Disinfectant products authorised as PMCs

When buying a disinfectant product, as it is often the case in these days, one should always read its label carefully. It is here that one can find the most important information about a disinfectant: not only the claims about its actions but also its ingredients, the name of the manufacturer, and its authorisation number as biocide or PMC. In fact, only […]

Natural vs. safe, the regulation on botanicals

“Natural” does not necessarily means “safe”; yet, many consumers perceive the use of dietary products and food supplements based on natural substances as generally safe. Actually, in the field of health products, herbal substances and preparations are the subject of a long-standing debate. A European centralised regulation on botanicals in food supplements is still missing and this lack of harmonisation […]

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 […]