The Medicines (Applications for Grant and Renewal of Licences) (Miscellaneous Amendments) Regulations 1992

Amendment of regulation 1(2) of the Renewal Regulations

5.  Regulation 1(2) of the Renewal Regulations (interpretation) shall be amended as follows—

(a) after the definition of “the Act” there shall be inserted the following—

““allergen product” means any product which is intended to identify or induce a specific acquired alteration in the immunological response to an allergising agent;and “blood product” means any industrially produced medicinal product for human use derived from human blood or human plasma and includes albumin, coagulating factors and immunoglobulins of human origin but does not include whole human blood, human plasma or blood cells of human origin;”;

(b) after the definition of “certificate” there shall be inserted the following—

““generator” means any system incorporating a fixed parent radionuclide from which is produced a daughter radionuclide which is to be removed by elution or by any other method and used in a radiopharmaceutical;”;

(c) after the definition of “medicinal product” there shall be inserted the following—

““radiopharmaceutical” means any medicinal product for human use which, when ready for use, contains one or more radioactive isotopes which are included for a medicinal purpose;”;

(d) after the definition of “renewal application” there shall be inserted the following—

““vaccine”, “toxin” and “serum” mean any such product for human use and include any agent which is used—

(a) to produce active immunity;

(b) to diagnose immunity; or

(c) to produce passive immunity.”.