Glossary
A practical reference point for the language of real-world pharmaceutical access and supply.
Across global pharma, the same concept is often described in different ways depending on region, regulation, and context. This glossary brings those variations together to create a clearer, more consistent understanding of the terminology used across access, clinical supply, regulated distribution, and commercialisation.
It is designed not only to define terms, but to show how they function in practice across real operating environments. By connecting industry language with operational context, the glossary helps make complex pathways easier to understand, navigate, and apply.
Access and Unlicensed Supply
Terminology across early access, unlicensed supply, and patient-specific pathways.
These terms cover the regulatory and operational routes used when medicines need to reach patients outside standard commercial availability.
Usage varies by country, authority, and product status. In practice, many of these terms overlap, but the underlying pathway, documentation, and supply model can differ significantly from one market to another.
1. Early Access Programs
Also known as: early access programmes, pre-approval access, pre-authorisation access, unlicensed access, managed access, compassionate use, expanded access, named patient supply
Definition: Programs that allow patients to access medicines before full commercial availability or before local marketing authorisation, usually where there is high unmet medical need.
Operational context: The term is used broadly, but the legal pathway varies by country. In practice, access depends on product status, local regulation, documentation, and the route by which supply is authorised.
Related terms: Compassionate Use, Expanded Access, Named Patient Programmes, Named Patient Programs, Specials, Individual Import, Unlicensed Supply
Related services: Managed Access Program / Market Access Solutions
2. Compassionate Use
Also known as: compassionate use programme, compassionate use program, early access, pre-approval access, managed access
Definition: A pathway that allows patients with serious or life-threatening conditions to receive a medicine before it is fully authorised, usually when no satisfactory alternatives are available.
Operational context: The meaning and formal pathway differ between jurisdictions. In some markets, compassionate use applies to groups of patients. In others, similar access may be handled under a different framework.
Related terms: Early Access Programmes, Early Access Programs, Expanded Access, Named Patient Programmes, Named Patient Programs
Related services: Managed Access Program / Treatment Access Solutions
3. Expanded Access
Also known as: expanded access program, expanded access programme, compassionate use, early access, pre-approval access
Definition: A term most commonly used in the United States for access to investigational medicines outside a clinical trial.
Operational context: Expanded Access is a defined regulatory concept in the US. Although often used interchangeably with compassionate use, the operational and regulatory requirements are market-specific.
Related terms: Compassionate Use, Early Access Programmes, Early Access Programs, Individual Import
Related services: Managed Access Program / Treatment Access Solutions /
4. Named Patient Programs
Also known as: named patient programmes, named patient supply, named patient access, patient-specific supply
Definition: A pathway under which a medicine is supplied for an individual patient on the request of an authorised treating physician, typically where the product is not locally available.
Operational context: This is one of the most important access models in international supply. Requirements vary by market, but execution is always patient-specific and documentation-driven.
Related terms: Early Access Programmes, Early Access Programs, Specials, Individual Import, Unlicensed Supply, Named Patient Supply
Related services: Managed Access Program / Treatment Access Solutions
5. Named Patient Supply
Also known as: named patient import, patient-specific supply, named patient access
Definition: A supply model in which an unlicensed or otherwise unavailable medicine is provided for an individual patient on the request of the treating physician.
Operational context: The term is often used interchangeably with Named Patient Programmes, but in practice it usually refers more directly to the supply pathway than to the broader access framework.
Related terms: Named Patient Programmes, Named Patient Programs, Individual Import, Unlicensed Supply, Specials
Related services: Individual Import / Treatment Access Solutions
6. Specials
Also known as: unlicensed specials, special-order medicines, UK specials, specials manufacture
Definition: A term used primarily in the UK for unlicensed medicines supplied to meet the special clinical needs of an individual patient.
Operational context: In UK practice, Specials have a distinct legal and operational meaning. The term is not universal, so international users often search for it alongside named patient or unlicensed supply terminology.
Related terms: Named Patient Programmes, Named Patient Programs, Named Patient Supply, Unlicensed Supply, Individual Import
Related services: Individual Import / Treatment Access Solutions
7. Managed Access Programs
Also known as: managed access programmes, MAPs, controlled access programmes, controlled access programs
Definition: Structured programs designed to provide access to medicines outside routine commercial supply, often under defined medical, regulatory, or reimbursement conditions.
