The Medicines (Products for Human Use — Fees) Regulations 1995

Marketing authorizations

1.  In this Part of this Schedule—

“Type I Application” means an application by a marketing authorisation holder to vary a marketing authorization (not being a marketing authorization (parallel import)) which is a “minor variation” within the meaning of Article 3.1(a) of Regulation (EC) No. 541/95(1);

“Type II Application” means any application to vary a marketing authorization (not being a marketing authorization (parallel import) or a product licence of right) which is neither a Type I Application nor an application for a Type II complex variation nor a change to which Annex II to Commission Regulation (EC) 541/95 applies;

“Type II complex variation” means a variation of a marketing authorization which relates to a change—

(a)

in the formulation of a medicinal product comprising one or more of the following

(i)

a change which necessitates in-vivo bioavailability studies to be performed on that product:

(ii)

a change in that product’s preservative system; or

(iii)

a change in that product’s excipients which significantly affects the pharmaceutical or the therapeutic properties of that product; or

(b)

in the therapeutic indications of a medicinal product, such as a change in respect of use in a new category of patients or as a treatment for a new category of disease, other than a change to which paragraph 2 (changes to therapeutic indications) of Annex II to Commission Regulation (EC) No. 541/95 applies;

(c)

in the composition, manufacture or use of a medicinal product to which any one or more of paragraphs (c), (e), (g) to (j) or (n) of the definition of complex application would apply where an application for a marketing authorisation is made in respect of a medicinal product.

(1)

OJ No. L55, 11.3.95,p. 7.