Brexit, AIFA on non compliant MAs

Following the exit of the United Kingdom from the European Union, the Italian Medicine Agency has informed that for medicinal product with MA holder, PSMF, QPPV, batch control and release sites for the finished product still located in the UK, and for which variations were not submitted nor pertinent actions were taken to ensure the compliance with the European regulations, […]

New EFSA regulation for transparency

The new Regulation EU 2019/1381, also known as “Transparency Regulation”, applicable as of 27 March 2021, will introduce important changes in the operational procedures of the European Food Safety Agency (EFSA). The scope of the new Regulation is to increase the transparency of risk assessment in the food chain, strengthening the reliability and objectivity of the studies submitted to EFSA, […]

The Italian Payback, why it is so important to contain pharmaceutical expenditure

The payback system is a mechanism introduced in Italy to collect financial resources to support pharmaceutical expenditure and contain the consumption of those drugs reimbursed at various levels by the Italian National Health System. Some critics have defined it as a sort of boomerang: the principle at the core of the payback is in fact to return part of the […]

IVDR, NB designation delayed

The application date of the IVD Regulation 2017/746 is still long to come but, in the meantime, progresses are being made to ensure everything is ready on 26 May 2022. Applications by notified bodies for designation under the IVDR have been received and, in some cases, assessed. Actually, five NBs have already been designated under the new regulation: three from […]

Environmental labelling for packaging: mandatory requirement in Italy

Since last September, in Europe, environmental labelling for packaging is mandatory for products intended for the final consumers. This new requirement is part of the EU efforts to promote recycling to turn waste into either new starting materials or energy. Two European directives on waste and on packaging and packaging waste (2018/851 and 2018/852) were implemented in Italy in Legislative […]

Updated report on biosimilar expense and consumption

The Italian Agency Medicine has made available the updated reports on themonitoring of biosimilar expense and consumption for the period January-December 2019. The reports include the consumption trends of the biological drugdistinguished as originator and relevant biosimilar; the regional variability of the biosimilar incidence; the summary of the regional incidence (%) of biosimilar consumption and the average price (ex-factory price […]

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 […]