New EU rules on prescription-only medicines information
Limits information to clear functional instructions
The European Commission has unveiled new proposals for European Union (EU) rules to tell pharma manufacturers what information they can and cannot provide about their prescription-only medicines.
In its latest reforms, to be discussed by the European Parliament and EU Council of Ministers, the Commission has limited the information that can be provided to clear functional instructions, notably labelling; package leaflets; information on prices; data on pre-clinical tests and clinical trials; and instructions for correct use. And importantly, it says this information can only be provided by in-house printed material and officially registered websites.
Under the proposals, the information ‘must be objective and unbiased; evidence-based; up-to-date; reliable; and factually correct’.
In addition it ‘should not be misleading; understandable and clearly understood; and meet the needs and expectations of patients’.