Smpc - Samenvattingen, Aantekeningen en Examens

(EU) MA - 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 - National, centralised, mutual recognition, decentralized procedures MAH - 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? - Active substance international non-proprietary name, trade name. SmPC - Summary of Product Characteristics PIL - Produ...

RAC DRUGS COMPLETE EXAM 2024. (EU) MA - CORRECT 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 - CORRECT ANSWER National, centralised, mutual recognition, decentralized procedures MAH - CORRECT 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? - CORRECT ANSWER Active substance inter...

RAC DRUGS Questions And 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, tr...

RAC Devices Exam Prep 2024 Questions and Answers Correct Who is the European Medicines Agency (EMA) - Answer ️️ -an agency of the European Union (EU) in charge of the evaluation and supervision of medicinal products. The primary reason for establishing EMA was to harmonise the work being done by the individual regulatory bodies in Europe. Relevance of EMA in EU - Answer ️️ -founded in 1995, working across the EU to protect human and animal health by assessing medicines to rigorous ...

Who is the European Medicines Agency (EMA) - correct answer an agency of the European Union (EU) in charge of the evaluation and supervision of medicinal products. The primary reason for establishing EMA was to harmonise the work being done by the individual regulatory bodies in Europe. Relevance of EMA in EU - correct answer founded in 1995, working across the EU to protect human and animal health...

(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 P...

RAC DRUGS REAL EXAM QUESTIONS AND ANSWERS |ALREADY PASSED| LATEST (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...

RAC Devices Prep Exam Updated 2024 (EU) Rated A+ 1990s, New Approach (impact on MDs) - EU regulations relating to medical devices' safety and performance were harmonised in the ____(date) _, following the _____ _____ legislative principles. AIMDD (# and date) - Council Directive 90/385/ EEC, 20 June 1990 MDD (# and date) - Council Directive 93/42/EEC, 14 June 1993 IVDD (# and date) - Directive 98/79/EC of the European Parliament and of the Council, 27 October 1998 key historic deve...

RAC DRUGS Final Exam With Correct Answers 2024.(EU) MA - CORRECT 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 - CORRECT ANSWER National, centralised, mutual recognition, decentralized procedures MAH - CORRECT 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? - CORRECT ANSWER Active sub...

RAC DRUGS STUDY GUIDE TEST 2024. (EU) MA - CORRECT 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 - CORRECT ANSWER National, centralised, mutual recognition, decentralized procedures MAH - CORRECT 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? - CORRECT ANSWER Active substance intern...