The European Medicines Agency is planning to include parallel-imported medicines in its annual Sampling and Testing Programme of centrally-authorised products (CAPs).
In its review of the Programme’s first 10 years, the EMEA says it has developed into one of the key tools for monitoring the quality of CAPs on the market in the European Economic Area member states, which include the European Union (EU) nations plus Iceland, Norway and Lichtenstein. The scheme also checks on CAPs’ compliance with EU regulations, and complements the surveillance programmes carried out by member states at national level, which focus mainly on medicines which have been authorised nationally and/or through the mutual recognition procedure.
“The Programme relies on the cooperation, resources and competences provided by the national authorities, and therefore helps to foster collaboration and mutual confidence” between them, says the agency.
Currently, around 40 medicines are selected for testing each year from products which: received their market authorisation (MA) three years previously; were authorised more than three years ago but which have never been tested because they were not actually marketed at the time of initial selection; or have been recommended for re-testing, based on the outcome of a previous test. A total of 280 CAPs were tested during the Programme’s first 10 years to 2007 and the number of products selected for retesting has been growing annually, says the EMEA.
However, from next year the agency plans to replace these criteria with a “risk-based” approach, under which 90% of the products in each year’s testing programme would be selected using a simple risk ranking tool, the other 10% being chosen at random.
Another change “under active consideration” is the inclusion in the programme of products which have undergone parallel distribution. “Checks on the packaging and labelling of these products will be carried out in addition to analytical testing of the products,” says the agency, which has pointed out the need to target parallel imports, “since these are more likely to have undergone more handling within the distribution chain than the original product.”
– In January, European Commission Vice President Guenter Verheugen told Parliament that the initial findings of a study into drug distribution had shown that parallel imports pose a “considerable” risk for patient safety for “numerous” reasons.
