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Rules for medicinal products
Rules for medicinal products |
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Rules of conditions for the import of medicines and medical devices which do not have the marketing authorization "Official gazette of RS", Nos. 37/08 and 45/08 |
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Rulebook on the contents and method of labelling the outer and immediate packaging of a medicine, additional labelling, and contents of the package leaflet ("Official Gazette of RS", No. 41/2011) |
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Rulebook on the Contents of the Application, and/or Documentation on the Approval of Clinical Trials for Medicines and Medical Devices, as well as the Method of Implementation for Clinical Trials of Medicines and Medical Devices ("Official Gazette of RS", No. 64/2011) |
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Rulebook on the method of reporting, collecting and monitoring adverse reactions to medicines ("Official Gazette of RS", No. 64/2011) |
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| EudraLex -
The Rules Governing Medicinal Products in the European Union,
Volume 4 EU Guidelines to Good Manufacturing Practice - Medicinal Products for Human and Veterinary Use |
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| European Medicines Agency // ICH Topic E 6 (R1) Guideline for Good Clinical Practice - NOTE FOR GUIDANCE ON GOOD CLINICAL PRACTICE | |
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| ICH HARMONISED TRIPARTITE GUIDELINE // CLINICAL INVESTIGATION OF MEDICINAL PRODUCTS IN THE PEDIATRIC POPULATION - E11 | |
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| Rules of the marketing authorization procedure and conditions ("The Official Gazette of the Republic of Serbia", 93/2005 ) | |
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| Rules of the content of a marketing authorization ("The Official Gazette of the Republic of Serbia", 93/2005) | |
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| Rules of the manner and conditions of the advertizing of medicinal products and medical devices ("The Official Gazette of the Republic of Serbia", 99/2006 ) | |
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| Regulation conditions and manner of clinical testing of medicinal products, procedure and contents of documentation for authorising clinical trials of medicinal products ("The Official Gazette of the Republic of Serbia" 19/2007) | |
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The rules governing clinical trials of medicines used exclusively in veterinary medicine ("The Official Gazette of the Republic of Serbia" 24/2008) |
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