4. Package labelling
1. Package labelling
1.1. Labelling content
The QRD template, ANNEX III A, lists all mandatory items which have to appear on the outer packaging and the immediate packaging irrespective of their sequence on the actual labelling and their position and possible repetition on the individual sides/flaps of the packaging (e.g. top flap, front, back etc.). The following gives the list of the items to appear on the packaging of a medicine:
PARTICULARS TO APPEAR ON <THE OUTER PACKAGING> <AND> <THE IMMEDIATE PACKAGING> |
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS |
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Name of the medicinal product |
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Expiry date |
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Name of the marketing authorisation holder |
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Batch number<, donation and product codes> |
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Other |
Blind or partially-sighted people have special challenges in handling their medicine. This is of particular relevance if they take several different medicines. The outer carton of a medicine must include information on the medicine in braille text. Braille is a tactile writing system in which characters of the alphabet are coded into raised dots. An example is in Figure 2. The braille text used for the package should be described in the application dossier.
Figure 2: Example of information in braille text used on an outer carton of a medicine.
Labelling requirements are harmonised within the EU. However, an individual member state may decide to additionally include in the label one or more of the following:
- The price of the medicine.
- The reimbursement conditions.
- The legal status - prescription, or over-the-counter (OTC).
The additional information that a member state may require to appear on the medicine package (national requirements) is included inside of a blue box located on the outer carton to be clearly distinguishable.