The Federal Drug Agency launches the call for applications for the Sunshine Act

The Federal Agency for Medicines and Health Products (FAMHP) has launched a call for applications to approve the organization that will carry out, on its behalf, the transparency missions provided for under the Sunshine Act. The notice, published in the Belgian Official Gazette on October 26, 2026, under reference C − 2026/007889 (p. 57549), sets the deadline for submitting applications as November 10, 2026. The approval will cover the period from January 1, 2026, to December 31, 2030.

The call is launched in application of Article 44 of the Law of December 18, 2016, containing various provisions regarding health. The mechanism is based on Articles 41 to 43 of the same law, which entrust the federal agency with transparency missions and allow them to be delegated to an approved organization acting “in the name and on behalf of the FAMHP.”

The published text does not designate any candidate or any prospective organization: it is limited to opening the procedure and setting its conditions. However, the announced approval period begins on January 1, 2026, nearly ten months before the publication of the notice in the Belgian Official Gazette.

A five-year approval based on Article 44

To be approved, the candidate organization must satisfy the conditions listed in Article 44, § 1, of the Law of December 18, 2016. The notice does not detail these criteria but refers expressly to the legal text, which therefore constitutes the basis for evaluating the files.

The approval covers a duration of five full calendar years, from January 1, 2026, to December 31, 2030. This span contrasts with the procedure itself, for which the schedule is tight: candidates have approximately two weeks between the publication of the notice and the closing of submissions.

Three required documents under penalty of inadmissibility

The application for approval must be accompanied by a file containing the recognition criteria referred to in Article 44, § 1. The notice specifies that it must include in particular:

• the consolidated statutes of the candidate organization;
• its internal procedures;
• the list of its members.

The submission of an incomplete file is penalized: the application is declared inadmissible. No possibility for regularization is mentioned in the notice.

Registered mail to the cabinet, before November 10, 2026

The form of submission is also regulated. The application must be sent by registered mail to the Minister of Health, at the following address:

• Strategic Unit and Secretariat of the Vice-Prime Minister and Minister of Social Affairs and Public Health;
• Rue de la Loi 23, 1000 Brussels.

Applicants may obtain further information from the agency’s DG Inspection at the email address publicity@fagg-afmps.be. No electronic submission of applications is provided for in the notice, which only mentions registered mail.

A timeline that raises questions for candidates

The dual timeline of the notice — retroactive accreditation as of January 1, 2026, and a closing date for applications on November 10, 2026 — means that the selected organization will be deemed accredited for missions carried out even before the publication of the call. Candidates must therefore demonstrate, in a file limited to three categories of documents, their capacity to cover the entire five-year period.

For sector stakeholders — pharmaceutical industry, patient associations, professional health organizations — the stake is direct: it is the accredited entity that will collect and publish the declarations of benefits granted to healthcare professionals and healthcare organizations. The date of November 10, 2026, therefore constitutes the sole submission window to influence the governance of transparency regarding conflicts of interest until the end of the decade.

Official source: Belgian Official Gazette of October 26, 2026, notice C − 2026/007889, p. 57549, adopted in application of Article 44 of the Law of December 18, 2016, laying down various provisions in health matters.