The Medicines (Products for Human Use — Fees) Regulations 1995

Regulation 17 (1)

SCHEDULE 4 TIME FOR PAYMENT OF CAPITAL FEES — APPLICATIONS MADE BY SMALL COMPANIES

1.  In this Schedule a reference to an application is to an application made by or on behalf of a small company.

2.  In connection with a major application for a marketing authorization for which the fee payable is that specified in entry 1(c) of the Table in paragraph 1 of Part II of Schedule 1, the fee payable under regulation 4(a) shall, if the applicant so requests in writing, be payable as to 25% at the time of the application and as to 75% within 30 days following written notice from the licensing authority that the application has been determined.

3.  In connection with a complex application for a marketing authorization, the fee payable under regulation 4(a) shall, if the applicant so requests in writing, be payable as to 50% at the time of the application and as to 50% within 30 days following written notice from the licensing authority that the application has been determined.

4.  In connection with an application to which paragraph 4 of Part II of Schedule 1 applies, the fee payable under regulation 4(a) shall, if the applicant so requests in writing, be payable—

(a) as to 50% of the aggregate payable in accordance with that paragraph at the time of the application; and

(b) as to 50% of that aggregate within 30 days following written notice from the licensing authority that the application has been determined.

5.  In connection with an application for a manufacturer’s licence or a wholesale dealer’s licence, the fee payable under regulation 4(a) shall, if the applicant so requests in writing, be payable as to 50% at the time of the application and as to 50% 12 months after that time.

6.  In connection with an application for a marketing authorization, manufacturer’s licence or wholesale dealer’s licence, the fee payable in respect of an inspection at any site other than one named as a possible site for manufacture of a medicinal product by three or more applicants shall, if the applicant so requests in writing, be payable as to 50% within the period of 14 days referred to in regulation 16(2) and as to 50% 12 months after that date.