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Australia
Piper Alderman
The changes aim to simplify the requirements of the Code while continuing to promote accurate and balanced advertising.
Canada
Bereskin & Parr LLP
Despite 2021 feeling like an extension of 2020, there were a number of notable developments related to intellectual property in the life sciences.
Fasken
After much anticipation in the industry, the regulatory amendments restoring access to restricted drugs under Health Canada's Special Access Program (the "SAP") finally came into force.
Cassels
Notably, these changes do not guarantee that requests for access to psychedelic restricted drugs will be authorized.
Cyprus
Areti Charidemou & Associates LLC
We would like to remind you that the Cyprus Tax Department had announced the submission deadlines with respect to the electronic declarations of withheld Special Defence Contribution and contributions to the General Healthcare System.
European Union
Cooley LLP
Cooley's Productwise Bitesize brings you a short overview of the transitional provisions in the new Clinical Trials Regulation.
Ganado Advocates
On the 25 November 2021, in ‘Delfarma sp.zoo vs. Prezes Urzędu Rejestracji Produktów Leczniczych, Wyrobów Medycznych i Produktów Biobójczych', the Court of Justice of the European Union (the ‘‘CJEU'') ruled that the automatic expiration of a parallel import license of a medical product.
Matheson
The new Regulations overhaul the EU regulatory framework for medical devices, improving clinical safety, traceability and market access for all manufacturers.
Ireland
Arthur Cox
In the final briefing of our Get Ready for Go-Live series, we focus on compliance with the new Clinical Trial Regulation, including serious breaches of the Regulation and Good Clinical Practice inspections.
Matheson
A parallel agreement was also secured with Medicines for Ireland ("MFI") on behalf of the generic and biosimilar industry in Ireland.
Arthur Cox
On 6 December 2021, the Irish Pharmaceutical Healthcare Association, the association representing the international originator biopharmaceutical industry in Ireland, published the finalised version of
Mexico
OLIVARES
After more than 10 years, the official standard of good manufacturing practices concerning medical devices has been updated. On December 20, 2021...
Nigeria
AELEX
With the pandemic and its associated developments, the ability to timeously and efficiently place orders for drugs and medicine to meet the needs of patients and consumers has become crucial...
Turkey
Esin Attorney Partnership
Türkiye İlaç ve Tıbbi Cihaz Kurumu ("Kurum") geçtiğimiz haftalarda (i) tıbbi cihazların test, kontrol ve kalibrasyonu, (ii) sahte, kaçak ya da yasal tedarik zinciri dışına çıkan ilaçlar, ...
Esin Attorney Partnership
The Turkish Pharmaceuticals and Medical Devices Authority (TİTCK) has published announcements regarding (i) testing, control and calibration of medical devices, ...
CETINKAYA
Çetinkaya Avukatlık Bürosu olarak temel odak alanlarımızdan biri olan sağlık hukuku ve uyumu konusunda sağlık sektöründe ulusal ve uluslararası pek çok paydaş ile iş birliği...
Moroglu Arseven
Yurt Dışından İlaç Temini ve Kullanım Kılavuzu ("Kılavuz"), Türkiye İlaç ve Tıbbi Cihaz Kurumu ("Kurum") tarafından güncellenerek 23 Ekim 2021 tarihinde yayımlanmıştır.
UK
BLM
Health and social care workers have been facing unprecedented pressures during the COVID-19 pandemic. The new wave of Omicron cases has swept across the UK causing staff shortages across the sector.
United States
Riker Danzig Scherer Hyland & Perretti
This time of year, numerous bills get passed and approved by the New Jersey Legislative Branch and Governor. This year is no different.
Arnold & Porter
On January 7, 2022, the US Department of Health and Human Services (HHS) Office of Inspector General (OIG) issued a final rule—to become effective 30 days after its...
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