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 (EU) 2017/745 (MDR) across the European Union.
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Apr 22
Deblistering: A new frontier for the “pharmacy of services”
The note on “the preparation of personalized packaging to improve therapeutic adherence of patients” released on February 3 by the Regione Lombardia sets a milestone in Italy for deblistering, which could soon become a standard service provided by Italian pharmacies as it already is provided by pharmacies in many other countries around the world.
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Apr 22
The new decree on non-profit studies: Data and results may now be sold
On February 16, 2022, more than two years later than planned, the Ministerial Decree of November 30, 2021, containing measures to facilitate and support the development of nonprofit clinical trials of medicinal products and observational studies, as well as to regulate the transfer of data and results of nonprofit trials for registration purposes, was finally published in the Official Gazette.
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Apr 22
Import and Distribution of Medical Devices in Switzerland – Amended Rules
The import and distribution of medical devices in Switzerland is governed by the Swiss Therapeutic Products Act and the Swiss Medical Devices Ordinance (MedDO). As of 26 May 2021, MedDO has been revised, foreseeing stricter and additional obligations for the operators active on the Swiss market.
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Apr 22
Repackaging, the spaces of parallel trade under EU regulations on QR Code, and anti-fraud seals
EU Regulation 2016/161, which since February 2019 requires the presence of anti-fraud seals on the packaging of medicines for human use, authorizes parallel importers to repackage only in the case of failure to ensure a tamper-prevention system “equivalent” to that used in the original packaging.
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Apr 22
Council of State revokes previous judgements in a medical oxygen cartel case due to omission of decisive facts and arguments in the reasoning
On February 15, 2022, Italy’s Consiglio di Stato revoked its previous rulings confirming fines levied on five companies by the Italian Competition Authority for participating in a medical oxygen cartel, as it found manifest omission of facts and reasoning in the judgements, and asked the ICA to produce a set of documents acquired during the proceedings so it can re-examine the case.
