This week
saw the EC advertise for Croatian translators via
Twitter. Now you may be thinking how this relates to a QP training blog?
On the
1st of July this year Croatia will become the 28th member of the European
Union. As a QP you are expected to have a 'comprehensive
knowledge of all EU and national legislation relating to the manufacture,
storage & supply of medicines...' as defined by the QP study guide.
In order to have this knowledge you first need to know which countries are
legally bound to this legislation and which countries are likely to join in the
near future.
The EC Europa website gives a useful overview of the
status of the EU member states and importantly those countries that are in the
process of applying for membership. In order to get to the first step in
the process the country has to meet strict conditions for membership including
incorporation of the 35 policy chapters of the EU, including chapter
28 (consumer & health protection) that covers EU legislation on medicines.
Potential
countries are grouped into 3 categories depending on their current
status. The first category is for Potential Candidates and are invited to
formally begin application proceedings only when they are ready. As
countries progress through their application they then become a Candidate
Country and finally an Acceding Country once EU membership terms have been
agreed.
Current
Status of EU enlargement:
Category
|
Country
|
Acceding
Country
|
Croatia
(Entry 1st July 2013)
|
Candidate
Countries
|
Macedonia,
Iceland, Montenegro, Serbia, Turkey
|
Potential
Candidates
|
Albania,
Bosnia, Kosovo
|
Montenegro
and Iceland are the 2 candidate countries where negotiations have been ongoing
for a number of years. These countries are the most likely to become
acceding countries over the next few years.
Relevance
to the QP viva?
Having
knowledge on the countries that are nearing EU membership (particularly the
acceding countries) will help in your preparation for the common 'round the
world' supply chain questions and scenarios. These typically involve
importation of APIs, intermediates or final products into the EU via a number
of 3rd countries.
Taking
Croatia as an example, from 1st July 2013 it goes from a 3rd country to a
Member State. Therefore if you viva is coming up soon there is a high
chance that the assessors will include Croatia in their supply chain
scenario. If you fail to recognise that Croatia is a 3rd country before
1st July 2013 then it is highly likely that your answers regarding importation
will be incorrect and will obviously not go down well with the assessors.
Having an awareness of upcoming additions to the EU shows the assessors that
you understand the structure of the EU & have an appreciation of how the
continuously evolving landscape within Europe affects your role as a QP.
The table below highlights some factors relevant to QPs regarding the inclusion of Croatia into the EU:
Croatia (pre 1st July)
|
Croatia
(post 1st July)
|
|
Legal Status
|
3rd Country
|
Member
State
|
Finished product import Croatia into UK
|
Testing on import required |
No testing on import required |
API import Croatia into UK
|
Written confirmation would have been required
|
No restriction
|
QC Testing location
|
Importation Testing not permitted
|
Importation testing allowed
|
Retention Sample
|
Cannot be stored here
|
Can be stored here
|
IMP comparator sourcing
|
Unlikely to be sourced (equivalent EU GMP to be determined)
|
Likely to be sourced (EU GMP incorporated into local law)
|
As I've mentioned previously it's important to maintain up-to-date regarding the relevant legislative & GMP updates in preparation for your viva and throughout your QP career. I would also recommend to include the structure of the EU (including EEA, EFTA etc) as well as upcoming changes as part of your update strategy leading up to your viva. Including this RSS feed into your updates folder is highly recommended.
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