RAC DRUGS QUESTIONS WITH 100% CORRECT ANSWERS!!

(EU) MA - Answer-Market Authorization or product license issued by health authority. Valid for 5 years and subject to 1 renewal. 4 EU procedures to obtain an MA - Answer-National, centralised, mutual recognition, decentralized procedures MAH - Answer-A legal person or legal entity who must be established in the European Economic Area comprising of 28 member states. What does an MA include? - Answer-Active substance international non-proprietary name, trade name. SmPC - Answer-Summary of Product Characteristics PIL - Answer-Product Information Leaflet 6 months - Answer-How many months prior to expiration should MA renewal be submitted? Qualified Person (QP) in charge of? - Answer-Pharmacovigilance, scientific service in charge of each medicinal products scientific info ASMF - Answer-Active Substance Master File, info regarding the drug substance consists of one Applicants Part (AP), and one Restricted Part (RP), or proprietary information. CEP - Answer-Certificate of Suitability EDQM - Answer-European Directory for the Quality of Medicines CTD Module 1 - Answer-Region specific administrative dataCTD Module 2 - Answer-Quality Overall Summary CTD Module 3 - Answer-Drug Substance and Drug Product Information CTD Module 4 - Answer-Nonclinical Study Reports CTD Module 5 - Answer-Clinical study reports DLP - Answer-Data lock point is cut off date for data to be included in PSUR PSUR - Answer-Periodic Saftey Update Report is a pharmacovigilance document intended to provide an update of the worldwide safety experience of a medicinal product to regulatory authorities at defined time points post-authorization. PBRER - Answer-Periodic benefit-risk evaluation reports (formerly PSUR format) DSUR - Answer-Development Safety Update Report RMP - Answer-Risk management plan ICH primary basis of assessment for antihypertensive drugs? - Answer-High systolic and diastolic blood pressures DHCP - Answer-Direct Healthcare professional communication, or Dear Doctor letter is correspondence in the form of a mass mailing from the MA intended to alert doctors and other health care providers about important new or updated information regarding a marketed medicine or biologic. SPC - Answer-Supplementary protection certificate is an extension granted to compensate for the patent protection period list between filing the patent and authorization to place the product on to the market.What information must appear in braille? - Answer-Product name on pack T or F. European Scientific guidelines do not have legal force - Answer-True Purpose of ICH? - Answer-To discuss and establish common guidelines for safe, effective, and high quality medicines for ICH regions What method is used for stability retest period? - Answer-Long term data and case by case assessment FOB - Answer-Follow on Biologics or biosimilars ICH Q10 - Answer-Pharmaceutical Quality System Biosimilar - Answer-New versions of existing biologics whose patents have expired. Fobs or SEBs SEB - Answer-Subsequent Entry Biologic (Canada) monoclonal antibodies - Answer-Structurally complex substances that can locate and bind to specific molecules Essential Requirements for permanently implanted active device - Answer-90/385/EEC Product change in Class III medical device requires approval if - Answer-Affects conformity with essential Requirements or with the conditions prescribed for the use of the product MDD 93/42/EEC - Answer-EU member states, electrical parts, EMC interference ISO 10993 - Answer-Biocompatibility GHTF - Answer-Global Harmonization Task Force