EMA Medicines Database Scraper

Search and export the European Medicines Agency's (EMA) public regulatory data — the full Medicines Database of centrally authorised human and veterinary medicines, orphan drug designations, herbal medicine monographs, referral procedures, medicine shortages, paediatric investigation plans (PIPs), veterinary maximum residue limits (MRLs), Direct Healthcare Professional Communications (DHPCs), scientific opinions for use outside the EU, periodic safety update report single assessments (PSUSA), and post-authorisation procedures. No login, no API key, no cookies required.

What this actor does

EMA publishes each of its public datasets as a regularly refreshed data export. This actor downloads the dataset you select, applies your search query and filters, and returns clean, structured JSON — ready for pharmacovigilance research, market access analysis, regulatory tracking, academic research, or building a medicines lookup tool.

• 11 datasets in one actor — switch between them with the mode field
• Free-text search across medicine name, active substance, INN, and ATC codes
• Rich filters — regulatory status, human/veterinary category, therapeutic area, and 10+ medicine attribute flags (orphan, biosimilar, generic, accelerated assessment, etc.)
• Full field coverage — every reliably extractable column from each EMA dataset, not just the headline fields
• Empty fields are omitted — you never see null, "", or [] in the output

Datasets (mode)

Mode	What it contains	Approx. size
medicines (default)	Centrally authorised human + veterinary medicines: status, active substance, therapeutic area, ATC codes, authorisation dates, and regulatory flags	~2,700 medicines
orphanDesignations	EU orphan drug designations: active substance, intended use, EU designation number, designation status	~3,300 designations
herbalMedicines	EU herbal monograph assessments: Latin/English/botanical name, therapeutic area, assessment status	~250 monographs
referrals	EU referral procedures (human + veterinary): referral name, INN, current status, safety-referral flag	~600 referrals
shortages	Ongoing and resolved EU medicine shortages: medicine name, INN, therapeutic area, shortage status, alternatives	~80 shortages
paediatricInvestigationPlans	Paediatric Investigation Plans (PIPs): active substance, PIP number, decision type/date, condition	~3,300 PIPs
maximumResidueLimits	Veterinary Maximum Residue Limits (MRLs): active substance, target species, MRL classification, regulation reference	~500 MRL entries
dhpc	Direct Healthcare Professional Communications: medicine name, DHPC type, regulatory outcome, therapeutic area	~170 DHPCs
opinionsOutsideEu	EMA scientific opinions on medicines intended solely for markets outside the EU: medicine name, opinion status, indication	~25 opinions
periodicSafetyUpdateReports	Periodic Safety Update Report single assessments (PSUSA): active substance(s) in scope, related medicines, regulatory outcome	~2,700 procedures
postAuthorisationProcedures	Post-authorisation variations and procedures for authorised medicines: procedure status, opinion status, opinion/authorisation dates	~150 procedures

Output fields

medicines

category, name, emaProductNumber, medicineStatus, opinionStatus, latestProcedureNumber, inn, activeSubstance, therapeuticArea[], targetSpecies[], patientSafety, atcCodeHuman, atcCodeVeterinary, pharmacotherapeuticGroupHuman, pharmacotherapeuticGroupVeterinary, therapeuticIndication, acceleratedAssessment, additionalMonitoring, advancedTherapy, biosimilar, conditionalApproval, exceptionalCircumstances, generic, orphanMedicine, primePriorityMedicine, marketingAuthorisationHolder, ecDecisionDate, rollingReviewStartDate, evaluationStartDate, opinionAdoptedDate, applicationWithdrawalDate, marketingAuthorisationDate, refusalDate, withdrawalExpiryDate, suspensionDate, revisionNumber, firstPublishedDate, lastUpdatedDate, sourceUrl, productInformationUrl

orphanDesignations

medicineName, emaProductNumber, activeSubstance, designationDate, intendedUse, euDesignationNumber, status, firstPublishedDate, lastUpdatedDate, sourceUrl

herbalMedicines

latinName, combinationHerbalMedicine, englishName, botanicalName, therapeuticArea[], assessmentStatus, assessmentOutcome, additionalInformation, dateAddedToInventory, dateAddedToPriorityList, firstPublishedDate, lastUpdatedDate, sourceUrl

referrals

category, name, inn, currentStatus, safetyReferral, referralType, associatedNamesCentrallyAuthorised[], associatedNamesNonCentrallyAuthorised[], referralClass, referenceNumber, nonPracDecisionMakingModel, pracDecisionMakingModel, authorisationModel, pracRecommendation, procedureStartDate, pracRecommendationDate, cmdhPositionDate, chmpCvmpOpinionDate, ecDecisionDate, firstPublishedDate, lastUpdatedDate, sourceUrl

