EMA Reduces Parallel Distribution Fees For Malta & Latvia To Improve Medicines Availability

The European Medicines Agency is charging a reduced fee for parallel distribution of centrally authorized medicines to smaller EU member states under a new initiative that aims to improve the availability of medicines. Malta and Latvia have joined in, and two other member states have showed interest in the initiative, which will end in July 2018.

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EMA Is Charging Reduced Fee For Parallel Distribution of Medicines To Smaller EU Member States

The European Medicines Agency has launched a new initiative under which, as of July 15, it is charging a reduced fee from companies involved in the parallel distribution of centrally authorized medicines to Malta and Latvia. The aim of the initiative is to improve the availability of medicines in these countries.

The initiative will run for one year and is open to other EU member states where the number of inhabitants who speak the national official EU language does not exceed two million, an EMA spokesperson told the Pink Sheet. The current participating member states - Malta and Latvia - both submitted their applications in March.

Any member state meeting certain criteria can apply to the EMA to take part in the initiative. Among other things, the agency will assess whether there is a demonstrated lack of accessibility to centrally authorized products in the applicant member state, and whether wholesalers do not engage in parallel distribution due to the EMA’s fees for administrative services.

While two other member states have expressed an interest in taking part in the initiative, no official applications have been delivered to the EMA as yet and so these states cannot be identified, the spokesperson added.

Parallel distribution is overseen by the EMA and involves the movement of centrally authorized medicinal products from one member state to another by a pharmaceutical company that is independent of the marketing authorization holder. Under this arrangement, the EMA checks whether the products being distributed comply with the conditions laid down in the EU legislation on medicinal products and in the marketing authorization of the product. It is different from parallel importation, which relates to the movement of nationally authorized products and is overseen by the national competent authority of the concerned member state.

During the initiative, the following fee reductions will be in place:

Fee Type	Regular Fee	Reduced Fee During Initiative
Initial notification of parallel distribution	€3,070	€450
Notification of changes	€580	€280
Notification of bulk changes	€3,070	€450

This latest initiative builds on a one-year pilot that was undertaken by the EMA in 2016 for fee reductions for notifications of parallel distribution in the Maltese language. The EMA said it was not planning to publish an ex-post evaluation of the pilot with Malta, but added that the outcome was “positive.” (Also see "EMA Pilots Reduced Parallel Trade Fee To Improve Availability Of Medicines In Malta" - Pink Sheet, 4 Mar, 2016.)

At the end of the latest initiative, however, there will be a formal assessment of the impact of parallel distribution on the availability of medicines in smaller member states. Any future plans regarding parallel distribution of medicines will depend on the experience gained from the initiative.

From the editors of Scrip Regulatory Affairs.