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Marketing authorization
Results: 396

#	Item
11	PSUR Submissions in Single Assessment via EMA Gateway Webclient An agency of the European Union Presenters of the Day, from EMA Add to Reading List Source URL: esubmission.ema.europa.eu Language: English - Date: 2016-08-19 03:15:50 Medical research Clinical data management Clinical research Health Pharmaceutical industry Health informatics Electronic common technical document Pharmaceuticals policy Marketing authorization Committee for Medicinal Products for Human Use Validation
12	B.08 GUIMA Transfer national requirements AT BE CZ DE(BVL, PEI) EE ES FI FR IE IS IT LT LV NL PL RO SE SK SI UKEMA-CMDv Add to Reading List Source URL: www.hma.eu Language: English - Date: 2016-02-02 09:57:36 Pharmaceuticals policy Health care Health Pharmaceutical industry Medical research Healthcare quality European Medicines Agency European Union Qualified Person Responsible For Pharmacovigilance Marketing authorization Summary of Product Characteristics Pharmacovigilance
13	CMDh_269_2012_Rev0_2012 10 (republished) Add to Reading List Source URL: www.hma.eu Language: English - Date: 2016-07-27 08:07:45 Pharmaceutical industry Pharmaceutical sciences Pharmacology Pharmaceuticals policy Health Directive 2001/83/EC Biopharmaceutical Denatured alcohol Marketing authorization Pharmaceutical drug
14	GUIPackaging national blue-box requirements in MRP-DCP EMA-CMDv Add to Reading List Source URL: www.hma.eu Language: English - Date: 2016-02-02 09:00:19 Economy Pharmaceuticals policy Pharmaceutical industry Business Health Packaging and labeling Retailing Marketing authorization Homeopathy Label
15	CMDv GUIPartial MAH transferEMA-CMDv Add to Reading List Source URL: www.hma.eu Language: English - Date: 2016-06-03 11:37:56 Pharmaceuticals policy Health care Health Healthcare quality Pharmaceutical industry Medical research Drug safety Agencies of the European Union Qualified Person for Pharmacovigilance European Medicines Agency Pharmacovigilance Marketing authorization
16	EMEA/CMDvCMDv/GUI/014 GUIDANCE for The Processing of Generic Applications Through MRP / DCP Add to Reading List Source URL: www.hma.eu Language: English - Date: 2015-11-16 09:50:36 Pharmaceutical industry Medical research Pharmacology Clinical research Pharmaceutical sciences Pharmaceuticals policy Marketing authorization Validation Bioequivalence European Medicines Agency
17	CMDh-IP Meeting on DCP/MRP Improvements\| London\| 18 MayResults of the AESGP Survey on MRP-DCP for non-prescription medicines Overall Conclusion Add to Reading List Source URL: www.hma.eu Language: English - Date: 2015-05-29 10:17:02 Pharmaceuticals policy Pharmacology Health care Pharmaceutical sciences Pharmaceutical industry Drugs Clinical pharmacology Marketing authorization Validation Prescription drug
18	The Agency for Medicinal Products and Medical Devices of the Republic of Slovenia has prepared the unofficial consolidated text for the Medicinal Products Act which includes:  Medicinal Products Act (Official Gazette Add to Reading List Source URL: www.jazmp.si Language: English - Date: 2013-07-12 06:13:47 Pharmaceuticals policy Health Medical research Clinical Trials Directive Directive 2001/83/EC Good laboratory practice Marketing authorization Good Clinical Practice Directive European Pharmacopoeia Biopharmaceutical Pharmacovigilance European Medicines Agency
19	BPGType II variationsEMA-CMDv Add to Reading List Source URL: www.hma.eu Language: English - Date: 2016-02-09 05:27:00 Pharmaceutical industry Medical research Evaluation Health care Marketing authorization Statistical process control Validation Variation
20	emea_strap_url_cmyk_rev_en_std_cent.eps MASTER Add to Reading List Source URL: www.hma.eu Language: English - Date: 2015-07-08 04:50:21 Pharmaceuticals policy Health Pharmaceutical industry Pharmacology European Medicines Agency European Union Marketing authorization European Directorate for the Quality of Medicines EudraLex European Pharmacopoeia Orphan drug Supplementary protection certificate