Operational context: The term can cover a range of models, from pre-approval access to post-approval controlled distribution. The key distinction is that supply is organised through a defined framework rather than standard commercial channels.
Related terms: Early Access Programmes, Early Access Programs, Compassionate Use, Patient Access, Market Access
Related services: Managed Access program / Market Access Solutions
8. Unlicensed Supply
Also known as: supply of unlicensed medicines, unlicensed medicines supply, non-commercial supply, pre-authorisation supply
Definition: The compliant supply of medicines that do not hold a local marketing authorisation in the country where they are being used.
Operational context: Unlicensed supply is not a single pathway. It can sit behind named patient, compassionate use, specials, or individual import models depending on the market and product.
Related terms: Named Patient Programmes, Named Patient Programs, Named Patient Supply, Specials, Individual Import, Early Access Programmes
Related services: Treatment Access / Individual Import
9. Unlicensed Medicines
Also known as: unregistered medicines, unauthorised medicines, non-authorised medicines
Definition: Medicines that do not hold a local marketing authorisation in the country where they are supplied or used.
Operational context: The term describes product status rather than a specific access pathway. In practice, supply depends on the legal route available in the relevant market.
Related terms: Unlicensed Supply, Early Access Programs, Early Access Programmes, Named Patient Programs, Named Patient Programmes, Specials
Related services: Treatment Access Solutions
10. Individual Import
Also known as: patient-specific import, import for individual patient use, named patient import
Definition: The regulated import of a medicine for use by a specific patient, typically where no suitable locally available alternative exists.
Operational context: Individual import is usually highly documentation-dependent and linked to physician request, patient need, and local authority requirements. It is often one operational route within broader access models.
Related terms: Named Patient Programmes, Named Patient Programs, Named Patient Supply, Unlicensed Supply, Compassionate Use
Related services: Individual Import / Regulatory Landscape Guidance
11. Patient Access
Also known as: access to treatment, access pathway, therapy access
Definition: The process by which eligible patients are able to receive a medicine or therapy within a given healthcare system.
Operational context: Patient access is broader than unlicensed supply. It may depend on regulatory status, reimbursement, supply routes, local infrastructure, funding mechanisms, and operational readiness.
Related terms: Market Access, Early Access Programmes, Early Access Programs, Managed Access Programmes, Managed Access Programs, Named Patient Programmes, Named Patient Programs, Individual Import
Related services: Patient Support Program / Market Access Solutions
Clinical Trial Supply
Key terminology across investigational products, study materials, and regulated trial execution.
These terms reflect the operational language of clinical trial supply, where protocol requirements, regulatory expectations, and site-level realities must align to keep studies running compliantly and on time.
Terminology varies across sponsors, CROs, regions, and study designs. In practice, the same function may be described in different ways, but the underlying requirement remains the same: controlled, traceable, and reliable trial execution.
1. Investigational Medicinal Product (IMP)
Also known as: investigational medicine, investigational drug, study drug, investigational product, trial drug
Definition: A medicinal product being tested or used as a reference in a clinical trial. This includes newly developed products as well as approved medicines used in a different indication, formulation, packaging, or trial setting.
Operational context: IMP supply depends on protocol alignment, regulatory compliance, packaging and labelling requirements, and reliable delivery to sites across multiple jurisdictions.
Related terms: Comparator, Placebo, Clinical Supply, QP Release, Investigational Product
Related services: Clinical Trial Solutions, CT Consulting
2. Investigational Product
Also known as: IP, investigational medicinal product, study drug, trial product
Definition: A broader term used in clinical research for a product being investigated in a trial. Depending on the study, this may refer to a medicinal product, device, biologic, or combination product.
Operational context: The term is widely used in international clinical operations, but the regulatory meaning may differ depending on whether the study involves medicines, devices, or both.
Related terms: Investigational Medicinal Product (IMP), Diagnostic Medical Devices, Therapeutic Medical Devices
Related services: Clinical Trial Solutions, CT Consulting
3. Comparator
Also known as: comparator drug, reference product, active comparator, reference medicine, comparator product
Definition: A medicinal product used as a reference in a clinical trial to compare safety, efficacy, or other study endpoints against an investigational product.
