53. 4. The performance of necessary studies, tests and experiments in connection with the application of Article 10(1) to (4) of Directive 2001/83/EC on the Community Code relating to medicinal products for human use (Official EC Journal L 311) or Article 13(1) to (5) of Directive 2001/82/EC on the Community Code relating to veterinary medicinal products (Official EC Journal L 311) and the ensuing practical requirements shall not be deemed to constitute an infringement of patents relating to medicinal products for human use or medicinal products for veterinary use, respectively.