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OC vigilance

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Dictionaries

HUMAN MEDICINES

Our staff has the training required for entering and updating data in XEVMPD and can offer your company the development of the following activities:

  • Compilation of the information required by the EMA
  • Introduction and updating of information directly to the EV-WEB
  • Introduction and updating of information in databases prepared for transmission via Gateway
  • Development of Standard Operating Procedures (SOPs )
  • Permanent support on new requirements planned for compliance with the ICH M5

COSMETICS

OC vigilance offers its services to enter information related to cosmetics and personal care products in the portal and / or keep the information previously entered as appropriate, in order to fulfill Article 13 of Regulation (EC)1223/2009 to:

  • companies that market cosmetics and personal care products
  • distributors of cosmetic and personal care products that modify or translate the labeling in order to suit national legislation