National drug regulatory databases (SmPC, PIL) - Europe
Public Assessment Reports

Explanatory note: ATC = database allows search according to ATC classification. Rx/OTC = database allows search according to Rx/OTC.

Seeking registration status of one medicine/active substance in more countries at the same time?

Selected CEE countries

  • Czech Republic SPC/PIL yes, Rx/OTC yes, ATC yes. Drug reimbursement info here in the database of Czech Ministry of Health. 

  • Czech Republic - AISLP (commercial database, less comprehensive)

  • Slovakia SPC/PIL yes, Rx/OTC yes, ATC yes. Slovak database of food supplements here.

  • Poland SPC/PIL no, Rx/OTC yes, ATC no. Monthly update here (pdf download with 5-years retrospect)

  • Hungary SPC/PIL yes, Rx/OTC yes, ATC yes

  • Romania SPC/PIL ne, Rx/OTC ?, ATC yes

  • Bulgaria - SPC here, PIL here, Rx/OTC ne, ATC yes

  • Lithuania - SPC/PIL yes, Rx/OTC v, ATC yes

  • Latvia - SPC/PIL yes, Rx/OTC yes, ATC yes

  • Estonia - SPC/PIL yes, Rx/OTC yes, ATC yes

  • Slovenia - only list of registred drugs in pfd for download. SPC/PIL no, Rx/OTC no. Here is the list og OTC drugs approved within 5 last months (updated). Slovenian drug database (login).

  • Croatia - drug database at Croation DRA website

  • Serbia - list of approved medicinal products

  • Serbia - drug database at Serbian DRA website

  • Ukraine - drug compendium

  • Russia - Database of medicines approved in Russia - Vidal (subscription only)

Western EU countries

  • Germany - Fachinformation or Summary of Product Characteristics and Package Leaflet, Public Assessment Reports (for medicines registered via NP or where BfArM is RMS). For detailed overview see German drug databases list.

  • Austria - SPC/PIL yes, Rx/OTC no, ATC no

  • Switzerland (not EU!). See German databases in left menu. Lists of drugs registred in CH also here.

  • UK compendium eMC: SPC/PIL yes, Rx/OTC yes, ATC no. eMC files in UK - registred drugs also all Variations. 

  • UK - MHRA files UKPARs - Public Assessment Reports of all drugs registred since approx. 2006. 

  • Ireland SPC/PIL yes, Rx/OTC yes, ATC no

  • France - search according active substance (Substance active, contenant, OK = check of French medical nomenclature). Rx/OTC is listed. SPC download by click at RCP in left coumn. PIL = clik at Notice. Here is a a downolad of list of French OTC drugs (Prescription Medical Facultatif). Several French Public Assessment Reports are available here. (But not for all drugs)

  • Spain SPC/PIL yes, Rx/OTC ne, ATC no

  • Portugal - SPC/PIL yes, Rx/OTC no, ATC no. Includes Public Assessment Reports of (several) medicines.

  • Belgium - SPC/PIL ?, Rx/OTC yes. ATC search in Belgium here.

  • Netherlands - SPC/PIL yes, Rx/OTC yes, ATC no. Several Public Assessment Reports - here.

  • Luxemburg - ?

  • Norway - SPC/PIL yes, Rx/OTC yes, ATC yes. Public assessment reports here.

  • Sweden - SPC/PIL yes, Rx/OTC yes, ATC yes. Public assessment reports here.

  • Finland - SPC/PIL yes, Rx/OTC yes, ATC yes

  • Denmark - SPC yes, PIL no, Rx/OTC yes, ATC no. There is no possibility of search according active substance in Danish regulatory database. FAQ here.

  • Island SPC/PIL yes, Rx/OTC ?, ATC yes - but limited. There is no possibility of search according active substance.

  • Greece - ?

  • Italy - Salus Compendium; SPC/PIL no (only short information),  only simple search according to drug name or substance name in Italian. No regular national database of registered medicines. Several SmPC might be here, or try Google - with "Riassunto delle Caratteristiche del Prodotto" phrase.

  • Malta - SPC/PIL yes, Rx/OTC no, ATC yes. English texts.