The term medicinal product is central to pharmaceutical regulation, but its legal definition and scope vary across regulatory jurisdictions. The European Union and the Eurasian Economic Union use the term as a defined legal concept, while other regulatory systems employ related terms such as medicine or drug.
Definition and Regulatory Context
A medicinal product is generally understood as a substance or combination of substances intended for use in the prevention or treatment of disease, diagnosis, or modification of physiological functions. However, this general description should not be treated as a universal legal definition. The precise scope of the term depends on the applicable legislation and regulatory framework.
The definitions below are taken from official regulatory and international sources. Their wording and legal scope are not necessarily equivalent.
Official Definitions and Regulatory Sources
1. European Union — Medicinal Product
Source: Directive 2001/83/EC on the Community code relating to medicinal products for human use
Reference: Title I, Article 1(2)
Under EU legislation, the term medicinal product covers two categories:
- Presentation criterion: Any substance or combination of substances presented as having properties for treating or preventing disease in human beings.
- Function criterion: Any substance or combination of substances which may be used in or administered to human beings either with a view to restoring, correcting or modifying physiological functions by exerting a pharmacological, immunological or metabolic action, or to making a medical diagnosis.
Official source: Directive 2001/83/EC — EUR-Lex
2. Eurasian Economic Union — Medicinal Product
Source: Agreement on Common Principles and Rules for the Circulation of Medicinal Products within the Eurasian Economic Union, 23 December 2014
Reference: Article 1
The Agreement defines a medicinal product as a substance or combination of substances that comes into contact with the human body, intended for the prevention or treatment of human diseases, or for the restoration, correction or modification of physiological functions through pharmacological, immunological or metabolic action, or for medical diagnosis.
The EAEU regulatory framework also distinguishes between a medicinal product and a pharmaceutical preparation. A pharmaceutical preparation is a medicinal product in a particular dosage form intended for use.
Official source: Eurasian Economic Commission — Legal Acts
3. World Health Organization — Medicine
Source: WHO Prequalification Programme Glossary
Reference: Entry “Medicine”
WHO defines a medicine as any substance or pharmaceutical product for human or veterinary use that is intended to modify or explore physiological systems or pathological states for the benefit of the recipient.
This definition is broader in scope than some national legal definitions and explicitly covers both human and veterinary use.
Official source: WHO Prequalification — Glossary
4. United States — Drug
Source: Federal Food, Drug, and Cosmetic Act (FD&C Act)
Reference: Section 201(g)(1), 21 U.S.C. § 321(g)(1)
US federal legislation uses the term drug rather than medicinal product. The statutory definition includes articles recognised in the official United States Pharmacopoeia, National Formulary or their supplements; articles intended for use in the diagnosis, cure, mitigation, treatment or prevention of disease; and articles intended to affect the structure or any function of the human or other animal body.
The definition also covers components of such articles.
Official source: 21 U.S.C. § 321 — Definitions
5. European Medicines Agency — Medicinal Product
Source: European Medicines Agency (EMA) Glossary
EMA describes a medicinal product within the framework established by EU pharmaceutical legislation: a substance or combination of substances intended for treating or preventing disease, making a medical diagnosis, or restoring, correcting or modifying physiological functions through pharmacological, immunological or metabolic action.
Official source: EMA Glossary — Medicinal Product
6. European Pharmacopoeia — Pharmaceutical Preparations
Source: European Pharmacopoeia, General Monograph 2619 — Pharmaceutical Preparations
The European Pharmacopoeia addresses the concept of pharmaceutical preparations, which concerns medicinal products in their formulated dosage forms. This is a more specific pharmaceutical and quality-related concept and should not be treated as a direct equivalent of the broader legal term medicinal product.
Source organisation: European Directorate for the Quality of Medicines & HealthCare (EDQM).
Official website: EDQM — European Directorate for the Quality of Medicines & HealthCare
Related Terminology in International Regulatory Frameworks
Several related terms are used in pharmaceutical legislation, regulatory guidance and quality standards. Although they may refer to overlapping concepts, they are not always interchangeable.
- Medicinal product: The principal legal term used in EU and EAEU pharmaceutical legislation.
- Medicine: A term commonly used by WHO and in international public health contexts.
- Drug: The statutory term used in US federal legislation.
- Pharmaceutical preparation: A term used in the European Pharmacopoeia to describe formulated medicinal products.
- Drug product: A term used in ICH quality guidance. In ICH Q7, it refers to the dosage form in the final immediate packaging intended for marketing.
The ICH term drug product therefore has a more specific manufacturing and quality context and should not automatically be used as a synonym for the broader legal term medicinal product.
Reference: ICH Q7 — Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients
Regulatory Significance
The distinction between these terms has practical implications throughout the pharmaceutical product lifecycle. The applicable definition may determine:
- whether a product falls within the scope of medicinal product legislation;
- which authorisation or registration procedures apply;
- which manufacturing, quality and GMP requirements must be followed;
- how the product is classified for regulatory assessment and market access;
- which terminology should be used in regulatory submissions and technical documentation.
For companies operating across several jurisdictions, it is particularly important to distinguish between the terminology used in EU, EAEU and US legislation and the broader terminology found in international guidance.
Editorial Note
The definitions presented in this entry are drawn from the cited regulatory and international sources. They should be interpreted within the context of the relevant legal framework. Where a precise legal meaning is required, the original legislation or official document takes precedence over general terminology descriptions.
