Schedule NEW SCHEDULE 2A TO THE PRINCIPAL REGULATIONS

“SCHEDULE 2A

TIME FOR PAYMENT OF FEES — APPLICATIONS MADE BY SMALL COMPANIES

Regulation 15(A)1

1

In connection with a major application for a product licence for which the fee payable is that specified in entry 1(b) of the Table in paragraph 1 of Part II of Schedule 1 to these Regulations, the fee payable under regulation 3(a) of these Regulations shall, if the applicant so requests in writing, by 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.

2

In connection with an application to which paragraph 3 of Part II of Schedule 1 to these Regulations applies, the fee payable under regulation 3(a) of these Regulations 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;

(b)

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

3

In connection with an application for a manufacturer’s licence or a wholesale dealer’s licence, the fee payable under regulation 3(a) of these Regulations 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.

4

In connection with an application for renewal of a product licence made by a holder of a licence 40% or more of whose product licences are due to expire in any one year (beginning on 1st January), the fee payable under regulation 10(a) of these Regulations shall, if the holder of the licence so requests in writing, be payable—

(a)

as to 20% at the time of the application;

(b)

as to the remaining 80% in four equal instalments payable respectively 1, 2, 3 and 4 years after that time.

5

In connection with an application for a product licence, 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 15(3) and as to 50% 12 months after that date.

6

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