Operational context: Comparator supply is often shaped by availability, documentation, batch consistency, and sourcing restrictions across different markets.
Related terms: IMP, Placebo, Comparator Sourcing, Clinical Supply
Related services: Comparator Sourcing, Clinical Trial Solutions
4. Comparator Sourcing
Also known as: reference product sourcing, comparator procurement, comparator supply
Definition: The process of identifying, procuring, and documenting comparator products for use in clinical trials.
Operational context: Successful sourcing depends on traceability, market availability, regulatory acceptability, and consistent product selection across countries and study sites.
Related terms: Comparator, Clinical Supply, Packaging and Labelling, Procurement
Related services: Comparator Sourcing
5. Placebo
Also known as: inactive control, placebo control, matched placebo
Definition: A substance or treatment designed to match an active investigational or comparator product in appearance and administration, but without therapeutic effect.
Operational context: Blinding integrity depends on exact matching in presentation, handling, and documentation. Even small inconsistencies can compromise trial validity.
Related terms: IMP, Comparator, Blinding, Packaging and Labelling
Related services: Packaging and Labeling, Clinical Trial Solutions
6. Ancillary Medication
Also known as: ancillary supplies, supportive medication, co-medication, concomitant support medication
Definition: Medicines or related products used alongside investigational treatment to support patient safety, protocol requirements, or study execution.
Operational context: Ancillary medication must align with protocol design, site-level clinical practice, and local regulatory expectations across participating countries.
Related terms: IMP, Clinical Supply, Diagnostic Medical Devices
Related services: Storage and Distribution, Clinical Trial Solutions
7. Clinical Supply
Also known as: clinical trial supply, study supply, trial materials supply, clinical materials supply
Definition: The planning, sourcing, packaging, labelling, storage, distribution, and return management of medicinal products and related materials used in a clinical trial.
Operational context: Clinical supply is shaped by protocol design, country-specific regulation, site requirements, and the need to maintain continuity throughout the study lifecycle.
Related terms: IMP, Comparator, Placebo, QP Release, Clinical Supply Chain, Clinical Trial Materials
Related services: Storage and Distribution, Clinical Trial Solutions
8. Clinical Trial Materials
Also known as: trial materials, study materials, clinical materials
Definition: The products and supporting materials required for the conduct of a clinical trial, including investigational products, comparators, placebos, ancillary items, and related packaging or labelling components.
Operational context: The term is often used broadly in trial operations and may extend beyond medicinal products alone, depending on the design and requirements of the study.
Related terms: Clinical Supply, IMP, Ancillary Medication, Packaging and Labelling
Related services: Storage and Distribution, Packaging and Labeling
9. Clinical Supply Chain
Also known as: trial supply chain, study supply chain, clinical trial logistics
Definition: The network of activities and stakeholders involved in moving clinical trial materials from manufacture or sourcing through to study sites and, where relevant, return or destruction.
Operational context: The clinical supply chain must remain aligned with timelines, temperature requirements, documentation standards, and changing protocol needs across markets.
Related terms: Clinical Supply, Cold Chain, Packaging and Labelling, Returns and Destruction
Related services: Storage and Distribution, CT Consulting
10. Blinding
Also known as: masking, blinded trial design, blinded supply
Definition: A trial design measure used to prevent participants, investigators, or study teams from knowing which treatment has been assigned, in order to reduce bias.
Operational context: Blinding depends not only on study design, but also on exact alignment in packaging, labelling, and presentation across all trial materials.
Related terms: Placebo, Comparator, Packaging and Labelling
Related services: Packaging and Labeling, Clinical Trial Solutions
11. Packaging and Labeling
Also known as: clinical packaging, trial labeling, trial labelling, study labeling, study labelling, clinical trial packaging
Definition: The processes used to prepare medicinal products for compliant identification, handling, and use in clinical trials.
Operational context: Requirements vary by country and study design. Errors in packaging or labeling can affect compliance, site usability, and blinding integrity.
Related terms: IMP, Placebo, Blinding, QP Release
Related services: Packaging and Labeling
12. Qualified Person (QP) Release
Also known as: Qualified Person Release, batch certification, QP certification
Definition: The certification of a medicinal product batch by a Qualified Person to confirm that it has been manufactured and checked in accordance with applicable regulatory requirements.
