Pharmaceutical Glossary
Pharmaceutical Export &
Wholesale Glossary.
A definitive plain-English reference for the regulatory, quality, supply, logistics and procurement terms that come up when sourcing medicines from the UK for hospital, institutional and international supply. 110+ terms across nine themed sections, written for procurement teams, regulatory affairs, journalists and policy writers, not for lawyers.
110+defined terms
9themed sections
25+international regulators
2026last reviewed
UK Regulatory & Licensing.
The UK bodies, authorisations and statutory frameworks that govern whether a wholesaler can legally handle, sell, import and export medicines.
Brexit Transition Pharmaceutical Impact
The UK's departure from the EU on 31 January 2020, with full pharmaceutical regulatory separation from 1 January 2021. The MHRA now operates as a fully sovereign regulator, accepting EU procedures via reliance routes but issuing its own MAs, WDAs and inspection regime. UK exporters increasingly act as the bridge between EU manufacturers and non-EU markets.
DHSC Department of Health and Social Care
The UK government department with overall policy responsibility for medicines, including national shortage management. DHSC issues Medicine Supply Notifications and Serious Shortage Protocols and oversees the MHRA.
GDP Good Distribution Practice
The EU and UK quality standard for medicines distribution, covering storage, temperature control, documentation, supplier qualification, recall capability and product release. Compliance is mandatory for WDA holders. Read the full GDP compliance guide, or see our GDP system.
GMP Good Manufacturing Practice
The quality standard applied to medicine manufacturing (not distribution). GMP covers premises, equipment, process validation, batch records and release. Licensed wholesalers source only from GMP-compliant manufacturers.
GSL General Sales List
A category of medicine that can be sold without prescription or pharmacist supervision, for example small packs of paracetamol. Wholesale supply still requires a WDA where a wholesale licence is in scope.
Manufacturer's Licence MIA / MS
An MHRA licence (Manufacturer's / Importer's Authorisation, or Manufacturer's Specials) permitting a UK site to manufacture or import medicines. MIA is for licensed products; MS is for unlicensed specials. Distinct from a WDA, which only covers wholesale distribution.
Marketing Authorisation MA
The licence held by an originator or generic company allowing a specific medicine to be sold in a given country. The MA holder is the entity legally responsible for the product. UK medicines hold MHRA marketing authorisations.
MHRA Medicines and Healthcare products Regulatory Agency
The UK executive agency responsible for regulating medicines, medical devices and blood products. MHRA grants wholesale dealer authorisations, inspects GDP compliance, and maintains public registers of licensed wholesalers. Euro Biom's WDA(H) 59239 is issued and inspected by the MHRA.
P Medicine Pharmacy Medicine
A medicine that can be sold from a registered pharmacy under the supervision of a pharmacist, without a prescription. Sits between POM and GSL in the UK supply hierarchy.
POM Prescription-Only Medicine
A medicine that can only be supplied against a valid prescription written by a registered prescriber. Most hospital medicines are POM. Wholesale supply of POM requires a WDA.
Regulation 167 Human Medicines Regulations 2012
The UK statutory provision permitting the supply of an unlicensed medicine to meet the special clinical needs of an individual patient. The legal foundation of named patient supply in the UK.
Responsible Person RP
A named, qualified individual on a WDA who carries personal regulatory accountability for the quality system, procurement integrity, storage conditions and product release decisions of the wholesaler. Euro Biom's RP is Mr Brian Lindsay.
Section 10 Exemption
A long-standing UK pharmacy exemption permitting registered pharmacies to prepare or assemble medicines for individual patients without holding a manufacturer's licence. The historic basis for hospital pharmacy compounding.
Specials UK Unlicensed Specials Medicines
Unlicensed medicines manufactured in the UK to meet a specific patient's needs, typically bespoke strengths, paediatric formulations, sugar-free liquids or compounded creams. Manufactured under an MS licence and supplied via WDA holders. Detailed in our specials and unlicensed medicines service.
