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" "the Decision" means Commission Decision 2007/554/EC concerning certain protection measures against foot-and-mouth disease in the United Kingdom[5] as amended by Commission Decision 2007/588/EC[6], Commission Decision 2007/608/EC[7], Commission Decision 2007/663/EC[8] and Commission Decision 2007/664/EC[9];".

    (3) In regulation 8 (Dispatch of semen, ova and embryos) after (c) insert—

" (d) the health certificate accompanying ovine or caprine semen shall bear the following words—


" Frozen ovine/caprine semen conforming to Commission Decision 2007/554/EC of 9 August 2007 concerning certain protection measures against foot-and-mouth disease in the United Kingdom.".


(e) The health certificate accompanying ovine or caprine embryos shall bear the following words—


" Frozen ovine/caprine embryos conforming to Commission Decision 2007/554/EC of 9 August 2007 concerning certain protection measures against foot-and-mouth disease in the United Kingdom."".



    (4) In regulation 10 (Dispatch of animal products) for paragraph 7(b) substitute—



"


(b) medicinal products as defined in Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community Code relating to medicinal products for human use[10], medical devices manufactured utilising animal tissue which is rendered non-viable as referred to in Article 1(5)(g) of Directive 93/42/EEC, veterinary medicinal products as defined in Directive 2001/82/EC of the European Parliament and of the Council of 6 November 2001 on the Community Code relating to veterinary medicinal products[11] and investigational medicinal products as defined in Directive 2001/20/EC of the European Parliament and of the Council of 4 April 2001 on the approximation of the laws, regulations and administrative provisions of the Member States relating to the conduct of clinical trials on medicinal products for human use[12],



provided they are accompanied by a commercial document stating that the products are for use as in-vitro diagnostic, laboratory reagents, medical products or medical devices and the products are clearly labelled "for in-vitro diagnostic use only" or "for laboratory use only" as "medicinal products" or as "medical devices".".





Sealed with the Official Seal of the Department of Agriculture and Rural Development on


23rd October 2007.

L.S.


Elizabeth Redmond
A senior officer of the Department of Agriculture and Rural Development



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EXPLANATORY NOTE

(This note is not part of the Regulations)

These Regulations amend The Export Restrictions (Foot-and-Mouth Disease) Regulations (Northern Ireland) 2007 (S.R. 2007 No. 357 as amended by S.R. 2007 No. 364 and S.R. 2007 No. 399). The Regulations give effect to Commission Decision 2007/663/EC of 12th October 2007 and Commission Decision 2007/664/EC of 12th October 2007 which amend Commission Decision 2007/554/EC concerning certain protection measures against foot-and-mouth disease in the United Kingdom.



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Notes:

[1] S.I. 2000/2812back

[2] 1972 c. 68back

[3] 1954 c. 33 (N.I.)back

[4] S.R. 2007 No. 357 as amended by S.R. 2007 No. 364 and S.R. 2007 No. 399back

[5] O.J. No. L210, 10.8.2007, p. 36back

[6] O.J. No. L220, 25.8.2007, p. 27back

[7] O.J. No. L241, 14.9.2007, p. 26back

[8] O.J. No. L270, 13.10.2007, p. 18back

[9] O.J. No. L370, 13.10.2007, p. 21back

[10] O.J. No. L311, 28.11.2001, p. 67back

[11] O.J. No. L311, 28.11.2001, p. 1back

[12] O.J. No. L121, 1.5.2001, p. 34back

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ISBN 978 0 337 97171 6


 © Crown copyright 2007

Prepared 29 October 2007