By way of derogation from point (b) of Article 8(1), in the case of veterinary medicinal products containing active substances used in the composition of authorised veterinary medicinal products it shall not be required to provide safety and efficacy data relating to each individual active substance.
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Chapter II · MARKETING AUTHORISATIONS – GENERAL PROVISIONS AND RULES ON APPLICATIONS › Section 5 · Specific requirements for generic, hybrid and combination veterinary medicinal products and for applications based on informed consent and bibliographic data › Article 20
Combination veterinary medicinal products
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