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GMP Authorisation

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...

Parallel Importation

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...

Pakistan adopts drug barcode

Pakistan adopts drug barcode

Two D barcode has become mandatory in Pakistan for drug packs. Back in February the Supreme Court had ordered the...

Australia and UK seek trade agreement

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...

AIFA publishes new Pharmacovigilance FAQs

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...

New use safety regulation for plant protection products

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...

New OsSC platform

New OsSC platform

A new platform is about to be set up for the Italian monitoring body on drug clinical trials (Osservatorio Nazionale...

US prepares for unique code for devices

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...

EMA redistributes UK DCP portfolio

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...