EU: Updated Q&A on Safety Features for Human Medicinal Products
The European Commission has published Version 22 of its Questions and Answers on Safety Features for Medicinal Products for Human Use.
The most significant addition is a new Q&A on the access of national competent authorities (NCAs) to audit trail data in the European Medicines Verification System (EMVS). The Commission clarifies that, upon request, NCAs should have full access to all audit trail information. This includes information on economic operators in other Member States, such as the names and addresses of wholesalers and persons authorised or entitled to supply medicinal products to the public who are involved in the verification of authenticity and the decommissioning of unique identifiers.
In addition, several existing Q&As have been revised. The updates mainly provide clarifications regarding the responsibilities of the different stakeholders involved in the medicines verification system and the requirements for anti-tampering devices (ATDs). The Commission now explicitly states that the integrity of an ATD should indicate whether the packaging has been opened or altered since leaving the manufacturer, thereby ensuring the authenticity of the package contents.
This version therefore mainly provides additional clarification rather than introducing new regulatory requirements, with the new guidance on NCA access to EMVS audit trail data representing the principal substantive update.
Source:
EU Commission: Safety Features for Medicinal Products for Human Use – Questions and Answers (Version 22)
Meet the GMP Compliance Adviser
The GMP Compliance Adviser is the world's largest knowledge portal for quality management in the pharma business.
The demo access is non-binding and ends automatically.
You may also be interested in the following articles:
