Europe

New procedure on medical devices import for their further registration

A new procedure on medical devices import for their further registration in Russia1 will enter into force from 1 January 2021.

According to the new procedure, Roszdravnazor (Russian Federal Service for Surveillance in Healthcare) issues an authorization for medical device import for its further registration in electronic format. Such authorization is valid within 1 year and allows the applicant to import a medical device once.

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HOMS NEWS ISSUE 1 2020

In this our 50th year in business we have successfully faced a variety of challenges with our clients, not least the Covid-19 pandemic and the threat posed by a hard Brexit.  I must acknowledge the continued support of you, our valued clients, the resilience of our dedicated staff in adjusting to changed working conditions and the ongoing commitment of our team to excellence in the delivery of legal services.

Having recently watched the Michael Jordan series “The Last Dance”, I would recommend it to you all. Michael Jordan realized as his career progressed that “talent wins games” but “teamwork and intelligence wins championships”.  You are not alone in the challenges you face.  We are keeping our focus on our core objective, how can we best help our clients at this time of crisis, support you and find solutions to your problems.  As a country, we have shown solidarity and one of our best qualities is that we thrive in the face of adversity. I am confident in our ability to overcome this pandemic. Pharma companies such as Regeneron are leading the global way in the fight against the virus.  I compliment the University of Limerick who are pioneering research into Covid-19 and I congratulate Kerstin Mey on her appointment as Interim President. Read more…

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HOMS News Issue 1 2020

In this our 50th year in business we have successfully faced a variety of challenges with our clients, not least the Covid-19 pandemic and the threat posed by a hard Brexit.  I must acknowledge the continued support of you, our valued clients, the resilience of our dedicated staff in adjusting to changed working conditions and the ongoing commitment of our team to excellence in the delivery of legal services.

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Fladgate survey reveals 35% of SMEs out of business within a year – but there is a solution

Presenting our Restart Capital campaign and survey results – private investment is the answer

We are delighted to present to you the results of our Restart Capital survey. The survey of over 500 SMEs and 100 investors confirmed to us some brutal realities.

We expected SMEs to confirm difficulties but we did not think that 35% of SMEs would expect to be out of business within the next 12 months.

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Ignoring or groundlessly rejecting to permit the goods import both constitute an act of unfair competition

18 September 2020 the Russian Federal Antimonopoly Service (the FAS) published the full decisions on cases No. 1-14-163/00-08-18 and 1-14-164\00-08-18. According to the decisions, Daimler AG and KYB Corporation breached art. 14.8 of the Russian Antitrust law by committing acts of unfair competition.

It was to consider whether a right holder is entitled to ignore or groundlessly reject requests from potential importers of goods, marked with right holder designations. The FAS rejected such a right and indicated the following criteria to be met to acknowledge unfair competition:

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Roszdravnadzor has defined criteria for blocking websites selling medicines

4 September 2020 the Russian Ministry of Justice registered the Order No. 5527 of Roszdravnadzor dd. 29 June 2020, approving criteria for evaluating the information, publication of which may result in a website inclusion in the register of prohibited websites and its blocking. The Federal Service for Surveillance in Healthcare (Roszdravnadzor) renders such a decision.

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The Russian Government passed new rules on the medicines interchangeability

The new rules on the medicines interchangeability No. 1360 (hereinafter – the Rules) enacted by the Russian Government have entered into force on 9 September 2020 .

The Rules do not cover herbal and homeopathic medicines.

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Donal Creaton shares how we are embracing technology and being resilient through change

JD Supra, a thought leadership knowhow publisher, shared our insights into how Holmes O’Malley Sexton are embracing technology, going paperless and being resilient lawyers to achieve success and support for our clients during these changing times.

Listen to Donal Creaton (a litigation partner at Holmes O’Malley Sexton) and Lindsay Griffiths (International Lawyers Network (ILN)) in this podcast for advice on how your organisation can grow resilience and welcome change. In this episode of ILN’s podcast series, Lindsay and Donal dive into the importance of embracing technology and becoming paperless to allow for full flexibility in serving clients, as well as the resilience of lawyers.

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E-LEGAL® NEWSLETTER – AUGUST 2020

I. EDITORIAL  –AMENDMENTS TO THE VAT CODE, THE VAT SYSTEM IN INTRA-COMMUNITY TRANSACTIONS AND TO THE PERSONAL INCOME TAX CODE

In the month of August there were several and relevant legislative approvals, of which we point out Law no. 47/2020, of August 24 which amended the VAT Code, the VAT System in Intra-Community Transactions and the complementary legislation related to this tax, in the context of the e-commerce processing, as well as Law no. 48/2020, of August 2 which proceeded with the amendment to the Personal Income Tax Code (“IRS”). Read more…

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The role of SIMEST S.p.A. as export and internationalization hub in Italy

The role of SIMEST S.p.A. as export and internationalization hub in Italy
Author: Stefano Rossi SIMEST is the company in the Cassa Depositi e Prestiti Group1 (CDP…
Stefano Rossi

Together with SACE, SIMEST represents the Export and Internationalization Hub of the CDP Group, which brings together all the instruments to support Italian companies that wish to compete and grow internationally.

SIMEST, in particular, supports companies through their whole expansion cycle abroad, from the initial assessment of opening up to a new market, to expansion through direct investments. It operates through loans aimed at internationalization, export credit support and capital investments.

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