REQUIREMENTS TO RELY ON AN EXISTING NSO IN THE CAN
To rely on an existing NSO in the Andean Community, importers must meet legal and technical requirements to ensure product traceability and regulatory compliance during commercialization.
LEGAL DOMICILE REQUIREMENT
Any natural or legal person wishing to rely on an NSO must have legal domicile in the country where the product will be marketed. This ensures that there is a responsible entity within the national territory to facilitate health surveillance and regulatory enforcement.
ONLY ONE HOLDER PER NSO
STEPS BEFORE THE NATIONAL AUTHORITY TO USE AN EXISTING NSO
The process to rely on an existing NSO requires compliance with formal steps and the submission of specific documentation that supports the legality and safety of the cosmetic product.
APPLICATION TO USE AN EXISTING NSO
The applicant must submit a specific form to request reliance on the valid NSO. This form must be fully completed and signed by both the legal representative and the technical manager (pharmaceutical chemist). It must also include a sworn statement affirming that the product retains the same characteristics as originally notified.
REQUIRED DOCUMENTS FOR NSO APPLICATION IN THE CAN
Essential documents include:
- Proof of legal representation or valid power of attorney
- A copy of the product label including the new importer’s details
- Manufacturer’s authorization (if applicable)
- Payment receipt for processing fees
It is critical that the product label includes the information of the parallel importer, who becomes the responsible operator within the destination country.
RESTRICTIONS WHEN USING AN EXISTING NSO IN THE CAN
Relying on an existing NSO does not authorize changes to the product’s composition or presentation. Any modification must be processed directly by the NSO holder. Additionally, if the importer decides to stop commercialization, they must notify the competent national authority in writing.
NSO VALIDITY IN THE CAN: WHEN TO RENEW
The validity of the reliance is tied to the original NSO’s expiration. Once the NSO is renewed by the holder, importers wishing to continue selling the product must also renew their reliance by submitting a new application. The product remains subject to sanitary control and monitoring under CAN standards.
In summary, relying on an existing NSO in a CAN member country is a valuable tool to facilitate the marketing of pre-approved cosmetic products in the subregion. However, it entails clear legal and technical responsibilities for parallel importers.
Our law firm offers specialized legal services in Andean Community health regulations. If you are dealing with an NSO-related case or need assistance complying with the applicable legal procedures, contact us. We are ready to help.
Frequently Asked Questions (FAQs)
What is an NSO?
It is the Notificación Sanitaria Obligatoria (Mandatory Sanitary Notification), a registration that authorizes the marketing of cosmetic products in the Andean subregion.
Can an NSO have more than one holder?
No. Each NSO can have only one official holder, although several parallel importers may rely on the same authorization.
Can a parallel importer modify the product?
No. The product must maintain the same characteristics as originally notified by the NSO holder.
What happens if the importer no longer wants to commercialize the product?
They must formally inform the national authority that they will no longer rely on the NSO.
Is it necessary to renew the reliance once the original NSO expires?
Yes. Once the NSO is renewed by the holder, the importer must submit a new request to continue relying on it.
- General Secretariat of the Andean Community. (2019).
- Regulation of Decision 833 on Harmonization of Legislation on Cosmetic Products.
- Resolution No. 2108.
The content of this article does not reflect the technical opinion of Rigoberto Paredes & Associates and should not be considered a substitute for legal advice. The information presented herein corresponds to the date of publication and may be outdated at the time of reading. Rigoberto Paredes & Associates assumes no responsibility for keeping the information in this article up to date, as legal regulations may change over time.
