Healthcare Professionals' Working Party

Minutes of the HMPC meeting 27-29 May 2024

Guideline on good pharmacovigilance practices: Annex I - Definitions (Rev. 5)

Guideline on good pharmacovigilance practices (GVP) Module XVI – Risk minimisation measures (Rev 3)

Union list of critical medicines: eXtended EudraVigilance Medicinal Product Dictionary (XEVMPD) / Product Management System (PMS) entries

Proposed invented name(s) request form for human medicinal products

Orphan designation: 2-(((2E)-3-(3-methoxy-4-(2-propyn-1-yloxy)phenyl)-1-oxo-2-propen-1-yl)amino)benzoic acid Treatment of systemic sclerosis, 28/06/2024 Positive

Orphan designation: 4-[[[4-[5-Chloro-2-[[trans-4-[[(1R)-2-methoxy-1-methyl-ethyl]amino]cyclohexyl]amino]-4-pyridinyl]-2-thiazolyl]amino]methyl]tetrahydro-2H-pyran-4-carbonitrile Treatment of acute myeloid leukaemia, 28/06/2024 Positive

Orphan designation: Human IgG1 monoclonal antibody against hepatitis B virus, surface antigen Treatment of hepatitis D virus infection, 28/06/2024 Positive

Guidelines on good pharmacovigilance practices (GVP): Introductory cover note, last updated with final revision 3 of Module XVI on risk minimisation measures and its Addendum II on their effectiveness evaluation, and revision 5 of Annex I on definitions