On January 1st 1994, regulations were established which require all newly-licensed medicines dispensed in an original pack to be accompanied by a user leaflet - the patient information leaflet. Other products will have to conform to the regulations as their licences are renewed.
The contents of the leaflet will have to be approved by the Medicines Control Agency. The information must be consistent with the Data Sheet and conform to the Regulations of EC Directive 92/27, notably:
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