In brief
On 13 May 2022, the AIFA’s regulation, which amends the procedures for the exercise of the right to documentary and simple civic access and introduces the criteria and procedures for the exercise of the general civic access, was published in the Official Gazette (“Regulation“).
- With regard to the submission of access applications, the Regulation provides for two procedures: (i) the ‘informal’ one, which applies where — based on the nature of the requested document — there are no counter-interested parties nor doubts on the legitimacy of the request; and (ii) the ‘formal’ one, which provides for the possibility for counter-interested parties to object to the request for access.
- The Regulation also extends the cases of exclusion, denial, limitation and deferral of access. With specific regard to requests filed by third parties to access documents relating to marketing authorization and classification procedures of medicinal products, the access can only be granted at the end of the relevant procedure. Conversely, if the request is submitted by the pharmaceutical company holding the medicinal product under evaluation, access can be granted even before the conclusion of the relevant procedure.
- The Regulation also provides for the institution of a register in order to track all applications and their processing. In this regard, for each request for access, the following information is recorded: (i) the progressive registration number of the request; (ii) the date of the request; (iii) the subject of the request (the data, document, etc.); (iv) the name of the applicant; (v) the office responsible for the investigation; (vi) the date and the outcome of the final decision; and (vii) the identification of any possible counter-interested parties.
