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Third Ratification: Sanitary Registration as a Key Requirement in Public Procurement of Medicines

Head of the Administrative and Constitutional Disputes Resolutions Department

 

Dear friends and clients,


We are happy to share with you that the Constitutional Court has ratified for the third time that sanitary registration is a mandatory and prior requirement to participate in public procurement processes for medicines. This means that all actors in the system, including SERCOP, must comply with this requirement.


The Court based its analysis on the judgment issued in case 13-21-IS, initiated by Johnson & Johnson del Ecuador with the sponsorship of Meythaler & Zambrano Abogados, to reaffirm that the sanitary registration is a requirement to participate in the public purchase of medicines and not an award requirement.


The Court has sought to ensure that all actors in the system clearly understand this provision. Therefore, by means of an order of clarification in process 13-21-IS/23, the Court once again ratified the sanitary registration as a prerequisite in public procurement processes:


7. [...] In relation to this, it is noted that in paragraph 26 of Judgment 13-21-IS/23, the Court determined that the measure provided in Judgment 679-18-JP/20 is that: 'The Ministry of Public Health must elaborate the 'Intersectoral and Interinstitutional Agreement for the availability and access to medicines', and SERCOP must regulate the planning of public purchases favoring the purchase by reverse auction, within which it must demand as one of the prerequisites to participate in the auctions (...), the presentation of the Ecuadorian health registration to guarantee the quality of the medicines. (Emphasis added).

Consequently, any contracting procedure that allows the participation of bidders without sanitary registration is considered unconstitutional.


We are at your disposal to clarify any doubts you may have (info@lmzabogados.com).

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The content of this blog is provided for informational and educational purposes only and should not be considered legal advice. Regulations in Ecuador are subject to changes and updates that may affect the applicability and accuracy of the content published here. We do not guarantee that the information presented is accurate, complete or current at the time of reading. Therefore, past postings should not be construed as necessarily reflecting current regulations. We strongly recommend that you consult with our qualified attorneys for specific and personalized advice.

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