As of Monday, March 30, the EMA is no longer routinely providing printed certificates for human and animal drugs, in keeping with its COVID-19 response. Instead, it is only granting electronically signed and authenticated certificates to confirm the marketing authorization status of drugs. The new format is based on an electronically signed PDF document, with the signature compliant with the eIDAS regulation that guarantees a unique link to the signatory and the full authenticity and integrity of the document. The new format will apply to all ongoing and future requests, according to the EMA. The agency is considering whether the electronic signature should become a permanent part of its efforts to digitalize its administrative processes for all documents requiring a signature. The EMA still will be able to provide printed copies of the certificates upon request, but it currently cannot print and dispatch printed certificates at its premises.
Beginning April 1, 2020, Health Canada is raising its fees related to drug master files (DMFs) and certificates of pharmaceutical product (CPP) by 2%, according to a notice in the March 28 Canada Gazette. Subsequently, the fee for registering new master files will increase to $1,273, the cost of updating a DMF will be $552, a DMF letter of access will be $180 and CPP fees will be $92.