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3. For sub-paragraph (a) of paragraph (2) of regulation 6 there shall be substituted the following sub-paragraph—
“(a)genetically modified organisms are cultured, stored, used, transported, destroyed or disposed of, where such organisms are or are contained in—
(i)a product marketed in pursuance of either—
(aa)a consent granted by the Department of the Environment for Northern Ireland under Article 8(1) of the Genetically Modified Organisms (Northern Ireland) Order 1991(1); or
(bb)a written consent given by another competent authority of a member State in accordance with Article 13(4) of Council Directive 90/220/EEC(2) on the deliberate release into the environment of genetically modified organisms; and
in either case, the operation is conducted in accordance with any conditions or limitations attached to that consent, or
(ii)a medicinal product for human or veterinary use marketed in accordance with Council Regulation (EEC) No. 2309/93(3); or”
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