Ministry of Health
Central Administration for
Pharmaceutical Affairs
Registration Department
Code No. FM-RHD-09-00001
List of references
Kindly find below (version 1 - dated 11-10-2015) for the guidance list of reference
countries to be used in checking the reference of your product submitted for new
request inquiry form acc. To ministerial decree 425/2015
Name of
regulatory Online drug database
authority
curl=/pages/medicines/landing/ep
EMEA ar_search.jsp&murl=menus/medicines/medicines.jsp&mid=WC
0b01ac058001 d125
FDA http://www.accessdata.fda.gov/scripts/cder/drugsatfda/
Orange Book http://www.accessdata.fda.gov/scripts/cder/ob/docs/queryai.cfm
TGA https://www.ebs.tga.gov.au/ebs/ANZTPAR/PublicWeb.nsf/cuMedi
(Australia) cines?Open
View
http://www.mhra.gov.uk/spc-pil/?prodName=ADULT
MELTUS CHESTY COUGHS SUGAR /// COLOUR
MHRA (UK) FREE&subsName=&pageID=ThirdLevel&searchTerm=ad
ult meltus#retainDisplayA
Health Canada lang=eng
http://www.pmda.go.jp/english/review-
PMDA (Japan) services/reviews/approved-
information/drugs/0002.html
http://www.hpra.ie/homepage/medicines/medicines-
IMB (Ireland) information/fnd-a- medicine/results?query=&field=
https://farmaci.agenziafarmaco.gov.it/bancadatifarmaci/farmaco
Italy ?farmaco=03
620 1
Germany system/index.html
France http://agence-prd.ansm.sante.fr/php/ecodex/index.php
Tel.: +202 23684288 +202 23640368 +202 23640368 Ext.:310 Fax: +202 - 23684194
Website: http://eda.mohp.gov.eg Email: [email protected]
Swissmedic
http://swissmedinfo.oddb.org/
(Switzerland)
Spain metodo=detalleForm
http://www.lakemedelsverket.se/Sok-efter-lakemedel-och-mediciner-i-
Sweden
Lakemedelsfakta/
Belgium http://www.fagg-afmps.be/fr/items/banque_donnees/
https://aspregister.basg.gv.at/aspregister/faces/aspregister.jspx?
Austria _afrLoop=12
state=1ws96ccp4_4
Denmark http://xnet.dkma.dk/indlaegsseddel/leafets/leafets.faces
Finland http://www.fimea.fi/medicines/fimeaweb
Iceland http://serlyfjaskra.is/
http://www.cbg-meb.nl/CBG/en/human-
Netherlands medicines/geneesmiddeleninformatiebank/d
efault.htm
New Zealand http://www.medsafe.govt.nz/regulatory/DbSearch.asp
http://www.legemiddelverket.no/custom/Preparatsok/prepSearch
Norway 80333.
aspx
Portugal http://www.infarmed.pt/infomed/inicio.php
Other Authorized References
BNF (Last
-----------------
Edition)
PDR
http://www.pdr.net/
online
Kindly note the following:
You have to follow this list of references for submission of request inquiries
form acc. To ministerial Dec. 425/2015.
The submitted request inquiry form should be matched to the Reference (the
same Active ingredient, Strength, Dosage Form, Route of administration)
otherwise it will be considered as no reference.
The submitted reference product should be valid (i.e. registered & marketed)
Any modification on this list will be announced.
