New use safety regulation for plant protection products

The Italian Ministry of Health has published Decree no. 33 of 22nd January 2018 (Regulation on the measures and requirements of plant protection products for a safe use by non professional users) on the Official Journal. The decree includes the measures and requirements of plant protection products to prevent dangerous handling and ensure safe use by non professional users (the […]

New OsSC platform

A new platform is about to be set up for the Italian monitoring body on drug clinical trials (Osservatorio Nazionale sulla Sperimentazione Clinica dei Farmaci – OsSC) and the Italian Medicine Agency has informed some useful information to all users. In particular, the new OsSC platform requires that the PCs used for the access are equipped with a Smart Card […]

US prepares for unique code for devices

The US Regulatory Agency FDA is preparing all the required information in view of the adoption of the unique code for medical devices and the relevant database (GUDID – Unique Device Identification Database). The information to be published within summer, will support the registrations of medical devices. The US Agency has recommended that companies check the data to be included […]

EMA redistributes UK DCP portfolio

In view of the Brexit, the European Medicine Agency has redistributed the portfolio of the medicinal product for human and veterinary use authorized at central level sharing more than 350 products currently managed by British agencies to rapporteurs and co-rapporteurs of other countries. At the moment, the staff of the British regulatory Agency (MHRA) and Veterinary Medicines Directorate (VMD) have […]