New guideline for labelling and package leaflets of medicinal products

Friday, July 11, 2014

The MPA has updated the common guideline for the labelling and package leaflets for medicinal products. The guideline provides explanations and examples of how the current regulations should be interpreted. The purpose of the regulations is to ensure that patients receive clear and relevant information, and reduce the risk of confusion and misuse.

The guidance is aimed at all companies that design leaflets and packaging for drugs, and is intended to promote a uniform practice of the MPA regulations (LVFS 2005:11) on the labeling and package leaflets for medicinal products.

The aim of the guideline is to describe and explain the contents of the current regulations for labeling and patient information to ensure that it is understandable and easy to use, and to reduce the risk of confusion and misuse. A guideline may contain more information than the regulations, with the aim of increasing understanding of legal requirements.

A guideline is not legally binding, but contains examples and recommendations that may be helpful in the assessment and application of legal provisions. The guidance does not preclude other actions to achieve the result sought by the regulations, but presents the MPA perception.

The guidance should be read as a complement to the regulation and not as a stand-alone document. The paragraphs in the guideline refer to the corresponding paragraph in the regulation. Only the sections where clarification was deemed necessary are commented.


Please note the news item’s date of publishing. The Swedish Medical Products Agency does not update news.


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