Product information texts
Product information texts
What are product information texts?
The product information includes the following:
Every authorised medicinal product has product information texts, which contain information about the medicinal product officially approved by the competent authority. These texts are an essential part of the marketing authorisation dossier. The information in these texts is also regulated and subject to strict legal requirements. For each country in which the product is authorised, the product information text must be written in the relevant official language and must also comply with national requirements.
The product information includes the following:
- Summary of Product Characteristics (SmPC)
- Package leaflet (PL)
- Labelling
Changing the product information texts
The text of the product information is approved as part of the marketing authorisation procedure for the medicinal product and cannot be changed subsequently without the approval of the competent authority.
The preparation of these texts is usually the responsibility of the regulatory affairs department, often in close collaboration with other departments, such as pharmacovigilance or medical science. The marketing authorisation holder is also obliged to regularly update the product information texts to keep them up to date with the latest scientific knowledge.
The text of the product information is approved as part of the marketing authorisation procedure for the medicinal product and cannot be changed subsequently without the approval of the competent authority.
The preparation of these texts is usually the responsibility of the regulatory affairs department, often in close collaboration with other departments, such as pharmacovigilance or medical science. The marketing authorisation holder is also obliged to regularly update the product information texts to keep them up to date with the latest scientific knowledge.