WDA(H) Wholesale Dealer Authorisation, Human Medicines
The MHRA licence permitting a UK company to procure, store, supply and export human medicines wholesale. Without a WDA(H) a company cannot legally handle prescription medicines at scale. See our WDA licensing guide.
WDA(WD) Wholesale Dealer Authorisation, Wholesale Distribution
A narrower MHRA wholesale licence variant covering specified distribution activities, sometimes used for veterinary medicine wholesale or restricted-scope distributors. Separate scope from a full WDA(H).
International Regulators.
The destination-country medicines regulators that decide whether a UK-sourced medicine can be imported, registered, sold or supplied to a named patient in their territory.
ANSM Agence Nationale de Sécurité du Médicament (France)
The French medicines agency, responsible for marketing authorisations, named patient and ATU early access frameworks, and shortage management. UK exporters into France typically engage with ANSM via authorised local intermediaries.
BfArM Federal Institute for Drugs and Medical Devices (Germany)
Germany's federal medicines regulator, responsible for marketing authorisations and pharmacovigilance for non-biological medicines. Biologicals are regulated separately by the Paul-Ehrlich-Institut. UK exporters into Germany engage BfArM for parallel import and shortage authorisations.
CBG-MEB Medicines Evaluation Board (Netherlands)
The Dutch medicines authority, regulating MAs and named patient access programmes. The Netherlands' Rotterdam port and Schiphol airport make CBG-MEB compliance important for EU-gateway distribution.
CDSCO Central Drugs Standard Control Organisation (India)
India's national medicines regulator under the Drugs Controller General of India. Issues import licences (Form 10/10A) and named patient permissions. UK exporters to Indian hospitals route through CDSCO-approved importers.
DAV Drug Administration of Vietnam
Vietnam's medicines regulator under the Ministry of Health. Issues marketing authorisations, import permits and named patient approvals. Vinmec, Cho Ray and Bach Mai hospital networks source UK medicines via DAV-approved channels.
DHA Dubai Health Authority (UAE)
The emirate-level health authority for Dubai, regulating hospital licensing and medicine procurement within Dubai. Operates alongside MOHAP (federal) and DOH (Abu Dhabi).
DHCR Dubai Healthcare City Regulatory
The independent regulator inside Dubai Healthcare City free zone, governing hospital, clinic and pharmacy licensing within DHCC. Distinct from DHA, with its own importation pathway for some specialty products.
DOH Department of Health Abu Dhabi
The emirate-level health regulator for Abu Dhabi, responsible for hospital licensing, medicine procurement and pricing rules within the emirate. Operates alongside MOHAP and DHA across the UAE.
DRAP Drug Regulatory Authority of Pakistan
Pakistan's medicines regulator, responsible for registration, import permits and post-marketing surveillance. UK exporters into Pakistan engage DRAP via licensed importers.
EDA Egyptian Drug Authority
Egypt's medicines regulator (formerly EDA / CAPA), responsible for product registration, batch release for biologicals, and tender qualification. UK exporters into Egypt require EDA registration or named patient approval.
FAMHP Federal Agency for Medicines and Health Products (Belgium)
Belgium's medicines regulator, governing marketing authorisations, named patient and medical need frameworks. Brussels' EU regulatory proximity makes FAMHP a frequent counterparty for cross-border supply.
FDA Ghana
Ghana's Food and Drugs Authority, regulating product registration, import permits and post-market surveillance. Registration timelines can extend for unregistered specialty products, often requiring named patient routes.
FDA Philippines
The Philippines Food and Drug Administration, under the Department of Health. Issues product registration (Certificate of Product Registration, CPR), import permits and licence to operate (LTO) for distributors.
HPRA Health Products Regulatory Authority (Ireland)
Ireland's medicines regulator. UK to Ireland represents a critical pharmaceutical corridor post-Brexit, with HPRA recognising MHRA decisions in many circumstances and operating named patient pathways.
