Representing non-EU based manufacturers in a successful EU Market entry and safeguarding their future across the European community.
Any non-EU based manufacturer which wishes to make their goods available within the EU market requires an EU based entity which meets the requirements laid out in the applicable legislation(s). Depending on the legislation, this may be referred to as European Authorized Representative (EC REP) or EU Responsible Person (EU RP).
While the EU is an economic and political union, it is still not one single country. It requires a professional representative to support you in navigating the complexities of changing legislation along with economic and political upheavals across any and all of the 28 EU Member States and 4 EFTA countries.
Authorized Representative (EC REP)
- Provide a registered address in the European Union
- Keep available the Technical Documentation for inspection by the European Authorities.
- Complete Notification to the European Authorities
- Complete (any) registration to National Databases
- Take care of (any) incident reporting
- Represent the manufacturer towards the Commission, Authorities and Notified Bodies.
- Safeguard compliance with constant regulatory updates.
- Consult on European Regulations.
EU Responsible Person
A professional EU Representative should be able to support you by:
- Guiding you through the regulatory compliance pathway
- Your primary regulatory contact to all EU entities
- Main contact with the European Competent Authorities
- Product Information File (PIF) compilation, verification and maintenance
- Cosmetic Products Notification Portal (CPNP) notification
- Claims Review
- EU labels including translations and language requirements
- Formula verification against the cosmetics Regulation 1223/2009/EC annexes of prohibited, restricted or permitted substances
- Trade Mark submission
- Post Market Surveillance
- Complaint handling
- Country specific requirements / Registrations
- Updates on the ongoing regulatory changes in EU
... thus ensuring a smooth EU Market penetration while also safeguarding continued success in an ever-changing marketplace.
Interested in other global markets? Learn more about how Obelis clients in the EU Market gain access to the Obelis global partners (OIO network) for further global solutions and support.Get in touch