Cosmetovigilance & cosmetic product safety


The EU Regulation on cosmetic products (1223/2009) applies in full since 11 July 2013 and completly replaces the Cosmetics Directive (76/768/EEC). 

The Regulation introduces new requirements related to cosmetic product safety as well as new registration procedures.


Our cosmetic product safety services include:


• Review of your current system and procedures and suggestion  

   of necessary actions to comply with the new Regulation.

• Providing a compliant cosmetics products system, including:

  • Responsible person (RP)

  • Registration of the products in cosmetic products notification portal (CPNP)

  • Preparation and maintenance of product information file (PIF)/

cosmetic product dossier within a web-based solution

  • Set-up of a complete post-marketing surveillance system of

serious undesirable effects (SUEs)

  • Reporting SUEs to the Competent

  • Authorities (CAs)

  • Cosmetic products safety assessment (Safety Report)

  • Preparation and maintenance of consumer information and


  • Labelling

  • Training and workshops

For more detailed information please contact us directly. Together we will find the best solutions to fit your individual needs.


Operational pharmacovigilance
ICSR management, EudraVigilance, RMP, CCSI, PSUR, DSUR, Signal management, XEVMPD, and many more.
Pharmacovigilance System
QPPV/deputy QPPV, SOPs, Quality Management Systems, (electronic) PSMF
Clinical trial safety
Management of SUSARs and SARs, safety narrative writing, medical assessments and DSUR
Medical Device Vigilance
Full range of medical device safety services for all different types of medical equipment
Quality Management System
Web-based quality management system software including training and document management
Audits & other support
Includes among others: ad hoc assistance, audits, training, assessment of risk-benefit, medical and scientific writing services
Pharmacovigilance related IT
PQ validations, data migrating and mapping, safety database software, EMA gateway testing
Full range of cosmetic product safety services for all different types of cosmetic products
Good Distribution Practice (GDP)
Lindeq provides GDP active substances quality system including web based QMS software (ItQMS)