Report from the meeting held on 18-20 November 2013 Pharmacovigilance Outcomes of informal PSUR work-sharing procedures The has adopted the conclusions of PSUR assessment for alprostadil, ciclosporin, dexketoprofen, econazole and ketoprofen for topical use which may require changes to the product information or introduction of other risk minimisation measures. The public summaries will be published on the website under Pharmacovigilance, PSURs, Outcome of informal PSUR work-sharing procedures. MAHs of the products concerned should implement the outcome of the assessment by the appropriate variation or other procedure (as advised) within 4 months of publication. EU Work-sharing Articles 45 & 46 of the Paediatric Regulation Public Assessment Reports The has agreed on public assessment reports for paediatric studies submitted in accordance with Article 45 of the Paediatric Regulation for terbutaline sulfate, latanoprost and latanoprost+timolol including recommendations for the text to be included in SmPCs and package leaflets. The public assessment reports will be published on the website, under Paediatric Regulation, Assessment reports. Marketing Authorisation Holders of medicinal products with same active substances and pharmaceutical forms are requested to include this information in their SmPCs and package leaflets within 90 days of publication of the public assessment reports, in accordance with the Best Practice Guide Article 45, EU work-sharing procedure. The has also agreed on public assessment reports for paediatric studies submitted in accordance with Article 46 of the Paediatric Regulation for Genotropin (somatropin). Pilot on work-sharing procedure for the assessment of the Active Substance Master File (ASMF) In order to prepare for the pilot for work-sharing procedure for the assessment of ASMF starting on 1 st December 2013, details on the work-sharing procedure and training material to the attention of stakeholders will be published on the website under working parties/working groups, Working group on active substance master file procedures. Electronic submissions The has decided to end the pilot phase for technical validation by the RMSs on 31 st December 2013. The agreed to resume technical validation by the RMSs once a more efficient process for the technical validation is in place. Discussions are ongoing that will take into account the objectives as set up in Page 1/6
the EMRN esubmissions Roadmap to be adopted by HMA. The draft Roadmap is published on the HMA CESP website (http://cesp.hma.eu/home). PSUR Work-Sharing Working Party The has adopted revised versions of the best practice guide for transitional arrangements for PSUR work-sharing and its Annex 1: EU PSURwork-sharing assessment report template. The updated documents will be published on the website under Pharmacovigilance, PSURs, Outcome of informal PSUR work-sharing procedures. Recommendation on submission dates for Applicants of the Mutual Recognition Procedure (MRP) and Decentralised Procedure (DCP) The has adopted an updated recommendation on submission dates for Applicants of the Mutual Recognition Procedure (MRP) and Decentralised Procedure (DCP) in order to facilitate planning of submission dates for new applications in the MRP/DCP in 2014. The updated tables will be published on the website under Procedural guidance, Application for new MA, MRP/DCP. meeting with representatives of Interested Parties The met with Interested Parties on Monday 18 November 2013 to discuss DCP improvement and implementation of the pharmacovigilance legislation. All presentations will be published on the website under About, Contact with Representative Organisations. Information on applications referred to the in accordance with Article 29(1) of Directive 2001/83/EC Information on the name of the product in the RMS, active substance, pharmaceutical forms, procedure number, CMS, legal basis, grounds for referral to, Day 60 and outcome of the procedure, for the referrals to the on 31.10.2013 will be available on the table with information on all applications referred to the, published under -Referrals. Implementation of Commission Decisions after Article 30 referral procedures A link to the Commission decisions, including SmPC, package leaflet and labeling, on the Article 30 referral procedures for Sandimmun and Sandimmun Neoral will be published on the website. Generic Companies are encouraged to contact the Reference Member State to harmonise the product information of the medicinal products authorised via MRP/DCP to conform to the Commission Decision, through submission of a type IB variation under classification C.I.1.b, provided the conditions set up in Regulation (EC) No 1234/2008 are met. The will update the tracking table on referrals in accordance with Article 30 of Directive 2001/83/EC to include MRP procedure numbers following the referral procedures, once known. The updated tracking table will be published on the website. NEW APPLICATIONS Page 2/6
