The MEB assesses the labelling text submitted by the company. There are fixed items that have to be printed on the label, such as the name of the medicinal product, the active ingredient, including its strength, and the expiry date.
If the product is available without prescription (e.g. paracetamol), then the indication of the medicinal product and when not to use it must also be printed on the label.
The European legislation makes it mandatory to state the name of new medicinal products on labelling in braille as well.
The following documents are important when drafting a good label text and a mock-up:
- MEB 6: Labelling of pharmaceutical products
- Guideline on the Readability of the Labelling and Package Leaflet for Medicinal Products for Human Use
Braille requirements for labelling and the package leaflet
New legislation requires the name of a medicinal product to be marked in braille on the label unless arguments can be put forward showing that this is unnecessary. The MEB will evaluate the arguments put forward.
For medicines that are already authorised, the requirement to alter labelling will not be a priority for enforcement at present. However, when the labelling of an authorised product is altered (e.g. updated), the opportunity should be taken to add the product name in braille. Applicants submitting minor amendments via a type I variation procedure are not required to alter the product's labelling to include braille, though they may of course do so if they wish. Companies will have to complete a Braille declaration.
The Guidance concerning the Braille requirements for labelling and the package leaflet explains what must appear on braille labelling. This guideline has been established at European level.
Corporate style for marketing authorisation holders
Marketing authorisation holders can have their corporate style assessed by the MEB.
You need to submit a national art. 61(3) notification, clearly requesting the assessment of a (new) corporate style. This notification cannot be linked to one specific product, but is submitted mentioning ‘corporate style’.
You must submit mock-ups for your notification. The marketing authorisation holder may decide to provide mock-ups for all relevant products. However, it is advisable to only enter a small number of mock-ups as examples. After the corporate style is approved, you can then submit the other mock-ups, on the condition that the submitted mock-ups are a representation of the other mock-ups. The mock-ups that have not yet been submitted should not contain any new elements. For instance: mock-ups for UR and NR products and/or different pharmaceutical forms.
The assessment is linked to a 60 day timetable. The assessment will take place based on the policy document MEB 6 ‘Labelling of pharmaceutical products’. The MEB will also assess the compliance with the ‘Guideline on the readability of the label and package leaflet’ (see volume 2c) and the QRD template.
The MEB will register the approved corporate style; the registration is only available for inspection by members of the MEB. An approved corporate style will prevent discussion about the packaging layout. The marketing authorisation holder will still have to meet the conditions for the individual mock-ups. Policy changes may therefore lead to required changes in the corporate style.
OTC medicinal products: listing of in-use shelf life
The in-use shelf life must be listed on the packaging of over-the-counter medicinal products.
