Glossary
Regulatory affairs glossary
Short, practical definitions of the terms EU regulatory teams use every day, from decentralised and mutual recognition procedures to variations, clock-stops, PSURs and data exclusivity. Each entry explains where the term sits in the procedure under Directive 2001/83/EC, Regulation (EC) No 726/2004 and the Variations Regulation, what commonly goes wrong, and, where it matters, the timing. Changes due under the new EU pharma package are flagged where they apply but are not yet in force.
- 8+2+1EU data and market protection formula8+2+1 is the EU regulatory protection formula: eight years of data exclusivity, two years of market protection and one more year for a new indication.Read the 8+2+1 entry
- Accelerated assessmentshortened centralised assessment for major public health interestAccelerated assessment shortens the CHMP's review of a centralised application from 210 to 150 days for a medicine of major public health interest.Read the Accelerated assessment entry
- Article 30 referralharmonisation of divergent national authorisationsAn Article 30 referral asks the CHMP to harmonise the product information of a medicine authorised nationally on differing terms across Member States.Read the Article 30 referral entry
- Article 31 referralreferral in the interest of the UnionAn Article 31 referral is an EU-level assessment of a medicine or class of medicines where the interests of the Union are involved, usually on safety.Read the Article 31 referral entry
- Article 5 recommendationclassification request under the Variations RegulationAn Article 5 recommendation is a formal classification ruling from the CMDh or EMA on a change that the variation classification guideline does not cover.Read the Article 5 recommendation entry
- Article 61(3) notificationlabelling or leaflet change outside the SmPCAn Article 61(3) notification tells the authority about a change to labelling or the package leaflet that does not affect the SmPC, with 90 days to object.Read the Article 61(3) notification entry
- ASMFactive substance master fileAn active substance master file (ASMF) lets an API manufacturer give regulators its confidential manufacturing data without disclosing it to the applicant.Read the ASMF entry
- ATMPadvanced therapy medicinal productAn advanced therapy medicinal product (ATMP) is a gene therapy, somatic cell therapy or tissue-engineered medicine under Regulation (EC) No 1394/2007.Read the ATMP entry
- Bioequivalenceequivalent rate and extent of absorptionBioequivalence means two products with the same active substance deliver it at the same rate and to the same extent, within accepted statistical limits.Read the Bioequivalence entry
- Biosimilarsimilar biological medicinal product under Article 10(4)A biosimilar is a biological medicine shown to be highly similar to an authorised reference biological product, authorised under Article 10(4).Read the Biosimilar entry
- Blue Boxnational information on packaging in MRP and DCPThe Blue Box is the blue-bordered area on EU packaging and leaflets that carries national particulars such as price, reimbursement and legal status.Read the Blue Box entry
- Bolar exemptionpatent exemption for development workThe Bolar exemption in Article 10(6) of Directive 2001/83/EC lets generic developers run the studies needed for an application during the patent term.Read the Bolar exemption entry
- Brailleproduct name in Braille on the outer packagingBraille on medicine packs is required by Article 56a of Directive 2001/83/EC: the name, and strength where needed, in Braille on the outer packaging.Read the Braille entry
- Centralised proceduresingle EU marketing authorisation via EMAThe centralised procedure grants one marketing authorisation valid across the EU and EEA after a single EMA assessment and a Commission decision.Read the Centralised procedure entry
- CEPcertificate of suitability to the European PharmacopoeiaA certificate of suitability (CEP) from the EDQM confirms that a substance's quality is suitably controlled by its European Pharmacopoeia monograph.Read the CEP entry
- CESPCommon European Submission PortalThe Common European Submission Portal (CESP) is the HMA platform through which applicants send dossiers electronically to EU/EEA national authorities.Read the CESP entry
- CHMPCommittee for Medicinal Products for Human UseThe CHMP is the EMA committee that assesses centralised applications and referrals for human medicines and adopts the opinions behind Commission decisions.Read the CHMP entry
- Classification guidelineCommission guideline on variation categoriesThe classification guideline is the Commission's list of variation changes, with the conditions and documents that make each one Type IA, IB or II.Read the Classification guideline entry
- Clock-stoppause in the procedure timetableA clock-stop is a pause in a regulatory procedure's timetable while the applicant prepares responses to questions from the assessing authority.Read the Clock-stop entry
