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,...
A distributor, an importer or any other subject making any change in a product already put on the market may,...
The activity of regulatory authorities aimed at protecting consumers’ health is attentive and continuous, and should keep up pace with...
The verification of the compliance with the regulations in force, in particular with the Good Manufacturing Practice (GMP), Eudralex vol.4,...
The market shortage of medicinal products is now a global issue, that is continuously discussed by regulatory authorities and trade...
A new decree of the Italian Medicine Agency is in the process of being published in the Official Journal, laying...
On 13 February 2026, Decree 29 December 2025 was published in the Official Journal of the Italian Republic, including the...
In the world of health and wellness, a graphic error is not only an aesthetic issue: it’s a legal and...
The European Commission recently published the implementing regulations for the good manufacturing practice (GMP) for veterinary medicinal products and active...
New technical functions are operative in the Conventions, Congresses and Meetings Authorisation System as of 19 January. This update has...
EUDAMED, the unique database of medical devices, introduced by the European Commission, is slowly finding its final form, thus leading...