Bill 712.

Summary.

The bill would add provisions to Law 90 of December 26, 2017 and Law 419 of February 1, 2024 governing health registration of laboratory products and supplies and proof of registration in public procurement. In the Republic of Panama (República de Panamá), the proposed rules would cover products subject to registration as determined by the competent health authority, regardless of their designation or technology. These include reagents, equipment, instruments, consumables, controls, calibrators and biological products used for diagnosis, handling human specimens, transfusion medicine and blood services.

A health registration would be issued for the product in the manufacturer’s name, on the basis of conditions assessed by the authority. The manufacturer could apply directly or through an authorized person. Applying for, managing or paying for the process, or being listed on the registration as a representative, importer or distributor, would not by itself confer ownership or commercial exclusivity. The manufacturer could authorize one or more distributors, including through an exclusive distribution arrangement. Commercial authorization would have to identify the manufacturer, authorized person, covered products, scope and period of validity, together with relevant product identifiers. It could cover the Republic of Panama generally or be limited to specified products, periods or public procurement procedures.

Adding, replacing or removing a distributor would not require a new health registration if the manufacturer, product and assessed conditions remained unchanged. The health authority could require notification or an update. Each importer or distributor would need its own Operating License and would be responsible for storage, distribution, traceability and surveillance obligations. A person other than the manufacturer could not import, distribute, market or offer the product under its registration without commercial authorization and the required health permits. A copy of the registration would grant no commercial rights. False, altered or expired documents, or documents concerning a revoked authorization, would trigger applicable administrative consequences and any corresponding civil or criminal liability.

In public procurement, a product’s current health registration would establish its health registration status. A bid could not be rejected solely because the bidder is not named on that registration, provided the product, manufacturer and registration clearly correspond, and the bidder provides commercial authorization, holds the required permits and meets the tender specifications. The contracting entity could require documents identifying the procedure and verify the authorization. It would retain authority to set specifications and requirements; registration and authorization would confer no right to acceptance or award. The tender specifications, amendments and duly incorporated clarifications would bind participants and the successful bidder.

The health authority would establish a verification mechanism, preferably electronic, and receive notices when authorized distributors are added, replaced, suspended or revoked. The bill would protect technical files and confidential information. Existing registrations would remain valid until expiry and could support additional authorized distributors without repeating the product assessment under the stated conditions. The Technical Criteria Certificate for medical devices and any other required assessments would retain separate legal regimes. Authorizing additional distributors would not change health requirements or permit use of a registration for different products.

The Executive Branch (Órgano Ejecutivo), through the Ministry of Health (Ministerio de Salud), would issue regulations within six months of promulgation. The Ministry of Health would bring Executive Decree 148 of August 9, 1999 and Executive Decree 490 of October 4, 2019, along with incompatible administrative provisions, into line with the bill without substantively changing the Technical Criteria Certificate regime. Compatible existing provisions would continue to apply in the interim. The proposal concerns public contracting entities, manufacturers, importers, distributors, laboratories, diagnostic services and blood services.