European Medicines Regulatory Network (EMRN) Electronic Product Information (ePI) Implementation Guide
1.0.0 - ci-build

European Medicines Regulatory Network (EMRN) Electronic Product Information (ePI) Implementation Guide - Local Development build (v1.0.0) built by the FHIR (HL7® FHIR® Standard) Build Tools. See the Directory of published versions

ValueSet: 06 CAP Code Value Set

Official URL: http://ema.europa.eu/fhir/ValueSet/EUepicapqrdcodesVs Version: 1.0.0
Active as of 2025-04-02 Computable Name: EUepicapqrdcodesVs

List of section codes allowed in Centrally Authorised Product (CAP) medicine documents, defined in EMA's Referentials Management Service.

References

Logical Definition (CLD)

Generated Narrative: ValueSet EUepicapqrdcodesVs

 

Expansion

Generated Narrative: ValueSet

Expansion done internally based on codesystem 02 Section Code System v1.0.0 (CodeSystem)

This value set contains 134 concepts

CodeSystemDisplay
  000000000000http://ema.europa.eu/fhir/CodeSystem/200000029659Code for custom sub-sections (reserved)
  200000029791http://ema.europa.eu/fhir/CodeSystem/200000029659SUMMARY OF PRODUCT CHARACTERISTICS
  200000029792http://ema.europa.eu/fhir/CodeSystem/2000000296591. NAME OF THE MEDICINAL PRODUCT
  200000029793http://ema.europa.eu/fhir/CodeSystem/2000000296592. QUALITATIVE AND QUANTITATIVE COMPOSITION
  200000029794http://ema.europa.eu/fhir/CodeSystem/2000000296592.1 General description
  200000029795http://ema.europa.eu/fhir/CodeSystem/2000000296592.2 Qualitative and quantitative composition
  200000029796http://ema.europa.eu/fhir/CodeSystem/200000029659Excipient(s) with known effect
  200000029797http://ema.europa.eu/fhir/CodeSystem/2000000296593. PHARMACEUTICAL FORM
  200000029798http://ema.europa.eu/fhir/CodeSystem/2000000296594. CLINICAL PARTICULARS
  200000029799http://ema.europa.eu/fhir/CodeSystem/2000000296594.1 Therapeutic indications
  200000029800http://ema.europa.eu/fhir/CodeSystem/2000000296594.2 Posology and method of administration
  200000029801http://ema.europa.eu/fhir/CodeSystem/200000029659Posology
  200000029802http://ema.europa.eu/fhir/CodeSystem/200000029659Paediatric population
  200000029803http://ema.europa.eu/fhir/CodeSystem/200000029659Method of administration
  200000029804http://ema.europa.eu/fhir/CodeSystem/200000029659Precautions to be taken before handling or administering the medicinal product
  200000029805http://ema.europa.eu/fhir/CodeSystem/2000000296594.3 Contraindications
  200000029806http://ema.europa.eu/fhir/CodeSystem/2000000296594.4 Special warnings and precautions for use
  200000029807http://ema.europa.eu/fhir/CodeSystem/200000029659Traceability
  200000029808http://ema.europa.eu/fhir/CodeSystem/200000029659Paediatric population
  200000029809http://ema.europa.eu/fhir/CodeSystem/2000000296594.5 Interaction with other medicinal products and other forms of interaction
  200000029810http://ema.europa.eu/fhir/CodeSystem/200000029659Paediatric population
  200000029811http://ema.europa.eu/fhir/CodeSystem/2000000296594.6 Fertility, pregnancy and lactation
  200000029812http://ema.europa.eu/fhir/CodeSystem/200000029659Pregnancy
  200000029813http://ema.europa.eu/fhir/CodeSystem/200000029659Breast-feeding
  200000029814http://ema.europa.eu/fhir/CodeSystem/200000029659Fertility
  200000029815http://ema.europa.eu/fhir/CodeSystem/2000000296594.7 Effects on ability to drive and use machines
  200000029816http://ema.europa.eu/fhir/CodeSystem/2000000296594.8 Undesirable effects
  200000029817http://ema.europa.eu/fhir/CodeSystem/200000029659Paediatric population
  200000029818http://ema.europa.eu/fhir/CodeSystem/200000029659Reporting of suspected adverse reactions
  200000029819http://ema.europa.eu/fhir/CodeSystem/2000000296594.9 Overdose
