Annual Report BASG - Federal Office for Safety in Health Care

Transcription

1 E 2015 Annual Report 2015 BASG - Federal Office for Safety in Health Care 1

2 Imprint BASG - Federal Office for Safety in Health Care 2015 Traisengasse 5 A-1200 Vienna Tel.: +43 (0) basg_anfragen@ages.at Responsible DI Dr. Christa Wirthumer-Hoche (Chair AGES, Procedural Member BASG) Design & Layout Petra Berger & Valerie Merl ebendadesign.at Photos Gerhard Wasserbauer Printing FDBS Schüller GmbH, 1210 Vienna Copyright BASG - Federal Office for Safety in Health Care 2016 Reproduction is authorised, provided the source is acknowledged, save where otherwise stated. Any restrictions on use will be referred to specifically. 2

3 content 1 Austrian Medicines and Medical Devices Agency (AGES) 9 AGES MEA 10 BASG 11 Strategic targets 14 Quality Management 15 Authorised medicinal products with new active ingredient 16 New Marketing Authorisations vs. Variations 17 Austria as Reference Member State (RMS) 18 Expertise of Austria as RMS 20 BASG is the most active national competent authority involved in the assessment of Certificates of Suitability (CEPs) 23 Scientific Board 24 AGES MEA dialogues 25 E 2 Services of the Federal Office for Safety in Health Care / Austrian Medicines and Medical Devices Agency 27 Scientific Advice 28 Clinical Trials 29 Marketing Authorisations 33 Paediatric Medicines 41 Pharmacovigilance 42 Pharmacovigilance veterinary 45 Import of medicines 45 Enforcement 46 Market surveillance 47 Quality defects 52 Inspections 52 Approval of Plasma Pools/Offical Control Authority Batch Release Vaccines 54 Medical Devices 56 Blood and Tissue 59 3 Organistation 63 4 Annual closure 67 JAB 2015 MEA 68 5 Attachment 71 Figures 73 3

4 SC Univ.-Doz. Dr. Pamela Rendi-Wagner Chair BASG prologue Dear readers As of 2016, the Federal Office for Safety in Health Care (BASG) is celebrating its 10 years of activity. Since its establishment, BASG has been able to cope with all the dynamically changing requirements, both at a technical and legislative level, particularly at the level of European Union legislation relevant also for Austria. In this sense, the year 2015 has also been successfully completed. The urgently needed reorganisation of structures and processes of the AGES MEA providing technical and human resources to BASG, complying with the legal provisions of the Health and Food Safety Act (GESG 2002) may undoubtedly be considered a success and has passed its practical test. The completed reorganisation assures - in an environment requiring continuous improvements in the efficiency of the sovereign acts of public institutions the future fulfillment of the legal and particularly ethical mission. In line with the current state of the art of sciences, this ensures a high degree of safety for medicinal products and medical devices for the benefit of patients. BASG ensures a high degree of safety for medicinal products and medical devices for the benefit of patients. The reorganisation of AGES MEA/BASG was also succesfull in terms of ensuring a solid and competent regulatory environment for the pharmaceutical industry in Austria, thereby creating a sustainable basis for the maintenance of added value and employments in this important economic sector. This provides an accurate contribution to safeguarding the supply of medicines in Austria by the public sector, as required. 4

5 E SC Univ.-Doz. Dr. Pamela Rendi-Wagner For the sake of completeness, the activity of BASG can not be considered to be limited to Austria only, but must be placed in a European context. The contingent of marketing authorisations of medicines proceeded according to provisions of the European legislation has been growing steadily and rapidly in recent years and now represents the majority of the current regulatory activity of BASG. As a prerequisite, BASG/AGES MEA is in constant coordination with the European Medicines Agency and the other EU Member States act. One should in this context attach particular importance to the active contribution of AGES MEA to the development of the European Pharmacopoeia within the framework of EDQM. Keeping pace with the scientific progress, this activity provides not only a precondition for increase in drug safety as appropriate, but also contributes to the generation and acquisition of sensitive specific knowledge, an expertise of vital interest for the future of Austrian based pharmaceutical enterprises. SC Univ.-Doz. Dr. Pamela Rendi-Wagner 5

6 DI Dr. Christa Wirthumer-Hoche Chair AGES, Procedural Member BASG prologue Dear readers, looking back to the last year, we recognise that an excellent job in all the different activities during the life cycle of medicinal products, especially assessing and evaluating the dossiers and post-marketing activities for medical devices in the interests of patients was done in The scope of our responsibilities is constantly growing, and not only for this reason, cooperation within the EU network, with the EMA and the other European authorities is essential, as well as the active participation in the 7 Scientific Committees of the EMA was also marked by intensive debates on the strategy At national level, the strategic objectives are especially in terms of the positioning of BASG in EU network in different areas, as Rapporteur in the centralised procedure and as Reference Member State in the decentralised procedure, as well as a further expansion of the inspection activities. It is of great advantage for the Austrian Agency that we have the expertise for all the procedures during a lifecycle of a medicinal product and this should be better promoted in the future. An enforcement unit will be established at the BASG and the cooperation with other authorities will be strengthened. For the Austrian pharmaceutical industry a competent authority is crucial. Reliable, high quality assessments done within the agreed deadlines are essential. We were able to attract new applicants and increased activities for existing applicants. Our target, to be among the first 10 EU Member States for the centralised and decentralised/mrp procedures was met. In addition, increases in numbers of procedures were possible in the OMCL activity on batch release for vaccines and biologicals, as well as in the number of inspections. The numbers of clinical trials in Austria is also increasing slightly again. Participation in research projects, directly related to our daily work, is ongoing. Currently, we have projects in the Department of blood and tissues, market surveillance on medical devices market, as well as an IMI (Innovative Medicines Initiative) project replacement of animal experiments in the context of batch release for TBE vaccines by an in vitro method is in progress. 6

7 E 2015 was marked by intensive debates on the strategy DI Dr. Christa Wirthumer-Hoche Databases, portals and electronic workflows are part of our daily work. IT work in progress and maintenance of existing IT systems are essential. Good contact with our applicants/users within the so-called IT-User Group was established. Training is a very important topic, for all of us. We ourselves are often the best trainers in-house for our colleagues and also for other EU-authorities. Employees of AGES MEA on behalf of BASG conducted in May 2015, with the support of the EMA, as the first NCA a webinar as part of the EU NTC ( Network Training Center ), nearly all other EU authorities participated. I would like to acknowledge the dedication and good work of all employees who contributed to these services in the interest of public health during the year Enjoy reading the BASG annual report DI Dr. Christa Wirthumer-Hoche 7

