EMA Launches Parallel Distribution Register


From DCAT Value Chain Insights (VCI)

By Regulatory News posted 07-21-2015 10:51

  

The European Medicines Agency (EMA) is launching a public register of parallel distribution notices to provide a more transparent and user-friendly access to information on centrally authorized medicines put on the market by means of parallel trade in the European Union (EU).

Parallel distribution means that a centrally authorized medicine on the market in one member state is distributed to another member state by a company independent of the marketing-authorization holder. To be able to sell a medicine in other member states, parallel distributors need to ensure that the packaging and labeling of the medicine is appropriate, e.g. that the label, box and package leaflet are up to date and available in the correct language.

Since 2004, it is mandatory for parallel distributors to notify the EMA of their intention to sell a centrally authorized medicine in a certain member state. The EMA then checks that the information and the conditions under which the medicine is to be distributed complies with the terms of the marketing authorization of the medicine concerned and the EU legislation. On positive conclusion of this check, the EMA issues the parallel distributor with a notice letter and informs the marketing-authorization holder as well as the national competent authority of the member state in which the medicine is to be sold. A parallel distributor can only place its product on the market once it has received this notice letter by the EMA.

The register will increase oversight of parallel distribution because it enables national authorities in charge of human and veterinary medicines, parallel distributors and the pharmaceutical industry, but also patients and healthcare professionals, to identify and have details on all centrally authorized medicines that have been considered compliant with the requirements for parallel distribution. If such a medicine does not appear in the register, it means either that no parallel distribution notice was issued at all, that the product has not been and/or will not be distributed for 12 months, or that subsequently to the issuance of a notice, the parallel distributor ceased to be compliant.

The EMA issues approximately 2,500 parallel distribution notices each year. Until now, the EMA published each month a list of new notices granted. With the new public register of parallel distribution notices, the information on medicines with parallel distribution notices is now easily available and searchable. The register currently holds over 15,000 notices and will be updated monthly.

Source: European Medicines Agency

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