  200000029820http://ema.europa.eu/fhir/CodeSystem/200000029659Paediatric population
  200000029821http://ema.europa.eu/fhir/CodeSystem/2000000296595. PHARMACOLOGICAL PROPERTIES
  200000029822http://ema.europa.eu/fhir/CodeSystem/2000000296595.1 Pharmacodynamic properties
  200000029823http://ema.europa.eu/fhir/CodeSystem/200000029659Mechanism of action
  200000029824http://ema.europa.eu/fhir/CodeSystem/200000029659Pharmacodynamic effects
  200000029825http://ema.europa.eu/fhir/CodeSystem/200000029659Clinical efficacy and safety
  200000029826http://ema.europa.eu/fhir/CodeSystem/200000029659Paediatric population
  200000029827http://ema.europa.eu/fhir/CodeSystem/2000000296595.2 Pharmacokinetic properties
  200000029828http://ema.europa.eu/fhir/CodeSystem/200000029659Absorption
  200000029829http://ema.europa.eu/fhir/CodeSystem/200000029659Distribution
  200000029830http://ema.europa.eu/fhir/CodeSystem/200000029659Biotransformation
  200000029831http://ema.europa.eu/fhir/CodeSystem/200000029659Elimination
  200000029832http://ema.europa.eu/fhir/CodeSystem/200000029659Linearity/non-linearity
  200000029833http://ema.europa.eu/fhir/CodeSystem/200000029659Pharmacokinetic/pharmacodynamic relationship(s)
  200000029834http://ema.europa.eu/fhir/CodeSystem/2000000296595.3 Preclinical safety data
  200000029835http://ema.europa.eu/fhir/CodeSystem/200000029659Environmental risk assessment (ERA)
  200000029836http://ema.europa.eu/fhir/CodeSystem/2000000296596. PHARMACEUTICAL PARTICULARS
  200000029837http://ema.europa.eu/fhir/CodeSystem/2000000296596.1 List of excipients
  200000029838http://ema.europa.eu/fhir/CodeSystem/2000000296596.2 Incompatibilities
  200000029839http://ema.europa.eu/fhir/CodeSystem/2000000296596.3 Shelf life
  200000029840http://ema.europa.eu/fhir/CodeSystem/2000000296596.4 Special precautions for storage
  200000029841http://ema.europa.eu/fhir/CodeSystem/2000000296596.5 Nature and contents of container [and special equipment for use, administration or implantation]
  200000029842http://ema.europa.eu/fhir/CodeSystem/2000000296596.6 Special precautions for disposal [and other handling]
  200000029843http://ema.europa.eu/fhir/CodeSystem/200000029659Use in the paediatric population
  200000029844http://ema.europa.eu/fhir/CodeSystem/2000000296597. MARKETING AUTHORISATION HOLDER
  200000029845http://ema.europa.eu/fhir/CodeSystem/2000000296598. MARKETING AUTHORISATION NUMBER(S)
  200000029846http://ema.europa.eu/fhir/CodeSystem/2000000296599. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
  200000029847http://ema.europa.eu/fhir/CodeSystem/20000002965910. DATE OF REVISION OF THE TEXT
  200000029848http://ema.europa.eu/fhir/CodeSystem/20000002965911. DOSIMETRY
  200000029849http://ema.europa.eu/fhir/CodeSystem/20000002965912. INSTRUCTIONS FOR PREPARATION OF RADIOPHARMACEUTICALS
  200000029850http://ema.europa.eu/fhir/CodeSystem/200000029659ANNEX II
  200000029851http://ema.europa.eu/fhir/CodeSystem/200000029659A. [MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) AND] MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE
  200000029852http://ema.europa.eu/fhir/CodeSystem/200000029659B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE
  200000029853http://ema.europa.eu/fhir/CodeSystem/200000029659Official batch release
  200000029854http://ema.europa.eu/fhir/CodeSystem/200000029659C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION
  200000029855http://ema.europa.eu/fhir/CodeSystem/200000029659Periodic safety update reports (PSURs)
  200000029856http://ema.europa.eu/fhir/CodeSystem/200000029659D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
  200000029857http://ema.europa.eu/fhir/CodeSystem/200000029659Risk management plan (RMP)
