Brexit brought new challenges to the pharmaceutical industry, one of them being the special situation of Northern Ireland (NI), which, although part of the UK, remained subject to EU law under the NI Protocol. Pharmaceutical products placed on the NI market had to comply with EU law. For import purposes this created de facto an EU border between NI and the rest of the UK (namely England, Wales, and Scotland). The Windsor Framework provides a new set of arrangements to restore the smooth flow of trade within the UK.
https://goodlifesci.sidley.com/wp-content/uploads/sites/6/2022/03/sidleyLogo-e1643922598198.png00Maria Isabel Manleyhttps://goodlifesci.sidley.com/wp-content/uploads/sites/6/2022/03/sidleyLogo-e1643922598198.pngMaria Isabel Manley2024-04-11 10:32:352024-04-15 09:29:03New Guidance on Parallel Import Licensing Applicable to Northern Ireland Under the Windsor Framework
On March 19, 2024, a set of 100 “Compromise Amendments” to the European Commission’s far-reaching overhaul of the EU’s rules for medicines, the Pharmaceutical Review, was adopted by the European Parliament’s ENVI Committee. Maarten Meulenbelt, Chris Boyle and Zina Chatzidimitriadou explain the main changes, associated risks, and next steps.
https://goodlifesci.sidley.com/wp-content/uploads/sites/6/2022/03/sidleyLogo-e1643922598198.png00Maarten Meulenbelthttps://goodlifesci.sidley.com/wp-content/uploads/sites/6/2022/03/sidleyLogo-e1643922598198.pngMaarten Meulenbelt2024-03-19 17:31:042024-03-20 11:00:24EU’s Overhaul Of Pharma Legislation Amended With Uneasy IP Compromises
Licensing deals are still relatively new in China compared to the United States and Europe. Tom Duley and Ruchun Ji explain why this means Chinese parties need to be careful about the history of terms and the choice of governing law and arbitration venue when negotiating contracts.
https://goodlifesci.sidley.com/wp-content/uploads/sites/6/2022/05/GLS-Blog_Generic-imagery-06.png606833Thomas Duleyhttps://goodlifesci.sidley.com/wp-content/uploads/sites/6/2022/03/sidleyLogo-e1643922598198.pngThomas Duley2024-03-18 14:18:502024-03-29 16:54:30Chinese Parties to International Licensing Deals Should Consider How Terms Translate
Major U.S. companies are expanding their vitamins, minerals, and botanicals businesses into Europe. Diane McEnroe, Anna-Shari Melin, and Nadja Schwarz explain what to consider in relation to formulation, labelling, and marketing language when targeting this market.
https://goodlifesci.sidley.com/wp-content/uploads/sites/6/2022/03/sidleyLogo-e1643922598198.png00Diane C. McEnroehttps://goodlifesci.sidley.com/wp-content/uploads/sites/6/2022/03/sidleyLogo-e1643922598198.pngDiane C. McEnroe2024-03-07 11:02:442024-03-07 11:02:44Points To Check When Selling Food Supplements Outside The U.S.
Our lawyers share the top investment and regulatory trends from last month’s agenda-setting JP Morgan Health Care Conference. We expect an abundance of novel financing structures, investment focus on new disease states, and important new U.S. Food and Drug Administration (FDA) guidance.
https://goodlifesci.sidley.com/wp-content/uploads/sites/6/2022/05/GLS-Blog_Generic-imagery-10.png606833Sharon Flanaganhttps://goodlifesci.sidley.com/wp-content/uploads/sites/6/2022/03/sidleyLogo-e1643922598198.pngSharon Flanagan2024-02-27 10:36:302024-02-28 10:40:45Deal Outlook for 2024 Includes GLP-1 Investments, APAC M&A, and More Spinoffs
EU member states are beginning to implement EU environmental, social, and governance (ESG) legislation into national law, meaning life sciences companies will need to look at its impact on their global supply chains, including for APIs. Michele Tagliaferri, Anna-Shari Melin, and Nadja Schwarz explain.
https://goodlifesci.sidley.com/wp-content/uploads/sites/6/2022/03/sidleyLogo-e1643922598198.png00Michele Tagliaferrihttps://goodlifesci.sidley.com/wp-content/uploads/sites/6/2022/03/sidleyLogo-e1643922598198.pngMichele Tagliaferri2024-02-16 14:25:472024-03-27 11:29:13Life Sciences Companies with Operations in EU Could Be Affected by ESG Law
FDA has published new draft guidance on the safe manufacturing of active pharmaceutical ingredients (APIs) for animal drugs. Following a consultation period, it is also expected to be implemented in Japan, the EU, and the UK. Chris Fanelli, Dr. Chris Boyle, and Dan Roberts discuss what the new guidance means for animal drug manufacturers.
