NBOG National Contact Points
In order to encourage better communication Member States established a communication protocol (see ANNEX 1 to Section 2 of the Designating Authorities Handbook) and national contact points.
The aims of the communication protocol are to encourage examples of possible poor performance to be passed to the appropriate Member State/Designating Authority for investigation.
In addition, the named individuals listed below can be used as a contact point by anyone wishing to obtain information on designation and control of Notified Bodies in individual countries.
Austria | Bundesministerium für Gesundheit, Familie und Jugend |
Belgium | Federal Agency for Medicines and Health Products |
Bulgaria | State Agency for Metrological and Technical Surveillance "Designation of Conformity Assessment Bodies" Directorate 21."6-th Septemvri",Str. BG-1000 Sofia Ms Mariana Tsaneva e-mail comfass@mail.orbitel.bg Fax +359-2-986-17-07 Phone +359-2-981-00-89 URL |
Cyprus | Cyprus medical Devices Competent Authority |
Czech Republic | Czech Office for Standards, Metrology and Testing |
Denmark | Ministry of Interior and Health Slotsholmsgade 10-12 DK-1216 Copenhagen K Mr Taruh Sekeroglu e-mail tse@sum.dk Fax +45-7226-9001 Phone +45-7226-9000 URL http://www.sum.dk |
Estonia | Health Board |
Finland | National Agency for Medicines Inspectorate Mannerheimintie 103b SF-00301 Helsinki Mr Hannu Seitsonen e-mail hannu.seitsonen@nam.fi Fax +358-9-4733-4266 Phone +358-9-4733-4249 URL http://www.nam.fi |
France | Agence francaise de Sécurité Sanitaire des Produits de santé 143-147 Bd Anatole France F-93285 Saint-Denis cedex Mr Francois Bruneaux e-mail francois.bruneaux@afssaps.sante.fr Fax +33-1-5587-4052 Phone +33-1-5587-40-06 URL http://www.afssaps.sante.fr |
Germany | Zentralstelle der Länder für Gesundheitsschutz bei Arzneimitteln und Medizinprodukten Abteilung Medizinprodukte Sebastianstrasse 189 D-53115 Bonn Mr Dr. Rainer Edelhäuser e-mail rainer.edelhaeuser@zlg.nrw.de Fax +49-228-97794-44 Phone +49-228-97794-12 URL http://www.zlg.de |
Greece | Minister of Health and Social Solidarity National Organisation of Medicines Head, Evaluation Division 284 Mesoghion Ave GR-15562 Holargos Ms Dr. Vasiliki Revithi e-mail vrevithi@eof.gr Fax +30-2132040450 Phone +30-2132040407 URL http://www.eof.gr |
Hungary | Office of Health Authorisation and Administrative Procedures Authority for Medical Devices Zrinyi u.3. H-1051 Budapest Mr György Ferenc Balázs e-mail balazs.gyorgy@eekh.hu Fax +36-1-269-1255 Phone +36-1-302-5060 URL http://www.eekh.hu |
Iceland | Directorate of Health |
Ireland | Irish Medicines Board |
Italy | Ministry of Health |
Latvia | Medical Devices Board for Latvia |
Liechtenstein | The Government of Liechtenstein |
Lithuania | State Health Care Accrediation Agency |
Luxembourg | Ministère de la Santé |
Malta | Regulatory Affairs Directorate Malta Standards Authority Second Floor Evans Building Merchants Street M-Valletta VLT 1179 Mr David Pulis e-mail david.pulis@msa.org.mt Fax +356-21242-406 Phone +356-2395-2000 URL http://www.msa.org.mt |
Netherlands | The Dutch Health Care Inspectorate P.O. Box 5837 2280 HV Rijswijk Mr L. W. Meinders e-Mail loket@igz.nl Fax +31-70-3723110 Phone +31-70-3723166 URL http://www.igz.nl |
Norway | Directorate of Health |
Poland | Ministry of Health |
Portugal | INFARMED, I.P. National Authority of Medicines and Health Products Paryue de Saude de Lisboa Av. do Brazil, no 53 P-1749-004 Lisboa Ms Judite Neves e-mail judite.neves@infarmed.pt Fax +351-21-79872-81 Phone +351-21-79872-35 URL http://www.infarmed.pt |
Romania | Ministry of Health 1-3 Cristian Popisteanu ST. Sector 1 R-010024 Bucharest Ms Ana Maria Tanase e-mail atanase@ms.ro Fax +40-21-307-2585 Phone +40-21-307-2581 URL http://www.ms.ro |
Slovak Republic | Slovak Office of Standards, Metrology and Testing |
Slovenia | Agency for Medial Products and Medial Devices of the Republic of Slovenia Ptujska ulica 21 SLO-1000 Ljublijana Ms Dr Petra Marinko e-mail meddev@jazmp.si Fax +386-82000-557 Phone +386-82000-500 URL http://www.jazmp.si |
Spain | Ministerio de sanidad y consumo Agencia Española de Medicamentos y Productos Sanitarios Parque Empresarial Las Mercedes Edificio 8.C/ Campezo 1. E-28022 Madrid Ms Carmen Abad e-mail sgps@agemed.es Fax +34-91-82252-89 Phone +34-91-82252-61 URL http://www.agemed.es |
Sweden | SWEDAC Styrelsen för ackreditering och teknisk kontroll Swedish Board for Accreditation and Conformity Assesment Box 2231 S-10315 Stockholm Mr Anders Hallberg e-mail anders.hallberg@swedac.se Fax +46-8-791-8929 Phone +46-8-406-8338 URL http://www.swedac.se |
Switzerland | Swissmedic, Schweizerisches Heilmittelinstitut Swiss Agency for Therapeutic Products Marktkontrolle Hallerstraße 7 CH-3000 Bern 9 Mr Peter Studer e-mail peter.studer@swissmedic.ch Fax +41-31-322-7646 Phone +41-31-322-9457 URL http://www.swissmedic.ch |
United Kingdom | Medicines and Healthcare Products Regulatory Agency 1 Nine Elms Lane UK- London SW8 5NQ Mr Rob Higgins e-mail rob.higgins@mhra.gsi.gov.uk Fax +44-207-084-3112 Phone +44-207-084-3185 URL http://www.mhra.gov.uk |