- CMDhCo-ordination Group for Mutual Recognition and Decentralised ProceduresThe CMDh is the group of national authority representatives that resolves disagreements in MRP and DCP and coordinates nationally authorised medicines.Read the CMDh entry
- CMSconcerned member stateA concerned member state (CMS) is any EU/EEA Member State, other than the reference member state, where an applicant seeks authorisation via a DCP or MRP.Read the CMS entry
- Conditional MAconditional marketing authorisationA conditional marketing authorisation is a one-year, renewable EU authorisation granted on less complete data for medicines that meet an unmet need.Read the Conditional MA entry
- Data exclusivityregulatory data protectionData exclusivity is the eight years after a reference product's first EU authorisation in which generics cannot rely on its preclinical and clinical data.Read the Data exclusivity entry
- DCPdecentralised procedureThe decentralised procedure (DCP) authorises a medicine in several EU/EEA Member States at once when it is not yet authorised in any of them.Read the DCP entry
- Decommissioningmarking a unique identifier as suppliedDecommissioning changes a pack's unique identifier status in the EU verification system to inactive, normally when the pack is supplied to the public.Read the Decommissioning entry
- DHPCdirect healthcare professional communicationA direct healthcare professional communication (DHPC) is a letter agreed with authorities that alerts prescribers and pharmacists to urgent safety issues.Read the DHPC entry
- eAFelectronic application formThe electronic application form (eAF) is the mandatory EU form for marketing authorisation, variation and renewal applications in every procedure type.Read the eAF entry
- eCTDelectronic Common Technical DocumentThe electronic Common Technical Document (eCTD) is the electronic format for regulatory dossiers, organised in the five-module structure defined by ICH M4.Read the eCTD entry
- EMA feescharges under Regulation (EU) 2024/568EMA fees are the charges set by Regulation (EU) 2024/568 for applications, variations, pharmacovigilance and other EMA procedures, applying from 2025.Read the EMA fees entry
- EPAREuropean public assessment reportA European public assessment report (EPAR) is EMA's published account of how a centrally authorised medicine was assessed and why it was approved.Read the EPAR entry
- ePIelectronic product informationElectronic product information (ePI) is the SmPC, leaflet and labelling published as structured data to a common EU standard instead of a static file.Read the ePI entry
- ERAenvironmental risk assessmentAn environmental risk assessment (ERA) evaluates the potential risk a medicinal product poses to the environment through its use and disposal.Read the ERA entry
- EudraVigilanceEU adverse reaction databaseEudraVigilance is the EU system for collecting, managing and analysing suspected adverse reaction reports for medicines authorised in the EEA.Read the EudraVigilance entry
- EURD listlist of Union reference dates and PSUR frequenciesThe EURD list sets the Union reference date, data lock points and PSUR submission frequency for each active substance authorised in the EU.Read the EURD list entry
- Exceptional circumstancesmarketing authorisation without comprehensive dataAn authorisation under exceptional circumstances is granted when full efficacy and safety data cannot be obtained, with obligations reviewed yearly.Read the Exceptional circumstances entry
- Fixed combinationapplication under Article 10b for a combined productA fixed combination application under Article 10b of Directive 2001/83/EC covers a product combining known active substances not used together before.Read the Fixed combination entry
- FMDFalsified Medicines DirectiveThe Falsified Medicines Directive (FMD), Directive 2011/62/EU, added safety features and supply chain rules to keep falsified medicines out of the EU.Read the FMD entry
- Generic applicationabridged application under Article 10(1)A generic application under Article 10(1) of Directive 2001/83/EC authorises a copy of a reference product by relying on that product's data.Read the Generic application entry
- GMAglobal marketing authorisationThe global marketing authorisation (GMA) groups an initial authorisation with its later strengths, forms and extensions, so exclusivity runs once for all.Read the GMA entry
- GMP certificateproof of good manufacturing practice complianceA GMP certificate is issued by an EU competent authority after an inspection confirms that a manufacturing site complies with good manufacturing practice.Read the GMP certificate entry
- Grouping of variationsseveral changes in one submissionGrouping of variations is the filing of several changes to one or more marketing authorisations in one submission under Article 7 of Regulation 1234/2008.Read the Grouping of variations entry
