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See also Table 1a- Authorised Medicinal Product – language requirements and Table 1b - Requirements
for AMP records and attachments for countries with more than one national language for related
information.
Where, in exceptional circumstances, the national SmPC for non-centrally authorised products
(MRPs/DCPs/NAPs) is not available, a similar text (i.e. the English common text, package insert or
other similar text as authorised by the Authorising Body) can be used as an attachment for the
submission in the XEVMPD. The data elements AP.13.1 - AP.13.6 must however be provided in the
language of the country where the marketing authorisation applies.
See also NOTE 17 for related information.
For centrally authorised products, the SmPC to be used for reference must be in English and the
data elements AP.13.1 - AP.13.6 must be provided in English.
Presentation Name elements structure:
Additional examples are also available in the 'European Medicines Agency splitting of the full
presentation name of the medicinal product best practice: Procedure and principles to handle product
name in the EudraVigilance Medicinal Product Dictionary (XEVMPD)' document published in the "Data
Quality-control methodology" section on the Agency's webpage.
1.2.13.1. Full Presentation Name (AP.13.1)
The medicinal product name stated in Section 1. Name of the medicinal product of the
corresponding SmPC must be specified.
See EXAMPLE 12.
According to the QRD templates, normally the trade mark symbol is not to be included in medicinal
product name stated in Section 1. Name of the medicinal product of the corresponding SmPC.
However, if a trade mark symbol (e.g. ®) is included in section 1 of the SmPC, then this trade mark
Detailed guidance on the electronic submission of information on medicinal products
for human use by marketing authorisation holders to the European Medicines Agency in
accordance with Article 57(2) of Regulation (EC) No. 726/2004
EMA/135580/2012 Page 46/163