The European Medicines Agency (EMA) has published an updated guidance on Product Management Service (PMS) – Implementation of International Organization for Standardization (ISO) standards for the identification of medicinal products (IDMP) in Europe. The guidance has updated information for on the Submission of medicinal products authorised in EEA countries outside the EU, Manufacturing authorisation reference number, Medicines Regulatory Agency Organisation, Marketing authorisation regulator and more.
Key highlights include:
Scope includes all authorized medicinal products, excluding investigational or unregistered medicines.
Clarification on Northern Ireland, Liechtenstein, and EEA product submissions.
Full mapping of product identifiers, manufacturing data, authorisation, and packaging.
Detailed instructions on submission via FHIR format.
Link to the document: https://lnkd.in/ecT_8uYD