KDFCA Kuwait Drug and Food Control Administration
Kuwait's medicines regulator within the Ministry of Health. Requires registered local agents for imports, and operates a named patient framework for unregistered specialty products.
MCAZ Medicines Control Authority of Zimbabwe
Zimbabwe's medicines regulator, responsible for product registration, import permits and pharmacovigilance. Often referenced alongside MCC South Africa as a comparator for SADC region pathways.
MOHAP UAE Ministry of Health and Prevention
The federal medicines and health regulator for the UAE, responsible for product registration and import permits at the federal level. UK exporters into the UAE typically require MOHAP registration before emirate-level (DHA, DOH) procurement begins. See our MOHAP import permits guide.
MOH-DGPA Oman Directorate General of Pharmaceutical Affairs
Oman's medicines regulator under the Ministry of Health. Operates product registration, import permits and a named patient framework for unregistered specialty medicines.
MOPH Qatar Ministry of Public Health Qatar
Qatar's medicines regulator under the Ministry of Public Health. Issues product registration, import permits and operates the special programme for unregistered medicines via Hamad Medical Corporation channels.
NAFDAC National Agency for Food and Drug Administration and Control (Nigeria)
Nigeria's regulatory body for medicines and food. NAFDAC registration and import permits are required for pharmaceutical supply into Nigeria. See our Nigeria supply page.
NHRA National Health Regulatory Authority (Bahrain)
Bahrain's medicines regulator. Operates product registration, GCC-aligned dossier review and a named patient pathway for unregistered medicines.
PPB Pharmacy and Poisons Board (Kenya)
Kenya's national medicines regulatory authority. PPB registration and batch verification are required for pharmaceutical supply into Kenya.
SAHPRA South African Health Products Regulatory Authority
South Africa's medicines and medical devices regulator, formerly the MCC. Responsible for product registration, named patient (Section 21) approvals and tender qualification.
SFDA Saudi Food and Drug Authority
The medicines, food and medical devices regulator in Saudi Arabia. SFDA registration governs which products may be imported and marketed in the Kingdom. See our Saudi Arabia export page, SFDA registration guide, and the broader product range.
TITCK Turkish Medicines and Medical Devices Agency
Turkey's medicines regulator under the Ministry of Health, responsible for marketing authorisations, named patient permissions and import licences.
Documentation & Quality.
The certificates, dossiers and quality records that travel with every legitimate consignment of medicines and that importing regulators ask for at customs and registration.
Apostille
A simplified legalisation certificate issued under the Hague Convention 1961 that authenticates the origin of a public document. Many destination regulators require apostilled CPPs and free sale certificates.
ASMF / DMF Active Substance Master File / Drug Master File
A confidential dossier submitted by an active substance manufacturer to a regulator, describing the manufacture and quality of the API. Referenced (not duplicated) in finished product dossiers.
Batch Release Certificate
A certificate issued after batch-specific quality review confirming that a particular batch may be supplied. Usually signed by a Qualified Person (manufacturing) or Responsible Person (wholesale).
BSE/TSE Certificate
A statement confirming that animal-derived materials in a medicine pose no risk of bovine spongiform encephalopathy or other transmissible spongiform encephalopathies. Required for import into many markets.
CMC Documentation Chemistry, Manufacturing and Controls
The technical section of a medicine dossier covering manufacture, formulation, specifications, analytical methods and stability. Forms the bulk of a Common Technical Document (CTD).
CoA Certificate of Analysis
A batch-specific document issued by the manufacturer certifying that the medicine meets its quality specification (identity, potency, purity, dissolution, microbial limits). Required for wholesale supply and import in most countries.
CoO Certificate of Origin
A trade document declaring the country in which goods were manufactured. Issued by a chamber of commerce. Required for many medicines imports especially where preferential tariffs or origin verification apply.