https://goodlifesci.sidley.com/wp-content/uploads/sites/6/2022/05/GLS-Blog_Generic-imagery-15.png606833Christopher A. Fanellihttps://goodlifesci.sidley.com/wp-content/uploads/sites/6/2022/03/sidleyLogo-e1643922598198.pngChristopher A. Fanelli2024-01-26 17:04:042024-02-28 10:40:02FDA Publishes New Draft Guidance Essentially Clarifying that the Human Drug GMP Guidelines (ICH Q7) Apply to the Manufacture of Veterinary Active Pharmaceutical Ingredients
September 24The Francis Crick Institute, 1 Midland Road, London, NW1 1AT, UK
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New Guidance on Parallel Import Licensing Applicable to Northern Ireland Under the Windsor Framework
Brexit brought new challenges to the pharmaceutical industry, one of them being the special situation of Northern Ireland (NI), which, although part of the UK, remained subject to EU law under the NI Protocol. Pharmaceutical products placed on the NI market had to comply with EU law. For import purposes this created de facto an EU border between NI and the rest of the UK (namely England, Wales, and Scotland). The Windsor Framework provides a new set of arrangements to restore the smooth flow of trade within the UK.
Maria Isabel Manley
London
mmanley@sidley.com
Dr. Alexandra Anna Theochari
Trainee Solicitor
atheochari@sidley.com
EU’s Overhaul Of Pharma Legislation Amended With Uneasy IP Compromises
On March 19, 2024, a set of 100 “Compromise Amendments” to the European Commission’s far-reaching overhaul of the EU’s rules for medicines, the Pharmaceutical Review, was adopted by the European Parliament’s ENVI Committee. Maarten Meulenbelt, Chris Boyle and Zina Chatzidimitriadou explain the main changes, associated risks, and next steps.
Maarten Meulenbelt
Brussels
mmeulenbelt@sidley.com
Dr. Chris Boyle
London
cboyle@sidley.com
Zina Chatzidimitriadou
London
zchatzidimitriadou@sidley.com
Chinese Parties to International Licensing Deals Should Consider How Terms Translate
Licensing deals are still relatively new in China compared to the United States and Europe. Tom Duley and Ruchun Ji explain why this means Chinese parties need to be careful about the history of terms and the choice of governing law and arbitration venue when negotiating contracts.
Thomas Duley
tduley@sidley.com
Ruchun Ji
Beijing, Palo Alto, Shanghai
rji@sidley.com
Points To Check When Selling Food Supplements Outside The U.S.
Major U.S. companies are expanding their vitamins, minerals, and botanicals businesses into Europe. Diane McEnroe, Anna-Shari Melin, and Nadja Schwarz explain what to consider in relation to formulation, labelling, and marketing language when targeting this market.
Diane C. McEnroe
New York
dmcenroe@sidley.com
Anna-Shari Melin
Munich
amelin@sidley.com
Nadja Schwarz
Munich
nadja.schwarz@sidley.com
Deal Outlook for 2024 Includes GLP-1 Investments, APAC M&A, and More Spinoffs
Our lawyers share the top investment and regulatory trends from last month’s agenda-setting JP Morgan Health Care Conference. We expect an abundance of novel financing structures, investment focus on new disease states, and important new U.S. Food and Drug Administration (FDA) guidance.
Sharon Flanagan
San Francisco, Palo Alto
sflanagan@sidley.com
Stephen Abreu
San Francisco
sabreu@sidley.com
Robert Darwin
London
rdarwin@sidley.com
Ruchun Ji
Beijing, Palo Alto, Shanghai
rji@sidley.com
Carlton Fleming
San Francisco, Palo Alto
cfleming@sidley.com
Frank Rahmani
Palo Alto, San Francisco
frahmani@sidley.com
Meenakshi Datta
Chicago
mdatta@sidley.com
Emily Marden
San Francisco
emarden@sidley.com
Torrey Cope
Washington, D.C.
tcope@sidley.com
Life Sciences Companies with Operations in EU Could Be Affected by ESG Law
EU member states are beginning to implement EU environmental, social, and governance (ESG) legislation into national law, meaning life sciences companies will need to look at its impact on their global supply chains, including for APIs. Michele Tagliaferri, Anna-Shari Melin, and Nadja Schwarz explain.
Michele Tagliaferri
Brussels
mtagliaferri@sidley.com
Anna-Shari Melin
Munich
amelin@sidley.com
Nadja Schwarz
Munich
nadja.schwarz@sidley.com
FDA Publishes New Draft Guidance Essentially Clarifying that the Human Drug GMP Guidelines (ICH Q7) Apply to the Manufacture of Veterinary Active Pharmaceutical Ingredients
FDA has published new draft guidance on the safe manufacturing of active pharmaceutical ingredients (APIs) for animal drugs. Following a consultation period, it is also expected to be implemented in Japan, the EU, and the UK. Chris Fanelli, Dr. Chris Boyle, and Dan Roberts discuss what the new guidance means for animal drug manufacturers.
Christopher A. Fanelli
Washington, D.C.
cfanelli@sidley.com
Dr. Chris Boyle
London
cboyle@sidley.com
Daniel J. Roberts
San Francisco
droberts@sidley.com
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