Glossary for Medicinal Product
The following definitions and abbreviations apply to this document:
Term | Definition |
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Active immunity | The usually long lasting immunity which results from the production of antibodies by the immune system within an organism in response to the presence of an antigen. |
Active ingredient substance | The substance that provides the intended therapeutic effect of the medicinal product; described usually, but not always, without modifiers such as esters, salts or other non-covalent derivatives. |
Active moiety | The molecule or ion, excluding those appended portions of the molecule that cause the drug to be an ester, salt (including a salt with hydrogen or coordination bonds), or other noncovalent derivative (such as a complex, chelate, or clathrate) of the molecule, responsible for the physiological or pharmacological action of the drug substance. |
Adjuvant | A substance added to a vaccine to enhance the immune response by degree and/or duration, making it possible to reduce the amount of immunogen per dose or the total number of doses needed to achieve immunity. Often aluminium salts (e.g. aluminium hydroxide, aluminium phosphate or potassium aluminium sulfate), which primarily enhance the immune response to proteins. |
Administrable dose form | The (pharmaceutical) dose form of a medicinal product for administration to a patient, after any necessary transformation (from the manufactured dose form) has been carried out. |
Adsorption | The adhesion of atoms, ions, or molecules from a gas, liquid, or dissolved solid to a surface. Similar to surface tension, adsorption is a consequence of surface energy. Atoms on the surface of the adsorbent are not wholly surrounded by other adsorbent atoms and therefore can attract adsorbates (the substance that is adsorbed - in vaccines, the antigen). Aluminium salts (e.g. aluminium hydroxide, aluminium phosphate or potassium aluminium sulfate) are absorbents in vaccine products; the adsorbent is acting as an adjuvant. |
Antibody | An immunoglobulin molecule produced by B lymphoid cells with a specific amino acid sequence evoked in humans or other animals by an antigen. |
Antigen | A substance that, as a result of coming into contact with appropriate cells, induces a state of sensitivity and/or immune responsiveness after a latent period (days to weeks) and that reacts in a demonstrable way with antibodies and/or immune cells of the sensitized subject in vivo or in vitro. [Stedman's Medical Dictionary]. |
BAN | British Approved Name |
Basis of Strength Substance (BoSS) | The substance that is the part of the ingredient that the strength of a given product is based upon; the substance against which the strength quantity of a medicinal product is measured. It may be a base, primary modified base, or secondary modified base. |
BoSS | see Basis of Strength Substance |
CDC | Centers for Disease Control and Prevention; CDC is a major operating component of the United States Department of Health and Human Services. https://www.cdc.gov/ |
Clinical drug (CD) | Clinical Drug; A representation of a medicinal product based on description of
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Combination Grouper | A concept grouping together medicinal products based on both the chemical structure and behavior (mechanism of action) of their active ingredient substance(s) |
Composite product | Product that contains more than one single or multiple ingredient product packaged together.
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Concentration strength | A type of strength description where the amount of the basis of strength substance (BoSS) present per unitary amount (volume, mass) of the single clinical drug being represented. |
Conjugate vaccine | Conjugate vaccines combine a weak antigen with a strong antigen (usually a protein/peptide carrier) so that the immune system has a stronger response to the weak antigen. Conjugation is usually used for polysaccharide antigens, because polysaccharide antigens on their own produce only a B cell response (they are not whole cells, just pieces of pathogen cell wall). The conjugated peptide stimulate T cells which gives a more vigorous immune response and also promotes a more rapid and long-lasting immunologic memory (e.g Haemophilus influenzae type b conjugate vaccine, meningococcal conjugate vaccine). The carrier protein may be the diphtheria toxoid or the tetanus toxoid. |
CVX code | The "vaccine administered" code set developed and maintained by the CDC's National Center of Immunization and Respiratory Diseases. When paired with a MVX (manufacturer) code, the specific trade named vaccine may be indicated. Each code is associated with a status indicating its availability in the United States (e.g. Active, Inactive, Non-US). https://www2a.cdc.gov/vaccines/iis/iisstandards/vaccines.asp?rpt=cvx |
Disposition | A behavior that an active ingredient will exhibit or participate in, given the appropriate context
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Disposition Grouper | A concept grouping together medicinal products based on the behaviour (mechanism of action) of their active ingredient substance(s) |
