Legal RDC ANVISA Letter

LEGAL RDC ANVISA LETTER

This Letter of Declaration (the Letter) is made effective as of by and between Company Name: , a legal entity with registered address at , registration/holder number (hereinafter referred to as Applicant), and Regulatory Representative Name: , with principal place of business at (hereinafter referred to as Representative).

Recitals

WHEREAS, Applicant is the holder, manufacturer, or authorized distributor of the product identified as Product Name: , intended for regulatory review under RDC No. ;

WHEREAS, Applicant seeks to furnish to Agência Nacional de Vigilância Sanitária (ANVISA) documentary and attestative information required by applicable RDC provisions in connection with the product, including but not limited to manufacturing site data, quality control documentation and declarations of compliance;

WHEREAS, Representative is retained to prepare and submit regulatory documentation on behalf of Applicant and to certify factual and documentary matters described herein.

NOW, THEREFORE

In consideration of the foregoing recitals and the mutual covenants contained herein, the parties agree as follows:

1. Definitions

For the purposes of this Letter, the following terms shall have the meanings assigned below: (a) "RDC Requirements" means the regulatory obligations set forth in the RDC referenced above and any implementing administrative guidance; (b) "Documentation" means records, certificates, batch release information, technical dossiers and other materials submitted to ANVISA in support of the product; and (c) "Confidential Information" means non-public information exchanged between the parties but does not include information required by law or regulatory authorities to be disclosed.

2. Declaration of Compliance

Applicant hereby declares, under penalty of law and to the best of its knowledge and belief, that the product identified above complies with the applicable RDC Requirements as of the effective date and that the Documentation submitted or to be submitted to ANVISA is true, complete and accurate in all material respects.

3. Representations and Warranties

Applicant represents and warrants that: (a) it is duly organized and validly existing under applicable law and has authority to execute this Letter; (b) it has obtained all necessary consents and authorizations to make the declarations herein; (c) Documentation provided to Representative for submission is genuine and derives from records maintained in the ordinary course of business; and (d) it will promptly notify Representative and ANVISA of any material change in the facts or data contained in the Documentation.

4. Obligations of Representative

Representative shall prepare and deliver the Documentation to ANVISA in a timely and professional manner, shall act only at the direction of Applicant with respect to substantive regulatory decisions, and shall maintain records evidencing submission and any correspondence with ANVISA for a period consistent with applicable regulatory retention obligations.

5. Attachments and Evidence

6. Confidentiality and Regulatory Disclosure

The parties acknowledge that information submitted to regulatory authorities may be subject to public disclosure under applicable law. Notwithstanding any confidentiality obligations between the parties, each party consents to disclosure of Documentation as required by law, regulation, or by instruction of ANVISA. For all other information exchanged between the parties, each party shall use reasonable measures to protect Confidential Information from unauthorized disclosure.

7. Notices

All notices, requests, consents and other communications required or permitted under this Letter shall be in writing and delivered to the addresses set forth below or to such other address as a party may designate in writing.

8. Recordkeeping; Audits

Each party shall maintain complete and accurate records supporting the representations made in this Letter. Upon reasonable notice, Applicant shall permit Representative or a regulatory authority to inspect records relevant to the Documentation and compliance with RDC Requirements, subject to applicable confidentiality protections.

9. Amendments; Waiver

No amendment, modification or waiver of any provision of this Letter shall be effective unless in writing and signed by both parties. No failure or delay by either party in exercising any right shall operate as a waiver of that right.

10. Governing Law; Dispute Resolution

This Letter shall be governed by and construed in accordance with the laws of the Federative Republic of Brazil without regard to principles of conflict of laws. Any dispute arising out of or relating to this Letter shall be resolved through good faith negotiations between the parties and, if unresolved, by the competent courts in the forum agreed by the parties.

11. Entire Agreement; Severability

This Letter constitutes the entire agreement between the parties with respect to the subject matter hereof and supersedes all prior oral or written agreements and understandings. If any provision of this Letter is held to be invalid or unenforceable, the remaining provisions shall remain in full force and effect.

Certification

The undersigned certify, under penalty of administrative and criminal sanctions applicable under Brazilian law for false statements, that the information and Documentation provided in connection with this Letter are true, complete and accurate to the best of their knowledge and belief.

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