Operational context: QP Release is a critical control point in clinical supply and may determine whether material can legally move into or within certain markets.
Related terms: IMP, Clinical Supply, GMP, Batch Certification
Related services: Clinical Trial Solutions
13. Batch Certification
Also known as: batch release certification, QP batch certification
Definition: The formal confirmation that a medicinal product batch meets the required standards and can be released for use or supply in accordance with applicable regulations.
Operational context: In some markets or contexts, batch certification is used more broadly than QP Release, but both sit at the point where quality and legal supply readiness intersect.
Related terms: QP Release, GMP, IMP
Related services: Clinical Trial Solutions
Quality and Regulated Distribution
Terminology across quality systems, licensed distribution, and controlled pharmaceutical operations.
These terms reflect the regulatory and operational framework required to maintain product quality, traceability, and compliance across storage, handling, distribution, and lifecycle management.
While some of these concepts are defined in regulation, their practical application depends on how quality systems, documentation, and distribution controls are implemented in real-world supply environments.
1. Good Distribution Practice (GDP)
Also known as: GDP compliance, GDP guidelines, GDP standards, wholesale distribution standards
Definition: The quality standard governing the proper distribution of medicinal products for human use.
Operational context: GDP is designed to protect product quality and integrity throughout storage, transport, and supply. In practice, compliance depends on controlled processes, documentation, trained personnel, and effective oversight across the distribution chain.
Related terms: Responsible Person, Pharmaceutical Wholesaler, Cold Chain, Documentation, Wholesale Distribution Authorisation
Related services: Storage and Distribution, Commercial Solutions
2. Good Manufacturing Practice (GMP)
Also known as: GMP compliance, GMP standards, cGMP, current Good Manufacturing Practice
Definition: The quality standard governing the manufacture of medicinal products to ensure they are consistently produced and controlled to the required quality level.
Operational context: GMP sits upstream of distribution, but it remains closely linked to release, documentation, and product quality throughout the supply chain.
Related terms: QP Release, Batch Certification, Documentation, Recall, GDP
Related services: Clinical Trial Solutions
3. Responsible Person
Also known as: RP, GDP Responsible Person, Responsible Person for GDP
Definition: The person designated under GDP requirements to ensure that pharmaceutical wholesale distribution activities comply with applicable regulations and licence conditions.
Operational context: The Responsible Person plays a central oversight role across quality systems, documentation, training, deviations, and recall readiness within regulated distribution operations.
Related terms: GDP, Pharmaceutical Wholesaler, Recall, Documentation, Wholesale Distribution Authorisation
Related services: Commercial Solutions
4. Pharmaceutical Wholesaler
Also known as: wholesale distributor, licensed wholesaler, pharmaceutical distributor, medicine wholesaler
Definition: An entity authorised to procure, hold, supply, import, export, or distribute medicinal products within a regulated supply chain.
Operational context: Wholesale distribution is not only a logistics function. It operates within a licensed framework that requires traceability, product control, and compliance with GDP and national authority requirements.
Related terms: GDP, Responsible Person, Pre-Wholesale, Controlled Substances, Wholesale Distribution Authorisation
Related services: Commercial Solutions, Treatment Access Solutions
5. Wholesale Distribution Authorisation (WDA)
Also known as: wholesale licence, wholesale dealer authorisation, WDA(H) where applicable
Definition: The regulatory authorisation required in many markets for the wholesale distribution of medicinal products.
Operational context: A WDA confirms that a company is permitted to carry out defined wholesale activities under applicable law. The scope and terminology vary by country, but the concept is central to regulated pharmaceutical distribution.
Related terms: Pharmaceutical Wholesaler, GDP, Responsible Person, Regulatory Authorities
Related services: Commercial Solutions
6. Documentation
Also known as: controlled documentation, quality documentation, records, GMP documentation, GDP documentation
Definition: The system of records, procedures, instructions, and evidence used to support compliant pharmaceutical operations.
Operational context: Documentation underpins traceability, quality control, audit readiness, and regulatory compliance. In regulated supply, what is not documented cannot be reliably demonstrated.