shortages

category, name, shortageStatus, inn, therapeuticArea[], pharmaceuticalFormsAffected[], strengthsAffected[], availabilityOfAlternatives, shortageStartDate, expectedResolution, firstPublishedDate, lastUpdatedDate, sourceUrl

paediatricInvestigationPlans

decisionNumber, pipNumber, activeSubstance, inventedName, therapeuticArea[], pharmaceuticalForms[], condition, routesOfAdministration[], decisionType, decisionDate, complianceOutcome, complianceOpinionDate, complianceProcedureNumber, contactForPublicEnquiries, firstPublishedDate, lastUpdatedDate, sourceUrl

maximumResidueLimits

title, activeSubstance, mrlClassification[], targetSpecies[], commissionDecisionDate, regulationNumber, regulationUrl, firstPublishedDate, lastUpdatedDate, sourceUrl

dhpc

category, name, procedureNumber, activeSubstances[], dhpcType[], regulatoryOutcome, referralName, atcCodeHuman, atcCodeVeterinary, therapeuticArea[], targetSpecies[], otherRelatedMedicinesNationallyAuthorised[], disseminationDate, firstPublishedDate, lastUpdatedDate, sourceUrl

opinionsOutsideEu

name, emaOpinionNumber, opinionStatus, activeSubstance, inn, therapeuticArea[], atcCodeHuman, latestProcedureNumber, opinionHolder, pharmacotherapeuticGroupHuman, therapeuticIndication, opinionDate, outcomeDate, firstPublishedDate, lastUpdatedDate, sourceUrl

periodicSafetyUpdateReports

category, activeSubstancesInScope[], activeSubstance, procedureNumber, regulatoryOutcome, firstPublishedDate, lastUpdatedDate, sourceUrl

postAuthorisationProcedures

category, name, emaProductNumber, activeSubstance, inn, therapeuticArea[], atcCodeHuman, atcCodeVeterinary, targetSpecies[], acceleratedAssessment, additionalMonitoring, advancedTherapy, biosimilar, conditionalApproval, exceptionalCircumstances, generic, orphanMedicine, primePriorityMedicine, marketingAuthorisationHolder, postAuthorisationProcedureStatus, postAuthorisationOpinionStatus, postAuthorisationOpinionDate, applicationWithdrawalDate, marketingAuthorisationDate, firstPublishedDate, lastUpdatedDate, sourceUrl, productInformationUrl

Every record also includes recordType and scrapedAt (UTC ISO timestamp).

productInformationUrl (on medicines and postAuthorisationProcedures only) is the direct link to the medicine's official English-language Product Information PDF (summary of product characteristics, package leaflet and labelling) — sourced from EMA's separate product-information index and joined by EMA product number. It's omitted when EMA hasn't published a matching entry (e.g. very recently authorised products).

Input

Field	Type	Applies to	Description
mode	select	all	Dataset to search (see table above). Default medicines.
searchQuery	string	all	Case-insensitive substring search against name / active substance / INN fields for the selected dataset.
category	select	medicines, referrals, shortages, dhpc, postAuthorisationProcedures	all / Human / Veterinary.
therapeuticArea	string	medicines, herbalMedicines, shortages, paediatricInvestigationPlans, dhpc, postAuthorisationProcedures	Substring match against therapeutic-area tags.
medicineStatus	select	medicines	Regulatory status — 11 values (Authorised, Refused, Withdrawn, Suspended, Expired, Lapsed, Revoked, Application withdrawn, Opinion, Opinion under re-examination, Withdrawn from rolling review).
orphanMedicineOnly / biosimilarOnly / genericOnly / conditionalApprovalOnly / acceleratedAssessmentOnly / additionalMonitoringOnly / advancedTherapyOnly / exceptionalCircumstancesOnly / primePriorityMedicineOnly / patientSafetyOnly	boolean	medicines	Restrict to medicines flagged with the corresponding attribute.
orphanDesignationStatus	select	orphanDesignations	all / Positive / Negative / Withdrawn / Expired.
herbalAssessmentStatus	select	herbalMedicines	EU monograph assessment stage.
referralStatus	select	referrals	Current referral procedure status.
safetyReferralOnly	boolean	referrals	Only referrals triggered by a safety concern.
shortageStatus	select	shortages	all / Shortage ongoing / Shortage resolved / Medicine discontinued.
availabilityOfAlternatives	select	shortages	Whether alternative medicines are available.
decisionType	select	paediatricInvestigationPlans	Type of PDCO decision on the PIP.
mrlClassification	string	maximumResidueLimits	Substring match against the MRL therapeutic classification.
dhpcType	string	dhpc	Substring match against the DHPC type tag(s), e.g. Quality defect, Referral.
regulatoryOutcome	select	dhpc, periodicSafetyUpdateReports	all / Maintenance / Variation / Suspension / Revocation / Withdrawal.
opinionStatus	select	opinionsOutsideEu	all / Positive opinion / Withdrawn opinion / Withdrawn application.
postAuthorisationProcedureStatus	select	postAuthorisationProcedures	all / Opinion / Application withdrawn.
postAuthorisationOpinionStatus	select	postAuthorisationProcedures	all / Positive / Negative.
maxItems	integer	all	Hard cap on emitted records (1–5000). Default 20.

