The Medicines (Products for Human Use) (Fees) Regulations 2016

PART 10 U.K. Periodic Fees for Authorisations, Registrations and Licences

Periodic fees U.K.

38.—(1) Unless paragraph (4), (5), (6) or (7) or Part 16 of, or Part 4 of Schedule 4 to, these Regulations applies, the periodic fee must be paid for each fee period during which the authorisation, registration or licence is in force, even if it is in force for only part of that fee period.

(2) For the purposes of paragraph (1), marketing authorisations of a type referred to in Part 3 of Schedule 4 shall be treated as if they were one marketing authorisation and only one periodic fee in respect of each relevant fee period is payable in connection with the holding of such authorisations.

(3) The periodic fee is the appropriate fee prescribed in Part 3 of Schedule 4 and, for the purposes of that Part, Parts 1 and 2 of that Schedule have effect.

(4) No periodic fee is payable in respect of the fee period during which a marketing authorisation or a traditional herbal registration is first granted unless the authorisation or registration is granted because of—

(a) a change of ownership application; or

(b) an application for a marketing authorisation or traditional herbal registration which—

(i) is for a product for which an authorisation or registration has expired;

(ii) will contain identical provisions to those contained in the expired authorisation or registration;

(iii) is made by the person who held the expired authorisation or registration; and

(iv) is made no later than three months after the expiry of the authorisation or registration referred to in paragraph (i),

and, in each case, a periodic fee has not been paid in respect of that fee period in connection with the expired marketing authorisation or a traditional herbal registration.

(5) An authorisation, registration or licence which is in force is treated for the purposes of this regulation as not being in force during any part of a fee period if—

(a) at least three months before the commencement of that fee period, the holder of that authorisation, registration or licence has given written notice to the licensing authority indicating that he wishes it to cease to have effect before the commencement of that period; and

(b) no products are sold, supplied or manufactured under that authorisation, registration or licence within that fee period.

(6) No periodic fee is payable in respect of the fee period during which a manufacturing authorisation, a manufacturer's licence or wholesale dealer's licence is first granted unless—

(a) that authorisation or licence is granted because of a change of ownership application; and

(b) a periodic fee has not been paid in respect of that fee period in connection with the manufacturing authorisation or manufacturer's licence or wholesale dealer's licence which is mentioned in that application in the statement of intention to cease activities.

(7) No periodic fee is payable in respect of a clinical trial authorisation, broker's registration or active substance registration.

Periodic fee for persons included on the list of online sellers of medicines U.K.

39.—(1) Unless paragraph (3) or (4) applies, the periodic fee must be paid for each fee period during which a person is included on the list of online sellers of medicines, even if the person is included on the list for only part of that fee period.

(2) The periodic fee is the appropriate fee prescribed in Part 3 of Schedule 4.

(3) A person included on the list of online sellers of medicines is treated for the purposes of this regulation as not being included on the list during any part of a fee period if—

(a) at least three months before the commencement of that fee period, the person included on the list of online sellers of medicines has given written notice to the licensing authority indicating that the person wishes to be removed from the list before the commencement of that period; and

(b) no products are sold or supplied, or offered for sale or supply, under that listing within that fee period.

(4) No periodic fee is payable in respect of a fee period if the person is not included on the list of online sellers of medicines on the first day of that fee period.