GenevièVe Michaux

New EU Regulation Extends Financial Penalties To Entities Beyond The Marketing Authorization Holder And Updates The Legal Framework For Medicinal Products For Human Use

Europe—New Regulation (EU) 2019/5 Extends Financial Penalties To Entities Beyond The Marketing Authorization Holder And Updates The Legal Framework For Medicinal Products For Human Use

Europe—General Court Confirms Obligation To Prove Significant Benefit Over All Authorized Medicinal Products, Including Those Authorized After The Submission Of The Marketing Authorization Application For The Future (Orphan) Product

Europe—Brexit Alert on Cosmetic Products

European Commission's Update Of Guideline On Duplicate Marketing Authorizations To Cover Biosimilars

Europe—Key Dates And Roadmap For Implementation Of New Rules On Medical Devices

Europe—The Draft New Definition Of "Similarity" For Orphan Products Is Out For Public Consultation Again

European Commission Issues Notice On Brexit's Implications For Pharmaceutical Companies

European Commission Publishes Revised Guidelines On Criteria For Orphan Designations Of Medicinal Products

European Commission Publishes Revised Guideline On Criteria For Orphan Designation Of Medicinal Products