Regulation 18 Insertion of Schedule 2A to the Homoeopathic Regulations

After Schedule 2 insert the following schedule—

“SCHEDULE 2A

FEES FOR ASSISTANCE IN OBTAINING CERTIFICATES OF REGISTRATION IN OTHER EEA STATES

Regulation 13(2)

1.

In this Schedule, 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 certificate of registration; and

(b)

an application for an EC registration 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 certificate of registration.

Outgoing mutual recognition applications

2.

The fee payable under regulation 13(2) in connection with an application to the licensing authority for regulatory assistance in connection with obtaining recognition in accordance with the procedure laid down in Article 28 and 29(1) to (3) of the 2001 Directive of a single certificate of registration in a concerned member State shall be—

(a)

if the application is in respect of a homoeopathic medicinal product prepared from not more than 5 homoeopathic stocks, £266; and

(b)

in any other case, £348.”.