Operation Types

The medicinal product information provided via the XEVPRM is owned by the Sender Organisation that submitted the information.

The Sendor Organisation can perform the following types of operations by sending an XEVPRM:

Operation Description
Insert Provide new medicinal product information via an XEVPRM.
Update Update the content of medicinal product information previously submitted via an XEVPRM.
Nullify Nullify medicinal product information previously submitted via an XEVPRM.

Invalidate

MA

 Inform about the withdrawal of an authorised medicinal product from the market via an XEVPRM. The Invalidate MA operation covers a number of scenarios including transfer of an authorised medicinal product to a third party and renewal of the MA by the same MAH.

Not all operations are available for all XEVMPD entity types. The following table presents the available XEVMPD entity types and Operation Types:

XEVMPD Entity Type/Operation Type Insert Update Nullify

Invali­

date MA

Authorised Product
Development Product N/A
Approved Substance N/A N/A N/A N/A
Attachment N/A N/A N/A
Master File Location N/A
Source N/A
MAH N/A
Sponsor N/A
Development Pharmaceutical Form N/A
Proposed Pharmaceutical Form N/A N/A N/A
Development Route of Administration N/A
Proposed Route of Administration N/A N/A N/A
Development ATC Code N/A
Proposed ATC Code N/A