European SPC/PIL/PAR search

Pharmaceutical companies can choose any one of the below three marketing authorization (MA) procedures to obtain MA in the countries of interest:

·         Centralized Procedure (CP)

·         Mutual Recognition Procedure (MRP)

·         Decentralized Procedure (DP)

Detail on each of these procedures is available here.

For marketing authorizations obtained through centralized procedure, Refer European Medicine Agency (EMA)’s website.

 

Important links for Centralized procedure:

EMA: Patient Information Leaflet (PIL), Summary of Product Characteristics (SPC) and European public assessment reports	Europe PIL/SPC search   European public assessment reports
Union register of medicinal products (To check market exclusivity, orphan rug exclusivity, date of entry in register etc.)	Link

 

Link for Mutual Recognition and Decentralized procedure:

MRI Product Index (contains PIL, SPC and PAR of products approved through MRP or DP): Link

Links of individual countries of European Union:

COUNTRY	LABEL (PIL)	PUBLIC ASSESSMENT REPORT (PAR)	COMMENT
Austria	Austria PIL search
Belgium	Belgium PIL search
Bulgaria	Bulgaria PIL search
Croatia	Croatia PIL search
Cyprus	Cyprus PIL search
Czech Republic	Czech Republic PIL search
Denmark	Denmark PIL search
Estonia	Estonia PIL search
Finland	Finland PIL search
France	France PIL search	France Public assessment reports	Public Assessment report (PAR) available only for the selected products
Germany	Germany PIL search	Germany Public assessment reports	Public Assessment report (PAR) available only for the selected products
Greece	Greece PIL search
Hungary	Hungary PIL search
Iceland	Iceland PIL search
Ireland	Ireland PIL search	Ireland Public assessment reports	Public Assessment report (PAR) available only for the selected products
Italy	Italy PIL search
Latvia	Latvia PIL search
Lithuania	Lithuania PIL search
Malta	Malta PIL search
Netherlands	Netherlands PIL search	Netherlands public assessment reports	Public Assessment report (PAR) available only for the selected products
Norway	Norway PIL search
Poland	Poland PIL search
Portugal	Portugal PIL search	Portugal public assessment reports	Public Assessment report (PAR) available only for the selected products
Romania	Romania PIL search
Slovakia	Slovakia PIL search
Slovenia	Slovenia PIL search
Spain	Spain PIL search
Sweden	Sweden PIL search	Sweden public assessment reports	Public Assessment report (PAR) available only for the selected products
United Kingdom	UK PIL search	UK Public assessment reports	Public Assessment report (PAR) available only for the selected products