Development of the European legislation

The European legislation about ‘information about medicines’ started in 1992 (Directive 92/27/EC). The regulatory framework has been frequently updated and extended. This website does not give a detailed chronological development of the European legislation. It just points to some of the regulations that are most relevant for the contents and visual presentation of information for patients.

Directive 2001/83/EC. Preliminary note 40 states that ‘The provisions governing the information supplied to users should provide a high degree of consumer protection, in order that medicinal products may be used correctly on the basis of full and comprehensible information’. Articles 54 and 55 state which information must appear on medicine packaging. Article 56 states that ‘The particulars referred to in Articles 54, 55 and 62 shall be easily legible, clearly comprehensible and indelible.’ Article 59 gives a list of items that must appear – in a specific order – in all package leaflets. Some items acknowledge the importance of understanding. For example, the pharmaco-therapeutic group or type of activity of a medicine must be provided ‘in terms easily comprehensible for the patient‘. Article 63 states that ‘The package leaflet must be written in clear and understandable terms for the user and be clearly legible in the official language or languages …‘.

Based on this legislation, information for patients must be ‘full and comprehensible’, ‘easily legible, clearly comprehensible and indelible’, ‘easily comprehensible’ and ‘written in clear and understandable terms for the user and be clearly legible’.

Directive 2004/27/EU. This Directive amends several items of Directive 2001/83/EC. A few main changes are: the obligation to print the name of the medicine on the outer packaging in Braille (Article 56). Article 59 also made user-testing obligatory. It states: ‘The package leaflet shall reflect the results of consultations with target patient groups to ensure that it is legible, clear and easy to use‘. Article 61 adds that ‘the results of assessments carried out in cooperation with target patient groups‘ must be submitted to the regulatory authorities. Article 63 was slightly modified too, and now states: ‘The package leaflet must be written and designed to be clear and understandable, enabling the users to act appropriately, when necessary with the help of health professionals. The package leaflet must be clearly legible in the official language or languages …‘.

This Directive makes the appearance of Braille on the outer packaging obligatory, and makes it essential to conduct user tests. It also adds the phrase ‘enabling users to act appropriately‘ to the requirements for package leaflet.

Directive 2010/84/EU. This Directive adds a paragraph to article 59 (4): “By 1 January 2013, the Commission shall present to the European Parliament and the Council an assessment report on the current shortcomings in the summary of product characteristics and the package leaflet and how they could be improved in order to better meet the needs of patients and healthcare professionals. The Commission shall, if appropriate, and on the basis of the report, and consultation with appropriate stakeholders, present proposals in order to improve the readability, layout and contents of these documents.”