Electronic notification for Inspection and GMP decrees

The Inspection and GMP Authorisation Unit of the Italian Medicine Agencyinformed that, in the frame of the extraordinary measures adopted to contain the COVID-19 pandemic, it will be possible to request the shipment of the decrees under notification via registered letter with return receipt. All interested companies shall send a request on unstamped paper signed by the legal representative, enclosing […]

AIFA clarifies variations and renewals for parallel importation

The Italian Medicine Agency clarified the modalities for the submission of variations and renewals of parallel importation medicine authorisations. These are further instructions to follow for the submission and any required integration of renewal applications submitted as of 1st January 2019. In particular, the modalities are clarified for the submission of the variations occurred for the imported product and the […]

Pakistan adopts drug barcode

Two D barcode has become mandatory in Pakistan for drug packs. Back in February the Supreme Court had ordered the implementation of this new technology granting all concerned companies 3 months to implement all necessary measures to comply with the new obligation. The barcode shall be included on the secondary packaging as well as on the immediate packaging (e.g. containers […]

Australia and UK seek trade agreement

The Australian government is looking for a new trade agreement with United Kingdom, in view of the future exit of UK from the European Union, which could mean new opportunities for investments for the former and a return to direct negotiations for the latter. For the moment there were only unofficial talks, but both countries set up working groups, with […]

AIFA publishes new Pharmacovigilance FAQs

The Italian Medicine Agency has published a new FAQ document on the management of reports in the National Pharmacovigilance Network (RNF) to provide practical indications to pharmacovigilance responsible persons and facilitate the inclusion of the information reported in the ADR sheet and the performance of pharmacovigilance activities in the light of the changes following the provisions on the simplified electronic […]

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 […]