8 July 2016 EMA/HMPC/474350/2016 Procedure Management and Committees Support Division

Committee on Herbal Medicinal Products (HMPC) Agenda for the meeting on 11-12 July 2016

Chair: Werner Knöss – Vice-Chair: Marisa Delbò 11 July 2016, 14:00 – 19:00, 3E 12 July 2016, 09:00 – 13:00, 3E

Health and safety information In accordance with the Agency’s health and safety policy, delegates are to be briefed on health, safety and emergency information and procedures prior to the start of the meeting. Disclaimers Some of the information contained in this agenda is considered commercially confidential or sensitive and therefore not disclosed. Of note, this agenda is a working document primarily designed for HMPC members and the work the Committee undertakes. Note on access to documents Some documents mentioned in the agenda cannot be released at present following a request for access to documents within the framework of Regulation (EC) No 1049/2001 as they are subject to ongoing procedures for which a final decision has not yet been adopted. They will become public when adopted or considered public according to the principles stated in the Agency policy on access to documents (EMA/127362/2006).

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© European Medicines Agency, 2016. Reproduction is authorised provided the source is acknowledged.

Table of contents 1.

Introduction

1.1.

Welcome and declarations of interest of members, alternates and experts ............ 4

1.2.

Adoption of agenda................................................................................................. 4

1.3.

Adoption of the minutes ......................................................................................... 4

2.

European Union herbal monographs and list entries

2.1.

Report on MLWP activities ...................................................................................... 4

2.1.1.

Report from the MLWP April 2016 meeting .................................................................... 4

2.1.2.

Appointment of Rapporteurs and Peer-reviewers ........................................................... 4

2.1.3.

MLWP membership .................................................................................................... 4

2.2.

Revised EU herbal monographs and list entries for final adoption .......................... 5

2.2.1.

Monograph on Althaeae radix and supporting documents ................................................ 5

2.2.2.

Monograph on Harpagophyti radix and supporting documents ......................................... 5

2.3.

Revised EU herbal monographs and list entries for public consultation .................. 5

2.4.

EU herbal monographs, list entries and public statements for final adoption ......... 5

2.4.1.

Monograph on Origani majoranae herba ....................................................................... 5

2.4.2.

Monograph on Pruni africanae cortex ........................................................................... 5

2.5.

EU herbal monographs, list entries and public statements for adoption for release for public consultation ............................................................................................ 5

2.5.1.

Monograph on Allii sativi bulbus and supporting documents ............................................ 5

2.5.2.

Monograph on Cisti cretici folium and supporting documents – postponed......................... 5

2.5.3.

Monograph on Lecithinum ex soya and supporting documents ......................................... 6

2.5.4.

Monograph on Soiae oleum raffinatum and supporting documents ................................... 6

2.5.5.

List Entry and Monograph on Saccharomyces cerevisiae CBS 5926 and supporting documents – postponed ............................................................................................. 6

3.

Referral procedures

6

4.

Guidelines and guidance documents

6

4.1.

Non-clinical/clinical safety and efficacy and multidisciplinary ................................ 6

4.1.1.

Revision of ‘Guideline on assessment of clinical safety and efficacy in the preparation of Community herbal monographs for well-established and of Community herbal monographs/entries to the Community list for traditional herbal medicinal products/substances/preparations (EMA/HMPC/104613/2005) ........................................ 6

4.1.2.

Revision of ‘Guideline on non-clinical documentation for herbal medicinal products in applications for marketing authorisation (bibliographical and mixed applications) and in applications for simplified registration’ (EMEA/HMPC/32116/2005)................................... 6

4.2.

Quality .................................................................................................................... 6

4.3.

Regulatory .............................................................................................................. 6

4.3.1.

Patient Leaflet template concerning advice on preparations of herbal teas by end-users ..... 6

4.3.2.

Revised regulatory questions and answers - EMA/HMPC/345132/2010 ............................. 7

4.4.

Report on HMPC Drafting Groups activities ............................................................. 7

Committee on Herbal Medicinal Products (HMPC) EMA/HMPC/474350/2016

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4.4.1.

Quality DG ................................................................................................................ 7

4.4.2.

ORGAM DG ............................................................................................................... 7

5.

Organisational, regulatory and methodological matters

5.1.

