+390677209020 | +39 0267380552 info@direnzo.biz | sedemilano@direnzo.biz | Italian Lenguage

Article 16: when does a distributor or importer become a manufacturer?

A distributor, an importer or any other subject making any change in a product already put on the market may,...

Cosmetic Safety

Cosmetic safety, new bans to protect consumers’ health

The activity of regulatory authorities aimed at protecting consumers’ health is attentive and continuous, and should keep up pace with...

GMP Pharmaceutical

The importance of GMP audits for Human and Vet drug manufacturing

The verification of the compliance with the regulations in force, in particular with the Good Manufacturing Practice (GMP), Eudralex vol.4,...

Drug Shortages

Managing shortages between regulatory obligations and patients’ protection

The market shortage of medicinal products is now a global issue, that is continuously discussed by regulatory authorities and trade...

Self-medication drugs, new AIFA guidelines for no prescription drugs and OTCs

A new decree of the Italian Medicine Agency is in the process of being published in the Official Journal, laying...

Italian Classification of Medical Devices: new CID adopted

On 13 February 2026, Decree 29 December 2025 was published in the Official Journal of the Italian Republic, including the...

pharmaceutical-packaging-design-regulatory

Why Healthcare Product Graphics can’t disregard Regulatory Requirements

In the world of health and wellness, a graphic error is not only an aesthetic issue: it’s a legal and...

GMP Veterinary

New GMP for veterinary medicinal products

The European Commission recently published the implementing regulations for the good manufacturing practice (GMP) for veterinary medicinal products and active...

Conventions, Congresses and Meetings Authorisation System: Procedure Updated

New technical functions are operative in the Conventions, Congresses and Meetings Authorisation System as of 19 January. This update has...

EUDAMED: First 4 modules

EUDAMED: First 4 modules become operative. Obligations as of May 2026

EUDAMED, the unique database of medical devices, introduced by the European Commission, is slowly finding its final form, thus leading...