Paragraph 4 Product licences

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

Sch.1, Pt III, para l(aa) added by Medicines (Products for Human Use—Fees) 1994 reg.7(4)(a)
Sch.1, Pt III, para 1(b) amended by Medicines (Products for Human Use—Fees) 1994 reg.2, Sch
Sch.1, Pt III, para 2 amended by Medicines (Products for Human Use—Fees) 1994 reg.7(4)(b)
Sch.1, Pt III, para 2A added by Medicines (Products for Human Use—Fees) 1994 reg.7(4)(c)
Sch.1, Pt III, paras 4, 5(a)(b), 6-10 amended by Medicines (Products for Human Use—Fees) 1994 reg.2, Sch
Sch.1 substituted by Medicines (Products for Human Use– Fees) 1992 reg.8(2)(c)
Sch.1, Pt I. para l(n), head (defn of complex application) substituted by Medicines (Products for Human Use– Fees) 1992 reg.8(2)(a)
Sch.1, Pt l(n). head (v) added by Medicines (Products for Human Use– Fees) 1992 reg.8(2)(b)
Sch.1, Pt III, paras l(a)(b), 4, 5(b), 9 amended by Medicines (Products for Human Use– Fees) 1992 Sch

The fee payable under regulation 7(a) in connection with an application for variation of a product licence shall be £80 in respect of each variation applied for which falls within one of the following paragraphs—

(a)

a change of either or both of the name and the address of the holder of the licence;

(b)

a change of either or both of the name and the address of a manufacturer, assembler, storer or distributor named in the licence where the change has been occasioned by the taking over of an existing business, whether by purchase, merger or otherwise and any change of address does not involve a change of the site of manufacture, assembly or storage or from which distribution takes place;

(c)

the removal from the licence of details of one or more sites of manufacture, assembly or storage or from which distribution takes place;

(d)

the removal from the licence of details of any of the activities to which the licence relates;

(e)

the removal from the licence of details of any of the indications authorised for administration of the medicinal product;

(f)

n relation to a product licence (parallel import), the removal from the licence of details of any of the medicinal products which the holder of the licence is authorised to import.