The Pharmaceutical Journal
Vol 279 No 7461 p65
21 July 2007

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News summary

EU introduces fines for licensing breaches

Pharmaceutical companies can now be fined up to 5 per cent of their EU turnover if they break the centralised European medicines licensing rules (PDF 80K).

The rules require companies to submit complete and accurate information when applying for centralised marketing authorisations and only to supply medicines in accordance with any conditions or restrictions set out on those authorisations.

A fine may also become payable if a company fails to tell the European Medicines Agency about any new information that might lead to a marketing authorisation being amended.