Which of the following is NOT true about Quality Systems /Legal requirements?

Question

BlackTom AI · Accepted Answer

Let's evaluate each statement about Quality Systems / Legal requirements to determine which one is not true.
Option 1: 'The EU directives are not binding for each EU Member States.' This is misleading. EU directives are indeed binding in the sense that they set out goals that member states must achieve, but they are not directly applicable; they must be transposed into national law by each member state. Saying they are 'not binding' for member states can be interpreted as implying no obligation at the national level, which is incorrect. Therefore, this option contains a false characterization of how directives operate and is likely the NOT true statement.
Option 2: 'The primary goal of the regulations for medicinal products is to protect the public health, and ensure safety, efficacy and quality for human and veterinary pharmaceuticals.' This aligns with the fundamental purpose of pharmacovigilance and regulatory frameworks: to safeguard public health by ensuring safety, efficacy, and quality. This statement is true.
Option 3: 'Directives cover marketing and manufacturing authorizations.' This statement is somewhat nuanced. While directives influence many aspects of national regulatory systems (including GMP and pharmacovigilance), the actual authorization processes for marketing and manufacturing are often governed by specific regulations or national implementations derived from directives. The blanket claim that directives cover these authorizations is not entirely accurate and can be considered misleading or incomplete, depending on jurisdiction. This makes the statement problematic and potentially not true in a strict sense.
Option 4: 'Safety, efficacy and quality are primary criteria used to determine and assess manufacturing and marketing authorizations.' This is consistent with regulatory practice: decisions on approvals are based on safety, efficacy, and quality data. This statement is true.
In summary, Option 1 misstates how directives function by implying they are not binding at the member-state level, which is not correct given they must be transposed into national law. Option 3 also contains an oversimplification about the scope of directives regarding marketing and manufacturing authorizations. The other options describe core regulatory goals and criteria that are accurate. Therefore, the NOT true option(s) are 1 (and arguably 3, depending on interpretation), but the clearest incorrect statement is 1.

RGA6221.21827.202525 Quiz # 4

Which of the following is NOT true about Quality Systems /Legal requirements?

View Explanation

Log in for full answers

Similar Questions

In a consumer society, many adults channel creativity into buying things

Economic stress and unpredictable times have resulted in a booming industry for self-help products

People born without creativity never can develop it

A product has a selling price of $20, a contribution margin ratio of 40% and fixed cost of $120,000. To make a profit of $30,000. The number of units that must be sold is: Type the number without $ and a comma. Eg: 20000

Which of the following statement regarding cost is correct:

Under the assumptions used in cost-volume-profit analysis, as the activity increases:

The CVP and break-even analysis are supported by a range of important assumptions. Which of the following is not an assumption of the CVP:

The break-even point is that at which:

More Practical Tools for Students Powered by AI Study Helper

Homework AI Solver

Stylized AI Paper Writer

Plagiarism Checker Assistant

Citation AI Academic Writing Tool

In-Class Translation Assistant

AI Note Generator

AI Quiz Answers

Past Exam Questions from University Test Bank

Smart Practice Assistant

Adaptive Practice

Making Your Study Simpler