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Option 2
AMP entry 1:
"Full Presentation Name" (AP.13.1) = Amoxicillin 200 mg tablets
"Authorisation Number" (AP.12.4) = PL 1234/001
"Package Description" (AP.13.7) = 15 tablets
AMP entry 2:
"Full Presentation Name" (AP.13.1) = Amoxicillin 200 mg tablets
"Authorisation Number" (AP.12.4) = PL 1234/001
"Package Description" (AP.13.7) = 30 tablets
EXAMPLE 3
In France, marketing authorisation has been granted for the medicinal product 'Paracétamol
150 mg comprimés'.
The medicinal product is available in the following pack sizes: 30 tablets and 60 tablets.
The marketing authorisation number applicable: 123 456-7 (30 tablets), 123 456-8 (60 tablets).
The marketing authorisation holder is company MAH-XYZ.
Based on the principles outlined above (different authorisation number for each pack size), the
marketing authorisation holder should submit two medicinal product entries to the XEVMPD:
AMP entry 1:
"Full Presentation Name" (AP.13.1) = Paracétamol 150 mg comprimés
"Authorisation Number" (AP.12.4) = 123 456-7
"Package Description" (AP.13.7) = 30 comprimés
AMP entry 2:
"Full Presentation Name" (AP.13.1) = Paracétamol 150 mg comprimés
"Authorisation Number" (AP.12.4) = 123 456-8
"Package Description" (AP.13.7) = 60 comprimés
EXAMPLE 4
In the UK, marketing authorisation has been granted for the medicinal product 'Ibuprofen 250 mg'.
The medicinal product is available as film-coated tablets and capsules in separate package
presentations.
The marketing authorisation number applicable for both medicinal products: PL 1234/004.
The marketing authorisation holder is company MAH-XYZ.
Based on the principles outlined above (different pharmaceutical forms), the marketing authorisation
holder should submit two medicinal product entries to the XEVMPD:
AMP entry 1 (film-coated tablet):
"Full Presentation Name" (AP.13.1) = Ibuprofen 250 mg
"Authorisation Number" (AP.12.4) = PL 1234/004
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 16/163