1u7kf0g

More documents

Recommendations

Info

plans to provide advance notification of signals on the PRAC agenda to relevant MAHs. EMA clarified this will be done for information only and MAHs must not contact PRAC members and/or the European Medicines Agency with regards to the signals listed when they receive the advance notification in this. 12.5. Adverse Drug Reactions reporting and additional reporting 12.5.1. Management and Reporting of Adverse Reactions to Medicinal Products Guidance on EudraVigilance analysis to support community procedures The EMA secretariat presented a draft paper that provides guidance on how to conduct the analyses of EudraVigilance data to evaluate safety concerns in the framework of Union procedures and describing EMA secretariat support in the analyses. Members commented on different aspects concerning the interface of EudraVigilance with the type of review performed during a referral procedure and made some recommendations that will be taken into account once analyses are performed. 12.5.2. List of Product under Additional Monitoring Consultation on the draft list, version June 2014 The PRAC was informed of the products newly added to the additional monitoring list and the updated list. Post-meeting note: The updated additional monitoring list was published on 25/06/2014 on the EMA website (see: Home>Human Regulatory>Human medicines>Pharmacovigilance>Signal management>List of medicines under additional monitoring). 12.6. EudraVigilance Database None 12.7. Risk Management Plans and Effectiveness of risk Minimisations 12.7.1. Risk Management Systems 12.7.2. Progressive multifocal leukoencephalopathy (PML): possibilities for monitoring and labelling Possibilities for monitoring and labelling: Development of an evidence-based strategy Following the circulation of documents after the presentation to PRAC in May 2014, members were asked to comment on the PML labelling initiative. A brief follow-up discussion took place at the current meeting after which it was agreed to commence a 1 year long pilot, applicable proactively only, to products with PML ADR(s). This initiative proposes a systematic approach to deal with SMPC and RMP handling of PML related information. The experience with this approach will be reviewed in July 2015. 12.8. Post-authorisation Safety Studies 12.8.1. Post-Authorisation Safety Studies Imposed PASS protocol workflow At the organisational matters teleconference held on 26 June 2014, the EMA secretariat presented a revised procedure for handling imposed non-interventional PASS protocols as well as a revised assessment report template, following a similar structure to the PSUR assessment report template. The Pharmacovigilance Risk Assessment Committee (PRAC) EMA/PRAC/438418/2014 Page 46/75
EMA secretariat also made a proposal to assign procedure numbers to such protocols concerning nationally approved products. The PRAC delegates were invited to send comments by 8 July 2014. 12.9. Community Procedures None 12.10. Risk communication and Transparency None 12.11. Continuous pharmacovigilance 12.11.1. Marketing cessation, marketing suspension and withdrawals of medicinal products from the market Update on the list of withdrawn products At the organisational matters teleconference held on 26 June 2014, the EMA secretariat presented the draft list of withdrawn products provided for in Article 123(4) of the Directive 2001/83/EC. The scope of the list focuses on the actions related to centrally and non-centrally authorised medicinal products initiated since 28 October 2013 (date of entry into force of Directive 2012/26/EU amending Directive 201/83/EC) on grounds provided in Articles 116 and 117 of the Directive. 12.12. Interaction with EMA Committees and Working Parties 12.12.1. Paediatric Committee (PDCO) EMA Extrapolation Group: call for expert nominations At the organisational matters teleconference held on 26 June 2014, the EMA Secretariat presented a call for interest for the creation of an EMA extrapolation group (see EMA/129698/2012 Concept paper on extrapolation of efficacy and safety in medicine development). The group will also include two contributors from the PRAC. PRAC delegates were invited to express their interest in participating. 12.12.2. Pharmacovigilance Inspectors Working Group (PhV IWG) Organisation of training course At the organisational matters teleconference held on 26 June 2014, the EMA Secretariat presented the draft agenda for the 2014 PhV IWG training course due to take place in October 2014. 12.13. Interaction within the EU regulatory network None 12.14. Contacts of the PRAC with external parties and interaction of the EMA with interested parties 12.14.1. International Organisation for Standardisation (ISO) - Identification of Medicinal Products (IDMP) standards EU Task Force Pharmacovigilance Risk Assessment Committee (PRAC) EMA/PRAC/438418/2014 Page 47/75
Page 1 and 2: 10 July 2014 EMA/PRAC/438418/2014 P
Page 3 and 4: More detailed information on the ab
Page 5 and 6: 5.1.6. Insulin degludec, liraglutid
Page 7 and 8: 12.8.1. Post-Authorisation Safety S
Page 9 and 10: 15.1.12. Human normal immunoglobuli
Page 11 and 12: 1. Introduction 1.1. Welcome and de
Page 13 and 14: Discussion The PRAC noted the notif
Page 15 and 16: The CMDh position on diacerein (see
Page 17 and 18: provides the best antimicrobial act
Page 19 and 20: Summary of recommendation(s) The M
Page 21 and 22: Summary of recommendation(s) The M
Page 23 and 24: The MAHs of nationally authorised m
Page 25 and 26: 5.1.6. Insulin degludec, liraglutid
Page 27 and 28: 5.2.3. Influenza vaccine (split vir
Page 29 and 30: Regulatory details: PRAC Rapporteur
Page 31 and 32: Summary of recommendation(s) and co
Page 33 and 34: effects with frequencies unknown, a
Page 39 and 40: 7.2. Protocols of PASS non-imposed
Page 43 and 44: MAH(s): Almirall, S.A., Temis Farma
Page 45: 12. Organisational, regulatory and
Page 49 and 50: 14. ANNEX I Risk Management Plans M
Page 51 and 52: MAH(s): AbbVie Ltd. 14.1.12. Dabiga
Page 53 and 54: RMP in the context of a variation -
Page 57 and 58: Procedure scope: Introduction of a
Page 59 and 60: RMP evaluated in the context of a s
Page 61 and 62: Administrative details: Procedure n
Page 63 and 64: 15.1.16. Irbesartan, hydrochlorothi
Page 67 and 68: MAH(s): Janssen-Cilag International
Page 71 and 72: Administrative details: Procedure n
Page 73 and 74: PRAC member PRAC alternate Country
Page 75: Additional European experts partici

1u7kf0g

Create successful ePaper yourself

Delete template?

Save as template?