by In2Pharma | Oct 16, 2025 | News
Europe The European Medicines Agency (EMA) has recently published several important updates to Good Pharmacovigilance Practices (GVP) guidance: GVP Module VI – Addendum II introduces new guidance on the masking of personal data in Individual Case Safety Reports...
by In2Pharma | Jun 24, 2024 | News
Europe In April 2024, the fourth revision of the Annex to the Guideline “Excipients in the labeling and package leaflet of medicinal products for human use” was published on the EMA website. Now the annex has been revised and the information for...
by In2Pharma | Mar 7, 2024 | News
Belgium On February 29th, EMA published the newest version (v29) of QRD Appendix V. In this version, the contact details for reporting adverse drug reactions in Belgium has been changed, since the authority has decided to abandon the use of a postal address and go...
by In2Pharma | Feb 11, 2024 | News
Luxembourg On January 17th, EMA published the newest version (v28) of QRD Appendix V. In this version, the contact details for reporting adverse drug reactions in Luxemburg has been changed, to include the German version of the address. Luxembourg/Luxemburg [French]...
by In2Pharma | Jun 27, 2023 | News
Europe EMA has published recommendations for industry on good practices to ensure continuity in the supply of human medicines, prevent shortages and reduce their impact . Medicine shortages are a global health problem and are increasingly affecting European...
