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The Medicines (Marketing Authorisations Etc.) Amendment Regulations 2005

The Medicines (Marketing Authorisations Etc.) Amendment Regulations 2005 reg 3

reg 3 Amendments of the Patents Act 1977

In section 60 of the Patents Act 1977 (meaning of infringement)— (a) in subsection (5), after paragraph (h), insert the following— (i) it consists of— (i) an act done in conducting a study, test or trial which is necessary for and is conducted with a view to the application of paragraphs 1 to 5 of article 13 of Directive 2001/82/EC or paragraphs 1 to 4 of article 10 of Directive 2001/83/EC , or (ii) any other act which is required for the purpose of the application of those paragraphs. (b) in subsection (7), at the end insert the following— “Directive 2001/82/EC ” means Directive 2001/82/EC of the European Parliament and of the Council on the Community code relating to veterinary medicinal products as amended by Directive 2004/28 of the European Parliament and of the Council ; “Directive 2001/83/EC ” means Directive 2001/83/EC of the European Parliament and of the Council on the Community code relating to medicinal products for human use, as amended by Directive 2002/98/EC of the European Parliament and of the Council, by Commission Directive 2003/63/EC and by Directives 2004/24/EC and 2004/27/EC of the European Parliament and of the Council

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