CPP Certificate of Pharmaceutical Product
A WHO-format document issued by the MHRA confirming that a medicine is authorised and manufactured in the UK to the standard required for export. Frequently requested by importing country regulators for registration or batch import.
FMD Falsified Medicines Directive
The EU framework, with equivalent UK rules post-Brexit, requiring unique pack identifiers, tamper-evident packaging and decommissioning at point of dispense. Designed to prevent falsified medicines entering the legal supply chain.
Free Sale Certificate FSC
A document certifying that a product is freely sold in the country of origin. Sometimes requested in place of, or alongside, a CPP by importing country authorities.
GMP Certificate
An MHRA-issued certificate confirming that a UK manufacturing site has been inspected and complies with Good Manufacturing Practice. Importing regulators frequently request copies as part of registration or batch release.
Halal Certification
A certificate confirming that a medicine, particularly a gelatin-based capsule, soft-gel or excipient-bearing product, meets Islamic dietary law. Increasingly required for GCC and South-East Asia procurement.
Kosher Certification
A certificate confirming that a medicine meets Jewish dietary law. Requested for some hospital and patient populations, particularly in Israel and Orthodox Jewish communities.
Legalisation
The process of authenticating a UK document for use abroad through a chain of stamps, typically Notary, Foreign Office and the destination country's embassy. Required where the destination is not a Hague Apostille signatory.
MA Verification Letter
A confirmation issued by the MHRA or MA holder, confirming that a medicine remains validly authorised. Sometimes requested by importing regulators alongside a CPP.
PIL Patient Information Leaflet
The folded paper leaflet inside a medicine pack giving patients information on how to take the medicine, side effects and precautions. Translated and approved versions may be required for some import markets.
Quarantine
The physical or system-based holding status for medicines received but not yet released. Quarantine prevents shipment until quality checks, documentation and batch release have been completed.
SmPC Summary of Product Characteristics
The legally binding prescribing information for a medicine, approved by the regulator and supplied to healthcare professionals. The basis for the PIL, advertising and prescriber decisions.
Supply Models.
The legal and commercial frameworks that allow medicines to reach patients when standard licensed channels do not, or cannot.
Comparator Drug
A licensed medicine sourced specifically for use as the active control in a clinical trial. Comparator sourcing requires audit-trail integrity, blinding-compatible packaging and protocol-aligned expiry. See our comparator drug sourcing service.
Compassionate Use
The supply of an unlicensed or pre-approval medicine to an identified patient with a serious condition, on humanitarian grounds. Typically requires regulator and ethics approval. Distinct from named patient supply but often overlapping in practice.
EAMS Early Access to Medicines Scheme (UK)
An MHRA scheme allowing patients with life-threatening or seriously debilitating conditions to access a promising unlicensed medicine before formal MA. Applicants receive a Promising Innovative Medicine designation followed by a positive scientific opinion.
Early Access ATU France / EAMS UK
The umbrella term for pre-approval medicine access pathways. France's ATU (Autorisation Temporaire d'Utilisation) is the most established, allowing named patient or cohort use on the prescriber's responsibility before MA.
Framework Agreement
A long-term contract with a hospital, NHS Trust or government buyer, against which call-off orders are placed. Provides supply continuity and pricing predictability. See our tender and government supply service.
IMP Investigational Medicinal Product
A medicine being tested in a clinical trial, including comparators and placebos. IMP supply is governed by GCP (Good Clinical Practice) and trial-specific protocols. See our clinical trials supply service.
Imported Unlicensed Medicines IUL
Medicines licensed in one country (typically the UK or EU) but unlicensed in the destination country, imported on a named patient basis to meet specific clinical need. A core area of UK exporter activity.
MAP Managed Access Programme
A structured scheme run by a manufacturer to provide pre-approval or non-reimbursed access to a medicine for defined patient cohorts, often with data collection. See our managed access programmes service.
