The Applicants sought judicial review of the Minister of Health's decision to issue a Notice of Compliance (NOC) to the Respondent, Médunik, for its drug RUZURGI.
The Applicants argued the decision contravened data protection provisions under the Food and Drug Regulations, as their own product, FIRDAPSE, had been granted innovative drug status shortly before.
The Federal Court held the Applicants had standing because the challenge pertained to data protection, not safety or efficacy.
The Court found the decision unreasonable because there were no reasons provided and the record did not reveal that the Minister applied or even considered the proper data protection framework before issuing the NOC.
The decision was set aside and the matter remitted for redetermination.
