manufacturers' obligations

Last reviewed 01/2018

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:

  • the brand name, followed by the generic title, and the pharmaceutical form and/or strength:
    • a full quantitative declaration of active ingredients, along with a qualitative listing of certain excipients, i.e. inactive ingredients
    • the pharmaceutical form and a determination of the contents by weight, volume, or number of dosage units
    • the therapeutic group in terms easily comprehensible to the patient
    • the name and address of the marketing authorisation holder
    • the name and address of the manufacturer
  • the therapeutic indication(s)
  • information necessary before taking the product:
    • contra-indications
    • precautions for use
    • drug interactions and other forms of interaction
    • any special warnings, e.g. pregnancy or breast feeding
  • instructions for use
  • description of adverse effects
  • expiry date and special storage instructions
  • date of most recent revision of leaflet