Named Patient Supply NPS
A framework for supplying a medicine that is not licensed in the destination country, or not available in a licensed form, to meet the specific clinical need of an individual identified patient on the prescriber's responsibility. See our named patient supply service and named patient guide.
Off-label Use
The clinical use of a licensed medicine outside the indications, dose, route or population stated in the SmPC. Legally permitted on the prescriber's responsibility but not a manufacturing or supply distinction.
Post-Trial Access
Continued supply of a clinical trial medicine to participants after the trial has formally ended, where standard care is not available or the participant has clinically benefited.
Reference Listed Drug RLD
A specific licensed medicine designated by a regulator as the reference standard for bioequivalence and comparability studies. Sourced for generic development and regulatory submissions. See our reference listed drug supply service.
Special Import UK Unlicensed Import
The MHRA-notification route for importing an unlicensed medicine into the UK to meet the special clinical needs of an individual patient. Notifications are filed before import; some products require additional approvals.
Specials Manufacturing
UK manufacture of unlicensed medicines under an MS licence, for individual patient supply. Typically bespoke strengths, paediatric formulations or compounded preparations. See our specials manufacturing service.
Tender Supply
Bidding for and supplying medicines under formal procurement processes run by hospitals, ministries of health or NGOs. Typically multi-line, multi-month contracts with strict compliance and reporting. See our tender supply service.
Unlicensed Medicine
A medicine without a valid marketing authorisation for the country where it is to be supplied. Unlicensed supply is legally permitted in the UK under strict named-patient conditions and forms a core area of wholesale exporter work.
Logistics & Cold Chain.
The temperature ranges, validation concepts, packaging and handling requirements that govern how medicines physically move from a UK warehouse to a hospital or pharmacy abroad.
2 to 8 degrees Celsius
The standard refrigerated temperature range for vaccines, insulins, most monoclonal antibodies and many biologics. Maintained continuously from manufacture through transit to dispensing. See our cold chain service and cold chain to UAE.
AWB Air Waybill
The freight contract and tracking document for air shipments, issued by the airline or freight forwarder. Essential for customs clearance at destination.
Cold Chain
The uninterrupted temperature-controlled handling of medicines from manufacturer to end user, typically 2 to 8 degC for vaccines, insulin and most biologics. Regional cold chain variants are detailed at cold chain to Saudi Arabia.
CRT Controlled Room Temperature
The temperature range, typically 15 to 25 degC, for most licensed oral solid medicines. Ambient-controlled shipments still require monitoring where transit passes through extreme climates.
Data Logger TempTale, ELPRO, Sensitech
A calibrated electronic device placed inside a cold chain shipment to record temperature continuously from pack-out to delivery. Logger data forms part of the release documentation. TempTale is one of the most widely used commercial brands.
Dry Ice Shipping
Use of solid carbon dioxide to maintain frozen or ultra-cold temperatures during transit, typically below minus 20 degC. Subject to IATA Dangerous Goods Regulations (UN 1845) including airline limits and documentation.
GDP Transport Requirements
The temperature, security, documentation and qualification standards a transport partner must meet under EU and UK GDP. Includes vehicle qualification, driver training, route risk assessment and validated packaging.
IATA Time and Temperature Sensitive Label
A standardised IATA label applied to air freight shipments of temperature-sensitive medicines, ensuring handlers prioritise the consignment for fast loading and minimise tarmac dwell time.
Lane Validation
The qualification of a specific origin-to-destination shipping lane, including transit times, ambient profiles, customs predictability and packaging performance. A GDP requirement for new high-value or temperature-sensitive routes.
Last-Mile Cold Chain
The final leg from a destination airport or warehouse to the receiving hospital pharmacy, often the highest-risk segment for excursions in countries with extreme ambient conditions.
