
1 

(1) These Regulations may be cited as the Medicines (Products for Human Use—Fees) Amendment Regulations 2000 and shall come into force on 1st December 2000.
(2) In these Regulations, “the principal Regulations” means the Medicines (Products for Human Use—Fees) Regulations 1995.
2 
In regulation 2(1) of the principal Regulations (interpretation), after the definition of “Community marketing authorization” there shall be inserted the following definitions—“
 “concerned member State” means an EEA State, the competent authorities of which receive an application to obtain recognition, according to the procedure laid down in Chapter III of Directive 75/319/EEC, of a United Kingdom marketing authorization;
 “Directive 75/319/EEC” means Council Directive 75/319/EEC on the approximation of provisions laid down by law, regulation or administrative action relating to medicinal products;
 “EEA State” means a contracting party to the Agreement on the European Economic Area signed at Oporto on 2nd May 1992 as adjusted by the Protocol signed at Brussels on 17th March 1993.”.
3 
After Part II of the principal Regulations (capital fees for applications for authorizations, licences or certificates and for associated inspections) there shall be inserted the following Part—“
PART IIA
4A 
For the purposes of this Part and Part IIA of Schedule 1, a “set of applications” means—
(a) a number of applications to the licensing authority for regulatory assistance in connection with obtaining recognition according to the procedure laid down in Chapter III of Directive 75/319/EEC of a single United Kingdom marketing authorization in other EEA States, where those applications to the licensing authority all relate to applications for marketing authorizations in other EEA States that have the same 90 day assessment period for the purposes of article 9.4 of Council Directive 75/319/EEC; or
(b) a number of applications to competent authorities of other EEA States for marketing authorizations relating to a single United Kingdom marketing authorization, where those applications all have the same 90 day assessment period for the purposes of article 9.4 of Council Directive 75/319/EEC.
4B 
Subject to regulation 19, in connection with each application or set of applications to the licensing authority for regulatory assistance in connection with obtaining recognition according to the procedure laid down in Chapter III of Directive 75/319/EEC of a single United Kingdom marketing authorization in another EEA State or in other EEA States, there shall be payable by the applicant the fee prescribed in Part IIA of Schedule 1 in connection with that application or set of applications.
4C 
Subject to regulations 17 and 19, all sums payable by way of fees under regulation 4B 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.”.
4 
In regulation 16 of the principal Regulations (time for capital fees in connection with applications or inspections), before the words “subject to” there shall be inserted the words “Except where regulation 4C applies and”.
5 
After Part II of Schedule 1 to the principal Regulations (capital fees for authorizations, licences and certificates) there shall be inserted the following Part—“
PART IIA
1 
In this Part, a reference to—
(a) an application to the licensing authority for regulatory assistance means a reference to—
(i) a single application of that type, or
(ii) a set of applications of that type,
relating to a single United Kingdom marketing authorization; and
(b) an application for a marketing authorization in a concerned member State means a reference to—
(i) a single application of that type, or
(ii) a set of applications of that type in a number of concerned member States,
relating to a single United Kingdom marketing authorization.
2 
The fee payable under regulation 4B in connection with an application to the licensing authority for regulatory assistance in connection with obtaining recognition according to the procedure laid down in Chapter III of Directive 75/319/EEC of a single United Kingdom marketing authorization in a concerned member State shall be—
(a) if the application in the concerned member State, had it been in the United Kingdom, would have been a major application—
(i) in respect of the first application for regulatory assistance to the licensing authority, a fee of £30,000, and
(ii) in respect of each other application for regulatory assistance to the licensing authority, a fee of £20,000;
(b) if the application in the concerned member State, had it been in the United Kingdom, would have been a complex application—
(i) in respect of the first application for regulatory assistance to the licensing authority, a fee of £7,500, and
(ii) in respect of each other application for regulatory assistance to the licensing authority, a fee of £5,000;
(c) if the application in the concerned member State, had it been in the United Kingdom, would have been a standard application—
(i) in respect of the first application for regulatory assistance to the licensing authority, a fee of £3,000, and
(ii) in respect of each other application for regulatory assistance to the licensing authority, a fee of £2,500; and
(d) if the application in the concerned member State, had it been in the United Kingdom, would have been a simple application, in respect of each application for regulatory assistance to the licensing authority, a fee of £1,795.”.
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.”.
Signed by authority of the Secretary of State for Health
Hunt
Parliamentary Under-Secretary of State,
Department of Health
9th November 2000