OMC Medical
OMC Medical

Cosmetics Regulations in Argentina

Regulatory Authority: National Administration of Drugs, Foods and Medical Devices (ANMAT)

Link for RA: http://www.anmat.gov.ar

Local regulation: GMC Res. No. 110/94

Who can register :  

 The manufacturers and/or importers of cosmetic products authorized by ANMAT

Data to be communicated :  

  • Receipt of payment of the fee
  • Product import authorization request form
  • Payment receipt for the corresponding fee.
  • Copy of the designation of a technical director other than the one designated in the enabling provision.
  • A copy of the demonstration given to the health authority for the cosmetics product in question, as well as the product’s data, owner, and importing firm, is kept on file.
  • Affirmation is required by ANMAT disposition 162/01.
  • Copy of letter of representation.
  • Document of transport.
  • Copy of the current Establishment Registration Certificate and the provision for the authorization of the establishment, stating the name of the current technical director and co-technical director (if any).
  • Admission of the product: photocopy of the first and second page containing the name of the product and the data of the holder and the importer, and where the seals and signatures of the INAME Cosmetics Service are verified.
  • Local declaration of Free from BSE (Bovine Spongiform Encephalopathy)/TSE (Transmissible Spongiform Encephalopathy).
  • Copy of customs clearance, bill of lading or transport document.

Process:  

Grade I products : 

For the firm to be established, two forms must be completed:

  1. An application for registration of the initiation of an electronic file system for cosmetic products, and an application for registration of the initiation of an electronic file system for cosmetic goods.
  2. Request for activities to be registered in the electronic file system for cosmetic items.

These forms are submitted at the entrance desk of Health Products Surveillance Directorate for addressing the inspection service of cosmetic products. After successful inspection, ANMAT computer coordination will deliver the password and username.

Grade II products:

  1. R-155 – Application form for admission.
  2. List of technical requirements for the product.
  3. Modification request form.
  4. Alternative establishment request form.
  5. Change of producer establishment request form.
  6. Formula change request form.
  7. Sign and label the change request form.

Timeframe and fees: 

Additional information:  

Certificate Of Free Sale (CLV)

Grade I

PLATFORMA DE TRAMITITES A DISTANCIA is the platform where to make the request (TAD). In order to do so, the applicant company must be registered with ANMAT’s electronic database. The CLV may be issued or rejected after the application has been examined. TAD will be used to send notification in both cases. In addition, the company must enter its “notifications,” indicating that the certificate should no longer be retrieved personally.

Grade II

The company is notified by mail in order to get the certificate given electronically through TAD. The responsible person will log in to the platform, go to the Notifications tab, and download the certificate, which will be cited alongside the other documents in the electronic file. The Health Authority will carry out a correction process if there are any inaccuracies in the application or if extra information is required. 

Labelling should be in the Spanish language and should be in accordance with Resolution GMC No. 36/04.

Animal testing: In Argentina, a measure has been presented that would put an end to cosmetics testing on animals.