Dose form (Pharmaceutical dose form) | The physical manifestation or formulation of a medicinal product that contains the active ingredient substance(s) intended to be delivered to a patient; the pharmaceutical dose form may be a manufactured dose form or an administrable dose form |
GTIN | Global Trade Item Number |
Hapten | A molecule that is incapable alone of causing the production of antibodies but can, however, combine with a larger antigenic molecule, called a carrier, to form an antigenic complex (see hapten-carrier complex). [Stedman's Medical Dictionary, adapted] |
Hapten-carrier complex | An association between a hapten molecule and an antigen molecule that can stimulate production of antibodies, some of which combine with the hapten portion of the complex. [Stedman's Medical Dictionary, adapted] |
Herbal medicine product | Herbal medicines include herbs, herbal materials, herbal preparations and finished herbal products, that contain as active ingredients parts of plants, or other plant materials, or combinations. http://www.who.int/medicines/areas/traditional/definitions/en/ |
Homeopathic product | An alternative approach to medicine based on the belief that natural substances, prepared in a special way and used most often in very small amounts, restore health. According to these beliefs, in order for a remedy to be effective, it must cause in a healthy person the same symptoms being treated in the patient. https://www.nhs.uk/conditions/homeopathy/#what-is-homeopathy |
IDMP | Identification of Medicinal Products; a set of five standards developed by the International Organization for Standardization (ISO) for the identification of medicinal products, primarily within the regulatory domain of use
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Immunogen | A complete antigen (i.e. can evoke the production of antibodies). Synonym for antigen except that it is sometimes used without the specificity of the serotype (e.g. no statement of valency) whereas an antigen should have the valency specified. |
Immunoglobulin | A class of polypeptide chain proteins in two pairs (one light, one heavy); antibodies are immunoglobulins and most immunoglobulins function as antibodies. The class of immunoglobulins also includes pathological proteins such as Bence Jones or myeloma globulins. |
Inactivated vaccine product | A vaccine product whose antigenic content consists of the disease-causing pathogen that has been inactivated ("killed") usually by heat or by chemicals such as formaldehyde. The pathogen cannot replicate itself at all, but it is still intact and can therefore evoke antibody production (example: polio vaccine). |
INN | see International Nonproprietary Name |
International Nonproprietary Name | INNs facilitate the identification of pharmaceutical substances or active pharmaceutical ingredients. Each INN is a unique name that is globally recognized and is public property. A nonproprietary name is also known as a generic name. For more information: http://www.who.int/medicines/services/inn/en/ To search for INNs: https://mednet-communities.net/inn/db/searchinn.aspx |
Intimate container | The receptacle or vessel used to contain (or bound) liquid medicinal products into countable entities |
Live attenuated vaccine product | A vaccine product whose antigenic content is derived from the disease-causing pathogen but which has been altered to make it less virulent. The pathogen in a live attenuated vaccine has lost its ability to replicate in human cells but still viable to evoke antibody production (e.g. measles, mumps, and rubella vaccine, varicella vaccine). |
Manufactured dose form | The (pharmaceutical) dose form of a medicinal product as it is presented by the manufacturer into the supply chain, before any transformation into an administrable dose form |
Monovalent vaccine | A vaccine product that contains a single antigenic serotype |
Medicinal Product (MP) | An abstract representation of a medicinal product based on description of active ingredient substance(s) that it contains (regardless of any modification of those active ingredient substance(s)), but not exclusively limited by those substances, in that other substances may be present |
Medicinal Product Form (MPF) | An abstract representation of a medicinal product based on description of active ingredients it contains, but not limited by that description, and on the (generalised) intended site of use for the product |
Medicinal Product only (MP only) | An abstract representation of a medicinal product based on description of only and exclusively the active ingredient substance(s) that it contains but regardless of any modification of those active ingredient substance(s) |
Medicinal Product precisely (MP precisely) | An abstract representation of a medicinal product based on description of only and exclusively the precise active ingredients it contains |
Medicinal Product Form Only (MPF only) | An abstract representation of a medicinal product based on description of only and exclusively the active ingredient(s) it contains and on the (generalised) intended site of use for the product |
Multiple ingredient product | Product that contains more than one active ingredient in a single manufactured dose form
