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Cape Verde Cosmetic Product Registration

COSMETIC REGISTRATION IN CAPE VERDE

Regulatory Authority:

  • Independent Health Regulatory Agency (ERIS)

Link for Regulatory Authority

https://www.eris.cv/

Local Regulation

  • Article 14 of Decree-Law no. 21/2016,

Who can Register?

Data to be Communicated

  • Registration of Cosmetic Products

Entities that carry out the first sale of cosmetic products for consideration in national territory must, in compliance with the obligation established in article 14 of Decree-Law no. 21/2016, of 21 March, register them with the Independent Health Regulatory Authority (ERIS).

All CPs falling into the categories mentioned in paragraph 1 or number 2 of the new wording of article 8 of Resolution no. 12/2016, of 24 February 2017, approved by Resolution no. 06 of 26 December 2019, published in Series II of B.O. no. 182, follow this regularization route.

For this purpose, the Responsible Person must complete the Cosmetic Products Registration Form ,the Registration process must be instructed with the following elements:

  • A photograph of the product’s original packaging or proposed labelling;
  • A proposal for the translation of essential information (product functions, nominal content, expiry date and/or special precautions for use), if these are not available in Portuguese; and
  • A declaration of conformity of the cosmetic product, signed by the Technician in Charge, according to the model (MOD. DRF.059).

  • Request for Proof of Registration Document (DCR)

In the event of any change to the information provided in the registration process, the Responsible Person shall immediately submit an update for the purpose of a new Conformity Check of the product. If justified by the changes, ERIS may issue a new DCR. To this end, the Responsible Person submits a request by filling in the respective form (MOD. DRF.055) and sending it, along with the changes.

Notification

  • All CPs that do not fall into the categories listed in number 1 or number 2 of the new wording of article 8 of Resolution No. 12/2016, of February 24, 2017, approved by Resolution No. 06 of December 26, 2019, follow this regularization route.To do so, the Responsible Person must complete the PC Marketing Notification form (MOD. DRF.00F). In addition to the form, the file must be prepared with:
    • Photograph(s) of the original PC packaging with the essential information in English (product functions, nominal content, expiry date and/or special precautions for use).

Timeframe and Fees

Within a maximum period of 60 days from the date of notification of receipt of the application, ERIS shall send the Proof of Registration Document or the Proof of Notification of placing on the market of the PC, as the case may be, and may, for verification and validation purposes, request additional elements and/or a scheduled inspection.

Additional Information

Labelling and Marking

All cosmetic products must adhere to specific labelling and marking requirements established by ERIS. This includes:

1. Information in Portuguese language

  • Product Name,
  • Ingredients list,
  • Manufacturer details,
  • Expiry date

2. Compliance with international norms

  • Date of manufacture,
  • Validity period,
  • Composition,
  • Trademark,
  • Manufacturer’s name.
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