English to Romanian Medical Livestock / Animal Husbandry

Any post-approval study which formally gathers information about the scientific characteristics, efficacy, safety or the appropriate use of XXX products under field conditions that is not directed by XXX R&D. These activities can be company initiated (i.e. where XXX initiates and conducts the study) or external investigator initiated (where an external investigator initiates and conducts the study and XXX provides some financial or product support). A MSS can involve the use of XXX products either according to the product label / within label or, where consistent with applicable law, off-label / extra-label. If the MSS covers off-label / extra-label product use, it is necessary to obtain concurrence from local regulatory affairs, the appropriate global scientific marketing affairs employee, global regulatory affairs, R&D and, where applicable, approval from the appropriate competent national authority, prior to starting the study.