The Ministry of Health of Costa Rica has published Ministerial Resolution RM-MS-DM-3307-2026, establishing interpretative criteria for the application of the provisions contained in RTCA 67.01.31:20 regarding third-party manufacturing within the sanitary registration procedures for processed foods.
The resolution aims to ensure a uniform and proportionate application of sanitary regulations, preventing authorities from requesting documentary requirements in situations that do not constitute genuine third-party manufacturing arrangements.
What does the new resolution clarify?
The health authority confirms that a third-party manufacturing agreement or an equivalent letter issued by the manufacturer will only be required when a third-party manufacturing relationship exists under the terms defined by RTCA 67.01.31:20; that is, when a product is manufactured by a producer on behalf of the sanitary registration holder pursuant to a prior contractual arrangement.
The resolution also establishes several important considerations for sanitary registration applicants:
- The sanitary registration holder must be the owner of the product and assume legal responsibility for it before the health authority.
- It is not appropriate to designate an authorized importer as the registration holder when it is neither the product owner nor the party legally responsible for the product.
- The Ministry of Health will assess each case based on the entirety of the documentation submitted in the application file, including information relating to the manufacturer, registration holder, authorized importer, applicable certificates, labeling, and any other relevant elements.
- Where a product has been acquired as a finished product and no third-party manufacturing arrangement exists, the applicant may demonstrate this through a declaration or supporting documentation evidencing the nature of the commercial relationship.
Why is this criterion relevant?
In practice, health authorities have frequently requested documentation related to third-party manufacturing during sanitary registration procedures, even where the registration holder merely commercialized finished products acquired from an independent manufacturer.
Through this resolution, the Ministry of Health more clearly defines the circumstances under which such documentation may be required, recognizing that not every relationship between a manufacturer and a registration holder necessarily constitutes a third-party manufacturing arrangement.
The measure provides greater legal certainty for manufacturers, distributors, marketers, sanitary registration holders, and authorized importers by establishing objective criteria to determine when the documentation required under section 4.1.h of RTCA 67.01.31:20 must be submitted.
In light of this new administrative criterion, we recommend:
- Verifying that sanitary registration ownership accurately reflects both product ownership and legal responsibility for the product.
- Assessing the nature of the relationship between the manufacturer and the sanitary registration holder to determine whether a third-party manufacturing arrangement exists.
- Reviewing available supporting documentation to demonstrate, where applicable, that products are acquired as finished goods rather than manufactured under contract.
- Evaluating ongoing sanitary registration procedures and future applications to ensure that the documentation submitted is consistent with the new criterion established by the health authority.
