Published on June 01, 2021

Central America | Registration and Sanitary Registration of Cosmetic Products

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Central American Technical Regulation: Cosmetic Products. Registration and Sanitary Registration of Cosmetic Products


The changes highlighted for C.R are as follows:

 

It isallowed to make a new registration and include several manufacturers.

Registration: Several manufacturers may beincluded in the application for registration, if the product belongs to the same owner, maintains the same formula, specifications and labeling by all its manufacturers. Likewise, the data and documents for each manufacturer must be provided.

 

Changes after registration.

 

Change in packaging or presentations: Clarifies that only one art is entered.

Original packaging or its legible projects corresponding to a single presentation, it is not necessary to submit an artwork for each presentation since all of them must contain the same information.

 

Change in the specifications, this change did not exist for CR.

Modification of the specifications of the finished product, without changes in the formula.

Request for modification signed by the responsible professional.

New finished product specifications issued bythe holder or by the manufacturing laboratory.

 

Renewal

It does not condition the time to enter therenewal, but to do it according to what is taken by the registering country.

 

The renewal of the registration or sanitary inscription of cosmetic products must be done before its expiration date. The applicant must manage the renewal contemplating the duration ofthe procedure in the registering country.

 

Request to enter the GMP

Certificate of Good Manufacturing Practices or cosmetic manufacturing authorization document duly legalized, issued by the regulatory authority or competent authority or authorized entity of the manufacturing country.

 

Renewal with parallel changes is allowed.

In case there are modifications that coincide with the time of renewal, both procedures may be submitted simultaneously, in which case the affidavit will not be submitted but the documents supporting the changes. In case the registration or registration of the product has expired, a new sanitary registration must be requested in accordance with the requirements established in numeral 6.1 and the process according to each State Party.

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