XVI.C.4. Transparency

The Agency shall make public the agendas and minutes from each meeting of the CHMP, the PRAC and the CMDh (see XVI.C.3.) as regards pharmacovigilance activities [REG Art 26(1)(b)], which includes activities on RMM.

For centrally authorised products, the Agency has legal obligations [DIR Art 21(3), DIR Art 21(4), DIR Art 106(a), DIR Art 106(b), DIR Art 106(c), REG Art 13, REG Art 26(1)(c), REG Art 26(1)(j), REG Art 57(2), IR Art 31(1)] to make public the European public assessment report (EPAR), the conditions of the marketing authorisation, which includes RMM, together with any deadlines for the fulfilment of those conditions, the SmPC, the package leaflet, the information on the outer and inner packaging, and information on the RMP including information on any additional RMM. Further, the Agency has transparency obligations for medicinal products subject to an EU referral procedure [REG Art 26(1)(i)]. To fulfil the obligations, the Agency follows the EMA Publication Policy “What we publish on medicines, and when”24 .

For nationally authorised products, the competent authorities of Member States shall make public assessment reports, conditions of the marketing authorisation together with any deadlines for the fulfilment of those conditions, the SmPC, the package leaflet, the information on the outer and inner packaging and a summary of the RMP with specific focus on RMM [DIR Art 21(3), DIR Art 21(4), Art 106(a), Art 106(b), DIR Art 106(c), IR Art 31(1)].

To promote public health, it is encouraged that the Agency and the competent authorities in Member States make available via their websites details on additional RMM materials.

Guidance on transparency applicable to RMPs, PSURs and PASS are likewise relevant for RMM (see GVP Module V, GVP Module VII and GVP Module VIII).