Example: search the Medicines Database

{
  "mode": "medicines",
  "searchQuery": "insulin",
  "category": "Human",
  "medicineStatus": "Authorised",
  "maxItems": 50
}

Example: orphan-designated cancer medicines

{
  "mode": "medicines",
  "therapeuticArea": "cancer",
  "orphanMedicineOnly": true,
  "maxItems": 100
}

Example: ongoing medicine shortages with no alternatives

{
  "mode": "shortages",
  "shortageStatus": "Shortage ongoing",
  "availabilityOfAlternatives": "No"
}

Example: veterinary maximum residue limits for antibiotics

{
  "mode": "maximumResidueLimits",
  "mrlClassification": "antibiotic",
  "maxItems": 100
}

Example: safety-referral DHPCs

{
  "mode": "dhpc",
  "dhpcType": "Referral",
  "maxItems": 50
}

Example: PSUSA procedures for an active substance

{
  "mode": "periodicSafetyUpdateReports",
  "searchQuery": "paracetamol",
  "regulatoryOutcome": "Variation",
  "maxItems": 50
}

Use cases

• Pharmacovigilance & regulatory intelligence — track authorisation status, additional-monitoring flags, and safety referrals for a portfolio of medicines
• Market access research — identify orphan, biosimilar, and generic medicines by therapeutic area
• Supply-chain monitoring — track ongoing medicine shortages and alternative availability across the EU
• Academic & public-health research — bulk-export paediatric investigation plans or orphan designations for a therapeutic area
• Veterinary compliance — look up maximum residue limits and target species for veterinary active substances
• Herbal medicine cataloguing — track EU monograph assessment progress for herbal substances

FAQ

What is the EMA Medicines Database? The European Medicines Agency's public register of all medicines that have been granted (or refused) a centrally authorised marketing authorisation valid across the EU, plus related regulatory datasets (orphan designations, referrals, shortages, PIPs, MRLs, herbal monographs). See ema.europa.eu.

How current is the data? EMA regenerates each dataset export on its own schedule (typically daily to weekly). firstPublishedDate / lastUpdatedDate on each record reflect EMA's own publication timestamps.

Why do some records lack a medicineName? In orphanDesignations, many designations are granted before a medicine has a brand name — the record is still fully identified by activeSubstance and euDesignationNumber.

What's the difference between medicineStatus and opinionStatus? medicineStatus reflects the medicine's overall regulatory lifecycle stage (e.g. Authorised, Withdrawn). opinionStatus is only populated for medicines still going through a CHMP/CVMP scientific opinion (Positive / Negative) before a final Commission decision.

Can I filter by ATC code? Yes — put the ATC code (e.g. N02AB03) in searchQuery; it's matched against atcCodeHuman / atcCodeVeterinary along with the medicine name, INN, and active substance.

What does additionalMonitoring mean? Medicines under additional EU-wide monitoring (marked with a black triangle ▼ on their packaging) because they are new or have limited long-term safety data.

Does this include national (non-centrally authorised) medicines? No — the Medicines Database covers centrally authorised medicines only (one EU-wide authorisation). Referral records may reference nationally authorised products by name, but full national registries are out of scope.

Is there a rate limit? EMA's data export files are generated statically and served over standard HTTPS with no documented rate limit for reasonable use.

Is this affiliated with the European Medicines Agency? No, this is a third-party actor using EMA's public data exports. It is not affiliated with, endorsed by, or officially connected to the European Medicines Agency.