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9 1 Austrian Medicines and Medical Devices Agency (AGES MEA) E 2 Services of the Federal Office for Safety in Health Care / Austrian Medicines and Medical Devices Agency 3 Organisation 4 Annual closure 5 Attachment 9

10 AGES MEA Austrian Medicines and Medical Devices Agency (AGES MEA) as a business area of the Austrian Agency for Health and Food Safety (AGES) The Austrian Agency for Health and Food Safety (AGES) is one of Europe s leading expert organisations, striving to minimise risks in areas of public health, animal health, food safety, medical and drug safety and consumer protection. Founded in 2002, AGES MEA is fully owned by the Republic of Austria and structured in a number of strategic business areas. One of its areas, the Austrian Medicines and Medical Devices Agency (AGES MEA) was established in AGES MEA is one of Europe s leading expert organisations, striving to minimise risks in areas of public health, animal health, food safety, medical and drug safety and consumer protection. Responsibilities of AGES MEA include issuing new marketing authorisations for medicinal products in Austria, as well as the national and European surveillance of medicinal products and medical devices already marketed, in terms of effectivity and possible side effects, also inspecting manufacture, transport and storage. AGES MEA is also monitoring bloodand tissue-vigilance issues. 10

11 BASG Federal Office for Safety in Health Care (BASG) and Austrian Medicines and Medical Devices Agency (AGES MEA) E The Federal Office for Safety in Health Care (BASG) and the Austrian Medicines and Medical Devices Agency (AGES MEA) were both set up in January The BASG is directly subordinated to the Austrian Federal Ministry of Health (BMG), carrying out sovereign tasks, including authorisation and control of medicinal products and medical devices. The BASG authorises and controls medicinal products and medical devices. BASG consists of three members appointed by the Federal Minister of Health, one member from BMG and from AGES MEA each. The third member is the head of the AGES MEA. AGES MEA is therefore closely linked to the BASG, providing BASG with necessary resources, staff and infrastructure. When carrying out sovereign activities, the employees of AGES MEA are acting on behalf of BASG. 11

12 Vison, Mission, Self-concept and Values Vision Mission We strive to continuously ensure effective and safe medicines and thus contribute to and maintain the highest levels of public health, taking a leading role among medicines agencies in Europe. We are dedicated to public health, both to patients and to health-care professionals. We are the national competent authority for regulation of medicinal products and medical devices and a partner to competent authorities and agencies throughout Europe and pharmaceutical industry. Self-concept We are dedicated to promoting and protecting both human and animal health by safeguarding and shaping the regulatory and scientific environment to ensure high-quality medicinal products and medical devices with a balanced benefit-risk ratio. Our scientific and regulatory experts are the knowledge-carriers of our organisation, constantly developing and sharing their expertise and knowledge with the public. 12

13 Our Values and the way as live them E Responsible We are committed to working for the health of humans, animals, and plants in a sound and responsible manner. We stand by our actions and decisions. Objective We are guided by facts, are impartial, and act with integrity. Competent We do the right things, and we do them in a serviceand results-oriented manner. As a team, we strive for innovation, interdisciplinarity, and excellence. European We live and promote the European idea. We actively participate in shaping the European regulatory environment, thereby contributing to safeguarding health in Europe. 13

14 Strategic targets Strategy of BASG/AGES MEA to achieve the effectiveness objective Nr. 6: Safe medicinal products and medical devices Focusing and specialisation on current and future-oriented subject areas, responding to market needs. Optimal positioning in the market and in the EU network Legally compliant fulfillment of all duties Contribution and timely implementation of legal provisions and guidelines Leading role in active dialogue with all relevant stakeholders Practicing and foster transparent and open, internal and external communication Balanced financial performance in the AGES MEA Economic and purposeful thought and action through the best use of our human and time resources, and balancing potential risks. Combining all resources available in the AGES MEA to attain effectiveness objective Nr. 6 In order to increase efficiency introduction of process management in BASG/AGES MEA Establishing a good working culture Development and expansion of the IT infrastructure 14

15 Quality Management The Official Medicines Control Laboratory (OMCL) of the Federal Office for Safety in Health Care was accredited in 2002 as testing laboratory according to ISO/IEC by Akkreditierung Austria as conformity assessment body No In 2007, all inspection services of the Surveillance Institute were accredited as inspection body type B according to ISO/IEC The current scope of accreditation is published at E The complete Austrian Medicines and Medical Devices Agency, which is a business area of the Austria Agency for Health and Food Safety (AGES), was certified in 2010 by Quality Austria according to ISO Further relevant quality requirements are implemented by the quality system, as Quality Assurance Guidelines of the OMCL-networks Quality Systems Framework for GMP Inspectorates GVP Module I Pharmacovigilance systems and their quality systems Commission Implementing Regulation (EU) No 520/2012 Compliance to these standards is verified by mutual audits of the European and international regulatory network. 15

16 Authorised medicinal products with new active ingredient CEFTOLOZANSULFAT SAFINAMID MESILAT IDARUCIZUMAB PANOBINOSTAT CANGRELOR TETRANATRIUM OMBITASVIR SECUKINUMAB GERMANIUMTETRACHLORID EVOLOCUMAB OSPEMIFEN HORNHAUTEPITHELZELLEN LUBIPROSTON ASFOTASE ALFA NETUPITANT SECRETIN PENTAHYDROCHLORID DINUTUXIMAB LENVATINIB MESILAT PEMBROLIZUMAB COBIMETINIB CERITINIB TEDIZOLIDPHOSPHAT APREMILAST NIVOLUMAB SEBELIPASE ALFA LUTETIUMCHLORID ALIROCUMAB SACUBITRIL GUANFACIN HYDROCHLORID TASIMELTEON DALBAVANCIN ELIGLUSTAT TARTRAT DASABUVIR ISAVUCONAZONIUMSULFAT CARFILZOMIB BLINATUMOMAB MEPOLIZUMAB SONIDEGIB TALIMOGEN LAHERPAREPVEC LUMACAFTOR IDEBENON EDOXABAN Number of authorised medicinal products with a new active pharmaceutical ingredient New authorisations Fig. 1 Number of authorised medicinal products with a new active pharmaceutical ingredient

17 New Marketing Authorisations vs. Variations For several years, the number of applications for marketing authorisations in Austria and in Europe generally decreases. By contrast, variation procedurces are increasing continuously. Since the beginning of 2014 lifecycle services in Austria are covered by an annual fee. This helps to minimise the administrative burden and to make the costs for industry better predictable. E New Marketing Authorisations vs. Variations Variations New Market Authorisations New Marketing Authorisations Variations (single applications) 0 Fig. 2 New Marketing Authorisations vs. Variations 17

