: Information of the President of the Office dated 12-Sep-2016 on deadline for Submission of Requests to Launch DC/MR Procedure with Poland Acting as Reference Member State in year 2017 new 2017.12.06 첨부파일
2286 폴란드 Decree 16.0.1085 of 07-Jul-2016: Issue of Wholesale Distribution Authorizations for Narcotics, Psychotropic Substances and Category 1 precursors new 2017.12.06 첨부파일
2285 폴란드 URPL: Annual Report of the President of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, 2015 new 2017.12.06 첨부파일
2284 폴란드 URPL Communication: Information of the President of the Office of 17-Jun-2016 on the Obligation to Use the Central Platform (PSUR Repository) to Submit Periodic Safety Update Reports for Medicinal Products new 2017.12.06 첨부파일
2283 폴란드 Information of the President of the Office of 09-Mar-2016: On the Rules on Assessment and Approval of the Educational Materials as Implementation of Risk Management Plan (RMP) new 2017.12.06 첨부파일
2282 폴란드 Communication of the President of the Office of 03-Nov-2015: On Wording of Information on Adverse Reactions Reporting in Summary of Product Characteristics and Package Information Leaflet new 2017.12.06 첨부파일
2281 폴란드 Decree 15.0.1979 of the Minister of Health of 09-Nov-2015: Good Manufacturing Practice new 2017.12.06 첨부파일
2280 폴란드 URPL Communication: Information of the President of the Office of 03-Dec-2015 on Use of Electronic Application Forms (eAF) in European Procedures new 2017.12.05 첨부파일
2279 폴란드 Form: Application for Variation of Manufacturing Authorisation or Import Authorization - Annex to the Decree 15.0.368 of 10-Mar-2015 new 2017.12.05 첨부파일