The Medicines (Products for Human Use—Fees) Amendment Regulations 2000

Amendment of Schedule 4 to the principal Regulations

6.—(1) In Schedule 4 to the principal Regulations (time for payment of capital fees—applications by small companies), after paragraph 4 there shall be inserted the following paragraph—

“4A.   As regards the fee payable under regulation 4B in connection with an application—

(a) to which paragraph 2(a) of Part IIA of Schedule 1 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 9.3 of Directive 75/319 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 2(b), (c) or (d), of Part IIA of Schedule 1 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 9.3 of Directive 75/319 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.”.