Paragraph 33 Regulatory assistance – same manufacturer

(1)

This paragraph applies if more than one application falling within regulation 26(1) is made by the same applicant at the same time, each of which relates to medicinal products which have the same active ingredient or combination of ingredients, dosage form, therapeutic indications and Periodic Safety Update Reports, and the United Kingdom marketing authorizations for those products have the same date for renewal.

(2)

The fee payable under regulation 26(1) for applications to which sub-paragraph (1) applies is—

(a)

if the applications fall within paragraph 32(a)—

(i)

for the first application considered by the licensing authority, the amount specified in paragraph 32(a), and

(ii)

£756, for each other application;

(b)

if the applications fall within sub-paragraph (1) of paragraph 32(b)—

(i)

for the first application considered by the licensing authority, the amount specified in paragraph 32(b), and

(ii)

£378, for each other application.