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Product information and Labelling
The Product Information (PI) is the core document providing information on the medicinal product for the physician and the patient.
It is a pivotal part of the Marketing Authorisation (MA) and includes the summary of product characteristics (SmPC), labelling and package leaflet.
The PI has to be available in the official language(s) of the Member State in which the medicinal product is authorised and planned to be placed on the market. The labelling and package leaflet may also be provided in more than one language, however, in that case the content of all language versions must be identical.
Format, content and review
The format and content of the product information is regulated by Quality Review of Documents ‘QRD’ templates for products approved via the European procedures (different QRD templates must to be used for centralised or MRP/DCP). QRD templates are available in all official European languages and supported by annexes, appendices and guidance documents.
The product information is submitted and assessed during the Marketing Authorisation Application (MAA) procedure. A MA granted in accordance with the centralised procedure or MRP/DCP procedure has a harmonised PI in the EU Member States concerned. The different language versions are written and submitted according to the QRD templates. National authorities may still have their own templates to follow for products approved via national procedures.
A Member State may ask for additional national information to appear on the outer packaging (e.g. in the ‘blue box’ for centrally authorised medicinal products or generally on the outer packaging for products approved via MRP/DCP or national procedures). Such national requirements may include information on legal status, pricing and reimbursement, MA number, local representative, symbols or pictograms etc.
For MA applications submitted to a Member State of the European Union or to the EMA, it is required that the package leaflet reflects the results of consultations with target patient groups to ensure that it is legible, clear and easy to use, and understandable by those who receive it so that the medicinal product can be used safely and appropriately. The results of such assessments (readability testing results) carried out in cooperation with target patient groups must be provided to the competent authority or EMA as part of the application dossier.
In most cases the name of the medicinal product should appear in Braille format on the packaging. The marketing authorisation holder (MAH) is also required to make the package leaflet available on request from patients’ organisations in formats appropriate for the blind and partially-sighted.
Safety features must be applied to the packaging of certain medicinal products for the purpose of identification and authentication of medicinal products. They consist of a unique identifier (a 2D data matrix code) to be placed on the outer packaging that can be scanned at fixed points along the supply chain, and tamper evident features on the pack.
The marketing authorisation holder has an obligation to continuously ensure that the product information is kept-up-to-date according to current scientific knowledge. During the lifecycle of a medicinal product, any changes required to the MA are implemented via different regulatory procedures and many of these will also affect the PI, which has to be updated as part of the procedure. For example the shelf life and/or storage conditions of a medicinal product may be changed during the lifecycle, and this will be reflected in the PI.