Mandate and organisation of the HMPC .................................................................. 7

5.1.1.

Mandate of Quality DG and expression of interest for members/observers ........................ 7

5.1.2.

Assessors Training 3-4 November 2016 ........................................................................ 7

5.1.3.

Strategic Review and Learning Meetings ....................................................................... 8

5.1.4.

Procedural guidance – revised SOP on MO & LE establishment ........................................ 8

5.2.

Coordination with EMA Scientific Committees or CMDh-v ....................................... 8

5.2.1.

Scientific Coordination Board Meeting held on 10 June 2016 ........................................... 8

5.2.2.

Coordination with CHMP/SWP - Public statement on the use of herbal medicinal products containing pulegone/menthofuran ................................................................................ 8

5.2.3.

Coordination with CMDh – Addendum to the QRD templates for SmPC, Labelling and Patient Leaflet on Mutual recognition and Decentralised procedures for (T)HMPs .......................... 8

5.3.

Coordination with EMA Working Parties/Working Groups/Drafting Groups ........... 8

5.3.1.

Coordination with PCWP/HCPWP .................................................................................. 8

5.4.

Cooperation within the EU regulatory network ....................................................... 9

5.4.1.

European Pharmacopeia ............................................................................................. 9

5.4.2.

Survey on uptake of the traditional use registration and implementation of Directive 2004/24/EC in EU Member States, 2015 ....................................................................... 9

5.5.

Cooperation with International Regulators............................................................. 9

5.5.1.

HMPC – International representation and cooperation .................................................... 9

5.5.2.

Announcement of the 9th Annual Meeting of IRCH to be held in New Delhi, India, 8-10 November 2016......................................................................................................... 9

5.6.

Contacts of the HMPC with external parties and interaction with the Interested Parties to the Committee ........................................................................................ 9

5.7.

HMPC work plan ..................................................................................................... 9

5.7.1.

Projects on the HMPC work plan 2016 .......................................................................... 9

5.7.2.

Preparation of HMPC work plan 2017.......................................................................... 10

5.8.

Planning and reporting ......................................................................................... 10

5.9.

Legislation and regulatory affairs ......................................................................... 10

6.

Any other business

6.1.

Topics for discussion ............................................................................................ 10

6.1.1.

ARSP...................................................................................................................... 10

6.1.2.

New EMA website “regulatory herbal” ......................................................................... 10

6.2.

Documents for information ................................................................................... 10

6.2.1.

HMPC ..................................................................................................................... 10

6.2.2.

MLWP ..................................................................................................................... 10

6.2.3.

Other ..................................................................................................................... 10

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1.

Introduction

1.1.

Welcome and declarations of interest of members, alternates and experts Pre-meeting list of participants and restrictions in relation to declarations of interests applicable to the items of the agenda for the HMPC plenary session to be held on 11-12 July 2016. See July 2016 HMPC minutes (to be published post Sept 2016 HMPC meeting). Swap of roles in Slovenia. New member is Samo Kreft and alternate Barbara Razinger; Starting date of mandate: 29 June 2016. End of mandate: Kapka Kaneva (Bulgaria) alternate retired, her membership in HMPC terminated on 21 June 2016.

1.2.

Adoption of agenda HMPC agenda for 11-12 July 2016 Time schedule for 11-12 July 2016

1.3.

Adoption of the minutes HMPC minutes for 30-31 May 2016

2.

European Union herbal monographs and list entries

2.1.

Report on MLWP activities

2.1.1.

Report from the MLWP April 2016 meeting Report: MLWP Chair Action: for information Document: Draft minutes for the MLWP meeting on the 1-2 June 2016

2.1.2.

Appointment of Rapporteurs and Peer-reviewers •

Changes of Rapporteur and Peer-reviewers for Monograph revision Grindeliae herba – Peer-reviewer: B Kroes Hippocastani cortex – Rapporteur: W. Dymowski, Peer reviewer: C. Purdel

2.1.3.

MLWP membership •

Nomination of new MLWP member (medical doctor with expertise in paediatrics) Report: HMPC Chair Action: for discussion Documents: Mandate of MLWP; “Call for nominations”, 29 April 2016; DE nomination; Correspondence with PDCO & HCPWG

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Resignation of M. Delbó as MLWP member Report: HMPC Chair, MLWP Chair, M. Delbó Action: for discussion Documents: Resignation letter, 1 July 2016; IT nomination

2.2.