Related terms: GDP, GMP, Recall, Returns and Destruction, QP Release, Quality Assurance
Related services: Clinical Trial Solutions, Commercial Solutions
7. Compliance
Also known as: regulatory compliance, quality compliance, pharmaceutical compliance
Definition: The state of operating in accordance with applicable laws, regulations, licences, standards, and internal procedures.
Operational context: In pharmaceutical operations, compliance is not a single activity. It is the ongoing alignment of quality systems, documentation, people, and processes with regulatory expectations.
Related terms: GDP, GMP, Regulatory Authorities, Documentation, Quality Assurance
Related services: Commercial Solutions
8. Regulatory Authorities
Also known as: competent authorities, health authorities, regulators, medicines authorities
Definition: National or regional bodies responsible for authorising, supervising, and enforcing the legal framework for medicinal products and related operations.
Operational context: Authority expectations vary by market. Effective execution requires understanding not only the regulation itself, but how specific authorities apply and interpret it in practice.
Related terms: Compliance, GDP, GMP, Recall, Controlled Substances, Wholesale Distribution Authorisation
Related services: Regulatory Landscape Guidance, Market Access Consulting
9. Recall
Also known as: product recall, market recall, drug recall, medicine recall
Definition: The removal of a medicinal product from the supply chain or market due to a quality defect, safety concern, or regulatory issue.
Operational context: A recall depends on speed, traceability, clear responsibilities, and effective communication across the supply chain. Readiness is as important as response.
Related terms: Documentation, Responsible Person, Returns and Destruction, Compliance, Quality Assurance
Related services: Commercial Solutions
10. Returns and Destruction
Also known as: compliant returns, product destruction, destruction of medicinal products, pharmaceutical returns
Definition: The controlled return and, where necessary, compliant destruction of medicinal products that are expired, damaged, recalled, or otherwise unsuitable for use.
Operational context: These processes require traceability, documentation, and alignment with both company procedures and local regulatory requirements.
Related terms: Recall, Documentation, GDP, Quality Assurance
Related services: Storage and Distribution, Commercial Solutions
11. Cold Chain
Also known as: temperature-controlled distribution, cold chain logistics, temperature-controlled supply, temperature-controlled logistics
Definition: A controlled supply chain in which products are stored and transported within a defined temperature range to maintain quality and usability.
Operational context: Cold chain control depends on validated packaging, monitoring, handling discipline, and escalation processes for temperature excursions or delays, with contingency planning across the full movement path.
Related terms: GDP, Pre-Wholesale, Documentation, Controlled Substances, Temperature Excursion
Related services: Storage and Distribution
12. Temperature Excursion
Also known as: temperature deviation, cold chain excursion, storage excursion
Definition: A deviation in which a product is exposed to temperatures outside its approved or validated storage or transport range.
Operational context: Temperature excursions require assessment, documentation, and decision-making based on product stability data, quality procedures, and the conditions of the deviation.
Related terms: Cold Chain, Documentation, Quality Assurance, GDP
Related services: Storage and Distribution
13. Quality Assurance (QA)
Also known as: QA, quality system oversight, pharmaceutical QA
Definition: The system of activities used to ensure that pharmaceutical products and operations meet defined quality requirements.
Operational context: Quality assurance links procedures, controls, documentation, training, and deviation handling into a structured system that supports consistent and compliant operations.
Related terms: GMP, GDP, Documentation, Recall, Compliance, Deviation
Related services: Clinical Trial Solutions, Commercial Solutions
14. Deviation
Also known as: quality deviation, process deviation, deviation management
Definition: A departure from an approved procedure, specification, process, or expected condition within a regulated pharmaceutical operation.
Operational context: Deviation handling is a core quality activity. It requires documentation, assessment of impact, root cause investigation where necessary, and defined corrective or preventive action.
Related terms: Quality Assurance, Documentation, Recall, Compliance
Related services: Commercial Solutions
15. Pharmacovigilance (PV)
Also known as: PV, drug safety, safety surveillance
Definition: The science and activities relating to the detection, assessment, understanding, and prevention of adverse effects or other medicine-related problems.
Operational context: Pharmacovigilance sits alongside quality and regulatory systems as a core part of compliant product oversight. In practice, it depends on timely reporting, clear responsibilities, documented processes, and alignment with local authority requirements.
