Resolution RM-MS-DM-3307-2026
The Ministry of Health establishes an official criterion for applying the regulations on sanitary registration of processed foods, specifically regarding third-party manufacturing, in order to avoid incorrect interpretations and unnecessary requirements.
- Third-Party Manufacturing
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- The requirement to submit a manufacturing authorization letter only applies when a third-party manufacturing relationship actually exists.
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- This document must not be required in cases where the product is acquired as a finished product.
- Holder of the Sanitary Registration
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- It must be the owner of the product, who assumes legal responsibility.
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- The authorized importer is not permitted to be the holder if they are not the owner of the product.
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- If the holder is a foreign party, they must demonstrate legal representation.
The requirement is enforced when there are indications of a contractual manufacturing relationship between the manufacturer and the holder.
The Ministry of Health will evaluate each case based on:
- Registration application
- Manufacturer and holder information
- Authorized importer
- Certificates (export/free sale)
- Labeling and other documents
In the event of not being a third-party manufacturer, this must be demonstrated with a Declaration from the holder or legal representative, or with Documentation proving that it is a finished product.
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