Revised EU herbal monographs and list entries for final adoption

2.2.1.

Monograph on Althaeae radix and supporting documents Action: for adoption Documents: MO, AR, LoR, OoC, References: 71/71

2.2.2.

Monograph on Harpagophyti radix and supporting documents Action: for adoption Documents: MO, AR, LoR, OoC, OoC 2, References: 57/109

2.3.

Revised EU herbal monographs and list entries for public consultation None

2.4.

EU herbal monographs, list entries and public statements for final adoption

2.4.1.

Monograph on Origani majoranae herba Rapporteur: C. Cavaleiro; Peer-reviewer: M. Heroutová Action: for adoption Documents: MO, AR, LoR, References: xx/109

2.4.2.

Monograph on Pruni africanae cortex Rapporteur: I. Chinou; Peer-reviewer: G. Calapai Action: for adoption Documents: MO, AR, LoR, OoC, References: xx/58

2.5.

EU herbal monographs, list entries and public statements for adoption for release for public consultation

2.5.1.

Monograph on Allii sativi bulbus and supporting documents Action: for adoption Documents: MO, AR, LoR

2.5.2.

Monograph on Cisti cretici folium and supporting documents – postponed

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2.5.3.

Monograph on Lecithinum ex soya and supporting documents Action: for adoption Documents: MO, AR, LoR, Presentation

2.5.4.

Monograph on Soiae oleum raffinatum and supporting documents Action: for adoption Documents: MO, AR, LoR

2.5.5.

List Entry and Monograph on Saccharomyces cerevisiae CBS 5926 and supporting documents – postponed

3.

Referral procedures None

4.

Guidelines and guidance documents

4.1.

Non-clinical/clinical safety and efficacy and multidisciplinary

4.1.1.

Revision of ‘Guideline on assessment of clinical safety and efficacy in the preparation of Community herbal monographs for well-established and of Community herbal monographs/entries to the Community list for traditional herbal medicinal products/substances/preparations (EMA/HMPC/104613/2005) Action: for adoption Document: Draft revised guideline for release for public consultation

4.1.2.

Revision of ‘Guideline on non-clinical documentation for herbal medicinal products in applications for marketing authorisation (bibliographical and mixed applications) and in applications for simplified registration’ (EMEA/HMPC/32116/2005) Action: for adoption Document: Concept paper

4.2.

Quality None

4.3.

Regulatory

4.3.1.

Patient Leaflet template concerning advice on preparations of herbal teas by endusers Action: for discussion Document: Template

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4.3.2.

Revised regulatory questions and answers - EMA/HMPC/345132/2010 Report: ORGAM Chair Action: for adoption Documents: Revised Q&A; Clarification from EC, 8 June 2010

4.4.

Report on HMPC Drafting Groups activities

4.4.1.

Quality DG Report: Q DG Chair Action: for adoption Document: Meeting report from Q DG meeting held on 28 June 2016 Action: for information Document: Draft agenda for the Q DG meeting to be held on 7 September 2016

4.4.2.

ORGAM DG Report: ORGAM DG Chair •

Meeting report Action: for adoption Document: Meeting report from ORGAM DG meeting held on 30 June 2016



Agenda Action: for information Document: Draft agenda for the ORGAM DG meeting to be held on 6 September 2016



Resignation of M. Delbó as ORGAM member effective from 10 July 2016 Action: for discussion Documents: Resignation letter; IT nomination



Draft revised template for EU herbal monographs Action: for discussion Documents: Draft revised MO template; Proposal from E. Svedlund, 13 June 2016

5.

Organisational, regulatory and methodological matters

5.1.

Mandate and organisation of the HMPC

5.1.1.

Mandate of Quality DG and expression of interest for members/observers Action: for adoption Documents: Overview of QDG member interests; New mandate; New nominations; Presentation

5.1.2.

Assessors Training 3-4 November 2016 Report: S. Bager Action: for adoption Document: Draft Agenda

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5.1.3.

Strategic Review and Learning Meetings Report: HMPC Chair; E. van Galen Action: for discussion Documents: Email from HMPC Chair, 26 May 2016; Summary in presentation; Summary of Strategic Review meeting in NL 2016; Transfer from Utrecht – Follow up; Breakout session groups

5.1.4.