18 Austria as Reference Member State (RMS) Austria s strong position as RMS within the national competent agencies For years Austria has held a top ten position as Reference Member State in the EU ranking for European authorisation procedures. For human medicinal products the Federal Office for Safety in Health Care (BASG) holds 8th position in started as well as finalised procedures in In herbal medicines, Austria has established itself in 2nd place. In the veterinary field Austria as Reference Member State has acted on 13th position for started and 10th position for finalised procedures. Recently, Austria has issued the 680th procedure number. Overview on finalised human MR- and DC-procedures per Overview on started MR- and DC-procedures per RMS RMS th Place EU-Ranking Fig. 3 Overview on finalised human MR- and DC-procedures per RMS NL DE UK DK PT SE HU AT ES CZ FI FR NO IS MT IE PL SI SK BE IT EE LV HR LT BG CY EL LU MRP DCP Sum 18

19 Austria convinces with its effective and pragmatic case management Austria has established itself with the so-called case managers as a reliable and competent interface between applicants, assessors and other European national agencies. This results in fast processing and optimised information flow between all parties involved: process time is kept as short as possible and many procedures can be finalised before day 210. E Number of DCPs finalised before d210 59% early finalised % timely finalised timely finalised early finalised Zeitgerecht abgeschlossene DCPs (%) Frühzeitig abgeschlossene DCPs (%) Fig. 4 Number of DCPs finalised before d210 19

20 Expertise of Austria as RMS An analysis of procedures led by Austria as RMS underlines assessors expertise. Austria has most frequently acted as RMS for medicinal products with the ATC codes C, N, J, A and G. The majority of the procedures corresponds to generic applications followed by hybrid applications (comparable to the EU-wide distribution by application types). ATC Codes of Procedures with AT=RMS C, Cardiovascular system N, Nervous system J, Antiinfectives for systemic use A, Alimentary tract and metabolism G, Genito urinary system and sex hormones R, Respiratory system M, Musculo-skeletal system L, Antineoplastic and immunomodulating agents S, Sensory organs Fig. 5 ATC Codes of Procedures with AT=RMS D, Dermatologicals B, Blood and blood forming organs V, Various

21 Legal basis of procedures with AT=RMS Well etablished use application 6% Fixed combination application 4% Full dossier application 4% E Hybrid application 14% Generic application 72% Fig. 6 Legal basis of procedures with AT=RMS Number of started MRPs/DCPs with AT=RMS at product level DCPs MRPs 0 Fig. 7 Number of started MRPs/DCPs with AT=RMS at products level 21

22 i Austria will take over the role as RMS in as many procedures as possible within its existing resources. The process of slot allocation for DCP submissions has continuously been optimised in order to guarantee the best possible planning of applications and efficient utilisation of expert resources. In order to make the availability of the respective expert teams visible, a slot matrix has been published on our website. DCP slot requests and -bookings are possible at any time, whether long-term or short-term, depending on the availability as shown in the slot matrix. Requests for Mutual Recognition-, Repeat-Use and Line Extension Procedures may also be submitted at any time. In addition, applicants can sign up for the UpToDate newsletter issued by BASG in order to receive by the latest news respective to European procedures. 22

23 BASG is the most active national competent authority involved in the assessment of Certificates of Suitability (CEPs) E In order to avoid multiple assessments of identical active substance documentations by different authorities during the different procedures, documentation on an active substance can be submitted to the European Directorate for the Quality of Medicines & HealthCare (EDQM). After a positive, centralised assessment by two assessors from different national competent authorities and one EDQM assessor, a Certificate of Suitability (CEP) is granted; the CEP certifies that the quality of the active substance in question has been adequately documented. Future application dossiers only need to include a copy of the CEP rather than an extensive active substance documentation, eliminating the need for repeat assessments of the active substance. Furthermore, the same procedure is in place to evaluate TSE (Transmissible Spongiform Encephalopathy) risk of active substances and excipients and hereby helps to guarantee TSE-free products. Currently, the Federal Office for Safety in Health Care is sending eleven experienced assessors to the CEP working party of EDQM (nine assessors responsible for chemical evaluations and two assessors responsible for TSE evaluation). To avoid multiple assessments, documentation on an active substance can be submitted to the EDQM. Since 2013, Austria has been the leading national competent authority within Europe, sending more assessors to Strasbourg than any other country. EDQM not only covers travel and accommodation expenses, furthermore, 23

24 the loss of assessing capacities is reimbursed to the national competent authorities. In addition, Austria (together with eight other countries) is represented in the Technical Advisory Board and, as a result, can actively participate in professional and strategic decisions. Furthermore, an Austrian delegate is also member of the Ad Hoc Committee and, thereby involved in discussions and decisions as regards CEP suspensions and withdrawals. Scientific Board The Scientific Board is an official committee of the Advisory Board on Medicinal Products to the Federal Ministry of Health and advises in matters related to the approval and safety of medicinal products. The Scientific Board has three meetings each year, chaired by Head of the AGES MEA. Currently, the Scientific Board consists of 35 members - representing a wide scope of expertise, coming mostly from university hospitals - appointed by the Federal Minister of Health. Permanent items on the agenda include discussions on open approvals and variation processes in which the decision is not clear as yet, moreover issues of Pharmacovigilance, as well as topics of current events. The Scientific Board of the AGES/MEA representing a wide scope of expertise, 24

25 AGES MEA dialogues In 2015 the BASG/AGES MEA organised a total of five AGES MEA dialogues. This information and discussion meetings have already a long tradition and are recognised by representatives of industry, interest groups and other stakeholders as well visited events. E Our experts started the lecture-year on with Update on Homeopathics, followed by Pharmacovigilance News Update on The AGES-dialogues on had the topics esubmission - eaf - eservices. On Medical devices and post-market surveillance, followed by the last one in this year on about Clinical trials, a meeting in an extern location of the Clinics of Vienna Medical University. i Other event highlights: BASG Press Conference for the new Internet Pharmacy-Logo and the start of the registration of legal internet pharmacies together with the Federal Minister of Health Dr. Sabine Oberhauser ( ) 25

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27 1 Austrian Medicines and Medical Devices Agency (AGES) E 2 Services of the Federal Office for Safety in Health Care / Austrian Medicines and Medical Devices Agency 3 Organisation 4 Annual closure 5 Attachment 27

