Regulatory framework for medicinal products

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Practice notes
A director who is in any way, directly or indirectly, interested in:•a proposed transaction or arrangement with the company of which they are a...
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9th Nov
Practice notes
In order to establish that an unauthorised use or dealing in a product or process amounts to infringement of a patent it is necessary to prove that:•a...
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9th Nov
Practice notes
This Practice Note provides an introduction to arbitration and its key features, with a particular focus on arbitration under the law of England and...
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Produced in partnership with Simmons & Simmons LLP 9th Nov
Practice notes
Brexit: The UK's departure from the EU on exit day, ie Friday 31 January 2020, has implications for practitioners considering applicable law. For...
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9th Nov
Practice notes
An intellectual property (IP) owner may choose to license its IP to a third party. This can be an effective route to generating revenue while...
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Produced in partnership with Jessica Stretch 9th Nov
Practice notes
This Practice Note provides an introduction to retained EU law, which is an entirely new legal concept introduced to UK domestic law in preparation...
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9th Nov
Practice notes
As of exit day (31 January 2020) the UK is no longer an EU Member State. However, in accordance with the Withdrawal Agreement, the UK has entered an...
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9th Nov
Practice notes
Brexit: The UK's departure from the EU on exit day ie Friday 31 January 2020 has implications for practitioners considering the use of ADR as it may...
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9th Nov
Practice notes
Introduction to infringementA patent owner has to prove two elements before it can secure an infringement finding (and then an injunction, damages,...
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9th Nov
Practice notes
As of exit day (31 January 2020) the UK is no longer an EU Member State. However, in accordance with the Withdrawal Agreement, the UK has entered an...
Read More >
9th Nov
Precedents
Option 1—deed executed by a company under its common seal (model articles, where the authorised signatory is an...
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9th Nov
Precedents
1 Intellectual property rights indemnity 1.1 The Supplier shall defend the Customer against any third party claim that...
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9th Nov
Practice notes
Brexit: The UK's departure from the EU on exit day, ie Friday 31 January 2020, has implications for practitioners considering applicable law. For...
Read More >
9th Nov
Precedents
Month means a calendar month; Close This is a suggested definition for the term 'month', which...
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9th Nov

Most recent Regulatory framework for medicinal products content

Practice notes
11 pm (GMT) on 31 December 2020 marks the end of the implementation period put in place to enable the UK to transition away from the EU’s laws and...
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2nd Dec
Practice notes
This Practice Note deals with key issues that are likely to affect the life sciences sector as a result of the UK’s withdrawal from the EU. It briefly...
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2nd Dec
Practice notes
On 31 January 2020, the UK ceased to be an EU Member State and entered an implementation period during which it continues to be treated by the EU as a...
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1st Dec
Practice notes
On 31 January 2020, the UK ceased to be an EU Member State and entered an implementation period during which it continues to be treated by the EU as a...
Read More >
1st Dec
Practice notes
On 31 January 2020, the UK ceased to be an EU Member State and entered an implementation period during which it continues to be treated by the EU as a...
Read More >
Produced in partnership with Geneviève Michaux, Partner, King & Spalding 30th Nov
Practice notes
On 31 January 2020, the UK ceased to be an EU Member State and entered an implementation period during which it continues to be treated by the EU as a...
Read More >
29th Nov
Practice notes
On 31 January 2020, the UK ceased to be an EU Member State and entered an implementation period during which it continues to be treated by the EU as a...
Read More >
29th Nov
Practice notes
On 31 January 2020, the UK ceased to be an EU Member State and entered an implementation period during which it continues to be treated by the EU as a...
Read More >
Produced in partnership with Peter Feldschreiber, 4 New Square, Lincolns’ Inn 29th Nov
Practice notes
On 31 January 2020, the UK ceased to be an EU Member State and entered an implementation period during which it continues to be treated by the EU as a...
Read More >
29th Nov
Practice notes
On 31 January 2020, the UK ceased to be an EU Member State and entered an implementation period during which it continues to be treated by the EU as a...
Read More >
Produced in partnership with Eleanor Denny, associate, and Claire Phipps-Jones, senior associate, of Bristows LLP 29th Nov
Practice notes
What are e-cigarettes?Electronic cigarettes (commonly known as ‘e-cigarettes’, ‘vapourisers’ or ‘vapes’) are products that can be used to consume...
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Produced in partnership with Jaspreet Takhar of Baker McKenzie 29th Nov
Practice notes
On 31 January 2020, the UK ceased to be an EU Member State and entered an implementation period during which it continues to be treated by the EU as a...
Read More >
29th Nov
Practice notes
On 31 January 2020, the UK ceased to be an EU Member State and entered an implementation period during which it continues to be treated by the EU as a...
Read More >
Produced in partnership with Elisabethann Wright, Marta Miglietti, Fabien Roy, Jane Summerfield, Julia Fraser and Richard Welfare of Hogan Lovells 29th Nov
Q&As
Two directives laying down principles and guidelines of good manufacturing practice (GMP) for medicinal products were adopted by the Commission....
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29th Nov
Q&As
The regulatory framework for e-cigarettes consists of a triumvirate of legislation consisting of Directive 2001/83/EC, (the Pharmaceutical Code) and...
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29th Nov
Q&As
Article 23(2) of Directive 2001/83/EC (consolidated version 26.07.2019), the Pharmaceutical Code requires the marketing authorisation holder (MAH) to...
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29th Nov
Q&As
A complex array of requirements and guidelines developed at both EU and EU Member State levels govern the development, authorisation, production,...
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29th Nov

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