Name of active substance(s)*
ATC Code*
Please complete the details for your product
legal basis of application: Art 8(3)Art 10(1)Art 10(3)Art 10(4)Art 10aArt 10bArt 10cArt 16aExtension
Details of the Reference Medicinal Product which must have been authorised for more than 8/10 years in the EEA
Product name, strength and pharmaceutical form
Marketing Authorisation Holder
First Authorisation Date DD/MM/YY
By providing the following details, you declare that no other Member State has agreed to act as Reference Member State for a Decentralised Procedure for the above mentioned product
Applicant's preferred submission date MM/YYYY
PL Number (If yes)
5 digit company number (If no)
Marketing Authorisation Holder*
Authorised Contact Person*
Marketing Authorisation Holder Address*
Email address*
Telephone*