Product information, ePI, Labelling

A medicine’s Product Information (PI) is a pivotal source of regulated and scientifically validated information that assists in prescribing and dispensing the medicine, and informs patients and consumers about its safe use.

Using READY! will increase efficiency in the approval of PI during regulatory procedures, and later dissemination in printed and in electronic format (ePI).

Authorised, statutory product information for medicines include:

  • A summary of product characteristics (SmPC, intended for healthcare professionals)
  • Labelling (outer and inner packaging information)
  • Package leaflet (PL, for patients/consumers)

PI must be updated as soon as changes to the SmPC and PL are authorised by regulatory authorities.

READY! tracks changes across all relevant PI annexes and products, and it eliminates many manually performed tasks and redundancies that are potential sources of error.

Using the READY! automated process simultaneously changes, or flags for change, all locations where the information occurs, leading to faster updates and reducing the risk of introducing errors.

PI contains the same information linked to several products and strengths registered in several countries, each of which has to be changed individually in case of an update to the information.

The approval process of PI documents in READY! to the metadata about medicinal products stored in READY!.

Each document gets the attributes from the respective marketing authorisation metadata.

For example:

  • Product information type (SmPC, PIL, outer & labelling)
  • Marketing Authorisation holder
  • Contract manufacturing organisation
  • Product
  • Pharmaceutical forms and strengths
  • Marketing Authorisations
  • Country
  • Pack size

The approval process in READY! can start in the development and medical departments, and once approved it can be distributed to the (contract) manufacturing organisation:

  • Documents preparation
  • Review document
  • Translation & Check
  • Approve document
  • Prepare for design
  • Design
  • Design check
  • Verify content
  • Final digital files
  • Technical verification
  • Submission to authority
  • Approved by authority
  • Submit PDF to manufacturing/CMO
  • Request OK to print file
  • Various final approvals
  • Approved & Effective
  • Obsolete

PI is updated as soon as changes to the SmPC and PL are authorised by the regulatory authorities.

The approval process can be based on electronic signatures, eliminating the need for paper-based signatures and paper approvals.

The result is a complete history (versions) of each PI document, and for every Marketing Authorisation you can always find approved and effective PI documents.

The most up-to-date PI version is always easily available.

Various departments, including Pharmacovigilance, can access this resource more easily for studies of active substances, indications, target populations, adverse events, and many other pieces of information contained in PI.

Approved and effective PI documents are available across the organisation and partners, including CROs, CMOs, translators, and medical professionals.

READY! also fully supports the management of the forthcoming electronic PI (ePI) in a semi-structured format created using common EU electronic standards.