- HTA RegulationRegulation (EU) 2021/2282 on health technology assessmentThe HTA Regulation, Regulation (EU) 2021/2282, sets up EU joint clinical assessments and joint scientific consultations for medicines from 2025.Read the HTA Regulation entry
- Hybrid applicationabridged application under Article 10(3)A hybrid application under Article 10(3) of Directive 2001/83/EC relies partly on a reference product's data and partly on new bridging studies.Read the Hybrid application entry
- Informed consent applicationapplication under Article 10c relying on another holder's dossierAn informed consent application under Article 10c of Directive 2001/83/EC copies a product using the original holder's dossier with its permission.Read the Informed consent application entry
- IRISEMA portal for regulatory and scientific proceduresIRIS is EMA's online platform for orphan designation, scientific advice, paediatric, parallel distribution and other procedures outside the dossier.Read the IRIS entry
- JCAjoint clinical assessmentA joint clinical assessment (JCA) is the EU-level review of a new medicine's relative effectiveness under the HTA Regulation, shared by all Member States.Read the JCA entry
- Labellingtext on the outer and immediate packagingLabelling is the information Articles 54 and 55 of Directive 2001/83/EC require on a medicine's outer and immediate packaging, from name to batch number.Read the Labelling entry
- Line extensionextension application to an existing authorisationA line extension (in EU terms, an extension application) adds a new strength, pharmaceutical form or route of administration to an authorised product.Read the Line extension entry
- LoEloss of exclusivityLoss of exclusivity (LoE) is the date when the last regulatory or patent protection on a medicine ends and generics or biosimilars can be marketed.Read the LoE entry
- MA withdrawalvoluntary withdrawal of a marketing authorisationAn MA withdrawal is the holder's decision to give up a marketing authorisation, notified to the authority with its reasons and any supply consequences.Read the MA withdrawal entry
- MAAmarketing authorisation applicationA marketing authorisation application (MAA) is the dossier submitted to EMA or a national authority for permission to market a medicine in the EU.Read the MAA entry
- MAH transfertransfer of a marketing authorisation to a new holderAn MAH transfer moves a marketing authorisation from one legal entity to another, making the new company legally responsible for the product.Read the MAH transfer entry
- Market protectionperiod in which generics cannot be marketedMarket protection is the period after data exclusivity ends during which a generic or biosimilar can be authorised but not placed on the market.Read the Market protection entry
- MIAmanufacturing and importation authorisationA manufacturing and importation authorisation (MIA) is the licence an EU site needs to manufacture, pack or import medicinal products from outside the EEA.Read the MIA entry
- Mock-upsfull-colour drafts of packaging and leafletMock-ups are full-colour, actual-size drafts of the outer packaging, immediate packaging and leaflet that authorities review before a medicine is marketed.Read the Mock-ups entry
- MRPmutual recognition procedureThe mutual recognition procedure (MRP) extends a national marketing authorisation from one EU/EEA Member State to others, which recognise it.Read the MRP entry
- NASnew active substanceA new active substance (NAS) is a substance not previously authorised in an EU medicine, whose first product starts a new protection period.Read the NAS entry
- National agency feescharges by national competent authoritiesNational agency fees are the charges each EU/EEA competent authority sets in national law for applications, variations, renewals and annual maintenance.Read the National agency fees entry
- National procedureauthorisation in a single Member StateA national procedure authorises a medicine in one EU Member State only, assessed by that country's competent authority under Directive 2001/83/EC.Read the National procedure entry
- OMSorganisation management serviceThe Organisation Management Service (OMS) is EMA's master list of organisations and locations whose identifiers must be used in EU regulatory forms.Read the OMS entry
- Orphan designationstatus for medicines for rare conditionsOrphan designation is EU status for a medicine for a rare condition, bringing fee reductions, protocol assistance and market exclusivity once authorised.Read the Orphan designation entry
- Orphan market exclusivityten-year protection for orphan medicinesOrphan market exclusivity gives an authorised orphan medicine ten years in which no similar product may be authorised for the same therapeutic indication.Read the Orphan market exclusivity entry
