Modification of the Guidance document Authorisation in accordance with Art. 14para. 1 abis-quater TPA HMV4


Section 7.3. “Medicinal product information”: Clarification of the “date of revision of the text”. If, at the company’s discretion, information for healthcare professionals is drawn up based on foreign information for healthcare professionals, only safety-related aspects may be added in terms of content.

Section 8.3. “Medicinal product information”: Clarification of disclaimer text: In accordance with Art. 17d para. 3 TPLO the correct term is “longstanding experience” (previously: longstanding use”)

The new version of the guidance document takes effect on 15 September 2020.