Mean Kinetic Temperature MKT
A single calculated temperature representing the cumulative thermal stress of a shipment, weighted for chemical degradation kinetics. Used in stability assessments after a temperature excursion.
Minus 20 degrees Celsius
The standard frozen temperature range for some plasma-derived products, vaccines and ATMPs. Maintained typically with dry ice or qualified frozen-state packaging.
Qualification & Validation
The documented evidence that equipment, packaging, processes and shipping lanes consistently meet specified requirements. Includes IQ, OQ, PQ for equipment and lane validation for transport.
Temperature Excursion
An event during storage or transit where the medicine temperature falls outside the validated range. Excursions trigger a documented quality investigation before product release.
Ultra-cold Minus 80 degrees Celsius
The deep-frozen temperature range for some mRNA vaccines, certain ATMPs and CAR-T cell therapies. Maintained with specialist freezers, vapour-shipper dewars and tightly controlled handover.
Validated Packaging
Cold chain packaging qualified through engineering tests to maintain a specified temperature range for a specified duration under defined ambient conditions. Selection is destination-specific.
Procurement Mechanisms.
The buying frameworks that hospitals, ministries and NGOs use to source medicines, plus the contract and ordering structures wholesalers must navigate.
Call-Off Contract
An order placed against a pre-agreed framework, with delivery quantity and timing called as needed. Common in NHS Supply Chain and large hospital group procurement.
Crown Commercial Service Framework
UK government-wide procurement framework operated by Crown Commercial Service. Pharmaceutical lots cover both routine and unlicensed medicines for public sector buyers.
e-Tender Portal
An online platform through which procurement bodies issue tenders, accept bids and award contracts. Examples include Etimad (Saudi), TED (EU) and various NHS portals.
Framework Agreement
A multi-supplier multi-year contract specifying terms (price, quality, delivery) under which call-off orders may be placed without re-tendering each time. Standard structure for NHS, Crown Commercial Service and many GCC ministries.
HMC Procurement Hamad Medical Corporation, Qatar
The principal government healthcare provider in Qatar, operating a centralised procurement function for hospitals across the country. The primary buyer of imported medicines in Qatar.
KEMSA Kenya Medical Supplies Authority
Kenya's central procurement and distribution body for medicines and medical supplies for public hospitals and health centres. Tender qualification is the primary entry route for Kenyan public-sector supply.
Master Service Agreement MSA
An overarching contract between a wholesaler and a recurring institutional buyer setting out general commercial, quality and liability terms, with specific transactions executed under separate purchase orders.
MOQ Minimum Order Quantity
The smallest quantity a supplier will accept on an order. Particularly relevant in named patient and specialty supply, where small quantities may be cost-prohibitive without negotiated MOQ flexibility.
NHS Supply Chain
The UK NHS body responsible for sourcing and distributing medicines and medical supplies to NHS trusts. Operates extensive framework agreements with licensed wholesalers and manufacturers.
NUPCO National Unified Procurement Company, Saudi Arabia
Saudi Arabia's centralised procurement body for medicines, medical devices and supplies for public hospitals and ministries. Under Vision 2030 reforms, NUPCO procurement increasingly favours SFDA-registered and locally manufactured products. See our NUPCO localisation analysis and the wider Euro Biom story.
Public Tender
A procurement process open to all qualifying suppliers, typically advertised publicly and awarded on price plus compliance criteria. The dominant procurement model in GCC and African public hospital sectors.
Restricted Tender
A procurement process limited to suppliers pre-qualified through a registration round. Common in regulated specialty categories (oncology, biologics) where buyer wishes to ensure regulatory and quality compliance before bidding.
Therapeutic & Drug Categories.
The clinical, regulatory and pharmacological classifications that recur in tender specifications, hospital formularies and shortage notices.
API Active Pharmaceutical Ingredient
The biologically active substance in a medicine. Global API supply disruption is a frequent underlying cause of finished-product shortages.