28 Scientific Advice Pharmaceutical companies have the opportunity to apply for Scientific Advice (SA) from regulatory authorities regarding questions related to development of medicinal products. These SAs may be requested either at the European level (at the European Medicines Agency, EMA) or at the AGES MEA. In 2015 a total of 119 EMA SA procedures have been reviewed on behalf of the Austrian agency. Fifty-eight percent were assessed exclusively by experts from BASG/AGES MEA. The remaining 42 percent were performed by external experts from the Department of Clinical Pharmacology at the Medical University of Vienna. As in previous years, a total of 20 percent of all EU SAs were given by the Austrian agency. Austria was with this regard ranking among the top 5 member states in the EU Number of EMA Scientific Advice Procedures Fig. 8 Number of EMA Scientific Advice Procedures AT Coordinator AT Peer Review

29 Also in 2015, national scientific advice (NASA) procedures could be further expanded: 24 procedures were finalized ( = 33.3% increase compared to the previous year). Feedback on the customer satisfaction confirmed excellent results. The questions covered criteria like waiting period between application of a NASA and advice meeting as well as adequacy of responses and expertise provided. E Number of National Scientific Advice Procedures Fig. 9 Number of National Scientific Advice Procedures Clinical Trials Further effort was invested in the harmonisation of administrative processes for Clinical Trials for medicinal products and medical devices. The IT Project Clinical Trials transitioned to its implementation phase. Clinical trials with Medicinal Products Submission activity has recovered from the exceptionally low values of 2014 to the approximate results of The number of submitted phase 29

30 I, III and IV studies falls within the expected average of previous years, whereas the downward trend for phase II studies continues. Phase III studies remain the largest proportion of studies submitted in Austria. The number of phase I studies remains stable, however, only a few of them are First-in-Man studies. The proportion of commercial versus academic studies remains constant at 70:30% in favour of commercial clinical trials. The EU average is 60% commercial trials. The trend towards multinational trials is continued. There is a trend towards multinational trials. Phases of Clinical trails Phase I Phase II Phase III Phase IV Fig. 10 Phases of Clinical trails

31 In annual safety reports (ASRs)/development safety update reports (DSURs) were submitted for ongoing clinical trials in Austria and subject to a risk based evaluation. Austria contributed with two procedures to the Clinical Trial Facilitation Group (CTFG) ASR Assessment Pilot Project, whose goal it is to establish a work sharing process for the future assessment of annual safety reports according to article 44 of Regulation Nr. 536/2014. E In the Voluntary Harmonisation Procedure (see medicines/prior-to-authorisation/clinical-trials/vhp/) 218 initial applications and 439 amendments were processed in the Voluntary Harmonisation Procedure in Austria took part in 58 initial applications, acting as reference member state in 5 procedures. Austria acted as reference member state for 11 substantial amendments and participated in 140 amendment procedures. Austria Two procedures to the Clinical Trial Facilitation Group (CTFG) ASR Assessment Pilot Project Austria took part in 58 initial applications, 5 rapporteurships, participated in 140 amendment procedures One compassionate use application was approved in

32 Clinical Investigation of Medical Devices and Performance Evaluation of In-Vitro-Diagnostics In 2015, 95 initial applications were submitted to the BASG (43 commercially sponsored / 52 academic studies). 89 applications concerned clinical investigations of medical devices, 6 were performance evaluations of IVDs and 7 combination studies of medical devices and medicinal products. In addition, notifications of serious adverse events, 70 substantial amendments, 120 additional information and miscellaneous notifications and 19 annual safety reports were submitted for ongoing procedures. Furthermore, 54 end of study notifications and 39 clinical study reports were received. The preparatory work for an electronic application form for clinical investigations with medical devices was conducted as part of the IT Project Clinical Trials AMG/MPG, considering current European developments as part of the compilation of the MedDev Guideline for clinical investigations with with medical devices. Distribution of initial study applications with medical devices per type of sponsor Academic 52 Sponsors Fig. 11 Distribution of initial study applications with medical devices per type of sponsor 49 Commercial Sponsors 32

33 Distribution of study applications per class of medical device/ivd 8 Class I 20 IVD E 16 AIMD 34 Class IIa 11 Class III 14 Class IIb Fig. 12: Distribution of study applications per class of medical device/ivd Marketing Authorisations In Austria, at the end of ,511 medicinal products have been approved, of which 87 percent for humans and the rest for animals authorised human medicinal products can be dispensed without prescription. Furthermore, there are medicinal products registered. In human and 80 veterinary medicinal products were newly authorised by the Federal Office for Safety in Health Care, whereas marketing authorisations of 471 human and 52 veterinary medicinal products have been withdrawn. After the number of new marketing authorisations has constantly decreased since 2012, more medicinal products were approved in 2015 again. Also for the first time since 2010, the ratio of marketing authorisations / withdrawals, moved towards approvals indicating an overall increase in authorised medicinal products In 106 cases, the distribution as parallel import has been approved. Since May 2007, product information (i.e. summary of product characteristics and package leaflet) of most medicinal products has been published online by BASG ( By the end of 2015, respective information has been available for medicinal products. 33

34 i National In 2015, 85 national marketing authorisations were issued. Furthermore, the Federal Office for Safety in Health Care has implemented registrations for 74 homeopathic, 17 traditional herbal and one pharmacy-owned medicinal products. MRP/DCP In human and 75 veterinary medicinal products were authorised in Austria. Austria acted as Reference Member State (RMS) in 28 human procedures (58 products) respectively in one veterinary procedure (one product) and herewith holds 8th place in the EU statistics with regard to human MRP / DCP procedures finalised in Austria was involved in 204 human procedures (420 products) as well as in 50 veterinary procedures (70 products) as Concerned Member State (CMS). In 2015, in 13 procedures (29 products) an RMS transfer towards Austria was completed. With the consent of the marketing authorisation holder, conditional approval can be issued for positively finalised human procedures on the European level (DCP / MRP), if marketing authorisation is granted, but marketing is not yet intended in Austria. The national marketing authorisation takes place on the basis of product information texts in the English language with which the DCP / MRP procedure was completed. Before marketing, product information in the German language needs to be submitted and approved. In 2015, 59 medicinal products were conditionally approved, accounting for approximately ten percent of all human medicinal products authorised in that year. 34

