Renewal

RO

European renewal application form

2

PSUR, incorporating compiled data on 5 years              (4.5 years for the first renewal)

1²⁵

Clinical expert report/statement that addresses the current risk/benefit of the product

1²⁶

Current mutually recognised SPC

1²⁷

Proposed SPC

1²⁸

Commitment to take account of new studies considered necessary by the expert through the variation procedure after the renewal process is complete

1

Copy of an updated statement of compliance with the GMP from the competent authority (not older than            3 years)

1

PIL and label text relevant to each member state, for national approval only

2²⁸

Payment of the national fee

YES²⁹