4. Package labelling

Site: EUPATI Open Classroom
Course: Product information and information to the public
Book: 4. Package labelling
Printed by: Guest user
Date: Monday, 6 February 2023, 8:15 AM

1. Package labelling

The text that appears on the label (inner (immediate) and outer packaging) of medicines is regulated in a similar way to the PL. The labelling gives information relevant for the patient as well as members of the distribution chain.

  • For the patient, there may be information on special storage conditions, e.g. store in a refrigerator or store protected from light.
  • For the pharmacy, there is information to identify the medicine, for example the name and active substance, route of administration etc.
  • In addition, batch numbers are important, e.g. in case a batch is recalled by the manufacturer.

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:

  1. Statement of active substance(s)

PARTICULARS TO APPEAR ON <THE OUTER PACKAGING> <AND> <THE IMMEDIATE PACKAGING>

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS

  1. Name of the medicinal product

Name of the medicinal product

 

  1. List of excipients [Express qualitatively those excipients known to have a recognised action or effect]

 

  1. Pharmaceutical form and contents

 

  1. Method and route(s) of administration

 

  1. Special warning that the medicinal product must be stored out of the sight and reach of children

 

  1. Other special warning(s), if necessary

 

  1. Expiry date

Expiry date

  1. Special storage conditions

 

  1. Special precautions for disposal of unused medicinal products or waste materials derived from such medicinal products, if appropriate

 

  1. Name and address of the marketing authorisation holder

Name of the marketing authorisation holder

  1. Marketing authorisation number(s)

 

  1. Batch number<, donation and product codes> [The proposed optional heading “donation and product codes” is for advanced therapy medicinal products only.]

Batch number<, donation and product codes>

  1. General classification for supply

 

  1. Instructions on use [Only for medicinal products not subject to medical prescription]

 

  1. Information in braille

 

  1. Unique identifier – 2d barcode

 

  1. Unique identifier – human readable data

 

  1.  

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 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.