35 Authorised human Medicinal Products Medicinal Product Type Legal Base Anzahl Allergen Manufacturing License Biological Medicinal Products 7a National Medicines Act 63 Full application (Article 8(3) of Directive No 2001/83/EC) 181 Known active substance (Article 8(3) of Directive No 2001/83/EC) 144 Similar biological application (Article 10(4) of Directive No 2001/83/EC 1 Well-established use application (Article 10a of Directive No 2001/83/EC) 24 E Homeopathic Medicinal Products Medical Gases Herbal Medicinal Products Radiopharmaceuticals Homeopathic marketing authorisation procedure (Article 16 of Directive No 2001/83/EC) Generic application (Article 10(1) of Directive No 2001/83/EC) Known active substance (Article 8(3) of Directive No 2001/83/EC) Well-established use application (Article 10a of Directive No 2001/83/EC) Fixed combination application (Article 10b of Directive No 2001/83/EC) Full application (Article 8(3) of Directive No 2001/83/EC) Generic application (Article 10(1) of Directive No 2001/83/EC) Known active substance (Article 8(3) of Directive No 2001/83/EC) Well-established use application (Article 10a of Directive No 2001/83/EC) Full application (Article 8(3) of Directive No 2001/83/EC) Generic application (Article 10(1) of Directive No 2001/83/EC) Hybrid application (Article 10(3) of Directive No 2001/83/EC) Known active substance (Article 8(3) of Directive No 2001/83/EC) New active substance (Article 8(3) of Directive No 2001/83/EC) Well-established use application (Article 10a of Directive No 2001/83/EC) Chemical Medicinal Products Fixed combination application (Article 10b of Directive No 2001/83/EC) Full application (Article 8(3) of Directive No 2001/83/EC) Generic application (Article 10(1) of Directive No 2001/83/EC) Hybrid application (Article 10(3) of Directive No 2001/83/EC) Informed consent application (Article 10c of Directive No 2001/83/EC) Known active substance (Article 8(3) of Directive No 2001/83/EC) New active substance (Article 8(3) of Directive No 2001/83/EC) Well-established use application (Article 10a of Directive No 2001/83/EC) Medicinal Products according to Pharmacopoeia Monograph 9c National Medicines Act 14 Total

36 Registered human Medicinal Products Medicinal Product Type legal base Number Pharmacy owned Medicines Homeopathic Medicinal Products Homeopathic simplified registration procedure (Article 14 of Directive No 2001/83/EC) Traditional Herbal Medicinal Products Traditional use registration for herbal medicinal product application (Article 16a of Directive No 2001/83/EC) 188 Total Authorised veterinary Medicinal Products Medicinal Product Type legal base Number Biological Medicinal Products Medicated Feedingstuffs Full application (Article 12(3) of Directive No 2001/82/EC) Informed consent application (Article 13c of Directive No 2001/82/EC Known active substance (Article 12(3) of Directive No 2001/82/EC) New active substance (Article 12(3) of Directive No 2001/82/EC) Full application (Article 12(3) of Directive No 2001/82/EC) Generic application (Article 13(1) of Directive No 2001/82/EC) Hybrid application (Article 13(3) of Directive No 2001/82/EC) Well-established use application (Article 13a of Directive No 2001/82/EC) Homeopathic Medicinal Product Chemical Medicinal Products Homeopathic marketing authorisation procedure (Article 19 of Directive No 2001/82/EC) 88 Fixed combination application (Article 13b of Directive No 2001/82/ EC) 28 Full application (Article 12(3) of Directive No 2001/82/EC) 475 Generic application (Article 13(1) of Directive No 2001/82/EC) 374 Hybrid application (Article 13(3) of Directive No 2001/82/EC) 131 Informed consent application (Article 13c of Directive No 2001/82/EC) 7 Known active substance (Article 12(3) of Directive No 2001/82/EC) 52 New active substance (Article 12(3) of Directive No 2001/82/EC) 1 Well-established use application (Article 13a of Directive No 2001/82/EC) 50 Total

37 Further information Number Marketing Authorisations for human Medicinal Products Withdrawals of human Medicinal Products Marketing Authorisations for veterinary Medicinal Products Withdrawals of veterinary Medicinal Products Marketing Authorisations for OTC human Medicinal Products (total) Registrations for for OTC human Medicinal Products (total) Parallel imports (total) E Overview of procedures finalised positively over the last years Proced. nat. Proced. MRP&DCP Sum of procedures finalised 691 Fig. 13 Overview of procedures finalised positively over the last years 37

38 Centralised Procedures 2015 the BASG/AGES MEA was involved in the assessment of 10 centralised procedures and 4 peer reviews for new active substances as well as generics. The products were generics, recombinant coagulation factors, biosimilars, analgetics and ophtalmologics. When applying for centralised procedures the BASG/AGES MEA in 2015 was appointed for 14 procedures (12 as Rapporteur and 2 as Co-Rapporteur) by the EMA. Compared to the other agencies of the Member States of the the EU / EEA area the BASG/AGES MEA is in sixth position Austria Rapporteur and Co-rapporteurships Fig. 14 Austria in comparison to other agencies per number of Rapporteur and Co-rapporteurships in the centralised procedure MS 1 MS 2 MS 3 MS 4 MS 5 Austria MS 7 MS 8 MS 9 MS 10 MS 11 MS 12 MS 13 MS 14 MS 15 MS 16 MS 17 MS 18 MS 19 MS 20 MS 21 MS 22 MS 23 MS 24 MS 25 MS 26 MS 27 MS 28 MS 29 MS 30 38

39 Variations Medicinal products are underlying permanent variations, which need to be submitted by the marketing authorisation holder and to be examined by the Federal Office for Safety in Health Care. For variations regarding MRP the Variation Regulation (EC) No. 1234/2008 already entered in force on Starting in August 2013, the Variation Regulation has also been implemented for purely nationally authorised products. According to this EU Regulation it is possible to combine/group certain variations instead of providing them on an individual basis. In 2015, applications for variations were submitted, corresponding to a number of 29,736 individual variations. E Changes of medicinal products are examined in line with the Variation Regulation. Number of submitted variation application Type II Type IA Total Type IB Fig. 15 Number of submitted variation application 39

40 Number of individual variations covered in applications human veterinary variations Fig. 16 Number of individual variations covered in applications 946 Typ IA 586 Typ IB Typ II RMS CMS NAT Typ IA 7 Typ IB Typ II For registered medicinal products in 2015 BASG additionally recorded 770 variations (corresponding to individual applications) in the national procedure in accordance with 24/25 AMG (Austrian Medicinal Products Act). It is noted that the number of individual variations has been increasing continuously for years. Through the introduction of the annual fee for lifecycle activities (comprising variations and renewal applications) since the beginning of 2014, resources could be saved and expenses can better be planned for the industry. 40

41 Number of individual variations covered in applications according to AMG 24/25 Human E 6 Veterinär Authorization requirement Approval mandatory Compulsory registration Fig. 17 Number of individual variations covered in applications according to AMG 24/25 Further submission in variations 119 Notifications according Art 61(3) Dir. 2001/83 EC Paediatric Medicines In total 174 new PIP submissions (Paediatric Investigation Plans) have started at the PDCO (Paediatric Committee) at EMA in BASG/AGES MEA contributed to the assessment in 8 of these (5 as rapporteur, 3 as peer reviewer). In addition PDCO received 237 requests for modifications of earlier agreed PIPs, 17 of these with contributions from BASG/AGES MEA (9 as rapporteur, 8 as peer reviewer). 41

