Product Information: ancient historics

• Before 1999. It is probable that there were some projects on product information at the European Commission, but no information is avaiable.
• 1999. The project Structured Product Information (SPI) was to be leadered by the EMEA and open to all stakeholders: pharmaceutical industry, patient groups, software vendors, private individuals, etc. The main component was a data format to be used as an interface. Created by M.T. Carrasco Benitez.
• 2000. SPI was renamed Product Information Management (PIM) became a joint EMEA-EFPIA project.
• 2000-09-22. PIM Open Day - agenda - all the presentations in a file named pim.zip
• 2000. Annual Report 2000 - page 52
• 2001. Annual Report 2001 - page 33
• 2001-03-26. Product Information Management Project - public announcement
• 2011-03-28. Closure of the PIM project

Product Information: recent historics

• 2017-03-27 Report from the Commission to the European Parliament and the Council relating to medicinal products for human use
• 2018-10-23 Follow-up to Commission's Report on Product Information Leaflets and related activities - 81th Pharmaceutical Committee
• 2018-03-8 EMA action plan related to the European Commission’s recommendations on product information - Pharmaceutical Committee meeting
• 2020-01-27 Digital Health
• 2020-01-28 Electronic product information for human medicines in the EU: key principles - A joint EMA–HMA–EC collaboration
• 2021-07-05 Open public consultation of the EMA

eSubmission: ancient historics

Product information is just a part of eSubmission.

• Electronic Submission Projects at EMEA in 2000
• Architecture - framework for electronic submission
• Electronic Marketing Application Authorization (eMAA). Completed in 1997.
• Electronic Common Technical Document (eCTD)
• Product Information Management (PIM), formelly SPI
• Electronic Maximum Residue Limits (eMRL)
• Pharmacovigilance