The Human Tissue (Quality and Safety for Human Application) Regulations 2007

Extent and application

2.—(1) These Regulations extend to England and Wales and Northern Ireland.

(2) Parts 1 to 5 and 7 of, and the Schedules to, these Regulations also extend to Scotland.

(3) These Regulations shall not apply in relation to the processing, preservation, storage, distribution, import and export of tissue or cells for use in manufactured products, including medical devices, to the extent that such activities are regulated by—

(a) the Medicines (Homeopathic Medicinal Products for Human Use) Regulations 1994(1),

(b) the Medicines for Human Use (Marketing Authorisations Etc.) Regulations 1994(2),

(c) the Medical Devices Regulations 2002(3), or

(d) the Medicines for Human Use (Clinical Trials) Regulations 2004(4).

(4) Paragraph (3) does not limit the application of the amendments made by Part 6 of these Regulations.

(1)

SI 1994/105, as amended by SI 1994/899, SI 1995/541, SI 1996/482, SI 1998/574, SI 1999/566, SI 2001/795, SI 2002/236 and 542, SI 2003/623 and 2321, SI 2004/666 and SI 2005/2753.

(2)

SI 1994/3144, as amended by SI 1998/3105, SI 2000/292, SI 2001/795, SI 2002/236, SI 2003/2321, SI 2004/3224, SI 2005/50, 768 and 2759 and SI 2006/1952.

(3)

SI 2002/618, as amended by SI 2003/1697, SI 2005/2759 and 2909.

(4)

SI 2004/1031, as amended by 2005/2754 and 2759 and SI 2006/1928 and 2984.