Regulation 20 Amendment of regulation 40 of the principal Regulations

In regulation 40 of the principal Regulations (grant or refusal of manufacturing authorisation), in paragraph (1), in sub-paragraph (a), for head (ii) substitute—

“(ii)

has at his disposal—

(aa)

the services of staff, and

(bb)

suitable and sufficient premises, technical equipment and control facilities,

complying with the requirements of Commission Directive 2003/94/EC, as regards the manufacture or import, and control, of the products to which the authorisation relates and the storage of such products,”.