Report of HMA Management Group Aginus Kalis, Chair of HMA Management Group Budapest, Hungary, 28th April 2011

HMA meeting Budapest 3rd - 4th February 2011 HMA-MG meetings 14 January February March March April April 2011

Membership of HMA Management Group Meetings with Stakeholders on 21 March and 21 April 2011 The MEB hosted two meetings with stakeholders in March and April 2011 under the auspices of Aginus Kalis, chair of the MG and Marcus Muellner as chair of the Telematics Support Group. The focus of the March meetings was focussed on the technicalities of the Common European eSubmission portal (CESP) and the advantages to the network and industry to develop the CESP. The April meeting was focussed on business leaders with more focus on strategic issues. Oral report by Aginus Kalis HMA meeting Budapest 3rd - 4th February 2011

The implementation plan for Strategy 2015 Following a teleconference between the HMA MG a proposal to oultine the means by which a small number of specific targets and priority actions for each of the eight work areas of the HMA Strategy can be identified and developed by the work area leads and their respective HMA Working Groups was developed. This is for approval by HMA Annex 1 Strategy Plan

HMA meeting Budapest 3rd - 4th February 2011 Following a training session for the HMA PS and website editors and discussion with the sub group from the WGCP a number of suggestions have been made for the layout of the HMA website for approval by HMA. Annex II Review of the HMA Website

HMA meeting Budapest 3rd - 4th February 2011 The MG attended a demo by BfArM for the DMS and agreed to a pilot period for use with the HMA PS. A roll out plan for the HMA working groups is being developed along with training webinar demo and training manual/guidance manual outlining the basic functions of the DMS which users can down load and use as a reference. The training of the whole of the working groups may take place virtually using the Webinar tool and the principle would be to “train the trainer”. In order to roll out the DMS and ensure its successful use a number of SOPs and protocols must be established and put in place prior to the roll out: Annex III HMA Document Management System

HMA meeting Budapest 3rd - 4th February 2011 HMA Management Group: Steve Dean will step down from the HMA and subsequently from the HMA Management Group in July The HMA are looking for nominations for the Management Group. Nominations can be sent to the hma- by close of business15 th June 2011.hma- The WGPT now requires a chair for the group following the step down by Jean Marimbert from the HMA. Volunteers are required to send their letter of application to the HMA PS at by close of business 13 th May Request for nomination to HMA MG and Chair for the WGPT

HMA meeting Seville 12th - 13th April 2010 Following a comment from the European Commission that it was approached by a number of stakeholders claiming that a document was not in line with Directive 2001/83/EC the HMA MG drafted an update for the SOP for working groups for posting of their documents to the website for HMA approval at this meeting. Annex IV Publication of documents on the website

The DIA meeting was attended by the Chair of the HMA Management Group who gave an overview of the HMA Strategic Plan Annex V HMA meeting Budapest 3rd - 4th February 2011 DIA meeting Geneva

Fees are diverse due to the different national structures. In many cases the national fees regulations have not been changed with regards to the new variations regulation and there is therefore a discrepancy between what is possible with the new regulation and how fees are charged. However, many NCAs are looking into revising the fees for variations in the near future. The administrative burden for NCAs increased initially after the implementation of the variations regulation, but there are some signs that it is improving as more experience is gained. Annex Vi HMA meeting Budapest 3rd - 4th February 2011 Costs of the variations regulation

HMA meeting Budapest 3rd - 4th February 2011 Following the dicussion under AOB at the HMA meeting in February 2011 the HMA MG responded on behalf of the HMA saying that the HMA would like to stress that product website addresses are not mentioned as mandatory information ( article 54 and 59 of the Directive of 2001/83/EC) nor as optional information in article 62 of the Directive. This provision makes it clear that other information can only be published if it is compatible with the SmPC. The letter also points out that Member States are required to monitor the advertising of medicinal products and to verify if the website address is not promotional or will become promotional (after publication of the PIL) will mean an enormous increase in workload and also an administrative burden for all Member States. Annex VII Medicines specific website in the package leaflets.

HMA meetings 2012/2013 Following a meeting in Amsterdam with the trio: Denmark, Cyprus and Ireland it was agreed that a rolling plan of HMA meetings would be prepared. Due to staffing restrictions during the Cypriot Presidency it was agreed to hold one HMA meeting and one Strategic Day meeting which would concentrate on a particular strategic issue of the HMA. It was agreed that the idea of a rolling meeting plan would enable future Presidencies better planning opportunities and where required to assist smaller countries with their planning. HMA meeting Seville 12th - 13th April 2010

HMA Visegrad 28th – 29th April May 23 May 8 June 28 June 3 July Next HMA-MG meetings