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 II, para 1, Table, entry l(a)(b), 2-6 amended by Medicines (Products for Human Use—Fees) 1994 reg.2, Sch
Sch.1, Pt II, para 1, Table, entry l(a)(i) amended by Medicines (Products for Human Use—Fees) 1994 reg.7(3)(a)
Sch.1, Pt II, para 2 amended by Medicines (Products for Human Use—Fees) 1994 reg.2, Sch
Sch.1, Pt II, para 4(1) (defn of primary applicant) amended by Medicines (Products for Human Use—Fees) 1994 reg.7(3)(b)(i)
Sch.1, Pt II, para 4(2) amended by Medicines (Products for Human Use—Fees) 1994 reg.7(3)(b)(ii)
Sch.1, Pt II, para 4(3) added by Medicines (Products for Human Use—Fees) 1994 reg.7(3)(b)(iii)
Sch.1, Pt II, paras 6(1)(a)(b), 7(1) amended by Medicines (Products for Human Use—Fees) 1994 reg.2, Sch
Sch.1, Pt II, para 7(2) substituted by Medicines (Products for Human Use—Fees) 1994 reg.7(3)(c)
Sch.1, Pt II, para 8, Pt III, para 1(a) 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)

(1)

In this paragraph—

“joint development” means the development by two or more applicants for product licences relating to medicinal products—
1. (a)
  
  each of which contains the same new active ingredient or combination of new active ingredients but with different proprietary names and which does not require separate consideration by a committee established under section 4 of the Act or by the Medicines Commission; and
2. (b)
  
  the development of which has been notified to the licensing authority at or before the time the application is submitted, as being a joint development undertaken by those applicants; and
3. (c)
  
  in respect of which applications for product licences have been received by the licensing authority within one month of each other;
“primary applicant” means that party to a joint development who first makes an application for a product licence relating to a new active ingredient which was the subject of that joint development; and
“secondary applicant” means any party to a joint development, other than the primary applicant, who makes an application for a product licence relating to the same new active ingredient as that which was the subject of the application made by the primary applicant.

(2)

Where a joint development relates to a medicinal product and an application for a product licence is submitted to the licensing authority by a secondary applicant, the fee payable under regulation 4(a) shall be—

(a)

in respect of the first or only product licence applied for by that secondary applicant, the amount payable in respect of a complex application under paragraph 1 above;

(b)

in respect of each additional product licence applied for by that secondary applicant relating to that medicinal product which is of the same dosage form, the amount payable in respect of a standard application under paragraph 1 above;

(c)

in respect of the first additional product licence applied for by that secondary applicant relating to that medicinal product which is of a different dosage form, the amount payable in respect of a complex application under paragraph 1 above, and in respect of any other such application by that secondary applicant, the amount payable in respect of a standard application under paragraph 1 above.