42 Pharmacovigilance Several measures were intitiated in the last years in order to educate health care professionals about their reporting obligations regarding pharmacovigilance issues. Trainings, periodical publications as well as distribution of educational material contributed to the increased cooperation and information exchange between stakeholders regarding pharmacovigilance. Austria acts as lead member state for 32 active substances and completed 316 signal detections in Individual Case Safety Reports Individual Case Safety Reports (ICSRs) for medicinal products for human use have been reported 2015, including both initial and follow-up reports of those were initial reports, including 657 (12%) health care professional reports, 124 (2%) patient reports and (86%) marketing authorisation holder reports. All case reports were submitted by BASG/ AGES MEA to the European Pharmacovigilance database Eudravigilance, and 15-day submission compliance was met by BASG/AGES MEA in 99,3% of all case reports. Signal detection and validation enables early identification of associated risks and ensures safe and adequate use of medicinal products for human use. According to the implementing regulation 520/2012/EC, worksharing should be performed within the EU for signal management of medicinal products being authorised in several member states, as well as for active substances included in several medicinal products. As part of that worksharing, Austria acts as lead member state for 32 active substances and completed 316 signal detections in In addition, 451 SUSARs (Suspected Unexpected Serious Adverse Reactions in Clinical Trials) were registered and assessed in

43 Case of completion Human Medicines Also in 2015, PSUSA-procedures could be further expanded with AT in the role of the lead member state: BASG/AGES MEA positioned itself successfully on the eight rank in application of these EU-procedures. E PSUSA: Lead Member States AT DE FR UK DK IT NL SE AT IE ES PT EE BE CZ HR FI SK RO HU LV PL LT MT NO BG EL SI CY IS Fig. 18 PSUSA: Lead Member States 2015 DCP AT finalised PSUSA-procedures in 2015 for the following active substances: Lisuride, Corticorelin, Saquinavir, Nitrendipine, Amlodipin/Ramipril, Febuxostat, Lormetazepam, Desmopressin, Azelastin and Methylprednisolon. 43

44 Based on the PRAC(Co-)Rapporteurships, AT was able to place itself among the top ten EU countries. PRAC-(Co-)Rapporteur appointments for initial applications Fig. 19 PRAC-(Co-) Rapporteur appointments for initial applications UK NL SE PT DE DK ES LT AT IE FR BE IT PL FI LV NO Co-Rapporteur Rapporteur Further activities: Procedures Issue Monitoring Reportings PSURs Authorization/Registration national Authorization MRP/RUP RMS 21 Authorization/Registration (MRP/DCP) 69 Fig. 20 Procedures Renewal RMS Renewal national

45 Pharmacovigilance - veterinary In 2015, a total of 943 PSURs (Periodic Safety Update Reports) regarding veterinary medicinal products have been assessed. Thereof 206 national PSURs, 19 PSURs as Reference Member State (RMS) and 21 PSURs as PSUR Reference Member State (P-RMS) have been assessed. Within the assessment of the procedures under the PSUR worksharing, Austria acts as P-RMS for currently a total of 14 substances. Nationally approved veterinary vaccines are still assessed nationally and not as part of the PSUR worksharing, a common Data Lock Point (DLP) was agreed however. In 2015, a total of 77 initial reports (120 reports including follow-up) on adverse reactions of veterinary medicinal products were reported and forwarded to the EMA EudraVigilance Veterinary database (EVVET). As in recent years, most adverse reactions have been reported to be related to vaccines and antiparasitics. Most adverse reactions in 2015 were reported in dogs and cats - followed by adverse reactions in cattle and pigs. Reports on horses, rabbits, birds (chickens) and small pets or exotic pets occured only rarely. In 2015, three cases of adverse reactions in humans by use of veterinary medicinal products were reported ( User safety ). 943 PSURs 77 Initial Reports E Import of medicines A total of import applications of medicines for therapeutical use, 442 import applications of bulk as well as starting material for blood products, shipment notifications for bulk as well as starting material and intermediate products, 171 import applications for imports dedicated to be exported, 89 importation applications of blood products for therapeutical use, one shipment notification of medicines for clinical trials, 26 import applications for reagents and diagnostics, 2 import applications 45

46 for veterinary vaccines, 371 shipment notifications of veterinary vaccines, shipment notifications of veterinary medicines and shipment notifications of medicines for therapeutical use were processed. Enforcement In 2015, 86 cases were registered in the area of enforcement (2006: 76, 2007: 164, 2008: 167, 2009: 201, 2010: 142, 2011: 170, 2012: 101, 2013: 116, 2014: 89). 31 of these cases were completed in Priorities were illegal drugs, their production and commercialisation (25 percent of total cases in 2015) and counterfeit medicines (22%). Illegal incidents at the tissue, medical devices and drug market ensued a total of 10% of all cases. In enforcement inspections (2009: 16, 2010: : : : : 16) were carried out and 3 charges were filed to the criminal authorities (2009: 20, 2010: : : 12, 2013: 8, 2014: 8). Overview of cases in the area of enforcement Fig. 21 Overview of cases in the area of enforcement

47 Enforcement inspections and charges filed E Enforcement inspections Competent criminal authorities Fig. 22 Enforcement inspections and charges filed Market surveillance The main task of the market surveillance is the analytical control of medicinal products sampled from the market. The assessment of risk signals from other departments of the AGES MEA and the EDQM (European Directorate for the Quality of Medicines) is used to generate the annual sampling plan. The sampling plan contains mainly three kinds of samples: Quality control of legal medicines (see highlights from the surveillance of the legal market) Quality control of illegal medicines (see highlights from the surveillance of the illegal market) Samples for the elaboration of monographs for the European Pharmacopoeia and the Austrian Pharmacopoeia (see highlights from the elaboration of monographs) 47

48 All samples are judged according to the four-level-scale of the EDQM (see chart) EDQM-Skala A A (all complies) = sample ok I I (issues) = sample ok but issues identified O O (out of specification) = result slightly deviates from manufacturers specification S S (serious) = result deviates significantly from manufacturers specification, immediate action necessary (health risk or violation of law) Market surveillance: sample structure Proben Samples vom from legalen the Proben Samples vom from illegalen the Proben Samples für for Pharmakopoe- the pharmacopoe legal market illegal market development Fig. 23 Market surveillance: sample structure 2015 QMM (reports of quality defects) QK national QK european 48

