Standard operating procedure for eligibility to the centralised procedure for medicinal products for human use
AdoptedReference Number: SOP/H/3462Summary:
To describe the process of handling requests for eligibility to the centralised procedure for medicinal products for human use, including the preparation of the eligibility report, the discussion of the requests and report at the CHMP meeting and the preparation and sending of eligibility letters to applicants.
Standard operating procedure for procedure for liaising between the European Medicines Agency, the Committee for Medicinal Products for Human Use (CHMP) and the Clinical Trials Facilitation Group on the potential CHMP ne...
Early dialogue between the Agency/CHMP (Co)-Rapporteurs/ Clinical Trials Facilitation Group (CTFG)/National Competent Authorities (NCA) is essential in case CHMP/(Co)-Rapporteurs identify safety issues or lack of efficacy that could lead to a regulatory action with potential impact on any ongoing/completed/future clinical trials.
Standard operating procedure for preparation of an initial European Public Assessment Report (EPAR) for a veterinary medicinal product following positive or negative opinion