The NRG Form is an electronic version of the Word (.doc) based forms ‘Proposed (invented) name(s) request form for human medicinal products’ and the ‘Proposed (invented) name(s) justification form for human medicinal products’ that have been used as part of the Medicinal Product naming process here at the EMA since 2004.

• The NRG Form replaces both the ‘(invented) name request’ and ‘(invented) name justification’ forms. A radio button near the beginning of the form provides relevant fields for completion by the applicant allowing re-use of common data if a justification takes place after an initial request.

• The process for submission of the NRG Form either as an ‘(invented) name request’ or as an ‘(invented) name justification’ is otherwise unchanged, though users are recommended to make use of Eudralink to securely supply documentation to EMA.

• The NRG Form is available to download from the Agency’s website at the following location: Human Medicines>Pre-authorisation>Guidance>Pre-submission>(Invented) Name

Business guidance on the completion of the paper form is available here: guideline on the acceptability of names for human medicinal products processed through the centralised procedure.

 

Posted on the EMA website on 24 January 2013