GMP Principles in Principalities

Following on from my previous post on the entry of Croatia to the EU this post aims to give an overview of how the small principalities within Europe are integrated within the EU.  As a trainee QP you will need to know how the EU operates and importantly know sufficient information to enable you to provide answers to the round-the-world supply chain viva scenario questions.  These scenarios often involve complex virtual supply chains throughout and outside the EU. 

I'm sure many of you are aware of the EFTA & EEA countries but how would you handle a scenario question that included importing medicines from Monaco, San Marino or Andorra?  This post will aim provide you with the information required to answer that potential scenario.

Monaco 

Famous for its grand prix, casino and tax exiles, Monaco is a small principality on the Mediterranean coast bordered by France.  It is the most densely populated country in the world with a population of ~36,000 squeezed into a land area of 2sqKm.  

Monaco is not a member of the EU, EFTA or EEA and has no MRA in place with the EU.  Hence it can be considered, at face-value, to be a 3rd country with regards to medicine legislation.  However, since 2003 Monaco has a formal agreement with the EU regarding legislation for medicines for human & veterinary use as well as medical devices and cosmetics.   The formal agreement stipulates that certain EU legislation shall apply within the principality of Monaco and includes a number of familiar EU directives.  

EU directives relevant to QP that are incorporated into Monaco law:

• 2001/83/EC
• 2001/82/EC
• 2001/20/EC
• 2002/98/EC (blood directive)
• 91/356/EEC (previous GMP directive, 2003/94/EC not explicitly stated)
• 91/412/EEC (Vet GMP) 

These EU directives should be familiar to you all.  In general terms this means that Monaco complies with EU medicines legislation with regards to both commercial and clinical trial products as if they were a member of the EU.  Therefore the rules surrounding marketing, manufacture or importation of medicines will apply in Monaco as per other member states.  There are manufacturing companies within Monaco (Monegasque companies) that produce pharmaceuticals and cosmetics and some have valid GMP certificates listed on the EudraGMP database. Monaco also has a bilateral agreement with France that covers customs/importation legislation.  As a result when France adopt specific EU directives into national law Monaco will directly apply this French legislation into their own legislative framework.  

It is important to remember that these agreements with Monaco do not remove the requirement for auditing any relevant site within Monaco to determine compliance with EU GMP.  

Andorra & San Marino

 











Both the Principality of Andorra and the Republic of San Marino are 3^rd countries.  They are not part of the EEA or EFTA therefore access to the EU internal-market is limited.  They each have bilateral agreements in place with their immediate neighbours but they do not cover any EU medicine legislation.  The EU has produced a concept paper stating that inclusion of Andorra & San Marino to the EFTA and then EEA is a viable option that should be explored in order to better integrate both countries into the EU framework. 

Currently Andorra and San Marino does not have any mutual recognition with regards to pharmaceuticals.  As a result movement of pharmaceuticals between the EU and San Marino is restricted and importation requirements as for other 3^rd countries will apply.

Summary

Understanding the intricacies of the EU is a vital part of your law & admin module of the study guide.  Expanding your knowledge into very specific areas & countries such as Monaco should give you more confidence during your viva supply chain scenarios.  

Of the 3 countries mentioned only Monaco has implemented EU legislation regarding medicines and hence can be deemed as a 'quasi-EEA' member.  Both Andorra & San Marino have not implemented any relevant EU legislation and are therefore true 3rd countries.