Report from the meeting held on 28-29 January 2025

Pamorelin LA 22.5 mg (triptorelin pamoate)End of procedure: 04/12/2024Date of publication: 06/02/2025

Member: Natasa KizaAlternate: Maria Eleni Avraamidou Ministry of HealthPharmaceutical Services7 Larnacos AvenueCY-1475 NICOSIA

Human Variation eAF form - parallel procedures section (further variation regulation update)

Meeting 28-30 January 2025: Agenda

Following the adoption of the E6(R3) Guideline on 6 January 2025, a Step 4 Introductory Training Presentation has been developed by the E6(R3) Expert Working Group.

The ICH E6(R3) “Good Clinical Practice” Guideline reached Step 4 of the ICH Process on 6 January 2025.

European Medicines Regulatory Network approach for the implementation of the CHMP Opinion pursuant to Article 5(3) An implementation plan agreed in February 2021 sets out how the European medicines regulatory network, together with the European Directorate for the Quality of Medicines & HealthCare (EDQM), will be implementing the outcome of the Art. 5(3) referral. This includes specific measures that the network will take if nitrosamines are [...]

Questions and answers A question-and-answer document is available for marketing authorisation holders on implementing the Article 5(3) CHMP opinion. It covers the following: Outcome of the Article 5(3) referral and its relation to lessons learned exercise from nitrosamines detected in sartansPrinciples, methodology and scope for nitrosamine management in human authorised productsGuidance for establishing and reporting acceptable intake limits derived from implemented approaches: carcinogenic [...]