ATMP Advanced Therapy Medicinal Product
A category covering gene therapy, somatic cell therapy and tissue-engineered products. ATMPs typically require ultra-cold logistics, hospital chain-of-identity tracking and pre-treatment patient certification.
Biologic
A medicine derived from living cells or biological systems, including monoclonal antibodies, vaccines, hormones and blood products. Biologics typically require cold chain and tight handling tolerances.
Biosimilar
A biological medicine highly similar to an already-authorised biologic (the reference product), licensed after comparability studies. Biosimilars offer comparable efficacy at lower cost in oncology, rheumatology and diabetes.
CAR-T Therapy Chimeric Antigen Receptor T-Cell
A patient-specific cancer immunotherapy in which a patient's T-cells are genetically engineered ex vivo and reinfused. Subject to ultra-cold logistics, vein-to-vein tracking and hospital qualification.
CD Controlled Drug
A medicine classified under the UK Misuse of Drugs Act with additional storage, prescription and record-keeping requirements. UK schedules range from CD1 (no medical use) through CD2 (strong opioids) to CD5 (low-strength preparations). Export requires Home Office licensing in addition to a WDA.
Formulation
The specific physical form and composition of a medicine (tablet, capsule, injection, suspension, inhaler, patch). Formulation drives handling, storage and labelling requirements.
Gene Therapy
A medicine that introduces, alters or replaces genetic material to treat or prevent disease. Often delivered as a one-time infusion, gene therapies are typically ultra-cold logistics products and require named-patient regulatory pathways.
Generic
A medicine containing the same active ingredient, strength and formulation as an originator product, marketed after the originator's patent has expired. Licensed as bioequivalent by the MHRA or equivalent regulators.
Insulin 2-8 degC Biologic
The hormone supplied as multiple licensed analogues (rapid, intermediate, long-acting) and biosimilars. Cold chain dependent. See our insulin to GCC supply page.
Monoclonal Antibody mAb
A laboratory-produced antibody designed to bind a specific molecular target. Used in oncology, autoimmune disease, transplant medicine and infectious disease. Cold-chain biologic.
Narcotic Drug
An internationally controlled substance under UN conventions, including most strong opioids. Export from the UK requires Home Office licensing plus destination-country narcotic permits.
Orphan Drug
A medicine designated for the treatment of a rare disease, granted orphan status by regulators (typically diseases affecting fewer than 5 in 10,000 in the EU, or fewer than 200,000 patients in the US). Designation brings extended market exclusivity and fee waivers.
Originator Branded / Innovator
The pharmaceutical company that first developed and licensed a medicine. Originator products often remain on hospital formularies alongside generics for specific clinical scenarios.
Paediatric Formulation
A medicine adapted for children, typically liquid, sugar-free, taste-masked or low-strength. Many paediatric needs are met via specials manufacturing where no licensed formulation exists.
Psychotropic Substance
A medicine acting on the central nervous system and internationally controlled under the 1971 UN Convention. Includes benzodiazepines, certain stimulants and barbiturates. Export requires destination-country psychotropic import permits.
Rare Disease Medicine
A medicine used to treat a rare disease, often with orphan designation. Frequently the subject of named patient supply because licensed availability in destination countries is limited.
Vaccine
A biological preparation that provides active acquired immunity against a specific infectious disease. Typically cold chain (2-8 degC) with some mRNA platforms requiring frozen or ultra-cold transport. See our vaccine export to Middle East page.
Commercial & Trade.
The contractual, customs and pricing concepts that frame how medicines move between licensed parties across borders, and what each party is responsible for at each stage.
Authorised Distributor
A company appointed in writing by an MA holder to distribute a medicine on its behalf in a defined territory. Distinct from an independent wholesaler. Authorised distribution terms appear on the manufacturer's distributor list.
Branded Generic
A generic medicine marketed under a distinct trade name rather than the international non-proprietary name (INN). Common in GCC and emerging-market formularies.
