All medicines for human and animal use derived from biotechnology and other high-tech processes (including biosimilars) must be approved via the centralized EMA procedure. EMA has both general and product specific guidelines giving information on the requirements for biosimilar applications submitted to E...
Changes In The Template The name and signature of the qualified person for pharmacovigilance (QPPV) should be presented on the title page to ensure that the RMP has been reviewed and approved by the MAH/applicant’s QPPV and that the electronic signature is documented. The revised gui...