Role Of The QP

Question 1

What does EU Directive 2001/83/EC Article 51 pertain to?

Answer 1

Legal duties for the QP for human medicine

Question 2

What are the Legal Duties of a Qualified Person (QP) for each batch of human medicine?

Answer 2

Manufactured and assembled in accordance with:
* National Law
* Marketing Authorisation (MA)
Certified in a register or equivalent
Imports outside EU
* Full qualitative analysis
* Quantitative analysis of active constituents
* all tests comply with MA
* Accepted off CofA where MRA in place
Safety features affixed to packaging (2011/62 - FMD)

Question 3

What must be done for medicinal products coming from third countries?

Answer 3

Each production batch must undergo a full qualitative analysis, a quantitative analysis of at least all active substances, and all necessary tests to ensure quality.

This must be in accordance with the requirements of the marketing authorization.

Question 4

Under what condition can batches of medicinal products be exempt from controls when marketed in another Member State?

Answer 4

If they are accompanied by control reports signed by the qualified person.

This ensures that proper checks have been conducted in the original Member State.

Question 5

How long must the register or equivalent document be kept available for review?

Answer 5

For at least five years.

This period may be specified further by the provisions of the Member State concerned.