Related terms: Adverse Event, Serious Adverse Event, Adverse Drug Reaction, Regulatory Authorities, Compliance
Related services: Patient Support Program
16. Adverse Event (AE)
Also known as: AE, adverse experience
Definition: Any untoward medical occurrence in a patient or clinical trial subject who has been administered a medicinal product, whether or not it is considered related to that product.
Operational context: Adverse event reporting requires clear capture, escalation, and documentation pathways. In regulated environments, speed and accuracy are critical.
Related terms: Pharmacovigilance, Serious Adverse Event, Adverse Drug Reaction
Related services: Patient Support Program
17. Serious Adverse Event (SAE)
Also known as: SAE, serious event
Definition: An adverse event that results in death, is life-threatening, requires hospitalisation or prolongation of hospitalisation, results in significant disability, or is otherwise medically important.
Operational context: SAEs require urgent assessment and reporting within defined timelines. The exact reporting pathway depends on study type, product status, and local regulatory requirements.
Related terms: Adverse Event, Pharmacovigilance, Adverse Drug Reaction
Related services: Patient Support Program
18. Adverse Drug Reaction (ADR)
Also known as: ADR, adverse reaction
Definition: A harmful and unintended response to a medicinal product where a causal relationship between the product and the event is at least a reasonable possibility.
Operational context: ADR assessment sits at the intersection of medical review, product knowledge, and reporting obligations. Not every adverse event is an adverse drug reaction, but the distinction is operationally important.
Related terms: Adverse Event, Serious Adverse Event, Pharmacovigilance
Related services: Patient Support Program
Product and Therapy Categories
Terminology across specialised product types, advanced therapies, and complex treatment categories.
These terms reflect the products and therapy types that carry distinct regulatory, handling, and access requirements across clinical and commercial settings.
In practice, product category is not just a scientific classification. It often determines how a therapy is sourced, stored, transported, administered, and made accessible across markets.
1. Advanced Therapy Medicinal Products (ATMPs)
Also known as: advanced therapies, advanced therapy medicines, cell and gene therapy, CGT where commonly used
Definition: Medicinal products based on genes, cells, or engineered tissues, including gene therapies, somatic cell therapies, and tissue-engineered products.
Operational context: ATMPs operate under specialised regulatory frameworks and often require strict control over identity, timing, storage conditions, and site readiness.
Related terms: Cell Therapy, Gene Therapy, Cold Chain, Chain of Identity
Related services: Clinical Trial Solutions, Market Access Solutions
2. Cell Therapy
Also known as: cell-based therapy, somatic cell therapy, cell and gene therapy where used collectively
Definition: A therapeutic approach based on the administration of living cells to repair, replace, or modify biological function.
Operational context: Cell therapies often require tightly controlled handling, rapid execution, and precise coordination between manufacturing, logistics, and clinical administration.
Related terms: ATMPs, Gene Therapy, Cold Chain
Related services: Clinical Trial Solutions
3. Gene Therapy
Also known as: gene-based therapy, genetic therapy, cell and gene therapy where used collectively
Definition: A therapeutic approach that modifies, replaces, or introduces genetic material to treat or prevent disease.
Operational context: Gene therapies often involve complex manufacturing, strict handling requirements, and highly controlled supply pathways linked to specific treatment centres.
Related terms: ATMPs, Cell Therapy, Cold Chain
Related services: Clinical Trial Solutions
4. Biologics
Also known as: biological medicines, biologic therapies, biologic drugs, biopharmaceuticals
Definition: Medicinal products derived from living organisms or biological processes, including monoclonal antibodies, recombinant proteins, and other complex therapies.
Operational context: Biologics often require temperature-controlled handling, careful supply planning, and alignment with specialised administration settings.
Related terms: Biosimilars, Cold Chain, Orphan Drugs
Related services: Clinical Trial Solutions, Commercial Solutions
5. Biosimilars
Also known as: biosimilar medicines, biosimilar biologics, biosimilar products
Definition: Biological medicines shown to be highly similar to an already approved reference biologic, with no clinically meaningful differences in safety, purity, or potency.
Operational context: Biosimilar uptake depends not only on approval, but also on stakeholder confidence, reimbursement conditions, switching practices, and structured integration into clinical practice.
