Point 39 of Directive 2004/27/EC replaces the text of article 51(b) of the original medicinal products for human use Directive
with the following text:
In the case of medicinal products coming from third countries, irrespective of whether the product has been manufactured in
the Community, that each production batch has undergone
in a Member State
a full qualitative analysis, a quantitative analysis of at least all the active substances and all the other tests or checks
necessary to ensure the quality of the medicinal products in accordance with the requirements of the marketing authorisation.
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[Emphasis added]
It is this statement from the directives that requires that a company wishing to market its product within the EU have testing
conducted on every batch of that product in one of the 27 EU member countries.
Other Locations for Testing: Mutual Recognition Agreements
In addition to the EU, there are other political and economic groupings in the geographical region of Europe. The directives
and the decisions of the EMEA are also agreed to by the European Economic Area (EEA); which comprises the EU member states
plus the three additional countries listed in the bottom half of Table 1. Testing conducted in these three countries is also
acceptable for product release in the EU.
Table 2. EU good manufacturing practice mutual recognition agreements (MRAs)
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A third mechanism exists to allow testing conducted outside the EU to be accepted: mutual recognition agreements (MRAs) covering
good manufacturing practices (GMPs) for the product under consideration. The current status of EU MRAs covering GMPs is shown
in Table 2.
Thus, if a medicinal product is to be marketed in Europe (i.e., the geographical region comprising the 27 EU member states
plus Iceland, Liechtenstein, Norway, and Switzerland, it must be tested against the EMEA-approved specification in one of
the 33 countries with fully operational agreements (if it is a blood-derived biological product) or 34 countries (if it is
not a blood-derived biological). Biological products tested in Japan or any form of pharmaceutical product tested in the US
must be retested.
Testing conducted in Europe is accepted in the US, provided the testing facility has been approved by the US FDA. Many companies
thus consider basing worldwide testing capabilities in Europe to minimize the need for repeat testing. For the rest of this
article, the term Europe will be used to refer to the 27 EU member states, plus Iceland, Liechtenstein, Norway, and Switzerland.
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