Penalties include: > €1,000 plus 20 times the value of each unreported TOV > €5,000 to €50,000 for failing to report shares or licenses > €5,000 to €100,000 for providing false information
Companies must report: > TOVs and agreements: within six months after the semester in which they occurred > Shares and licenses: by January 31st of the following year
As of now, the official reporting template is pending release. Companies should monitor updates from the Italian Ministry of Health and prepare internal systems to align with forthcoming requirements.
Yes. The Act mandates disclosure of agreements that result in direct or indirect benefits to HCPs or HCOs. Therefore, if an educational grant facilitates HCP attendance at events, those beneficiaries must be individually disclosed.
Yes, your company is responsible for reporting if it manufactures or markets products in the Italian healthcare sector, regardless of having a physical presence in Italy. It's advisable to designate a local representative to manage compliance and communication...