Related terms: Biologics, Market Access, Branded Drugs
Related services: Market Access Consulting, Market Access Solutions
6. Orphan Drugs
Also known as: orphan medicines, orphan medicinal products, rare disease drugs, ultra-orphan drugs
Definition: Medicinal products developed for the diagnosis, prevention, or treatment of rare diseases affecting small patient populations.
Operational context: Orphan drugs often involve fragmented access pathways, limited supply, and highly individualised patient journeys that require close coordination across stakeholders.
Related terms: Market Access, Patient Access, ATMPs
Related services: Managed Access Program, Market Access Solutions
7. Controlled Substances
Also known as: controlled drugs, controlled medicines, narcotics, psychotropics
Definition: Medicinal products subject to additional legal controls because of their risk of misuse, dependence, or diversion.
Operational context: These products require enhanced documentation, secure storage, restricted access, and close alignment with national authority requirements.
Related terms: Regulatory Authorities, GDP, Pharmaceutical Wholesaler, Compliance, Documentation
Related services: Storage and Distribution, Treatment Access Solutions
8. Diagnostic Medical Devices
Also known as: diagnostic devices, companion diagnostics, in vitro diagnostics where relevant, IVDs where applicable
Definition: Devices or tests used to identify, stratify, or monitor patients before or during treatment.
Operational context: Their role often extends beyond supply. Successful use depends on integration into clinical workflows, data processes, and treatment decision pathways.
Related terms: Therapeutic Medical Devices, Clinical Supply, Packaging and Labelling
Related services: Clinical Trial Solutions
9. Therapeutic Medical Devices
Also known as: treatment devices, therapeutic devices, treatment-enabling devices
Definition: Medical devices used to deliver treatment through mechanical, physical, or digital means.
Operational context: Implementation often requires coordination across logistics, training, site readiness, and patient-facing care pathways.
Related terms: Diagnostic Medical Devices, Clinical Supply, Market Access
Related services: Market Access Solutions, Clinical Trial Solutions
10. Nutraceuticals
Also known as: nutritional products, functional nutrition products, supplements where locally applicable, nutraceutical products
Definition: Products derived from food sources that provide nutritional or wellness-related value beyond basic dietary intake.
Operational context: Their classification and permitted use vary by market. In regulated settings, their role depends on local law, intended application, and how they fit within broader care or support pathways.
Related terms: Patient Access, Market Access, Commercial Distribution
Related services: Commercial Solutions
11. Veterinary Drugs
Also known as: veterinary medicines, animal health products, veterinary medicinal products
Definition: Medicinal products used for the prevention, diagnosis, or treatment of diseases in animals.
Operational context: Veterinary products are governed by separate regulatory frameworks and distribution channels from human medicines, which can significantly affect sourcing and supply models.
Related terms: Regulatory Authorities, Pharmaceutical Wholesaler
Related services: Commercial Solutions
Commercial and Market Access Language
Terminology across approval, launch, reimbursement, and post-authorisation supply.
These terms reflect the commercial and access-related frameworks that determine how a product moves from authorisation into real-world use.
In practice, commercial availability is shaped not only by approval status, but also by pricing, reimbursement, distribution structure, and local market conditions.
1. Marketing Authorisation Holder (MAH)
Also known as: MAH, licence holder, authorization holder, marketing authorization holder, marketing authorisation holder
Definition: The legal entity that holds the marketing authorisation for a medicinal product in a given market.
Operational context: The MAH carries responsibility for the product’s legal status, compliance obligations, and lifecycle management in the relevant jurisdiction.
Related terms: Market Launch, Market Access, Pharmaceutical Wholesaler, Regulatory Authorities
Related services: Partnering, Commercial Solutions
2. Market Access
Also known as: reimbursement access, payer access, access strategy, pricing and reimbursement
Definition: The set of processes that determine how a medicine becomes available and funded within a healthcare system after regulatory approval or as part of a structured access pathway.
Operational context: Market access sits at the intersection of regulation, pricing, reimbursement, and implementation. Approval alone does not guarantee that a therapy will reach patients in practice.