- Package leafletpatient information leaflet in the packThe package leaflet is the patient-facing text in every medicine pack, required by Articles 58 and 59 of Directive 2001/83/EC and based on the SmPC.Read the Package leaflet entry
- PACMPpost-approval change management protocolA post-approval change management protocol (PACMP) pre-agrees the data for a future CMC change so the change can later be filed in a lower category.Read the PACMP entry
- Paediatric extensionsix-month SPC extension for a completed PIPThe paediatric extension adds six months to a supplementary protection certificate as a reward for completing an agreed paediatric investigation plan.Read the Paediatric extension entry
- Parallel distributiondistribution of a centrally authorised product across Member StatesParallel distribution is resale of a centrally authorised medicine from one Member State in another, notified to EMA, which checks the pack and leaflet.Read the Parallel distribution entry
- Parallel importimport of a nationally authorised product from another Member StateParallel import is trade of a nationally authorised medicine from one EU Member State to another, outside the holder's channel, under a simplified licence.Read the Parallel import entry
- Patent linkagetying regulatory approval to patent statusPatent linkage ties a generic's regulatory approval to the originator's patents; EU law does not permit it, so patent disputes are settled in the courts.Read the Patent linkage entry
- PIPpaediatric investigation planA paediatric investigation plan (PIP) is the agreed programme of studies in children a new medicine must complete, waive or defer before EU authorisation.Read the PIP entry
- PLM PortalEMA product lifecycle management portalThe PLM Portal is EMA's product lifecycle management platform for electronic application forms and eSubmissions for centrally authorised products.Read the PLM Portal entry
- PRACPharmacovigilance Risk Assessment CommitteeThe PRAC is the EMA committee that assesses the safety of human medicines in the EU, from risk management plans and PSURs to signals and safety referrals.Read the PRAC entry
- Pricing and reimbursementnational decisions on price and public fundingPricing and reimbursement are the national decisions, taken after authorisation, that set a medicine's price and whether a health system pays for it.Read the Pricing and reimbursement entry
- PSMFpharmacovigilance system master fileThe pharmacovigilance system master file (PSMF) is the holder's detailed description of its pharmacovigilance system, kept in the EU for inspectors.Read the PSMF entry
- PSURperiodic safety update reportA periodic safety update report (PSUR) is a holder's periodic benefit-risk evaluation of a medicine, due at intervals set by the EURD list or the MA.Read the PSUR entry
- PSUSAPSUR single assessmentA PSUSA is the single EU assessment of all periodic safety update reports for one active substance, led by the PRAC and binding on every holder.Read the PSUSA entry
- Public service obligationArticle 81 supply duty of holders and distributorsThe public service obligation in Article 81 of Directive 2001/83/EC requires holders and wholesalers to keep a marketed medicine appropriately supplied.Read the Public service obligation entry
- PUMApaediatric-use marketing authorisationA paediatric-use marketing authorisation (PUMA) covers a medicine developed only for children from an off-patent substance, with its own protection.Read the PUMA entry
- QPqualified personThe qualified person (QP) is the named individual at an EU manufacturer or importer who certifies that each batch complies with its authorisation and GMP.Read the QP entry
- QPPVqualified person responsible for pharmacovigilanceThe QPPV is the named individual, resident in the EU, who is personally responsible for a marketing authorisation holder's pharmacovigilance system.Read the QPPV entry
- QRD templateEMA template for product informationThe QRD template is EMA's standard layout for the SmPC, Annex II, labelling and package leaflet, with fixed headings and statements in every EU language.Read the QRD template entry
- Readability testinguser testing of the package leafletReadability testing is the user consultation Article 59(3) of Directive 2001/83/EC requires to show patients can find and understand leaflet information.Read the Readability testing entry
- Reference productreference medicinal productThe reference medicinal product is the product, authorised in the EU on a full dossier, whose data a generic or hybrid application relies on.Read the Reference product entry
- ReferralEU-level assessment of a disputed or safety issueA referral is an EU procedure that resolves a scientific or regulatory issue about a medicine, or a class of medicines, in a single EU-level assessment.Read the Referral entry
- Renewalfive-year re-evaluation of a marketing authorisationA renewal is the re-evaluation of a marketing authorisation's benefit-risk balance after its first five years, after which it is normally unlimited.Read the Renewal entry
