Amendment of regulation 14 of the principal Regulations6.

For paragraph (4) of regulation 14 of the principal Regulations (periodic fees for licences) there shall be substituted the following paragraph—

“(4)

No periodic fee shall be payable in respect of the licence fee period during which a licence is first granted except where that licence was granted pursuant to—

(a)

a change of ownership application; or

(b)

an application, made no later than three months after the expiry of a licence, which is for a licence containing identical provisions to those contained in the expired licence and which is made by the person who held the expired licence,

and, in each case, a periodic fee has not been paid in respect of that licence fee period in connection with the holding of a licence for the medicinal product to which the licence relates.”.