Related terms: Patient Access, Managed Access Programmes, Early Access Programmes, Market Launch, MAH, Reimbursement, Pricing and Reimbursement
Related services: Market Access Consulting, Market Access Solutions
3. Pricing and Reimbursement
Also known as: P&R, reimbursement strategy, pricing strategy, payer reimbursement
Definition: The framework through which a medicine is priced and assessed for funding within a healthcare system.
Operational context: Pricing and reimbursement decisions often determine whether approved products can achieve practical uptake. They are shaped by national policy, payer expectations, clinical value, and market dynamics.
Related terms: Market Access, Reimbursement, Patient Access, Market Launch
Related services: Market Access Consulting
4. Market Launch
Also known as: product launch, commercial launch, market introduction, launch readiness
Definition: The first commercial introduction of a medicinal product into a market following approval or completion of required access preparations.
Operational context: Launch readiness depends on more than approval. Distribution setup, documentation, local regulatory requirements, and supply continuity all affect whether a product can enter the market effectively.
Related terms: MAH, Market Access, Commercial Distribution, Pre-Wholesale, Reimbursement
Related services: Fostering, Commercial Solutions
5. Commercial Distribution
Also known as: commercial supply, post-approval distribution, post-authorisation supply
Definition: The regulated supply of approved medicinal products through standard commercial channels after authorisation.
Operational context: Commercial distribution must align with product status, market structure, customer channels, and local wholesale requirements to ensure continuity and compliance.
Related terms: Pharmaceutical Wholesaler, Pre-Wholesale, Market Launch, GDP
Related services: Commercial Solutions, Partnering
6. Pre-Wholesale
Also known as: pre-wholesaling, pre-wholesale services, pre-wholesale distribution
Definition: The storage and handling of medicinal products between manufacture and onward distribution into wholesale or commercial channels.
Operational context: Pre-wholesale is a controlled stage in the supply chain that supports product readiness, traceability, and compliant onward distribution.
Related terms: Commercial Distribution, GDP, Pharmaceutical Wholesaler, Cold Chain
Related services: Commercial Solutions
7. Branded Drugs
Also known as: branded medicines, originator medicines, innovator products, originator drugs
Definition: Medicinal products approved for clinical use and marketed under a proprietary brand, usually while protected by intellectual property rights.
Operational context: Commercial strategy for branded products often depends on market timing, reimbursement conditions, competition, lifecycle stage, and regional payer dynamics.
Related terms: Generics, Biosimilars, Market Launch, Market Access, MAH
Related services: Fostering, Commercial Solutions
8. Generics
Also known as: generic medicines, generic drugs, multisource products
Definition: Medicinal products containing the same active substance as a reference product and demonstrating bioequivalence after patent expiry.
Operational context: Generic market access is influenced by substitution rules, procurement models, pricing pressure, reimbursement logic, continuity requirements, and local prescribing dynamics.
Related terms: Branded Drugs, Market Access, Pharmaceutical Wholesaler, Procurement
Related services: Commercial Solutions
9. Reimbursement
Also known as: payer funding, reimbursement approval, coverage, formulary access where relevant
Definition: The mechanism by which a healthcare system, insurer, or payer agrees to fund the cost of a medicine or therapy.
Operational context: Reimbursement is often the key gate between approval and practical access. Delays or restrictions at this stage can limit uptake even after regulatory authorisation.
Related terms: Market Access, Pricing and Reimbursement, Patient Access, Market Launch
Related services: Market Access Consulting
10. Consignment Stock
Also known as: consignment inventory, vendor-owned stock, consignment supply
Definition: A supply model in which products are stored at or near the point of use, while ownership remains with the supplier until the product is used or sold.
Operational context: In pharmaceutical settings, consignment stock can support responsiveness and continuity, but it must operate within clear quality, traceability, and contractual controls.
Related terms: Commercial Distribution, Pre-Wholesale, Pharmaceutical Wholesaler
Related services: Commercial Solutions
11. Procurement
Also known as: sourcing, purchasing, supply procurement, pharmaceutical procurement
Definition: The process of acquiring products or services in line with operational, quality, regulatory, and commercial requirements.
Operational context: In regulated pharmaceutical supply, procurement is shaped not only by price and availability, but also by product status, documentation, and market-specific restrictions.
Related terms: Comparator Sourcing, Pharmaceutical Wholesaler, Market Access, Generics
Related services: Comparator Sourcing, Commercial Solutions