Guidelines Competent Authorities 2.12-1 June 2001
of 3
Transcript of Guidelines Competent Authorities 2.12-1 June 2001
-
8/8/2019 Guidelines Competent Authorities 2.12-1 June 2001
1/3
11
MMEEDDDDEEVV 22..1122--11 rreevv 44 --APPENDIX 1LIST OF VIGILANCE CONTACT POINTS WITHIN THE COMPETENT AUTHORITIES (June 2001)
update : 23.07.2001 JJuullyy 22000011
COUNTRIES NAMES E-mail/ Web site ADDRESSES PHONE FAX
AUSTRIA
Federal Ministry ofSocial Security and
Generations
AIMD
MDD
Dr. W Ecker
Dr. Renhardt
ng. Gutruf
Abt. VIII/A/22- Medical Devices/MedizinprodukteRadetzkystrasse 2A-1031 Vienna
+43 1 71100 4206 or 4487or 4492
+43 1 71100 4217
or 43 1 715 73 12
AIMD
MDD
Mr. P. BauwinMrs. Mignon
Vesalius Building Rijksadministratief CentrumB- 1010 Brussels
32/2/210.63.58 32/2/210.49.01BELGIUM
The Ministry of Health,
PharmaceuticalInspectorate, Medical
Devices Vigilance
IVD Dr. JL Libeer [email protected]
Institut Scientifique de la Sant Publique Louis PasteurRue Juliette Wytsman 141050 Bruxelles
+32 2 642 55 27 +32 2 642 56 45
DENMARKDanish Medicines
Agency
Mr H-KAndersen
[email protected] Frederikssundsvej 378DK- 2700 Brnshj
+45/44/889.111+45/44/889.265 (direct line)
+45/44/889.195
IVDMDD
AIMD
Mr PetriPommelin
+358/9/4733-4249 +358/9/4733-4266
IVD Dr JarkkoIhalainen
[email protected] +358-9-4733 42 64
FINLAND
Medical Devices CentreNational Agency forMedicines
MDDAIMD
Mr HarrySievnen
Mannerheimintie 166 PO Box 55
FIN- 00301 Helsinki
+358-9-4733 41
FRANCEAgence Franaise deScurit Sanitaire des
Produits de Sant
MDDIVD
Dr J-C Ghislain [email protected]
http://afssaps.sante.fr
AFSSAPS143 / 147 Boulevard Anatole FranceF-93285 Saint - Denis Cedex
+33 1 55 87 37 47 +33 1 55 87 37 42
AIMDMDD
Dr. E. Stlein [email protected] Geschftsstelle Medizinprodukte (BfArM)Friedrich-Ebert-Allee 38D-53113 Bonn
+49/228/207.53.84+49 228 207 53 60
+49/228/207.53.00+49 228 207 53 00GEMANY
Bundesinstitut frArzneimittel und Medizin-
produkte IVD Dr. R. Siekmeir [email protected] certain products (most Annex II products): Paul-Ehrlich-Institute (PEI)Paul-Ehrlich-Strasse 51-5963225 Langen in Hessen
+49 6103 77 33 04 +49 6103 77 12 65
GREECEMinistry of Health,Welfare and Social
Dr. G.P.Demagos
Services National Organization for Medicines
284 Messogion Avenue15562 Holargos Attikis
+30/1/65 07 380 +30/1/65 49 585
mailto:[email protected] -
8/8/2019 Guidelines Competent Authorities 2.12-1 June 2001
2/3
22
Ms. S. PhelanMr. A. Ryan
Hawkins HouseIRL-Dublin 2
+353/1/675.41.77+353/1/675.41.78
+353/1/635.43.74IRELAND
Department of Healthand Children IVD Ms Ann
O'Connor
Irish Competent Authority for IVD's
ICELAND
Ministry of Health andSocial Service
Mrs. VilborgIngolfsdottir
vilborg@landlaeknir Laugavegur 116IS- 150 Reykjavik
+35/45/609.700 +35/45/519.165
Dottissa M.Marletta
Department II - P. le Industria 20I-00144 ROMA
+39/6/5994.2423 +39/6/5994.2111ITALY
Ministry of Health IVD DDrr..ssssaa MMiirreellllaa
CCoolleellllaaDipartimento per la Valutazione dei Medicinalie laFarmacovigilanza Ufficio IX,Via della CiviltaRomana,7I-00144 Roma
+39 06 59 94 37 22 +39 6 59 94 32 85
LUXEMBOURGMinistre de la SantDirection de la Sant
Dr. G Scharll [email protected] Villa Louvigny - Alle Marconi
L-2120 Luxembourg
+352/478.56.34 +352/262.03.296
NETHERLANDSHealth Care Inspectorate
IVDMDD
Mr. J. Moleveld [email protected] Cluster Medical TechnologyPO Box 16119NL-2500 BC Den Haag
+31/70/340.74.36 +31/70/340.71.59
Mrs. I Hagerup [email protected]
PO Box 8128 Dep.N- 0032 Oslo
+ 47/22/24.89.53+47/22/24.89.40
+ 47/22/249.017NORWAY
National Board of Health Mrs. Tove
Farstad
http://www.helsetilsynet.no/
Medical Device Unit
Calmeyersgate 1PoB 8128 Dep.N - 032 OSLO
+47-22 24 89 42
+47-22 24 89 88
+47-22 24 90 17
MDDIVD
Dr. H.M. RibeiroCosta
[email protected]@[email protected]
Parque de Sade de Lisboa;Av. do Brasil, 53P-1749 - 004 Lisboa
+351/21/798 71 79+351/21/798 71 51+351/21/798 71 45
+351/21/798 71 55PORTUGAL
Centro Nacional deFarmacogivilncia do
INFARMEDAIMD
Mr Faria-Gomes Av. Padre CruzP-1699 Lisboa Codex
+351/1/757.35.57 +351/1/757.36.71
SPAINMinisterio de Sanidad y
Consumo
Mrs. C. AbadLunaMrs. C. Valls
[email protected]+ [email protected] Direccin General de Farmacia y Productos SanitariosPaseo del Prado 18/20E-28014 Madrid
+34/91/596.43.48 +34/91/ 596 44 00
Dr M Soop [email protected] Division of Medical DevicesS- 106 30 Stockholm
+46/8/55.55.33.28 +46/8/55.55.32.94SWEDEN
The National Board ofHealth and Welfare Mr Lars
www.sos.seSOCIALSTYRELSENvisit Rlambsvgen 3Mail SE-106 30 STOCKHOLM
08-5555 530 00+46-8-555 530 00dir.+46-8-555-532 16
+46-8-555 532 94
mailto:[email protected]:[email protected]://www.helsetilsynet.no/ -
8/8/2019 Guidelines Competent Authorities 2.12-1 June 2001
3/3
33
SWITZERLANDOffice fdral de la Sant
Publique
Mr A Sparti [email protected] Medical Devices Unit, VigilanceCH-3003 Bern
+41/31/322.98.03+41 31 323 22 51
+41/31/322.76.46
UNITED KINGDOMMedical Devices Agency
Mr A. Sant [email protected] Adverse Incident CenterHannibal House, Elephant and CastleUK-London SE1 6TQ
+44/171/972.80.80 +44/171/972.81.09