  200000029858http://ema.europa.eu/fhir/CodeSystem/200000029659Additional risk minimisation measures
  200000029859http://ema.europa.eu/fhir/CodeSystem/200000029659Obligation to conduct post-authorisation measures
  200000029860http://ema.europa.eu/fhir/CodeSystem/200000029659E. SPECIFIC OBLIGATION TO COMPLETE POST-AUTHORISATION MEASURES FOR [THE CONDITIONAL MARKETING AUTHORISATION] [THE MARKETING AUTHORISATION UNDER EXCEPTIONAL CIRCUMSTANCES
  200000029861http://ema.europa.eu/fhir/CodeSystem/200000029659LABELLING
  200000029862http://ema.europa.eu/fhir/CodeSystem/200000029659PARTICULARS TO APPEAR ON [THE OUTER PACKAGING] [AND] [THE IMMEDIATE PACKAGING] {NATURE/TYPE}
  200000029863http://ema.europa.eu/fhir/CodeSystem/2000000296591. NAME OF THE MEDICINAL PRODUCT
  200000029864http://ema.europa.eu/fhir/CodeSystem/2000000296592. STATEMENT OF ACTIVE SUBSTANCE(S)
  200000029865http://ema.europa.eu/fhir/CodeSystem/2000000296593. LIST OF EXCIPIENTS
  200000029866http://ema.europa.eu/fhir/CodeSystem/2000000296594. PHARMACEUTICAL FORM AND CONTENTS
  200000029867http://ema.europa.eu/fhir/CodeSystem/2000000296595. METHOD AND ROUTE(S) OF ADMINISTRATION
  200000029868http://ema.europa.eu/fhir/CodeSystem/2000000296596. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE SIGHT AND REACH OF CHILDREN
  200000029869http://ema.europa.eu/fhir/CodeSystem/2000000296597. OTHER SPECIAL WARNING(S), IF NECESSARY
  200000029870http://ema.europa.eu/fhir/CodeSystem/2000000296598. EXPIRY DATE
  200000029871http://ema.europa.eu/fhir/CodeSystem/2000000296599. SPECIAL STORAGE CONDITIONS
  200000029872http://ema.europa.eu/fhir/CodeSystem/20000002965910. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE
  200000029873http://ema.europa.eu/fhir/CodeSystem/20000002965911. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER
  200000029874http://ema.europa.eu/fhir/CodeSystem/20000002965912. MARKETING AUTHORISATION NUMBER(S)
  200000029875http://ema.europa.eu/fhir/CodeSystem/20000002965913. BATCH NUMBER[, DONATION AND PRODUCT CODES]
  200000029876http://ema.europa.eu/fhir/CodeSystem/20000002965914. GENERAL CLASSIFICATION FOR SUPPLY
  200000029877http://ema.europa.eu/fhir/CodeSystem/20000002965915. INSTRUCTIONS ON USE
  200000029878http://ema.europa.eu/fhir/CodeSystem/20000002965916. INFORMATION IN BRAILLE
  200000029879http://ema.europa.eu/fhir/CodeSystem/20000002965917. UNIQUE IDENTIFIER - 2D BARCODE
  200000029880http://ema.europa.eu/fhir/CodeSystem/20000002965918. UNIQUE IDENTIFIER - HUMAN READABLE DATA
  200000029881http://ema.europa.eu/fhir/CodeSystem/200000029659MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS {NATURE/TYPE}
  200000029882http://ema.europa.eu/fhir/CodeSystem/2000000296591. NAME OF THE MEDICINAL PRODUCT
  200000029883http://ema.europa.eu/fhir/CodeSystem/2000000296592. NAME OF THE MARKETING AUTHORISATION HOLDER
  200000029884http://ema.europa.eu/fhir/CodeSystem/2000000296593. EXPIRY DATE
  200000029885http://ema.europa.eu/fhir/CodeSystem/2000000296594. BATCH NUMBER[, DONATION AND PRODUCT CODES]
  200000029886http://ema.europa.eu/fhir/CodeSystem/2000000296595. OTHER
  200000029887http://ema.europa.eu/fhir/CodeSystem/200000029659MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS {NATURE/TYPE}
  200000029888http://ema.europa.eu/fhir/CodeSystem/2000000296591. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION
  200000029889http://ema.europa.eu/fhir/CodeSystem/2000000296592. METHOD OF ADMINISTRATION
  200000029890http://ema.europa.eu/fhir/CodeSystem/2000000296593. EXPIRY DATE
  200000029891http://ema.europa.eu/fhir/CodeSystem/2000000296594. BATCH NUMBER[, DONATION AND PRODUCT CODES]
  200000029892http://ema.europa.eu/fhir/CodeSystem/2000000296595. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT
