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• The date of transfer of the marketing authorisation must be entered in the "Invalidated date"
field (AP.12.12) when the value "Not Valid – Superseded by Marketing Authorisation Transfer (11)"
is specified in the "Authorisation status" field (AP.12.3)
• The date of renewal of the marketing authorisation must be entered in the "Invalidated date"
field (AP.12.12) when the value "Not Valid – Superseded by Marketing Authorisation
Renewal/Variation (10)" is specified in the "Authorisation status" field (AP.12.3)
• No value should be entered in the "Invalidated date" field (AP.12.12) when the marketing
authorisation remains valid after the suspension of a marketing authorisation has been lifted - the
authorisation status should be changed to one of the other "valid" values (1, 8 or 9) and the date
when the suspension was lifted must be specified in the "Info Date" field (AP.11).
For centrally authorised medicinal products see the below documents for further instructions:
Renewals: questions and answers and Sunset-clause monitoring: questions and answers.
1.2.12.13. Legal basis (AP.12.13)
The description of the legal basis for the marketing authorisation must be specified based
on the available values.
One of the available values must be selected:
• Full application (Article 8(3) of Directive No 2001/83/EC) (1)
• Generic application (Article 10(1) of Directive No 2001/83/EC) (2)
• Hybrid application (Article 10(3) of Directive No 2001/83/EC) (3)
• Similar biological application (Article 10(4) of Directive No 2001/83/EC) (4)
• Well-established use application (Article 10a of Directive No 2001/83/EC) (5)
• Fixed combination application (Article 10b of Directive No 2001/83/EC) (6)
• Informed consent application (Article 10c of Directive No 2001/83/EC) (7)
• Traditional use registration application for a herbal medicinal product
(Article 16a of Directive No 2001/83/EC) (8)
• Simplified registration application for a homeopathic medicinal product (Article 14 of Directive No
2001/83/EC) (9)
• Medicinal product authorised according to Article 126a of Directive No 2001/83/EC (10)
• Application according to Article 58 of Regulation (EC) No 726/2004 (11)
NOTE 5
As regard medicinal products for which the legal basis of the marketing authorisation predates
Directive 2001/83/EC: taking into account that the pharmaceutical Acquis communautaire has been
amended over time, the legal basis applicable under the current Union legal framework which
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 44/163