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The Health Registration is a requirement to participate in the Public Procurement of Medicines


Dear friends and clients,

The demand filed by Meythaler & Zambrano has received attention from the Constitutional Court. In this specific case, the objective was to challenge the constitutionality of Resolution RE-SERCOP-2020-0111 issued on September 23, 2020, regarding the requirement of a health registration to participate in public procurement of medicines.

Although Resolution 0111 was repealed by SERCOP during the judicial process, the Constitutional Court went beyond simply rejecting the demand. In its ruling, the Court emphasized the importance of properly understanding judicial decisions and considering the procedural context in which they are issued. To support its reasoning, the Court referred to paragraph 134 of Ruling 679-18-JP/20, which clearly establishes the presentation of the Ecuadorian health registration as one of the requirements to participate in medicine auctions, with the aim of ensuring their quality.

The Court emphasizes the need for a "proper understanding" of its Ruling 679 and seeks to eliminate any ambiguity in its interpretation. It underscores that the health registration is a prerequisite for participating in auctions, emphasizing its importance. Thus, the Court reiterates and elevates this requirement to the category of a constitutional norm as a condition for participating in public procurement processes for medicines.

These are the exact words of the ruling:

"25. Regarding this particular issue, this Court has expressed that a proper understanding of the judicial decision, especially in cases of ambiguity, must take into account the reasons that justified such decision and the procedural context in which it is issued. Under this logic, this Court considers that in order to fully understand the content and scope of the measure ordered in the fifth decision of ruling 679-18-JP/20, it is imperative to address paragraph 134 of said ruling 679-18-JP/20, which states:
'The purchase of medicines will be regulated by SERCOP in accordance with the law, which has the power to regulate and issue complementary regulations to the law and the corresponding regulation... One of the prerequisites to participate in the auctions will be the presentation of the Ecuadorian health registration to guarantee the quality of the medicines.' (Emphasis added).

In conclusion, the Court has been clear and emphatic in requiring the Ecuadorian health registration as a prerequisite to participate in public procurement processes for medicines. Any corporate auction process that allows the participation of a bidder without an Ecuadorian health registration is considered unconstitutional. Furthermore, if the purchase is awarded to a bidder without said registration, the award is illegal and must be corrected.


Managing Partner


aviso legal

Legal disclaimer

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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