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EXAMPLE 7
The SmPC of a medicinal product authorised in the UK states the following information:
1. Name of the medicinal product
Kassa tablets
8. Authorisation number(s)
PL 1234/0001
Based on the information stated in section 8. Authorisation number(s) of the SmPC (i.e. one
authorisation number listed), one medicinal product entries should be submitted to the XEVMPD:
"Full Presentation Name" (AP.13.1) =
Kassa tablets
"Authorisation Number" (AP.12.4) = PL 1234/0001
EXAMPLE 8
The SmPC of a medicinal product authorised in the UK states the following information:
1. Name of the medicinal product
Triamcinolone acetonide tablets
8. Authorisation number(s)
PL 12345/0001
PL 12345/0002
Based on the information stated in section 8. Authorisation number(s) of the SmPC (i.e. two
authorisation numbers listed), two medicinal product entries should be submitted to the XEVMPD:
AMP entry 1:
"Full Presentation Name" (AP.13.1) = Triamcinolone acetonide tablets
"Authorisation Number" (AP.12.4) = PL 12345/0001
AMP entry 2:
"Full Presentation Name" (AP.13.1) = Triamcinolone acetonide tablets
"Authorisation Number" (AP.12.4) = PL 12345/0002
• For centrally authorised medicinal products (CAPs), the marketing authorisation number as
assigned by the stated in the European Commission Decision and as stated in section 8.
Marketing authorisation number(s) of the SmPC must be entered in the "Authorisation Number"
field (AP.12.4) as well as in the "EU Number" field (AP.12.8) – See EXAMPLE 5 and EXAMPLE 9.
EXAMPLE 9
AMP authorised via the centralised procedure with EU number: EU/1/23/456/789 and EMEA
number: EMEA/H/C/123456 should be entered in the corresponding fields as follows:
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 40/163