Applications in electronic form
JAZMP accepts e-submissions in eCTD and NeeS formats for all medicinal products for human use and VNeeS for medicinal products for veterinary use. Applicants may submit all marketing authorization and maintenance applications, including pharmacovigilance and ASMF submissions in these formats.
JAZMP will accept e-submissions for MRP, DCP, NP and CP procedures where applicable. Applicants must adhere to harmonized guidance and validation criteria as set forth by EMA. Details may be found at this address: esubmission.ema.europa.eu.
JAZMP strongy recommends use of CESP for esubmissions. Details on the use of CESP may be found at this address: https://cespportal.hma.eu