Medicinal products are no exception and must be accompanied by outer and/or immediate packaging information (labelling) and a package leaflet providing information enabling the safe and effective use of the medicinal product. In fact, medicinal products are legally required to have certain information on the labels and package leaflets as defined in Title V of Directive 2001/83/EC on the ‘Community code relating to medicinal products for human use’ (as amended).
The outer and/or immediate packaging must include information such as:
- the name of the medicinal product
- its strength and pharmaceutical form
- a statement of the active substance(s)
- and the method of administration
How easy is the package leaflet to read?
User consultations are required to demonstrate the readability and usefulness of the package leaflet to patients. One of the possible ways of complying with this is by performing ‘user testing’. This means testing the readability of a package leaflet with a group of selected test subjects to identify whether or not the information as presented, conveys the correct messages to those who read it. In accordance with European legislation, the Marketing Authorisation Holder (MAH) must also place the name of the medicinal product in braille format on the outer packaging of medicinal products and must ensure that the package leaflet is made available in formats appropriate for the blind and partially sighted. In addition to the HPRA Guide to Labels and Leaflets of Human Medicines, European guidance documents on medicinal product labelling and package leaflet also include;- The European Medicines Agency‘s Working Group on Quality Review of Documents (QRD) templates for the product information for human medicines.
- Guideline on the readability of the label and package leaflet for medicinal products for human use.
- Guideline on excipients in the label and package leaflet of medicinal products for human use.
Summary
Medicinal product labelling and the package leaflet provides the patient with important information about their medicine to allow the safe and effective use of the product, whether it be an over the counter medicine or one prescribed by the doctor. If you would like to discuss this issue further with us, then please call us on 00353 52 61 76706 or complete your details below. [ninja_form id=1]More About Labelling
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