# The Human Medicines Regulations 2012, Regulation 94: Failure to submit report to EMA


The holder of a marketing authorisation is guilty of an offence if the holder fails to submit an annual report to the EMA as required by Article 34(4) of the Paediatric Regulation.

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Source: https://www.legislation.gov.uk/uksi/2012/1916/regulation/94 (the official version)
Page: https://openlegislation.uk/human-medicines-regulations-2012/regulation-94
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.