Portolano Cavallo

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15 Sep 21
European Court of Justice focuses on the requirements for the cross-border online sale of non-prescription medicines
On July 8, 2021, the European Court of Justice ruled on the interpretation of Directive 2001/83/EC in case C-178/20.
1 Jun 21
Online sales of counterfeit medicines: AIFA recommendations and actions to combat the issue
On April 9, 2021, the Italian Medicines Agency, or Agenzia Italiana del Farmaco (the “AIFA” or the “Agency”) published a Nota informativa notice containing details regarding risks stemming from online purchases of medicines.
2 Dec 20
E-commerce of medicinal products: According to the Court of Justice, a foreign pharmacy may be subject to the restrictions in force in Member States where it sells medicines online
With e-commerce becoming more and more widespread, including in the pharmaceutical sector, we are taking a close look at the small but growing number of decisions in both national and European courts that are already providing early indication and some interpretation of the many gray areas left by applicable legislation in this field.
13 Oct 20
Ecommerce of medicines: the European Court of Justice states the applicability of certain restrictions imposed by a Member State destination of ecommerce upon a provider established in another Member State
On October 1, 2020, the European Court of Justice (“ECJ”) issued a very interesting judgment in a case between a company incorporated under Netherlands law that operates both a dispensing pharmacy established in the Netherlands and a website specifically targeting French customers and associations representing the professional interests of pharmacists in France.
Ecommerce of medicinal products: according to the European Court of Justice, certain legislative restrictions imposed by the Member State where medicines are offered to public also apply to the online pharmacy established in another Member State
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11 Feb 20
Medicine and medical device e-commerce: regulatory restrictions and opportunities
More and more healthcare and pharmaceutical companies are entering the world of e-commerce.
Welcome to the Portolano Cavallo Life Sciences blog focusing on legal development and key legal issues affecting the life sciences and healthcare industry.
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Our highly-ranked team of professionals will provide newsinsights and multidisciplinary commentary on the hottest and most recent regulatory, transactional and contentious aspects of the pharmaceutical, bio-tech, med-tech, food supplement and healthcare world with an eye on its digital transformation and technological developments.

This blog will be a place for focusing on digital health, telemedicine and artificial intelligence, as well as more traditional topics: from the protection of intellectual properties to performance of clinical trials, from the market access to advertising and competition issues, from internal and criminal investigations to M&A and venture capital transactions.

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September 21, 2022
Payback for medical devices: Decree quantifying the exceeding of the expenditure ceiling for medical devices at national and regional level for the years 2015, 2016, 2017 and 2018 published ...
September 1, 2022
The 2021 annual law for market and competition addressing, as to the healthcare sector, reimbursement of drugs, intermediate distribution, patent linkage and institutional accreditation of p...
July 19, 2022
Guidelines for the implementation of the Electronic Health Record (EHR) to ensure dissemination, uniformity and accessibility of the EHR at national level now published in the Official Gazet...
June 6, 2022
The National Coordination Centre for Ethics Committees published new draft agreements for conducting clinical trials on drugs and medical devices
April 27, 2022
EU Medical Device Coordination Group (MDCG) approves “Guidance” on the borderline between medical devices and medicinal products in order to support the uniform application of Regulation...
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