Combination Product

Combination product regulations are a relatively recent, and specific regulations only exist in certain markets

• No specific regulatory submission formats exist for combination products – all markets use existing drug, device or biologic application / submission procedures

• Combination products are, therefore, submitted either as drugs and/or devices and/or biologics in line with the national procedures for those product types – multiple applications may be required in some cases

• The determination as to which regulations, submission procedure and pathway to market is followed is largely based on Primary Mode of Action and whether the product forms a single integral unit (not re-usable) or is a copack, kit or set

Medicinal Product 

“Any substance or combination of substances which may be used in or administered to human beings either with 1) a view to restoring, correcting or modifying physiological functions by exerting a pharmacological, immunological or metabolic action or 2) to making a medicinal diagnosis.” (Directive 2001/83/EC as amended by Directive 2004/27/EC)

Medical Device

“Any instrument, apparatus, appliance, software, material or other article, whether used alone or in combination, intended by the manufacturer to be used for medical purposes for human beings, which does NOT achieve its principal intended action in or on the human body by pharmacological, immunological or metabolic means but which may be assisted in its function by such means.” (Directive 93/42/EC)

Regulatory Framework for MDs in the EU

• Directive 93/42/EC • Directive 98/79/EC In Vitro Diagnostic Devices

• Directive 90/385/EC Active Implantable MDs

• Essential Requirements (ER) (Annex 1 to 93/42/EC)

• MEDDEV Guidelines – not legally binding

Regulatory Framework for MPs in the EU

• Regulation 726/2004: establishment of European Medicines Agency (EMA)

• Directive 2001/83/EC: medicinal products for human use

• Amended by Directives: 2002/98/EC; 2004/24/EC; and 2004/27/EC