Article 57 (2) of Regulation (EC) No 726/2004
The submission of medicinal product data by marketing-authorisation holders (MAHs) is a legal requirement introduced by Article 57(2) of Regulation (EC) No 726/2004.
This legal provision requires all holders of marketing authorisations for medicinal products for human use in the European Economic Area (EEA) to submit information to the European Medicines Agency (EMA) using the electronic format referred to as Article 57 format or eXtended EudraVigilance Product Report Message (XEVPRM) format.
MAHs are also obliged to maintain the submitted medicinal product information and notify the EMA of any newly authorised medicines or variations to the terms of the marketing authorisation using the XEVPRM format.
ISO standards for IDMP (ISO 11238, 11239, 11240, 11615 and 11616)
Commission Implementing Regulation (EU) No 520/2012 (articles 25 and 26) obliges Member States, marketing-authorisation holders and EMA to make use of the terminologies defined in ISO IDMP standards from July 2016.
The five ISO standards for IDMP should simplify the exchange of information between regulatory authorities, enhancing interoperability of systems at EU level and internationally
The European Commission, the European Union (EU) Network Data Board and the EU ISO IDMP Task Force have endorsed a phased implementation of the ISO IDMP standards.
The phased implementation will commence in July 2016 with the release of terminologies, or so-called controlled vocabularies, and organisation identifiers. Once implemented, EMA will replace its current data submission format, the eXtended EudraVigilance Product Report Message (XEVPRM) format, with the HL7 SPL format based on the ISO IDMP standards, ISO IDMP technical specifications and HL7 common product model.
21 CFR Part 11
Title 21 CFR Part 11 is the part of Title 21 of the Code of Federal Regulations that establishes the United States Food and Drug Administration (FDA) regulations on electronic records and electronic signatures (ERES). Part 11, as it is commonly called, defines the criteria under which electronic records and electronic signatures are considered trustworthy, reliable, and equivalent to paper records (Title 21 CFR Part 11 Section 11.1 (a)).