Public register of parallel distribution now available
New system provides better access to information on compliance of medicines sold by parallel distributors
The European Medicines Agency (EMA) is launching a public register of parallel distribution notices, providing a more transparent and user-friendly access to information on centrally authorised medicines put on the market by means of parallel trade in the European Union (EU).
Parallel distribution means that a centrally authorised medicine on the market in one Member State is distributed to another Member State by a company independent of the marketing-authorisation holder. To be able to sell a medicine in other Member States, parallel distributors need to ensure that the packaging and labelling 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 EMA of their intention to sell a centrally authorised medicine in a certain Member State. EMA then checks that the information and the conditions under which the medicine is to be distributed complies with the terms of the marketing authorisation of the medicine concerned and the EU legislation. On positive conclusion of this check, EMA issues the parallel distributor with a notice letter and informs the marketing-authorisation 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 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-authorised medicines which 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 Agency issues approximately 2,500 parallel distribution notices each year. Until now, 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.