Cosmetics Registration in Honduras

Regulatory Authority:

Sanitary Regulation Agency (ARSA)

Link for RA:

http://www.arsa.gob.hn/

Local regulation:

Central American Technical Regulation RTCA 71.01.35: 21

Who can register : 

  • Importer
  • Distributer
  • Third party agent

Data to be communicated :

Application of registration:

  • Product data 
  • Manufacturer data
  • Data of the importer or distributor
  • Data of the responsible professional
  • Details of the legal representative of the company registering the product:
  • Product registrant details
  • Owner data

SANITARY REGISTRATION IS REQUESTED and includes the following information:

  • Product data
  • Manufacturer’s data
  • Importer or distributor details
  • Data of the responsible professional
  • Data of the legal representative of the company registering the product
  • Data of the registering company of the product 

Process:  

  • Application for registration or health registration.
  • Certificate of Good Manufacturing Practices or duly legalized manufacturing authorization document, issued by the regulatory authority or competent authority or authorized entity of the manufacturing country. Each country internally establishes the way to recognize the competent authority or authorized entity of the manufacturing country.
  • Power of attorney in favour of the responsible legal and professional representative. If the document is granted abroad, it must be legalized.
  • Complete qualitative formula indicating the quantities of the restricted substances, issued by the manufacturer or by the holder and endorsed with the signature and seal of the professional responsible for the registration.
  • Finished product specifications are issued by the owner or by the manufacturing laboratory.
  • Original packages or their legible projects correspond to a single presentation; not necessary to present art for each presentation since they all must contain the same information. In the case of cosmetic products with several shades, fragrances and variants, a label must be presented for each of them only if there are differences in the labelling arts.
  • Proof of payment of the right to process registration or health registration includes health surveillance.
  • Submission of a copy of the contract by third parties or a manufacturer’s document that clarifies the relationship between them if this type of negotiation exists.

Timeframe and fees: 

The validity of cosmetic products’ registration or sanitary registration will be five (5) years counted from its granting.

Additional information:  

All documentation must be submitted in Castilian/Spanish, and official documents written in a different language must be submitted with their respective official translation.