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When a sponsor wishes to carry out a clinical trial in two or more EU member states, they can choose to go through the Voluntary Harmonization Procedure (VHP) as an alternative to the classical sep
A substantial amendment (SA) is a change to the conduct of the clinical trial that has a significant impact on the safety of the subjects or the scientific value of the study.
A non-substantial amendment is a change to the conduct of the clinical trial that does not have a significant impact on the safety of the subjects or the scientific value of the study.
Sponsors who are not based in the EU/EEA must appoint a legal representative based in the EU/EEA.
An applicant is the sponsor’s representative for all communications with the competent authorities/ethics committees.
A Post-Authorization Efficacy Study (PAES) is a study performed after the marketing authorization and aiming principally to further evaluate the efficacy of the medicinal product.