Regulatory roles · Cosmetic products · Portugal
Your Responsible Technician for cosmetic products in Portugal
Cosmetic Products
Decreto-Lei n.º 189/2008 provides for a Responsible Technician for cosmetic products in Portugal. We can take on the role: the contact point with INFARMED, the import and export documents, and serious undesirable effects.
What the role covers and who contracts it
What we do as your Responsible Technician
- The contact point with INFARMED.
- The request to INFARMED for the conformity document (Documento de Conformidade) for imports and exports, and the import and export documentation.
- Upkeep of the Product Information File (PIF).
- Support with the notification on the Cosmetic Products Notification Portal (CPNP).
- Monitoring, and handling of serious undesirable effects.
- Support with distribution practice.
For which companies. Companies that manufacture, import or distribute cosmetic products in Portugal. What the role covers depends on which of the three you do.
Who contracts it. CRITICAL CATALYST - Health Consulting, Lda., Matosinhos, Portugal.
Portugal and the EU
CRITICAL CATALYST - Health Consulting, Lda., Matosinhos
Questions people ask
Is the Responsible Technician the same as the EU Responsible Person?
No. The Responsible Technician is a Portuguese role under Decreto-Lei n.º 189/2008. The EU Responsible Person is the EU role under Article 4 of Regulation (EC) No 1223/2009. A Responsible Technician service is not a Responsible Person service. See EU Responsible Person.
In Portuguese, a device distributor's Technical Manager is also a "Responsável Técnico". Same role?
No. The words are the same; the laws are not. The device role rests on Decreto-Lei n.º 29/2024, Article 27, and is for companies that distribute or import medical devices. See Technical Manager, medical device distribution (Portugal).
What happens when a serious undesirable effect is reported?
We handle it inside the role. Cosmetovigilance and serious undesirable effects are part of the Responsible Technician service.
We make small batches by hand. Do the same rules apply?
Yes. Artisanal and small-scale producers fall under the same legal requirements as industrial ones.
Where this role sits
- Step: Responsible Person and notification (Portugal)
- After it: After launch (cosmetovigilance)
- Related roles: EU Responsible Person · Technical Manager, medical device distribution (Portugal) · all Regulatory roles
- Beside the role: Ongoing support for monthly regulatory support
What happens next
Our team replies to every enquiry and asks what you make, import or distribute in Portugal, and the date you are working to.