Mutual Recognition Procedure The noted that 16 Mutual Recognition Procedures were during the month of October 2013. No Mutual Recognition Procedure was referred to in this period. No Mutual Recognition Procedure was referred to CHMP in this period. The status as of 31 st October 2013 of procedures under Mutual Recognition is as follows: Year applications 1 applications in process Referred to Agreement reached in the Withdrawn during referral Applications referred to CHMP referred to in 2012 2013 2012 2013 2012 2013 2013 186 26 5 1 2 0 2 1 1 15 Mutual Recognition Procedures (regarding 30 products) started in October 2013. The categories of these procedures are as follows: - 11 abridged applications, including 8 repeat use applications; - 3 known active substance applications, including 1 repeat use application; - 1 new active substance application (repeat use procedure). The new procedures started in October 2013 related to the following applications: 1 full dossier, 11 generic, 1 well-established use and 2 hybrid. All these procedures consisted of chemical substances. 14 of these procedures related to prescription-only medicinal products and 1 procedure related to nonprescription medicinal products in the reference Member State 2. applications in Mutual Recognition procedure started in October 2013: Member State Number of times involved in a Number of times involved in a procedure as RMS procedure as CMS Austria 1 1 Belgium 1 Bulgaria 1 Croatia Cyprus 2 Czech Republic 3 Denmark 2 Estonia 3 1 Finland 2 France 2 Germany 1 2 Greece 4 Hungary 1 1 Due to late database updates cumulative yearly figure differs from the monthly figures. Cumulative yearly figure includes late database updates on procedures not captured in the monthly figures published in press releases. The applications referred to CHMP are included in the new applications. 2 In this category products are classified as prescription-only or Non-prescription (OTC) products when the RMS has approved them accordingly, although the legal status is not part of the Mutual Recognition Procedure. Page 3/6
Member State Number of times involved in a Number of times involved in a procedure as RMS procedure as CMS Iceland 6 Ireland 2 Italy 1 Latvia Liechtenstein Lithuania Luxembourg 2 Malta 1 Netherlands 2 2 Norway 2 Poland 1 Portugal 1 1 Romania 3 Slovak Republic 2 Slovenia 2 Spain 1 Sweden 5 1 United Kingdom 1 Decentralised Procedure The noted that 83 Decentralised procedures with positive outcome and no procedure with negative outcome were during October 2013. 5 Decentralised procedures were withdrawn after day 120 in this period. 2 Decentralised Procedures were referred to the in this period. 2 Decentralised Procedures were referred to the CHMP in this period. The status as of 31 st October 2013 of procedures under Decentralised Procedure is as follows: Year applications 3 applications withdrawn 3 (After day 120) applications in process Referred to Agreement reached in the Withdrawn during referral Referred to CHMP referred to in 2012 2013 2012 2013 2012 2013 2013 894 80 964 12 2 3 3 4 3 3 83 Decentralised Procedures (regarding 183 products) started in October 2013. The categories of these procedures are as follows: - 58 abridged applications, including 7 multiple applications; - 22 known active substance applications, including 1 multiple application; - 2 extension applications - 1 new active substance application. The new Decentralised Procedures started in October 2013 related to the following applications: 5 full dossier, 58 generic, 7 well-established use and 13 hybrid. 3 Due to late database updates cumulative yearly figure differs from the monthly figures. Cumulative yearly figure includes late database updates on procedures not captured in the monthly figures published in press releases. For procedures, this cumulative figure includes positive and negative procedures as well as those referred to CHMP. Page 4/6
All of these procedures consisted of chemical substances. 74 of these procedures related to prescription-only medicinal products and 9 procedures related to nonprescription medicinal products in the reference Member State 4. applications in Decentralised procedure started in October 2013: Member State Number of times involved in a Number of times involved in a procedure as RMS procedure as CMS Austria 16 Belgium 24 Bulgaria 18 Croatia 8 Cyprus 12 Czech Republic 2 26 Denmark 6 19 Estonia 10 Finland 2 19 France 1 24 Germany 8 27 Greece 13 Hungary 14 Iceland 6 Ireland 2 14 Italy 1 22 Latvia 10 Liechtenstein Lithuania 1 12 Luxembourg 17 Malta 15 Netherlands 13 14 Norway 20 Poland 23 Portugal 11 18 Romania 1 20 Slovak Republic 20 Slovenia 10 Spain 1 28 Sweden 16 20 United Kingdom 18 19 VARIATIONS AND RENEWALS Mutual Recognition and Decentralised Procedures The noted that 172 type IA variations, 198 type IB variations and 42 type II variations were during October 2013. 68 renewals were in this period. No Type II variation procedure was referred to the in this period. No Type II variation procedure was referred to the CHMP in this period. The status as of 31 st October 2013 of variations and renewals under Mutual Recognition is as follows: 4 In this category products are classified as prescription-only or Non-prescription (OTC) products as applied for in the RMS, although the legal status is not part of the Decentralised Procedure. Page 5/6
Year Type IA variations Type IB variations Type II variations Variation work-sharing 5 Renewals 2013 1742 1926 477 85 619 2013 Referred to Agreement reached in the Applications referred to CHMP referred to Withdrawn during in referral 2012 2013 2012 2013 Type II 3 0 3 0 0 0 Worksharing 0 0 0 0 0 0 Renewal 0 0 0 0 0 0 All documents mentioned in this press release can be found at the website under the heading Press Releases. Information on the above mentioned issues can be obtained from the chair of the or from the Secretariat: Dr. Peter Bachmann Phone: + 49 228 207 4163 Bundesinstitut für Arzneimittel und Fax: + 49 228 207 3452 Medizinprodukte (BfArM) E-mail: Peter.Bachmann@bfarm.de Kurt-Georg-Kiesinger-Allee 3 D 53175 Bonn, Federal Republic of Germany Secretariat E-mail: H-Secretariat@ema.europa.eu Or you could visit the website at: http://www.hma.eu/cmdh.html 5 Finalised work sharing do not include work sharing involving centrally approved products coordinated by EMA Page 6/6