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9 Feb
The new version of the Code of Ethics of the Italian association of pharmaceutical companies: Key developments
The Italian association of pharmaceutical companies (“Farmindustria”) released the new version of its Code of Ethics on January 19, 2022. Some of the main changes concern i) hybrid events (art. 3.7 bis); ii) activities that pharmaceutical companies are allowed to carry out for non-prescribing HCPs (art. 3.25); iii) information provided to the public (art. 3.26); iv) interactions other than drug promotion (art. 3.28); and v) Patient Support Programs (article 4.7).
EU pharmaceutical strategy: today the Commission launched a public consultation on the revision of the EU general pharmaceuticals legislation (open until December 21, 2021)
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.
17 Feb 21
New AIFA guidelines for compiling dossiers for medicine reimbursement and pricing requests effective March 1, 2021
On December 23, 2020, the Italian Agency of Medicines (Agenzia Italiana del Farmaco – the “AIFA”) issued Guidelines for the compilation of the dossier to support the request for reimbursement and pricing of a medicine (“Guidelines”), pursuant to the Ministerial Decree of August 1, 2019 (“Decree”).
Dematerialization of prescriptions: Ministerial Decree allowing e-prescriptions for drugs not reimbursed by the NHS has been published in the Italian Official Journal.
15 Oct 20
EMA launches public consultation on the draft Guideline concerning registry-based studies
Last September, the EMA published its draft Guideline on registry-based studies (“Guideline”). This draft Guideline is currently open for public consultation: stakeholders may post comments until December 31, 2020.
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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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...
April 5, 2022
Electronic prescriptions: the current modalities of transmission from doctors to patients and from patients to pharmacies are extended until 31st December 2022
March 24, 2022
EU Medical Device Coordination Group (MDCG) approves “Guidance” on appropriate surveillance of devices covered by certificates according to the MD Directives, under the transitional prov...
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