The Medicines (Products for Human Use– Fees) Amendment Regulations 1992

Amendment of regulation 14 of the principal Regulations

6.—(1) Regulation 14 of the principal Regulations (periodic fees for licences) shall be amended in accordance with the following paragraphs of this regulation.

(2) In paragraph (1), for “(2)and (4)”, there shall be substituted “(2), (4) and (5)”.

(3) At the end of paragraph (3), there shall be added the words “and Part II of that Schedule shall have effect in relation to periodic fees.”.

(4) At the end of paragraph (4), there shall be added the words– “except where that licence was granted pursuant to a change of ownership application and 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.”.

(5) After paragraph (4), there shall be inserted the following paragraph–

“(5) Notwithstanding that a licence has neither expired nor been revoked, it shall be treated for the purposes of this regulation as not being in force during any part of a licence fee period if–

(a) not less than three months before the commencement of that period, the holder of that licence has given written notice to the licensing authority indicating that he wishes the licence to cease to have effect before the commencement of that period; and

(b) no products are sold, supplied or manufactured pursuant to that licence within the licence fee period.”.