The Medicines (Products for Human Use) (Fees) Regulations 2012

Outgoing mutual recognition application

5.  As regards the fee payable under regulation 16 in connection with an application—

(a)to which paragraph 34(2) of Part 3 of Schedule 2 applies—

(i)25% of that fee shall be payable at the time when, in connection with the application or set of applications for regulatory assistance, a request is made pursuant to the second sub-paragraph of Article 28(1) of the 2001 Directive for an assessment report to be prepared or updated; and

(ii)75% of that fee shall become payable within 30 days following written notice from the licensing authority that the regulatory assistance is at an end;

(b)to which paragraph 34(3), (4) or (5), of Part 3 of Schedule 2 applies—

(i)50% of that fee shall be payable at the time when, in connection with the application or set of applications for regulatory assistance, a request is made pursuant to the second sub-paragraph of Article 28(1) of the 2001 Directive for an assessment report to be prepared or updated, and

(ii)50% of that fee shall become payable within 30 days following written notice from the licensing authority that the regulatory assistance is at an end,

if the applicant so requests in writing.