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Life Sciences, Biotechnology & Nanotechnology
Austria
Schoenherr Attorneys at Law
Unbelievable but true – due to the outbreak of COVID-19, hand and surface disinfectants are currently hardly available anywhere in the shops.
European Union
Reed Smith (Worldwide)
If they serve health care professionals (HCPs) in EU member states, manufacturers that provide personal protective equipment (PPE) or medical devices used by HCPs caring for known or suspected COVID-19
Hogan Lovells
As the number of cases of COVID-19 (coronavirus) grows around the world, so too have questions regarding the potential impact of the pandemic on the medical device industry.
Reed Smith (Worldwide)
The Innovative Medicines Initiative (IMI) was created in 2008 as a public-private partnership between the European Union and the European Federation of Pharmaceutical Industries and Associations (EFPIA).
Arnold & Porter
The Neurim CJEU decision of July 2012 has arguably caused an equal amount of excitement and controversy.
Hogan Lovells
Our team is always thinking about how to conquer and foresee the most significant industry issues facing our clients.
Reed Smith (Worldwide)
The Court of Justice of the European Union (CJEU) upheld decisions by the European Medicines Agency in two identical rulings on January 22, 2020.
DLA Piper
On 7 January 2020, the EU Medical Device Coordination Group published new guidance to help manufacturers fulfil all relevant cybersecurity requirements in Annex I ...
DLA Piper
On 7 January 2020, the EU Medical Device Coordination Group published new guidance to help manufacturers fulfil all relevant cybersecurity requirements in Annex I to the new Medical Device Regulations
Germany
Hogan Lovells
Last month, Germany introduced the Digital Health Service Act, which grants German patients access to reimbursable digital health applications.
Kazakhstan
GRATA International
The new rules for regulating the prices of medicines ('Price Regulation Rules 2019') were adopted in April 2019. Over the past five years, this is the third regulatory legal act establishing
Poland
Hogan Lovells
In preparation for situations of crisis caused by a potential spread of the coronavirus, the Polish Parliament has adopted a draft bill that introduces certain new obligations upon...
Slovakia
Dentons
To address the spread of COVID-19 in Europe and Slovakia, the Slovak Government has declared an ‘extraordinary situation' under Act No 42/1994 Coll. On Civil Safety
Spain
Hogan Lovells
Spain's Ministry of Health initiated proceedings for approval of the new regulation on medical devices with a call for a prior public consultation...
Switzerland
Baer & Karrer
Last month, Germany introduced the Digital Health Service Act, which grants German patients access to reimbursable digital health applications.
Turkey
Esin Attorney Partnership
Türkiye İlaç ve Tıbbi Cihaz Kurumu 25 Şubat 2020 tarihinde yaptığı duyuruda Klinik Araştırmalar Modülüne yapılacak araştırma kayıtları ve yıllık bildirimlere ilişkin yönlendirmelerde bulundu.
Esin Attorney Partnership
On February 25, 2020, the Turkish Medicine and Medical Devices Authority ("TİTCK") announced the instructions for clinical trial registrations and annual notifications through the Clinical Trials Module.
ELIG Gürkaynak Attorneys-at-Law
In May, 2019, the Agency had announced the Draft Regulation on Sales, Advertising and Promotion of Medical Devices, expected to replace the Regulation on Sales, Advertising and Promotion of Medical Devices, ...
UK
Hogan Lovells
At the end of last week, the World Health Organisation (WHO) upgraded the global risk assessment of the novel coronavirus to "very high." This comes shortly after the United Kingdom ...
Hogan Lovells
We are pleased to provide you with the third annual installment of our Life Sciences and Health Care Horizons guide.
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