Undesirable effects and cosmetovigilance after product launch
How to receive, assess, document and report undesirable and serious undesirable effects associated with cosmetic products in the EU.
Read the guide →Service area 05 · specialist support
EU Responsible Person for cosmetic products
Every cosmetic product placed on the EU market must be linked to a Responsible Person established within the Union. The role includes compliance verification, PIF availability, CPNP notification and post-market action.
Scope of support
What we can deliver for your project
EU Responsible Person and regulatory representation services for cosmetic brands, manufacturers and importers, including ongoing compliance maintenance.
- 39Acting as the Responsible Person for a cosmetic product
- 40Retention and availability of the PIF
- 41Regulatory verification before placing a product on the market
- 42Management of CPNP notifications
- 43Communication with competent authorities
- 44Management of regulatory changes
- 45Handling complaints and undesirable effects
- 46Handling serious undesirable effects
- 47Coordination of corrective action, withdrawals and recalls
- 48Annual product maintenance and representation of non-EU manufacturers
Project outcomes
From a question to an actionable regulatory solution
The exact scope is confirmed after reviewing the product, target markets and available documentation.
01
Clearly assigned regulatory responsibility
02
Availability and maintenance of documentation
03
Communication with competent authorities
04
Procedures for complaints, corrective action and recalls
Frequently asked questions
Before the project starts
Who needs an EU Responsible Person?+
In particular, non-EU manufacturers and brands that do not have a suitable entity established within the Union.
Must the Responsible Person appear on the label?+
Yes. The name or registered name and address of the Responsible Person are mandatory label particulars.
Does the role end after CPNP notification?+
No. The obligations continue throughout the period in which the product is made available on the market.
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Read the guide →Next step
Do you have a product or portfolio for the EU market?
Send us the essential product details, target markets and available documentation. We will respond by email.