49 Market surveillance: results ,8 E 52,8 50% 34,2 6,2 13,5 6,8 6,2 4,5 A I O S Samples from the legal market Samples from the illegal market Fig. 24 Market surveillance: results 2015 Highlights from the surveillance of the legal market Incoming reports of quality defects of medicinal products are evaluated at the Institute for Surveillance and categorised according to class of risk. In cases of health risk samples are forwarded to the OMCL-AT to be analyzed. 35 samples were analyzed 2015, the results showed 7 serious findings, 2 of them were MRP products. 7 serious findings 49

50 Highlights from the surveillance of the illegal market Since 2012 a steadily increasing number of samples of the illegal herbal drug Khat (fresh or dried leaves) has been forwarded to the OMCL-AT. More than 50 samples were analyzed from 2012 until the end of A special success is the confirmation from the High Court of Justice ( ) that the Controlled Substances Law as well as the Limit Quantity Act has to be applied in court procedure as a consequence of the expert opinion offered by the Austrian OMCL. Illegal medicimal products analyzed ( ) Doping + Legal Highs Fig. 25 Illegal medicimal products analyzed ( ) Homeopathy Pig scandal

51 Highlights from the elaboration of monographs for the European Pharmacopoeia and the Austrian Pharmacopoeia E Austrian Pharmacopoeia (ÖAB) The Austrian Pharmacopoeia contains monographs for medicines not described in the European Pharmacopoeia and which are manufactured primarily by Austrian manufacturers and paid by the consumers. After an OMCL proposal the Austrian Ministry of Health started the revision in In the Austrian Pharmacopoeia Expert Group the OMCL-AT chairs and is responsible for the publication of the draft monographs for annotation. Of the approximately 200 monographs of the 2015 edition nearly 75% are new or revised. European Pharmacopoeia (Ph. Eur.) A special honor and challenge for the OMCL-AT was the acceptance of the development of the first Finished Product Monograph in addition to the trial phase for Raltegravir Tablets and Raltegravir Chewable Tablets for the European Pharmacopoeia. Highlights from committee activities Within the framework of the various committee activities of the OMCL-AT one aspect ist the collaboration in the Working Group on the Implementation of the RB Model developed by the HMA Drafting Group for Risk-based Approach to Product Testing (HMA WGPT). The aim of this working group is the establishment of a standardised risk based sampling plan for the market surveillance of all European OMCL s (ongoing). 51

52 Quality defects In 2015, 74 quality defects, 165 product defects without health hazards and 175 Rapid Alert Notifications have been processed. 40 percent of the notifications (quality defects, product defects, recalls) came from the marketing authorisation holders and manufacturers, followed by pharmacies (32 percent). Additionally, twelve percent were reported internally and 8 percent were received from other authorities. (eg the European Medicines Agency). Six percent of the reports were submitted by the users and patients, two percent by wholesalers / distributors. In 2015, 74 quality defects, 165 product defects and 175 Rapid Alert Notifications were processed. 83 percent of the Rapid Alert Notifications were relating to recalls, 17 percent were relating to GMP / GDP Non-compliance reports. For 23 quality defects a recall had to be carried out to ensure patient safety and in three cases, several countries have been informed via the Rapid Alert System on quality defects. In addition, 44 cases of drug shortages MEA have been processed, a total of 68 were products affected by unavailability. Inspections The GMP (Good Manufacturing Practice) inspections are the basis not only for an manufacturing license according to national Medicinal Products Act, Blood- or Tissue Safety Act. On the other hand these periodic inspections are intended to ensure the quality of medicines in accordance with legal requirements. Compliance with applicable legislation is confirmed by an appropriate certificate. Generally it is distinguished between application and routine inspections. In total 132 applications were filed pursuant to 52

53 Medicinal Products Act. In total 240 GM(D)P-inspections were carried out, 73 of them in third countries (especially in the USA). Most of the inspections in the USA covered human plasma where the BASG/AGES MEA has a key role in Europe with more than 10 years of expertise. This activity involves close cooperation with other European agencies and the EMA. The need to assess compliance with regulatory requirements in advance of Inspections (Inspections of design qualifications) could not be offered due to lack of resources. 7 GLP inspections and 4 inspections of bioequivalence trials were done. E In inspections of clinical trials have been conducted in Austria. 5 inspections have been conducted on behalf of the European Medicines Agency which led the inspectors to countries as distant as Thailand. Numbers of domestic and foreign countries inspections FIGURE! Inlandsinspektionen Auslandsinspektionen Fig. 26 Numbers of domestic and foreign countries inspections In 2015, 3 pharmacovigilance system inspections of Austrian Marketing Authorisation Holders (MAHs) were performed according to Good Vigilance Practices (GVP). One of those inspections was performed on behalf of the European Medicines Agency (EMA) and carried out together 53

54 with the medicines authority of the United Kingdom (MHRA) under the lead of BASG/AGES Pools of human plasma for fraction Approval of Plasma Pools/Offical Control Authority Batch Release Vaccines Altogether 3368 pools of human plasma for fraction were approved in All of them were tested negative for markers of hepatits B, C and HIV1/2. Pools for the manufacturing of Human Plasma pooled and treated for Virus Inactivation were also tested for negative for HAV and HEV and below the limit specification for Parvo B19 virus. These results indicate that the measures for the avoidance of human pathogens in the starting material for plasma fractionation are well implemented in the manufacturing processes. These measures are an essential part for protecting against viral contamination in medicines derived from human plasma. Approval of plasma pools Fig. 27 Approval of plasma pools

55 In 2015 the number of released batches for medicinal products derived from human plasma increased by 12.6% compared to In total, batches were released. E Batch release of plasma derived medicinal products SD Plasma Immun Globulins Human Albumin Fibrin Sealants Coagulation Concentrates all Plasma Products Fig. 28 Batch release of plasma derived medicinal products The total number of released vaccine batches decreased compared to For tick borne encephalitis virus vaccines the number decreased by 24.3% whereas the release of menigococcal group C vaccines increased by 10.6%. Additionally, vaccines for clinical studies were released by AGES. 55

56 Batch Release of vaccines Fig. 29 Batch Release of vaccines TBE Others Total number of human vaccines Influenza Meningococcal group C vaccines Veterinary vaccines Medical Devices Market Surveillance Vigilance Free Sales Certicates European cooperation and communication is rapidly increasing to make effective market surveillance a reality. This is of utter importance for medical devices which may be moved freely once put on the European Market in any member state. The number of European notified bodies leaving the market is severely increasing (according to nando.europa.eu the number of NBs for medical devices decreased from 72 to 52 by the end of 2015, as well the scopes 56

