Package labelling means the markings printed directly onto the immediate or outer packaging or the label of a medicinal product. At least the following information shall usually be printed on the packaging in Finnish and in Swedish:
- name of the medicinal product, strength and pharmaceutical form (and the user group or target animal, if necessary)
- active substance(s)
- package size
- composition (active substance[s] and, if necessary, excipients)
- method of administration and, if necessary, route of administration (parenteral products or if otherwise necessary)
- necessary warnings
- expiry date (month/year)
- storage conditions, if necessary
- special precautions for the disposal of unused medicine or packaging, if necessary
- name and address of holder of the marketing authorisation (and name of authorised representative, if necessary)
- number of the marketing authorisation
- batch number
- Nordic product number (Vnr xx xx)
- dosage instructions for non-prescription medicines
- text ‘Itsehoitolääke / Receptfritt läkemedel’ is added on the outer package of the medicinal products not subject to medical prescription
The requirements,for example, for small immediate packaging and blisters are less comprehensive. Detailed instructions on package labelling are provided in Fimea Administrative Regulation 3/2013 and Normative Guideline 1/2013 “Labelling and package leaflets for medicinal products”. The labelling must be based on the QRD template.
Labelling as part of the procedures for marketing authorisation
Fimea reviews and approves the labelling proposed for a medicinal product as part of the processing of marketing authorisation, variation and renewal applications. In the national, decentralised and mutual recognition procedure, the mock-ups of the proposed labelling are submitted to Fimea. In the centralised procedure, translation of the text proposal (labelling) approved in the process will suffice.
If necessary, labellings can also be changed by submitting a separate 90-day notification. For closer instructions concerning the notification, see: Changes to the labelling
Medicine packages or parts thereof can be shared by several countries, the most common version being the Nordic package. In such a case, the national requirements of each country concerning, for example, the languages used must be taken into account.
The Nordic Package Group has drawn up the documents “Guideline on Nordic packages” and “Frequently Asked Questions” to make the design of Nordic medicine packages easier. These documents apply to medicinal products intended for both human and veterinary use. The Guideline on Nordic packages document contains general information on Nordic packages, whereas the Frequently Asked Questions document gives detailed advice on different package issues.
If necessary, marketing authorisation holders can submit questions regarding issues relating to Nordic packages. For this purpose a specific form, “Question to the Nordic Package Group”, is published and should be used. For request for a joint Nordic assessment of mock-ups, please use the form “Request for a Nordic mock-up co-operation”. The instructions for changes in labelling should be followed when submitting the request. The documents have been drawn up in co-operation between the medicines agencies of Denmark, Finland, Iceland, Norway and Sweden.
- Guideline on Nordic packages
- Frequently Asked Questions
- Question form - Question to the Nordic package group
- Request for a Nordic mock-up cooperation
All documents are published on the website of the Medical Products Agency (Sweden).