  200000029893http://ema.europa.eu/fhir/CodeSystem/2000000296596. OTHER
  200000029894http://ema.europa.eu/fhir/CodeSystem/200000029659PACKAGE LEAFLET
  200000029895http://ema.europa.eu/fhir/CodeSystem/2000000296591. What X is and what it is used for
  200000029896http://ema.europa.eu/fhir/CodeSystem/2000000296592. What you need to know before you [take] [use] X
  200000029897http://ema.europa.eu/fhir/CodeSystem/200000029659Do not [take] [use] X
  200000029898http://ema.europa.eu/fhir/CodeSystem/200000029659Warnings and precautions
  200000029899http://ema.europa.eu/fhir/CodeSystem/200000029659Children [and adolescents]
  200000029900http://ema.europa.eu/fhir/CodeSystem/200000029659Other medicines and X
  200000029901http://ema.europa.eu/fhir/CodeSystem/200000029659X with [food] [and] [,] [drink] [and] [alcohol]
  200000029902http://ema.europa.eu/fhir/CodeSystem/200000029659Pregnancy [and] [,] breast-feeding [and fertility]
  200000029903http://ema.europa.eu/fhir/CodeSystem/200000029659Driving and using machines
  200000029904http://ema.europa.eu/fhir/CodeSystem/200000029659X contains {name the excipient(s)}
  200000029905http://ema.europa.eu/fhir/CodeSystem/2000000296593. How to [take] [use] X
  200000029906http://ema.europa.eu/fhir/CodeSystem/200000029659Use in children [and adolescents]
  200000029907http://ema.europa.eu/fhir/CodeSystem/200000029659If you [take] [use] more X than you should
  200000029908http://ema.europa.eu/fhir/CodeSystem/200000029659If you forget to [take] [use] X
  200000029909http://ema.europa.eu/fhir/CodeSystem/200000029659If you stop [taking] [using] X
  200000029910http://ema.europa.eu/fhir/CodeSystem/2000000296594. Possible side effects
  200000029911http://ema.europa.eu/fhir/CodeSystem/200000029659Additional side effects in children [and adolescents]
  200000029912http://ema.europa.eu/fhir/CodeSystem/200000029659Reporting of side effects
  200000029913http://ema.europa.eu/fhir/CodeSystem/2000000296595. How to store X
  200000029914http://ema.europa.eu/fhir/CodeSystem/2000000296596. Contents of the pack and other information
  200000029915http://ema.europa.eu/fhir/CodeSystem/200000029659What X contains
  200000029916http://ema.europa.eu/fhir/CodeSystem/200000029659What X looks like and contents of the pack
  200000029917http://ema.europa.eu/fhir/CodeSystem/200000029659Marketing Authorisation Holder and Manufacturer
  200000029919http://ema.europa.eu/fhir/CodeSystem/200000029659This leaflet was last revised in [{MM/YYYY}][{month YYYY}].
  200000029920http://ema.europa.eu/fhir/CodeSystem/200000029659Other sources of information
  200000029921http://ema.europa.eu/fhir/CodeSystem/200000029659The following information is intended for healthcare professionals only:
  200000044333http://ema.europa.eu/fhir/CodeSystem/200000029659Level=H4 SmPC custom subsection
  200000044346http://ema.europa.eu/fhir/CodeSystem/200000029659Level=H3 PL custom subsection
  200000044347http://ema.europa.eu/fhir/CodeSystem/200000029659Level=H5 SmPC custom subsection

Explanation of the columns that may appear on this page:

Level A few code lists that FHIR defines are hierarchical - each code is assigned a level. In this scheme, some codes are under other codes, and imply that the code they are under also applies
System The source of the definition of the code (when the value set draws in codes defined elsewhere)
Code The code (used as the code in the resource instance)
Display The display (used in the display element of a Coding). If there is no display, implementers should not simply display the code, but map the concept into their application
Definition An explanation of the meaning of the concept
Comments Additional notes about how to use the code