Every cosmetic manufacturer, sooner or later, will be faced with a cosmeto-vigilance case. If there are sales, the undesirable effects will happen. It is therefore crucial to react to every case in an appropriate manner and for the Serious Undesirable Effects (SUE) to inform the relevant authorities – which is a legal obligation.
I outline below the most important points/questions every manufacturer should pay particular attention to while dealing with the cosmeto-vigilance:
1) What happened?
It is very important to gather as much information as possible concerning the case.
2) Was a medical professional contacted by the user?
If the user is experiencing any undesirable effects and requires a medical attention, he should consult immediately a doctor or other medical professional.
3) Which is the product in question?
It is necessary to clarify which product was used.
i. Commercial name
ii. LOT or batch number
iii. Expiration date
4) How was the product used?
Did the user follow the instructions?
5) Have I informed my Responsible Person about all the vigilance cases from the EU?
Obelis as your Responsible Person will assess each case and provide you with continuous support and guidance during the vigilance process.
Szymon Nowak-Rogozinski
Deputy Manager – Post Marketing Activities (PMA) Department
November 6th, 2019
Obelis as your Responsible Person will assess each case and provide you with continuous support and guidance during the vigilance process.
If you have a cosmeto-vigilance case – contact us without delay!