Clarifications from the detailed Information for healthcare professionals and Patient information templates have been incorporated into the guidance document Product information for human medicinal products. The two detailed templates will therefore no longer be available. However, the two basic templates with requirements from the TPLRO will continue to be available: Information for healthcare professionals for human medicinal products template and Patient information for human medicinal products template.
The new version of the guidance document Product information for human medicinal products enters into force on 1 March 2023.