§ Nick HarveyTo ask the Secretary of State for Health (1) what recent representations he has received from the pharmaceutical industry about compliance with the Labels and Leaflets Directive (Directive 92/27/EEC); [15659]
(2) what steps his Department takes to ensure that patients receive the information required by the Labels and Leaflets Directive (Directive 92/27/EEC) when a prescription medicine is dispensed; [15657]
(3) if he will list the information that is required to be provided to a patient about a prescription medicine when it is dispensed and the form in which that information should be provided; [15660]
(4) what guidance (a) his Department and (b) its agencies have issued to pharmacists to ensure that they comply with the Labels and Leaflets Directive (Directive 92/27/EEC) when dispensing a prescription medicine; [15658]
(5) what steps he will take to ensure that patients receive the information that is required by the Labels and Leaflets Directive (92/27/EEC) when prescription medicines are dispensed. [18392]
§ Ms BlearsThe Directive was incorporated into United Kingdom law by the Medicines (Marketing Authorisations Etc) Regulations 1994. It is an offence for any person in the course of business to sell or supply a medicine to which the Directive relates without the approved leaflet and appropriate label. Neither the Department nor its agencies have issued guidance to pharmacists.
The information required to be provided to a patient about a prescription medicine when it is dispensed, and the form in which the information should be provided, is set out in the Medicines for Human Use (Marketing Authorisations Etc) Regulations 1994 and Directive 92/27/EEC—copies of which are available in the Library.
We receive representations about compliance with the Directive from time to time from the pharmaceutical industry and others.