Regulation 14 Periodic fees

Changes not yet applied. Later legislation changes this provision in ways not yet written into the text below:

reg.14(4) rev.in pt. by Medicines (Products for Human Use—Fees) 1996 reg.4(a)
reg.14(6) added by Medicines (Products for Human Use—Fees) 1996 reg.4(b)
reg. 14(1) words inserted by Medicines for Human Use (Clinical Trials Fees Amendments) 2004 reg. 7(2)(a)(i)
reg. 14(1) words substituted by Medicines for Human Use (Clinical Trials Fees Amendments) 2004 reg. 7(2)(a)(ii)
reg. 14(6) words inserted by Medicines for Human Use (Clinical Trials Fees Amendments) 2004 reg. 7(2)(b)(i)
reg. 14(6)(a) words substituted by Medicines for Human Use (Clinical Trials Fees Amendments) 2004 reg. 7(2)(b)(ii)
reg. 14(6)(b) words inserted by Medicines for Human Use (Clinical Trials Fees Amendments) 2004 reg. 7(2)(b)(iii)
regs 13, 13A, 14, 14A am by Medicines for Human Use (Fees Amendments) 2005 regs 9, 10

(1)

Subject to paragraphs (2), (4) and (5) and to regulations 19 and 23, there shall be payable by the holder of a marketing authorization (other than a Community marketing authorization), a manufacturer’s licence or a wholesale dealer’s licence a fee in connection with the holding of the authorization or licence in respect of each fee period during any part of which the authorization or licence is in force.

(2)

Marketing authorizations of a type referred to in Part IV of Schedule 3 shall be treated for the purposes of paragraph (1) as if they were one marketing authorization and only one periodic fee in respect of each relevant fee period shall be payable in connection with the holding of such authorizations.

(3)

The periodic fee shall be the appropriate fee prescribed in Part III of Schedule 3 and, for the purposes of that Part, Parts I and II of that Schedule shall have effect.

(4)

No periodic fee shall be payable in respect of the fee period during which a marketing authorization or licence is first granted except where a marketing authorization 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 marketing authorization, which is for a marketing authorization containing identical provisions to those contained in the expired authorization and which is made by the person who held the expired authorization,

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

(5)

Notwithstanding that an authorization or 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 fee period if—

(a)

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

(b)

no products are sold, supplied or manufactured pursuant to that authorization or licence within that fee period.