57 of several NBs has been significantly reduced). This generates an extra workload of market surveillance activity, as there are now many manufacturers who lost their certificates and are not allowed to place their products on the market potentially inceasing the likelihood of non-compliant products. E The number of vigilance reports remained at the same level of recent years at reports. This year s vigilance work focused primarily on large European cases, such as silicone breast implants. The amount of reported corrective actions in the field and field safety Notices also remained almost unchanged. The reports of vigilance reports were focused on large European cases such as silicone breast implants, In on-site inspections have been performed. Manufacturers and other actors in the market, as well as sterilisers and health care facilities using and operating medical devices have been inspected. The average duration per inspection has been increased to improve the overall quality. The inspections were focusing onto pediatric departments in hospitals, whilst manufacturers have been inspected focusing on the functioning of their Post Market Surveillance System and the product validation, which required longer inspections durations and good preparatory work. As a service for the exporting medical device industry 398 Free Sales Certificates have been issued based on 229 applications. There has been a backlog at the end of the year built up due to condensed number of application towards the end of the year and also necessary requests for improvements of many applications. Issued free sales certificates are supporting exports of medical devices into countries outside the Common Market, as these help to access these markets, in certain cases they even may replace the necessity of approvals, related assessments and documentation. Eight applications for certificate of exemption and one on classification of a medical device have been submitted. The number of enquiries have 57

58 significantly increased by 34% to a total of 359 altogether. Enquiries by telephone are not fully included in this number. Safety related information on medical devices have been published on our homepage, and were directly sent out to medical professionals in cases warranted. Examples for these cases related to breastimplants, Heater-Cooler-Units and products for adaptive servo-ventilation-therapy. Austria took the lead on an EU-funded market surveillance project. Within this Joint Action it will be checked and reviewed if the manufacturers provide the required accompanying information for medical devices intended to be re-used / re-sterilized. This will be done on large scale by 13 member states representing more than 50% of the union s population. Increase of incoming reports and data over time Fig. 30 Increase of incoming reports and data over time incidents market surveillance inspections FSCA FSC Applications enquiries total 58

59 Blood and Tissue The area of expertise includes inspections according to the tissue safety act and blood safety act, as well as receipt and evaluation of haemovigilance and tissue vigilance notifications and determination/surveillance of necessary measures within Austria and the EU network. E Despite the ever increasing workload in routine vigilance and inspection activities, BASG/AGES MEA could again position their experts in the relevant European expert network in order to facilitate further harmonization and information exchange. The EU joint action project Vigilance and Inspection for the Safety of Transfusion, Assisted Reproduction and Transplantation VISTART, where BASG/AGES MEA participates as active partner in 2 inidvidual work packages, entered into the operative project phase in Inspections In 2015, a total of 15 applications according to the tissue safety act, and 4 applications according to the blood safety act were processed by BASG/ AGES. In addition, 84 routine (periodical) inspections according to the tissue safety act, and 19 routine (periodical) inspections according to the blood safety act were carried out by expert inspectors. Haemovigilance In 2015, a total of 535 haemovigilance reports were received and assessed by BASG/AGES. Of those, 60 were serious adverse transfusion reactions, 50 were serious adverse reactions during donation, 11 were serious adverse events during manufacturing (product defects) and 22 were near-miss events. 59

60 Furthermore, the annual haemovigilance report as well as the activity report on blood establishments were accumulated and was published according to applicable national regulations. Tissue Vigilance In 2015, a total of 307 tissue vigilance reports has been received and assessed by BASG/AGES. Of those, 7 were serious adverse reactions and 10 were serious adverse events related to procurement or application of human tissues or cells. Furthermore, out of 78 reports according to 16 of the tissue safety act, the annual activity reports on tissue establishments was accumulated and published accordingly. 60

61 61 E

62 62

63 1 Austrian Medicines and Medical Devices Agency (AGES) E 2 Services of the Federal Office for Safety in Health Care / Austrian Medicines and Medical Devices Agency 3 Organisation 4 Annual closure 5 Attachment 63

64 Organisation Federal Office for Safety in Health Care BASG Austrian Agency for Health and Food Safety (AGES) Wolfgang Hermann Austrian Medicines and Medical Devices Agency (MEA) Christa Wirthumer-Hoche Bureau of the Austrian Federal Office for Safety in Health Care (BBSG) Thomas Reichhart Scientific Office (SCIO) Andrea Laslop Quality Management (QMGT) Klaus Stüwe Business Development (GFEV) Arnold Herzog Institute Marketing Authorisation of Medicinal Products & Lifecycle Management (LCM) Peter Platzer Institute Assessment & Analytics (BGA) Gerhard Beck Institute Surveillance (INS) Ronald Bauer Regulatory Affairs Alexander Ertl Analytics of Biological Medicinal Products (BAMA) Heidemarie Schindl Good Manufacturing Practice (GMDP) Andreas Kraßnigg Medical Assessment (MRAT) Ingeborg Gerngroß Analytics of Chemical-pharmaceutical Medicinal Products (CPAA) Roman Macas Clinical Trials (CLTR) Ilona Reischl Quality Assessment Medicinal Products (QUAL) Susanne Stotter Clinical Assessment of Safety & Efficacy (CASE) Barbara Tucek Medical Devices Market Surveillance ((MDVI) Reinhard Berger Herbal, Homeopathic & Veterinary Medicinal Products (HEVE) Reinhard Länger Biologicals, Preclinical & Statistical Assessment & Centralised Procedures of Veterinary Medicinal Products (BPSV) Barbara Zemann Blood, Tissue & Vigilance (BTVI) Verena Plattner Assessment Pharmacovigilance (APHV) Barbara Tucek 64

65 E BASG - Federal Office for Safety in Health Care The BASG consists of three members: BASG - Federal Office for Safety in Health Care Chair SL Priv. Doz. Dr. Pamela Rendi-Wagner, MSc, DTM&H Procedural Member Dipl.-Ing. Dr. Christa Wirthumer-Hoche Member Dr. Michael Behounek 1. Alternate Member Dr. Silvia Türk 1. Alternate Member Mag. Thomas Reichhart 1.Alternate Member Dr. Reinhard Berger 2. Alternate Member Dr. Robert Semp 2. Alternate Member Dipl.-Ing. Dr. Ronald Bauer 2.Alternate Member Dr. Gerhard Beck 65

66 66

67 1 Austrian Medicines and Medical Devices Agency (AGES) E 2 Services of the Federal Office for Safety in Health Care / Austrian Medicines and Medical Devices Agency 3 Organisation 4 Annual closure 5 Attachment 67

68 JAB 2015 MEA EUR EUR gross revenues tariff fees net revenues inventory change other revenues material costs personal costs other operating expenses depr./amortisation operating profit financial income EBIT extraord. profit/loss net loss for the year

69 E EUR EUR Service Payments acc. 12, 4 GESG Compensation net loss for the year Balance Charging receivable BMG

70 70