Labelling in Pharmacovigilance

Labelling is an Information on the immediate or outer packaging. For a product with an approved marketing application, any reaction which is not mentioned in the official product information is unlabeled. If it is included, it is termed labeled. 

Labelling in Pharmacovigilance
Labelling in Pharmacovigilance

Reference safety information

In periodic benefit-risk evaluation reports for medicinal products, all relevant safety information contained in the reference product information (e.g. the company core data sheet) prepared by the marketing authorisation holder and which the marketing authorisation holder requires to be listed in all countries where it markets the product, except when the local regulatory authority specifically requires a modification.

It is a subset of information contained within the marketing authorisation holder’s reference product information for the periodic benefit-risk evaluation report. Where the reference product information is the company core data sheet, the reference safety information is the company core safety information.

Core labeling documents

The core labeling documents include:

  1. CCDS
  2. SmPC
  3. IB
  4. USPI

Company Core Data Sheet (CCDS)

Company Core Data Sheet (CCDS) is a document that reflects the full company’s knowledge and data evaluation for a medicinal product.

For medicinal products, a document prepared by the marketing authorisation holder containing, in addition to safety information, material related to indications, dosing, pharmacology and other information concerning the product.

Company Core Safety Information (CCSI)

Company Core Safety Information (CCSI) is the safety information contained in the CCDS.
The CCSI is generally used in all countries where the company markets the medicinal product and is the reference information used to determine listed and unlisted events for the purpose of periodic reporting for marketed products.

Summary of Product Characteristics (SmPC) 

Summary of Product Characteristics (SmPC) is a legal document approved as part of the marketing authorisation of a medicinal product in the European Union.

– The SmPC is the basis of information for the healthcare professional on how to use the medicine. Its information is updated throughout the life-cycle of the product as new data emerge.

– The SmPC is the reference information used to determine expected or unexpected status of events for marketed products for the purpose of expedited reporting.

Part of the marketing authorisation of a medicinal product setting out the agreed position of the product as distilled during the course of the assessment process which includes the information described in Article 11 of Directive 2001/83/EC. It is the basis of information for healthcare professionals on how to use the product safely and effectively. The package leaflet is drawn in accordance with the summary of product characteristics

Investigator´s Brochure (IB)

Investigator´s Brochure (IB) is a compilation of the clinical and nonclinical data on the investigational product(s) that are relevant to the study of the product(s) in human subjects.

– The IB provides the investigators and others involved in the trial with the information to facilitate their understanding of the rationale for, and their compliance with, many key features of the protocol, such as the dose, dose frequency/interval, methods of administration, and safety monitoring procedures.
– The IB also provides insight to support the clinical management of the study subjects during the course of the clinical trial.

– For investigational products not yet authorised, the IB serves as the CCDS.

United States Prescribing Information (USPI)

United States Prescribing Information (USPI) sets out the agreed usage of the drug. It provides information on usage for healthcare professionals and is an intrinsic part of the application for marketing authorisation of a new drug or medicine within the United States.

Package Leaflet

A leaflet containing information for the user which accompanies the medicinal product.


PV Drug Safety Academy

Leave a Comment

Your email address will not be published. Required fields are marked *