The Blood Safety and Quality Regulations 2005

Consequential amendments

25.—(1) The Medicines Act 1968 shall be amended as follows—

(a) in section 7 (general provisions as to dealing with medicinal products) omit paragraph (a) of subsection (6A)(1);

(b) in section 8 (provisions as to manufacture and wholesale dealing), omit paragraph (a) of subsection (4)(2);

(c) in section 130 (meaning of “medicinal product” and related expressions) in subsection (5), after paragraph (b), insert the following new paragraph—

“(ba) whole human blood and human blood components;”.

(d) In section 130, after subsection (5A) insert the following new subsection—

“(5B) For the purposes of this section, “human blood component” means any of the following constituents of human blood: red cells, white cells, platelets and plasma.”.

(2) The Medicines (Standard Provisions for Licenses and Certificates) Regulations 1971 shall be amended as follows—

(a) in regulation 2 (interpretation), after the definition of “BCG vaccine” insert the following definitions—

““blood” means whole human blood;

“blood component” means a therapeutic constituent of blood (red cells, white cells, platelets and plasma);”; and

(b) in Schedule 2 insert the following new paragraph—

“5C.   The licence holder shall ensure that any blood or blood component imported into the United Kingdom and used by him as a starting material or raw material in the manufacture of a medicinal product, shall meet equivalent standards of quality and safety to those laid down in Commission Directive 2004/33/EC, implementing Directive 2003/98/EC of the European Parliament and of the Council as regards certain technical requirements for blood and blood components.”.

(3) In the Medicines for Human Use (Marketing Authorisations Etc.) Regulations 1994(3), in regulation 1 (citation, commencement and interpretation), in paragraph (2), in the definition of “the 2001 Directive”, after “as amended by” insert—

• “Directive 2002/98/EC of the European Parliament and of the Council setting standards of quality and safety for the collection, testing, processing, storage and distribution of human blood and blood components and amending Directive 2001/83/EC,”.

(1)

Subsection (6A) was inserted by S.I. 1992/604 and amended by S.I. 1994/276.

(2)

Subsection (4) was substituted by S.I. 1992/604 and amended by S.I. 1994/276.

(3)

S.I. 1994/3144; relevant amending instruments are S.I. 2001/795, 2002/236, 2003/2321 and 2004/3224.