The Medicines for Human Use and Medical Devices (Fees and Miscellaneous Amendments) Regulations 1999

Amendment of the General Fees Regulations

4.—(1) In paragraph 6(a) of Part III of Schedule 1 to the General Fees Regulations (capital fees for applications for, and variations to, marketing authorizations, licences and certificates—fees payable in connection with an application for variation of a marketing authorization (parallel import)), after head (vi)(1) there shall be inserted the following head–

“(vii)subject to paragraph 6(b) of Schedule 5, a change consequential upon any or any combination of the following–

(aa)a change of ownership of the United Kingdom marketing authorization in respect of which the marketing authorization (parallel import) was granted,

(bb)a change to the number of the United Kingdom marketing authorization in respect of which the marketing authorization (parallel import) was granted,

(cc)a change to the name of the holder of the United Kingdom marketing authorization in respect of which the marketing authorization (parallel import) was granted,

(dd)a change to the address of the holder of the United Kingdom marketing authorization in respect of which the marketing authorization (parallel import) was granted,

(ee)a change of ownership of the marketing authorization for the product in the country where the product originates,

(ff)a change to the number of the marketing authorization for the product in the country where the product originates,

(gg)a change to the name of the holder of the marketing authorization for the product in the country where the product originates,

(hh)a change to the address of the holder of the marketing authorization for the product in the country where the product originates,

where the change has been occasioned by the taking over of an existing business, whether by purchase, merger or otherwise,”.

(2) In each provision of the General Fees Regulations specified in the entries in column (1) (the content of which is described in column (2)) of the Schedule to these Regulations, for the amount specified opposite that provision in column (3) of that Schedule there shall be substituted the amount specified opposite that provision in column (4) of that Schedule.