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Drugs agency reminds companies of duty to report side effects

BMJ 2002; 324 doi: https://doi.org/10.1136/bmj.324.7343.938/b (Published 20 April 2002) Cite this as: BMJ 2002;324:938
  1. Rory Watson
  1. Brussels

    The London based European Agency for the Evaluation of Medicinal Products is reminding pharmaceutical companies of their responsibility to report any previously unknown side effects that might emerge when new drugs are put on the market.

    The initiative reflects the agency's determination since the start of the year to emphasise its establishment of a strong pharmaceutical vigilance system to ensure the safety of drugs, in addition to its role of granting licences for new products.

    Under existing rules companies have to report any adverse effects …

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