Europa - Enterprise - Medical Devices - List of vigilance Competent Authorities

Shortcuts	AUSTRIA - BELGIUM - BULGARIA - CYPRUS - CZECH REPUBLIC - DENMARK - FINLAND - FRANCE - GERMANY - GREECE - HUNGARY - ICELAND - IRELAND - ITALY - LATVIA - LITHUANIA - LUXEMBOURG - MALTA - NETHERLANDS - NORWAY - POLAND - PORTUGAL - ROMANIA - SLOVENIA - SLOVAKIA - SPAIN - SWEDEN - SWITZERLAND - UNITED KINGDOM

Country and name	Dir.	Contact person	E-mail/ Web site	Address	Phone/Fax

AUSTRIA Federal Ministry of Health and Women	AIMD MDD IVD	Dr. Wolfgang Ecker DI Dr. Martin Renhardt Ing. Andreas Gutruf	devigi@bmgf.gv.at www.bmgf.gv.at	Medical Device Dept. Radetzkystrasse 2; A-1030 Vienna Austria	Ph : +43 1 71100 4206 or +43 1 71100 4487 or +43 1 71100 4602 (Secretariat)
					Fax : +43 1 71100 4217

BELGIUM Federal Public Service Health, Food Chain Safety and Environment. Directorate General Public Health Protection : Medicinal Products Medical Devices Unit	AIMD MDD	Mr. P. Bauwin Mrs. S. Mignon	meddev@afigp.fgov.be www.afigp.fgov.be	Vesalius Building – Rijksadministratief Centrum B- 1010 Brussels	Ph : +32-2 210.63.58
					Fax : +32-2 210.49.01
BELGIUM Institut Scientifique de Santé Publique	IVD	Dr. JL Libeer	Jean-Claude.Libeer@ipf.fgov.be	Louis Pasteur Rue Juliette Wytsman 14 1050 Bruxelles	Ph : +32-2 642 55 27
					Fax : +32-2 642 56 45

BULGARIA (Candidate)

CYPRUS (Candidate)

CZECH REPUBLIC (Candidate)

DENMARK Danish Medicines Agency	AIMD MDD IVD	Mr H-K Andersen	hka@dkma.dk	Danish Medicines Agency Axel Heides Gade 1 DK-2300 København S Denmark	Ph : +45-4488 9111 Ph : +45-4488 9265
					Fax : +45-4488 9314

ESTONIA (Candidate)

FINLAND Medical Devices Centre National Agency for Medicines	AIMD	Mr Petri Pommelin	petri.pommelin@nam.fi	Mannerheimintie 166 – PO Box 55 FIN- 00301 Helsinki	Ph : +358-9-4733 4241 Fax : +358-9 4733 4266
	IVD	Dr Kimmo Linnavuori	kimmo.linnavuori@nam.fi		Ph : +358-9 4733 4264 Fax : +358-9-4733 4266
	MDD	Mr Petri Pommelin	petri.pommelin@nam.fi		Ph : +358-9-4733 4241 Fax : +358-9 4733 4266

FRANCE Agence Française de Sécurité Sanitaire des Produits de Santé	MDD IVD	Dr J-C Ghislain	jean-claude.ghislain@afssaps.sante.fr www.afssaps.sante.fr	AFSSAPS 143 / 147 Boulevard Anatole France F-93285 Saint - Denis Cedex	Ph: +33 1 55 87 37 47
					Fax: +33 1 55 87 37 42

GERMANY Bundesinstitut für Arzneimittel und Medizin-produkte	AIMD MDD	Dr. E. Stößlein	e.stoesslein@bfarm.de	Geschäftsstelle Medizinprodukte (BfArM) Friedrich-Ebert-Allee 38 D-53113 Bonn	Ph : +49-228 207.53.84 Fax:+49-228 207.53.00
					Ph : +49-228 207 53 60 Fax : +49-228 207 53 00
	IVD^a)	Dr. R. Siekmeir	r.siekmeir@bfarm.de ^a) (ex most Annex II devices)
		Dr. J.Halbauer	s-ivd@pei.de	Paul-Ehrlich-Institute (PEI) Paul-Ehrlich-Strasse 51-59 63225 Langen	Ph : +49- 6103 77 7000 or 49- 6103 77 3114 Fax : +49- 6103 77 1268

GREECE Ministry of Health, Welfare and Social	AIMD MDD IVD	Dr. G.P. Demagos	Nihil	Services National Organization for Medicines 284 Messogion Avenue 15562 Holargos Attikis	Ph : +30- 1 65 07 380
					Fax : +30-1 65 49 585

HUNGARY (Candidate)

ICELAND (EFTA) Ministry of Health and Social Service	AIMD MDD IVD	Mrs. Vilborg Ingolfsdottir	vilborg@landlaeknir	Laugavegur 116 IS- 150 Reykjavik	Ph : +35-45 609.700
					Fax : +35-45 519.165