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MVX Code | The "Manufacturers of vaccines" code set developed and maintained by the CDC's National Center of Immunization and Respiratory Diseases. When paired with a CVX (vaccine administered) code, the specific trade named vaccine may be indicated. Each code is associated with a status indicating if the manufacturer is currently making vaccines for distribution in the United States (e.g. Active, Inactive). https://www2a.cdc.gov/vaccines/iis/iisstandards/vaccines.asp?rpt=mvx |
Packaged Clinical Drug (PCD) | The class “below” Clinical Drug in the national extension model; An abstract representation of a medicinal product as it is supplied in a package for placement into the supply chain, based on description of and quantity of the clinical drug(s) contained within that package |
Passive immunity | The time limited, usually short lived, immunity acquired by direct transference of antibodies into an organism (e.g. by injection of immunoglobulin) |
Polyvalent vaccine | A vaccine product that contains multiple antigenic serotypes; the number of which may be stated (e.g. tetravalent (4), pentavalent (5)) |
Precise active ingredient | The actual active ingredient that is contained in the product; The substance that provides the therapeutic effect of the medicinal product, described using the fullest and most specific description of the substance as it is used in the product(s) being represented. This may include various modifiers, such as salts, esters, polymers (e.g. pegylation), and/or solvates. |
Presentation strength | A type of strength description where the amount of the basis of strength substance present in the unit of presentation of or in the volume (or mass) of the single clinical drug being represented |
Real Clinical Drug (RCD) | The representation of a medicinal product marketed by a by a single organisation (supplier) in a single jurisdiction under a single name and which contains the same set precise active ingredient substances and strengths in a single manufactured dose form |
Real Medicinal Product (RMP) | The representation of a medicinal product marketed by a single organisation (supplier) in a single jurisdiction under a single name (which may be a trade or brand name) and which contains the same set of active ingredient substances, regardless of any modification of those active ingredient substances |
Real Packaged Clinical Drug (RPCD) | The representation of a medicinal product as it is supplied in a package, by a single organisation (supplier), in a single jurisdiction, under a single name, for placement into the supply chain |
Serotype | A subdivision of a species or subspecies distinguishable from other strains therein on the basis of antigenicity [Stedman's Medical Dictionary] |
Single ingredient product | Product that contains one and only one active ingredient in a single manufactured dose form
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Subunit vaccine | A vaccine product whose antigenic content is a target part of a pathogen (e.g. a specific protein from the pathogen) rather than the whole pathogen, produced either by isolation from the pathogen or by recombinant technology |
Structural Grouper | A concept grouping together medicinal products based on the chemical structure of their active ingredient substance(s) |
Therapeutic Role Grouper | A concept grouping together medicinal products based on a broad description of their use in treatment of disease |
Toxoid | A vaccine product whose antigenic content is a toxin produced by a pathogen that has been treated, commonly with formaldehyde, so as to destroy its toxic property but retain its antigenicity (i.e. its capability of stimulating the production of antitoxin antibodies and thus of producing an active immunity). |
Traditional medicine product | Traditional medicine is the sum total of the knowledge, skills, and practices based on the theories, beliefs, and experiences indigenous to different cultures, whether explicable or not, used in the maintenance of health as well as in the prevention, diagnosis, improvement or treatment of physical and mental illness. https://www.who.int/traditional-complementary-integrative-medicine/en/ |
UCUM | Unified Code for Units of Measure; http://unitsofmeasure.org/trac |
Unit of Presentation (UoP) | A qualitative concept that describes a countable entity in which the clinical drug is presented, or in which it is bounded; the denominator concept in presentation type Clinical Drugs |
USAN | United States Adopted Name |
Vaccine | Any preparation intended for active immunologic prophylaxis (e.g. preparation of killed microns of virulent strains or living microbes of attenuated (variant or mutant) strain; or microbial, fungal, plant, protozoal or metazoan derivatives or products. [Stedman's Medical Dictionary] Originally only applied to live vaccine (vaccinia, cowpox) virus inoculated in the skin as prophylaxis against smallpox and obtained from the skin of calves inoculated with seed virus. |
Vaccine pharmacovigilance | Vaccine pharmacovigilance is defined by the WHO as "the science and activities relating to the detection, assessment, understanding and communication of adverse events following immunization and other vaccine- or immunization-related issues, and to the prevention of untoward effects of the vaccine or immunization". https://www.who.int/vaccine_safety/initiative/tools/CIOMS_report_WG_vaccine.pdf |
Vaccine valency Antigenic valency | The number of antigenic serotypes present in a vaccine product |
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