- RMPrisk management planA risk management plan (RMP) describes a medicine's known and potential risks, how they will be studied and minimised, and forms part of the authorisation.Read the RMP entry
- RMSreference member stateThe reference member state (RMS) is the EU/EEA Member State that leads the assessment in a decentralised or mutual recognition procedure.Read the RMS entry
- RUPrepeat-use procedureA repeat-use procedure (RUP) is a further mutual recognition wave that adds new concerned member states to a product already authorised by DCP or MRP.Read the RUP entry
- Scientific adviceEMA or national guidance on development before submissionScientific advice is formal guidance from EMA or a national authority on the studies and data a developer should generate before applying for an MA.Read the Scientific advice entry
- Shortage notificationnotice of a supply interruption under Article 23aA shortage notification is the holder's advance notice to the national authority that a medicine will stop being supplied, temporarily or permanently.Read the Shortage notification entry
- Signal detectionidentifying new safety information from pharmacovigilance dataSignal detection is the process of finding information that suggests a new or changed causal link between a medicine and an adverse event.Read the Signal detection entry
- SmPCsummary of product characteristicsThe summary of product characteristics (SmPC) is the approved document that tells healthcare professionals how to use a medicine safely and effectively.Read the SmPC entry
- SPCsupplementary protection certificateA supplementary protection certificate (SPC) extends patent protection for an authorised medicine by up to five years to offset regulatory review time.Read the SPC entry
- SPORsubstances, products, organisations and referentialsSPOR is EMA's set of four master data services (substances, products, organisations, referentials) that implement ISO IDMP for EU regulatory submissions.Read the SPOR entry
- Sunset clauselapse of an unused marketing authorisationThe sunset clause ends a marketing authorisation if the product is not marketed within three years of grant, or later leaves the market for three years.Read the Sunset clause entry
- Suspension and revocationauthority action pausing or ending a marketing authorisationSuspension and revocation are the measures an authority takes under Article 116 of Directive 2001/83/EC to pause or end a marketing authorisation.Read the Suspension and revocation entry
- TEVtransferable data exclusivity voucherA transferable data exclusivity voucher (TEV) is a pharma package reward: a priority antimicrobial earns 12 extra months of data protection to use or sell.Read the TEV entry
- Type IA variationminor change notified after implementationA Type IA variation is a minor change with minimal or no impact on quality, safety or efficacy, which can be implemented before the authority is notified.Read the Type IA variation entry
- Type IAIN variationminor change notified immediately after implementationA Type IAIN variation is a minor change the holder may implement first but must notify to the authority immediately afterwards, not in an annual update.Read the Type IAIN variation entry
- Type IB variationminor change notified before implementationA Type IB variation is a minor change that is neither Type IA nor Type II and must be notified to the authority before it is implemented.Read the Type IB variation entry
- Type II variationmajor change requiring prior approvalA Type II variation is a major change that may significantly affect a medicine's quality, safety or efficacy and needs approval before implementation.Read the Type II variation entry
- Unique identifierserialised code on prescription medicine packsThe unique identifier is the serialised 2D code on a prescription medicine pack that pharmacies verify against the EU repository before supply.Read the Unique identifier entry
- USRurgent safety restrictionAn urgent safety restriction (USR) is a provisional change to a medicine's product information imposed at once because of a risk to public health.Read the USR entry
- WEUwell-established useWell-established use (WEU) is an application route that shows efficacy and safety through published literature instead of the applicant's own studies.Read the WEU entry
- Worksharingone assessment of a variation across several authorisationsWorksharing lets one authority assess the same Type IB or Type II variation for several marketing authorisations of the same holder in a single procedure.Read the Worksharing entry
- xEVMPDextended EudraVigilance medicinal product dictionary (Article 57 database)The xEVMPD, or Article 57 database, is EMA's record of every medicine authorised in the EU, which holders must keep updated within 15 days of changes.Read the xEVMPD entry
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