Distribution Arrangement
A contract between a manufacturer and a wholesaler defining product range, territory, exclusivity (or not), pricing, ordering and reporting. Distinct from a one-off purchase order.
Exclusive Territory Agreement
A distribution arrangement granting one wholesaler the sole right to sell a medicine in a defined country or region. Relatively rare in commodity products but common in specialty and orphan medicines.
Generic Medicine
A medicine bioequivalent to an originator product, marketed after originator patent expiry. Generics are licensed by the MHRA on the basis of comparator-drug bioequivalence data rather than de-novo clinical trials.
Grey Market
Trade in genuine medicines outside the manufacturer's authorised distribution channels. Often legal but discouraged by MA holders. Wholesalers must apply rigorous due diligence to grey-market sourcing.
Incoterms EXW, FOB, CIF, DDP, DAP
International Commercial Terms published by the International Chamber of Commerce. Each term (Ex Works, Free On Board, Cost Insurance Freight, Delivered Duty Paid, Delivered At Place) defines how cost and risk transfer between seller and buyer at named points in the journey.
Original Brand
The innovator product as originally launched by its developer. Distinguished in formularies and tenders from generics and biosimilars.
Parallel Export
The export of a medicine purchased on the domestic market of one country to another country where market conditions or pricing differ. Subject to regulatory and contractual constraints.
Parallel Import
The import of a medicine licensed in another European market into the UK (or vice versa) through authorised distributors, typically to address shortages or price differences. Each parallel import pack carries its own licence reference.
Secondary Market
Trade in medicines outside the original manufacturer-to-distributor channel, including grey-market and authorised resale. Wholesalers operating in the secondary market must apply enhanced supplier and product due diligence.
Quality & Safety.
The post-marketing safety, anti-falsification and recall mechanisms that protect patients across the licensed supply chain.
2D Barcode Data Matrix Code
A two-dimensional barcode applied to medicine packs under FMD, encoding product code, batch number, expiry date and unique serial number. Scanned at dispense to verify authenticity and decommission the pack.
ADR Adverse Drug Reaction
A harmful or unintended reaction to a medicine occurring at normal therapeutic doses. ADRs are reported through pharmacovigilance systems (Yellow Card in the UK).
Batch Traceability
The ability to trace a specific batch of medicine forward through the supply chain to dispensing point and backward to manufacture. A core GDP requirement and the foundation of effective recalls.
Market Withdrawal
A manufacturer-initiated removal of a medicine from sale, often for commercial reasons rather than safety. Distinct from a recall, but with similar logistical implications for wholesalers.
Pharmacovigilance PV
The discipline of monitoring, detecting, assessing and preventing adverse drug reactions and other medicine safety issues. UK wholesalers cooperate with MHRA pharmacovigilance systems including the Yellow Card Scheme. Background reading on UK regulatory practice is collected on our insights blog.
Recall Classification Class 1, 2, 3
The MHRA's tiered urgency for medicines recalls. Class 1 is most urgent (potentially life-threatening); Class 2 is less urgent but still serious; Class 3 is for non-critical defects. Each class triggers defined response timelines for wholesalers.
Serialisation
The application of a unique serial number to each medicine pack at the point of manufacture, enabling end-to-end pack identification under FMD and similar international anti-falsification frameworks.
SSP Serious Shortage Protocol
A UK statutory instrument issued by DHSC that temporarily authorises pharmacists to supply specified alternatives to a prescribed medicine where a serious shortage is in effect. Read the drug shortages guide.
Tamper-Evident Packaging
Packaging design that visibly indicates if it has been opened or interfered with after manufacturing seal. An FMD requirement for prescription medicine packs sold in the EU and UK.
Yellow Card Scheme
The UK MHRA system for reporting suspected adverse drug reactions, medical device incidents and defective medicines. Open to healthcare professionals, patients and the public.
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