S.L. 483.8 Art. 1Citation and scope. S.L. 483.01 S.L. 483.02 S.L. 483.01

(1) The title of these regulations is the Equivalent

Standards of Quality and Safety of Imported Tissues and Cells Regulations.

(2) The scope of these regulations is to transpose Commission Directive 2015/566/EU of 8 April 2015 implementing Directive 2004/23/EC as regards the procedure for verifying the equivalent standards of quality and safety of imported tissues and cells.

(3) These regulations apply to the importation of human tissues and cells for human application and manufactured products derived from human tissues and cells intended for human application:

Provided that these regulations shall not apply to:

(a) the import of tissues and cells provided for under regulation 16 of the Tissues and Cells (Quality and Safety) Regulations;

(b) the import of tissues and cells which are directly authorised in case of emergencies;

(c) blood and blood components as defined under the Blood (Quality and Safety) Regulations; and

(d) organs and parts of organs as defined under the Tissues and Cells (Quality and Safety) Regulations.