IRELAND Irish Medicines Board	AIMD MDD IVD		medicaldevices@imb.ie www.imb.ie	Irish Medicines Board Earlsfort Centre Earlsfort Terrace Dublin 2 Ireland	Ph.: +353-1-676.49.71
					Fax : +353-1-676 78 36

ITALY Ministry of Health	AIMD MDD	Dr. M. Marletta	Nihil	Dipartimento II Piazza Industria, 20 I-00144 ROMA	Ph : +39-6 59 94.2423
					Fax : +39-6 59 94.2111
	IVD	Dr. Mirella Colella	Nihil	Dipartimento per la Valutazione dei Medicinali Farmacovigilanza Ufficio IX, Via della Civiltà Romana ,7 I-00144 Roma	Ph : +39-06 59 94 37 22
					Fax : +39-6 59 94 32 85

LATVIA (Candidate)

LITHUANIA (Candidate)

LUXEMBOURG Ministère de la Santé. Direction de la Santé	Dr. G Scharll		gerard.scharll@ms.etat.lu	Villa Louvigny - Allée Marconi L-2120 Luxembourg	Ph : + 352- 478 56 34
					Fax : +352-262 03296

MALTA (Candidate)

NETHERLANDS Health Care Inspectorate	AIMD MDD	Mr. J. Moleveld	medtech.higz@igz.nl	Cluster Medical Technology PO Box 16119 NL-2500 BC Den Haag	Ph : +31-70 340 74 36
					Fax : +31-70 340 71 59
	IVD	Ms L.M. de Vries	medtech.higz@igz.nl igz.nl	Healthcare Inspectorate Postal address : Parnassusplein 5, 2511 VX The Hague Visitors address : P.O. Box 16119, 2500 BC The Hague	Ph. : +31 70 340 7118
					Fax : +31 70 340 7159

NORWAY (EFTA) Norwegian Directorate for Health and Social Welfare	AIMD MDD	Mrs. I. Hagerup-Jenssen	ingeborg.hagerup-jenssen@shdir.no	PO Box 8054 Dep. N-0031 Oslo	Ph : +47-24 16 31 76 Fax : +47-24 16 30 21
		Mrs. Tove Farstad	tove.farstad@shdir.no		Ph : +47-24 16 31 72 Fax : +47-24 16 30 21
	IVD	Mrs. S. Dyrnes	sissel.dyrnes@shdir.no		Ph : +47-24 17 31 67 Fax : +47-24 16 30 21

POLAND (Candidate)

PORTUGAL Direcção Operacional de Farmacogivilância e Segurança de Medicamentos e Produtos de Saúde do INFARMED	MDD IVD	Mr.Miguel Antunes	miguel.antunes@infarmed.pt adriana.gamboa@infarmed.pt dvps@infarmed.pt	Parque de Saúde de Lisboa; Av. do Brasil, 53, Pav. 24 1749 - 004 Lisboa	Ph : +351-21 798 71 79 Ph : +351-21 798 71 51 Ph : +351-21 798 71 45 Fax : +351-21 798 71 55
Instituto Nacional de Saúde (INSA) Dr. Ricardo Jorge	AIMD	Dr João Lavinha	Nihil	Av. Padre Cruz P-1649-016 Lisboa Codex	Ph : +351-21-751 92 00 Fax : +351-21-752 64 00

ROMANIA (Candidate)

SLOVENIA (Candidate)

SLOVAKIA (Candidate)

SPAIN Ministerio de Sanidad y Consumo	AIMD MDD IVD	Mrs. C. Valls	cvalls@msc.es	Agencia Española del Medicamento y Productos Sanitarios Subdirección General de Productos Sanitarios Paseo del Prado 18-20 E-28014 Madrid	Ph: +34-91 596 43 48 Fax : +34-91 596 44 00
					Ph : +34-91 596 43 48 Fax : +34-91 596 44 00

SWEDEN MPA - Medical Products Agency 'Läkemedelsverket'	AIMD MDD IVD	Mr Lennart Philipson Mr Lars Johansson	www.mpa.se/eng/index.shtml lennart. philipson@mpa.se lars.johansson@mpa.se	Box 26, SE - 751 03 UPPSALA	Ph : +46-18 17 46 00
					Fax : +46-18 50 31 15

SWITZERLAND (EFTA) Swissmedic Swiss Agency for Therapeutic Products	AIMD MDD IVD	Mr A Sparti	medical.devices@swissmedic.ch	Medical Devices Division Erlachstrasse 8 CH-3000 Bern 9	Ph : +41-31 323 22 51
					Fax : +41-31 322 76 46

UNITED KINGDOM Medicines and Healthcare products Regulatory Agency	AIMD MDD IVD	Mr A. Sant	aic@mhra.gsi.gov.uk	MHRA Adverse Incident Center Hannibal House, Elephant and Castle UK-London SE1 6TQ	Ph : +44 (0) 20 7972 8080 (for any general enquiries on notification)
					Fax : +44 (0) 20 7972 8109

List of vigilance contact points within the National/Competent Authorities