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

ValueSet: SmPC Codes

Official URL: http://ema.europa.eu/fhir/ValueSet/EUepismpcqrdcodesVs Version: 1.0.0
Active as of 2026-08-26 Computable Name: EUepismpcqrdcodesVs

List of section codes allowed in SmPC documents, defined in EMA's Referentials Management Service.

References

Logical Definition (CLD)

 

Expansion

Expansion performed internally based on codesystem Sections v1.0.0 (CodeSystem)

This value set contains 62 concepts

SystemCodeDisplay (en)JSONXML
http://ema.europa.eu/fhir/CodeSystem/200000029659  000000000000Code for custom sub-sections (reserved)
http://ema.europa.eu/fhir/CodeSystem/200000029659  200000029791SUMMARY OF PRODUCT CHARACTERISTICS
http://ema.europa.eu/fhir/CodeSystem/200000029659  2000000297921. NAME OF THE MEDICINAL PRODUCT
http://ema.europa.eu/fhir/CodeSystem/200000029659  2000000297932. QUALITATIVE AND QUANTITATIVE COMPOSITION
http://ema.europa.eu/fhir/CodeSystem/200000029659  2000000297942.1 General description
http://ema.europa.eu/fhir/CodeSystem/200000029659  2000000297952.2 Qualitative and quantitative composition
http://ema.europa.eu/fhir/CodeSystem/200000029659  200000029796Excipient(s) with known effect
http://ema.europa.eu/fhir/CodeSystem/200000029659  2000000297973. PHARMACEUTICAL FORM
http://ema.europa.eu/fhir/CodeSystem/200000029659  2000000297984. CLINICAL PARTICULARS
http://ema.europa.eu/fhir/CodeSystem/200000029659  2000000297994.1 Therapeutic indications
http://ema.europa.eu/fhir/CodeSystem/200000029659  2000000298004.2 Posology and method of administration
http://ema.europa.eu/fhir/CodeSystem/200000029659  200000029801Posology
http://ema.europa.eu/fhir/CodeSystem/200000029659  200000029802Paediatric population
http://ema.europa.eu/fhir/CodeSystem/200000029659  200000029803Method of administration
http://ema.europa.eu/fhir/CodeSystem/200000029659  200000029804Precautions to be taken before handling or administering the medicinal product
http://ema.europa.eu/fhir/CodeSystem/200000029659  2000000298054.3 Contraindications
http://ema.europa.eu/fhir/CodeSystem/200000029659  2000000298064.4 Special warnings and precautions for use
http://ema.europa.eu/fhir/CodeSystem/200000029659  200000029807Traceability
http://ema.europa.eu/fhir/CodeSystem/200000029659  200000029808Paediatric population
http://ema.europa.eu/fhir/CodeSystem/200000029659  2000000298094.5 Interaction with other medicinal products and other forms of interaction
http://ema.europa.eu/fhir/CodeSystem/200000029659  200000029810Paediatric population
http://ema.europa.eu/fhir/CodeSystem/200000029659  2000000298114.6 Fertility, pregnancy and lactation
http://ema.europa.eu/fhir/CodeSystem/200000029659  200000029812Pregnancy
http://ema.europa.eu/fhir/CodeSystem/200000029659  200000029813Breast-feeding
http://ema.europa.eu/fhir/CodeSystem/200000029659  200000029814Fertility
http://ema.europa.eu/fhir/CodeSystem/200000029659  2000000298154.7 Effects on ability to drive and use machines
http://ema.europa.eu/fhir/CodeSystem/200000029659  2000000298164.8 Undesirable effects
http://ema.europa.eu/fhir/CodeSystem/200000029659  200000029817Paediatric population
http://ema.europa.eu/fhir/CodeSystem/200000029659  200000029818Reporting of suspected adverse reactions
http://ema.europa.eu/fhir/CodeSystem/200000029659  2000000298194.9 Overdose
http://ema.europa.eu/fhir/CodeSystem/200000029659  200000029820Paediatric population
http://ema.europa.eu/fhir/CodeSystem/200000029659  2000000298215. PHARMACOLOGICAL PROPERTIES
http://ema.europa.eu/fhir/CodeSystem/200000029659  2000000298225.1 Pharmacodynamic properties
http://ema.europa.eu/fhir/CodeSystem/200000029659  200000029823Mechanism of action
http://ema.europa.eu/fhir/CodeSystem/200000029659  200000029824Pharmacodynamic effects
http://ema.europa.eu/fhir/CodeSystem/200000029659  200000029825Clinical efficacy and safety
http://ema.europa.eu/fhir/CodeSystem/200000029659  200000029826Paediatric population
http://ema.europa.eu/fhir/CodeSystem/200000029659  2000000298275.2 Pharmacokinetic properties
http://ema.europa.eu/fhir/CodeSystem/200000029659  200000029828Absorption
http://ema.europa.eu/fhir/CodeSystem/200000029659  200000029829Distribution
http://ema.europa.eu/fhir/CodeSystem/200000029659  200000029830Biotransformation
http://ema.europa.eu/fhir/CodeSystem/200000029659  200000029831Elimination
http://ema.europa.eu/fhir/CodeSystem/200000029659  200000029832Linearity/non-linearity
http://ema.europa.eu/fhir/CodeSystem/200000029659  200000029833Pharmacokinetic/pharmacodynamic relationship(s)
http://ema.europa.eu/fhir/CodeSystem/200000029659  2000000298345.3 Preclinical safety data
http://ema.europa.eu/fhir/CodeSystem/200000029659  200000029835Environmental risk assessment (ERA)
http://ema.europa.eu/fhir/CodeSystem/200000029659  2000000298366. PHARMACEUTICAL PARTICULARS
http://ema.europa.eu/fhir/CodeSystem/200000029659  2000000298376.1 List of excipients
http://ema.europa.eu/fhir/CodeSystem/200000029659  2000000298386.2 Incompatibilities
http://ema.europa.eu/fhir/CodeSystem/200000029659  2000000298396.3 Shelf life
http://ema.europa.eu/fhir/CodeSystem/200000029659  2000000298406.4 Special precautions for storage
http://ema.europa.eu/fhir/CodeSystem/200000029659  2000000298416.5 Nature and contents of container [and special equipment for use, administration or implantation]
http://ema.europa.eu/fhir/CodeSystem/200000029659  2000000298426.6 Special precautions for disposal [and other handling]
http://ema.europa.eu/fhir/CodeSystem/200000029659  200000029843Use in the paediatric population
http://ema.europa.eu/fhir/CodeSystem/200000029659  2000000298447. MARKETING AUTHORISATION HOLDER
http://ema.europa.eu/fhir/CodeSystem/200000029659  2000000298458. MARKETING AUTHORISATION NUMBER(S)
http://ema.europa.eu/fhir/CodeSystem/200000029659  2000000298469. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
http://ema.europa.eu/fhir/CodeSystem/200000029659  20000002984710. DATE OF REVISION OF THE TEXT
http://ema.europa.eu/fhir/CodeSystem/200000029659  20000002984811. DOSIMETRY
http://ema.europa.eu/fhir/CodeSystem/200000029659  20000002984912. INSTRUCTIONS FOR PREPARATION OF RADIOPHARMACEUTICALS
http://ema.europa.eu/fhir/CodeSystem/200000029659  200000044333Level=H4 SmPC custom subsection
http://ema.europa.eu/fhir/CodeSystem/200000029659  200000044347Level=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