Europe – MA Electronic Submission : New Rules

For a set of entities (e.g. organisation, pharmaceutical dose form) with exception of the Anatomical Therapeutic Chemical (ATC) Classification System code, the receiving system of the Agency automatically generates a unique key referred to as an EV Code (EudraVigilance Code). The EV Code is a global key that identifies an entity within the database and in the XEVPRM. The Sender Organisation can uniquely refer to an entity generated using the EV Code.

The ATC Code is the EV Code for an ATC Term.

The following keys are the global keys generated for each entity:

1. EV Code Organisation
2. EV Code Source
3. ATC Code
4. EV Code Pharmaceutical Dose Form
5. EV Code Administration Route
6. EV Code Substance
7. EV Code Product
8. EV Code Attachment
9. EV Code Master File Location

These global keys are used to join different entities within the database. For example, when a Sender Organisation has to specify a substance as an ingredient of a medicinal product, it uses the “EV Code Substance” to refer to the correct entity.

The EV Code is also used to support the operation types, which are used to maintaining the
information on medicinal products submitted via the XEVPRM…