Notice MS-DRPIRS-3069-2025 / Legal documents for procedures related to health-interest products / Costa Rica

 

The Ministry of Health issued this statement to clarify the formal requirements for submitting notarial certifications, powers of attorney, and contracts used in registration procedures and authorizations for products of sanitary interest. This clarification arises because, in practice, registrars have rejected numerous applications based on criteria from Communication MS-DM-4164-2025, which has caused confusion even among notaries and resulted in significant delays. This document aims to unify criteria, correct interpretations, and prevent new rejections by establishing how documents must be submitted:

  1. Notarial Certifications

They may be issued on paper or in digital format, but they must comply with strict rules according to notarial regulations.

  1. Paper Certifications
  • They must be issued on security paper, with embossed seal and handwritten signature.
  • They must include mandatory information: notary’s full name, office, date and time of consultation, type of certification, and confirmation that the copy is faithful to the original.
  • Fiscal stamps are no longer required for documents issued after December 3, 2024 (Law 10586).
  • For digital procedures of the Ministry, the paper certification must be fully scanned and then digitally signed by the notary.
  1. Digital Certifications
  • They must be prepared with official formats, certified digital signature, and timestamp.
  • They must verify the original in the same way as paper certifications.
  • They must comply with the Notarial Code, the Digital Signature Law, notarial guidelines, and the Regulation of electronic notarial documents.
  1. What to do according to the type of document
  • Physical document + paper certification
    → Traditional certification; then it is digitized and uploaded to the system.
  • Physical document + digital certification
    → The document is scanned, converted to PDF, merged with the digital certification, and digitally signed by the notary indicating “faithful and exact digitized copy”.
  • Digital document + digital certification
    → Everything must remain digital; printing is not allowed.
  • Documents taken from the internet (screenshots)
    → They can be certified on paper or digitally.
    → The notary only certifies what was seen, not the accuracy of the website.
    → The domain, date and time of consultation, and content of the QR code (if any) must be indicated.
  1. Power of Legal Representation

Document through which the product owner appoints a representative in Costa Rica.

Key recommendations:

  • If the applicant is a legal entity, the power must be issued in the name of a legal entity and not an individual.
  • If the power comes from a parent company and applies to subsidiaries or affiliates, it must include the list of those companies and clarify that the representative acts on their behalf.
  • The power must include the minimum authorities established in Communication MS-DRPIS-2033-2025.
  • The format in that communication is only a guide; it is not mandatory.
  1. Manufacturing Contract

Document between the product owner and the manufacturer that demonstrates a third-party manufacturing relationship.

  • It is not required when the product owner and manufacturer are subsidiaries or affiliates.
  • In such cases, a letter from the parent company confirming the corporate relationship is sufficient.
  • If the power issued by the parent company already includes the list of related companies, that power may serve as justification for not submitting the contract.

The Communication MS-DRPIRS-3069-2025 aims to indicate the correct way to issue certifications and legal documents and to reduce rejections resulting from erroneous interpretations. Likewise, this communication includes examples of incorrect Notarial Certifications to prevent common mistakes, such as:

  • Stating that a digitized physical document is a faithful copy of an original digital document.
  • Certifying a digitized copy as if it came directly from a digital copy.


📄 Download Official Statement 1


📄 Download Official Statement 2