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Status om lovgivningen fra CMDh

This document provides updates on the pharmacovigilance regulations and transitional arrangements. It includes information from the European Commission, EMA, and CMDh. Topics covered include dossier formats, pharmacovigilance system master files, QPPV changes, best practice guides, PRAC procedures, and more.

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Status om lovgivningen fra CMDh

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  1. Status om lovgivningen fra CMDh Sundhedsstyrelsens informations- og dialogmøde for industrien 11. september 2012 Joan Boye Sektionsleder Enhed for Markedsføringstilladelser og Lægemiddelregulering

  2. Procedure/dossier/format relaterede overgangsordninger er publiceret af Kommissionen/EMA/CMDh : Kommissionen:Questions and answers on transitional arrangements concerning the entering into force of the new pharmacovigilance provisions in July 2012 (http://ec.europa.eu/health/human-use/pharmacovigilance/developments/index_en.htm) EMA: Questions and answers on practical transitional measures for the implementation of the pharmacovigilance legislation (http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/general/general_content_000520.jsp&mid=WC0b01ac05804fa031) CMDh: Questions and answers from CMDh: MRP/repeat use and variations a new RMP/update RMP(http://www.hma.eu/310.html)

  3. CMDh’s hensigtArticle 5-Recommendation for classification Publiceret (http://www.hma.eu/293.html): • Introduction or change of the Pharmacovigilance system Master file(PSMF) IAIN • Change in the QPPV, including contact details, and/or the location of the PSMF as part of the summary of the pharmacovigilance system for medicinal products for human use IAIN • Evt. Andre: sorte symbol, standardsætning underkastet supplerende overvågning

  4. CMDh Best Practice Guides, 1 Publiceret udkast: CMDh Best Practice Guide on the processing of renewals in the MRP/DCP - draft revision 7 (April 2012) - Link Afventer svar fra Kommissionen i hvilke situationer, er det nødvendigt at rejse PRAC (article 107i)? eller CHMP henvisning? f.eks. hvis ikke-renewal

  5. CMDh Best Practice Guides, 2 Offentlig evalueringsrapport incl. resumé i lægmandssprog Resumé for generika: • Tager udgangspunkt i indlægssedlens anvisninger og sprogbrug • Overskrift som spørgsmål/afsnit med svaret Hvorledes virker X? Hvad er fordele/ulemper ved X? Samarbejde med EMA

  6. CMDh Best Practice Guides, 3 CMDh juli 2012 mødet: Sammendrag af risikostyringsplanen(RMP) Engelsk version publiceres MRI Product Index’et

  7. CMDh Best Practice Guides, 4 Ingen EU Single assessment for NAPs(nationalt godkendte lægemidler), foreløbig: CMDh Best practice Guide for transitional arrangements for PSUR worksharing (concerning the assessments of PSUR’s of Products for which an EU harmonised virtual birth date and related harmonised data lock point have been agreed) PSUR WS med P-RMS fortsætter for en tid! Publicering af resultatet/anbefaling af ændringer af PRS(generika opdatering)

  8. CMDh Best Practice Guides, 5.1 Coordination Group for Mutual Recognition and Decentralised Procedures (human) (CMDh) Standard Operating Procedure Process for adopting CMDh position and timelines for implementation of Pharmacovigilance Risk Assessment Committee (PRAC) recommendations 30 dages proceduren i CMDh: Praktiske aflevering fra PRAC til CMDh Hvem er Leading CMDh Member States Uret starter ved førstkommendeCMDh møde

  9. CMDh Best Practice Guides, 5.2 A reference to the CMDh adopted positions on PRAC recommendations to be included in the monthly CMDh press release. The CMDh positions, together with the PRAC AR outlining the PRAC recommendation, to be published on the EU web-portal / EMA website on a monthly basis, with links / sign posts to the CMDh website and the various NCA websites Oversættelser, MAH –NCA?

  10. CMDh Best Practice Guides, 5.3 Hvorledes: • Jf. Artikel 107g, stk.2: Når de medlemsstater, som er repræsenteret i koordinationsgruppen, til enighed om de foranstaltninger, der skal træffes, registrerer formanden, at der er enighed, og sender den fastlagte holdning til indehaveren af markedsføringstilladelsen og medlemsstaterne.

  11. Procedural Advice on Referral Procedures for Safety Reasons(artikel 107 i) • Ikke en del af GVP-modulerne • Projektteams forslag til proces diskuteret i CMDh • NCA har haft mulighed for kommentering Afventer Kommissionen del af Notice to Applicants?

  12. Andre tiltag med baggrund i PhV • Forslag til revideret ansøgningsskema er sendt til Kommissionen • EMAs WG on Quality Review of Documents (QRD), opdatering af templates følges (rev. templates er endnu ikke godkendt)

  13. CMDh møde17-19 september 2012 Konklusion: Nok at tage fat på! Forhåbentlig hurtig afklaring samt publicering

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