Procedural guidance – revised SOP on MO & LE establishment Action: for adoption Documents: Revised SOP on MO & LE establishment; Presentation

5.2.

Coordination with EMA Scientific Committees or CMDh-v

5.2.1.

Scientific Coordination Board Meeting held on 10 June 2016 Report: HMPC Vice-Chair Action: for discussion Document: Agenda

5.2.2.

Coordination with CHMP/SWP - Public statement on the use of herbal medicinal products containing pulegone/menthofuran Rapporteur: J. Wiesner, HMPC Chair Action: for discussion Documents: PS; OoC; CHMP Safety Working Party response to HMPC/CHMP questions on Pulegone and Menthofuran; HMPC letter to EDQM on pulegone menthofuran, 24 June 2016; Annex

5.2.3.

Coordination with CMDh – Addendum to the QRD templates for SmPC, Labelling and Patient Leaflet on Mutual recognition and Decentralised procedures for (T)HMPs Report: ORGAM Chair Action: for adoption Document: Addendum to the QRD templates for SmPC, Labelling and Patient Leaflet on Mutual recognition and Decentralised procedures for (T)HMPs (EMA/HMPC/770889/2014)

5.3.

Coordination with EMA Working Parties/Working Groups/Drafting Groups

5.3.1.

Coordination with PCWP/HCPWP Observer: S. Bager •

EMA PCWP/HCPWP session on communication and information on medicines, 8 March 2016 Action: for information Document: Report

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EMA PCWP/HCPWP joint meeting, 9 March 2016 Action: for information Document: Minutes

5.4.

Cooperation within the EU regulatory network

5.4.1.

European Pharmacopeia •

EDQM 13A expert group meeting held on 8-10 June 2016 EDQM: M. Bald; HMPC Observer: I. Chinou Action: for information Document: Summary of discussion

5.4.2.

Survey on uptake of the traditional use registration and implementation of Directive 2004/24/EC in EU Member States, 2015 Action: for discussion Documents: Presentation; EMA/HMPC/322570/2011 Rev. 6

5.5.

Cooperation with International Regulators

5.5.1.

HMPC – International representation and cooperation Report: HMPC Chair Action: for discussion Document: Draft proposal HMPC international cooperation

5.5.2.

Announcement of the 9th Annual Meeting of IRCH to be held in New Delhi, India, 8-10 November 2016 Report: HMPC Chair, HMPC Vice-Chair Action: for information Document: Draft Agenda

5.6.

Contacts of the HMPC with external parties and interaction with the Interested Parties to the Committee None

5.7.

HMPC work plan

5.7.1.

Projects on the HMPC work plan 2016 Action: for discussion Documents: Work plan 2016 – current status; HMPC work plan tracking tool 2016 •

Harmonisation of assessment practice for herbal substances of non-European origin Report: E. van Galen Action: for discussion Documents: Comparative List for Ayurveda Herbs; Discussion paper

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5.7.2.

Preparation of HMPC work plan 2017 Action: for information Document: Presentation

5.8.

Planning and reporting None

5.9.

Legislation and regulatory affairs None

6.

Any other business

6.1.

Topics for discussion

6.1.1.

ARSP •

English summaries for publication; Documents: Aniseed; Anise oil; Bearberry leaf; Hop strobili; Passion flower; Primula flower; Primula root; Thyme



English template



Procedural challenges

6.1.2.

New EMA website “regulatory herbal”

6.2.

Documents for information

6.2.1.

HMPC Table of Decisions from HMPC meeting held on 30-31 May 2016 Overview of expertise of members HMPC and subgroups Meeting report from HMPC meeting held on 30-31 May 2016 Overview of status of HMPC assessment work – priority list Inventory of herbal substances for assessment work – alphabetical order Abbreviations in HMPC agendas/minutes Common names of herbal substances in all languages

6.2.2.

MLWP •

Overview of status of HMPC/MLWP assessment work



Draft agenda of MLWP meeting to be held on 12-14 July 2016

6.2.3.

Other •

Updated Welcome Packs uploaded in MMD (MMD/HMPC/General)



Article 57, Documents: Dashboard report to EMA Committees; EVDAS User Guide

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