The Medicines (Products for Human Use– Fees) Amendment Regulations 1992

Amendment of Schedule 1 to the principal Regulations

8.—(1) Schedule 1 to the principal Regulations (capital fees for applications for, and variations to, licences and certificates), shall be amended in accordance with the following paragraphs of this regulation.

(2) In paragraph 1 of Part I–

(a) for head (iv) of sub-paragraph (n) of the definition of “complex application”, there shall be substituted the following–

“(iv) a change in two or more of that product’s excipients which significantly affects the pharmaceutical or the therapeutic properties of that product; or”;

(b) after that head (iv) there shall be inserted the following–

“(v) a change in the chemical form of that product’s active ingredient.”;

(c) for the definition of “standard application” there shall be substituted–

““standard application” means any application for a product licence which is not a major, complex, simple or change of ownership application or an application for a product licence (parallel import).”;

(3) After the entries numbered 5 in Columns 1 and 2 of the Table in paragraph 1 of Part II there shall be inserted in Columns 1 and 2 respectively the following:–

“6.   Change of ownership application

6.   £1,200”.

(4) In paragraph 2 of Part II (capital fees for applications for licences and certificates), for the words “to which Part II of the Act applies by virtue of” there shall be substituted the words “described in paragraph 3 of the Schedule to”.