Tag Archives: medicines

EU Vote on First Borderline Decision Confirms: Cranberry Products Are Not Medical Devices

This article was originally posted on our sister blog Inside Medical Devices The EU Regulatory Committee on Medical Devices recently voted in favor of the European Commission’s draft decision on the classification of cranberry products (the “Cranberry Decision”).  In essence, the Cranberry Decision provides that cranberry products intended to prevent or treat cystitis and that … Continue Reading

Italian Council of State Improves Access to Investigational Medicines

Recently, the Council of State (i.e., the Italian supreme administrative court and consultative body) adopted an important advisory opinion, which allows for improved access to investigational medicines by patients in Italy.  In particular, the Council of State found that patients may be enrolled in compassionate use programmes or supplied with a medicine listed in the … Continue Reading

Another round of upcoming amendments to the medicines laws in Germany – Clinical Trials, Advertising, Biologics and more…

On 11 November 2016, the German Parliament passed another new law amending different parts of the German Medicines Act (Arzneimittelgesetz) and the Act on Advertising for Healthcare Products (Heilmittelwerbegesetz). The law is titled “Viertes Gesetz zur Änderung arzneimittelrechtlicher und anderer Vorschriften“. The draft was deliberated in the health committee of the Federal Council (Bundesrat) on … Continue Reading

Upcoming Changes to Italy’s Biosimilar Landscape

On 28 November 2016, the Italian Chamber of Deputies approved the Draft Budgetary Law of 2017.  Among other things, the Draft Law introduces new rules on the substitutability of biologics and the procurement of biosimilars. In particular, Article 59(11) of the Draft Law provides that: two products enjoy a biosimilarity relationship only where this has … Continue Reading

Italian Medicines Agency Publishes New Concept Paper on Biosimilars

Recently, the Italian Medicines Agency (AIFA) has published a new Concept Paper on Biosimilars.  The Concept Paper outlines the regulatory status of biosimilars in Italy as well as their importance for the Italian healthcare sector. The new Concept Paper constitutes a revision of AIFA’s Position Paper on Biosimilars of 13 May 2013.  Overall, the Concept … Continue Reading

Italian Administrative Court Finds That All Non-Prescription Medicines May Be Advertised to the Public

On 30 June 2016, the TAR Lazio, a lower Italian administrative court, found that all non-prescription medicines may be advertised to the public.  This ruling is of particular importance as until now the Italian Ministry of Health has interpreted the Italian medicines legislation as allowing the advertising to the public only of Over-the-Counter (OTC) products. … Continue Reading

Italian Medicines Agency Publishes Public Assessment Reports of Medicines Authorised Through the National Procedure

The Italian Medicines Agency (AIFA) has announced that, as of 22 July 2015, it makes available on its website the Public Assessment Reports (PARs) of medicinal products authorised in Italy through the national procedure. For the medicines authorised from 2015 onwards, AIFA will publish the full PARs together with a summary understandable to a lay … Continue Reading

New Draft EMA-Guideline On Clinical Development Of Fixed Combination Medicines

The European Medicines Agency (EMA) has recently published for public consultation its draft guideline on clinical development of fixed combination medicinal products (Draft Guideline), which is intended to replace CHMP/EWP/240/95 Rev. 1 (Existing Guideline).  The Draft Guideline applies to fixed combination medicinal products containing two or more active substances within a single pharmaceutical form.  The … Continue Reading
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