Regulatory framework for medicinal products

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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
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
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
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
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
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 12th Jan
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
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 12th Jan
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
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
What is a company's constitution?A company’s 'constitution' is defined under the Companies Act 2006 (CA 2006) as including:•the company’s articles of...
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9th Nov
Practice notes
This Practice Note considers the meaning and use of conditions precedent in commercial arrangements. It also considers typical conditions precedent...
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9th Nov
Practice notes
Unlike many other countries, the UK has no unfair competition law. Brand owners seeking to prevent competitors from marketing ‘copycat’ products or...
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9th Nov
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ContractWhere a contract is made by two or more parties it may contain a promise or obligation made by two or more of those parties. Any such promise...
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Most recent Regulatory framework for medicinal products content

Practice notes
Directive 2001/83/EC (consolidated version 26.07.2019), the Pharmaceutical Code establishes a period of ‘data exclusivity’ from the initial...
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Produced in partnership with Elisabethann Wright of Hogan Lovells, Fabien Roy of Hogan Lovells, Jane Summerfield of Hogan Lovells and Richard Welfare of Hogan Lovells 6th May
Practice notes
As explained in the Practice Note: Marketing authorisations in the EU—regulatory procedures for approval of medicinal products, no medicinal product...
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6th May
Practice notes
No medicinal product may be placed on the market without having first obtained an approval known as a marketing authorisation (MA). The MA sets out...
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6th May
Practice notes
IP COMPLETION DAY: 11pm (GMT) on 31 December 2020 marks the end of the Brexit transition/implementation period entered into following the UK’s...
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Produced in partnership with Geneviève Michaux, Partner, King & Spalding 6th May
Practice notes
EU and UK legal framework governing medicinal productsA complex array of requirements and guidelines developed at EU, EU Member State and UK levels...
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6th May
Practice notes
This Practice Note explores unlicensed medicinal products and the various ways that such products may be made available to patients in the EU and UK,...
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Produced in partnership with Peter Feldschreiber, 4 New Square, Lincolns’ Inn 6th May
Practice notes
IP COMPLETION DAY: 11pm (GMT) on 31 December 2020 marks the end of the Brexit transition/implementation period entered into following the UK’s...
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6th May
Practice notes
This Practice Note provides an introduction to the concept of borderline products, how the regulatory status of such products is determined in the EU...
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6th May
Practice notes
IP COMPLETION DAY: 11pm (GMT) on 31 December 2020 marks the end of the Brexit transition/implementation period entered into following the UK’s...
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6th May
Practice notes
This Practice Note considers the relevance of the Withdrawal Agreement to the life sciences sector and the respective roles of the EU and UK...
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12th Apr
Practice notes
IP COMPLETION DAY: 11pm (GMT) on 31 December 2020 marks the end of the Brexit transition/implementation period entered into following the UK’s...
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Produced in partnership with Eleanor Denny, associate, and Claire Phipps-Jones, senior associate, of Bristows LLP 9th Apr
Practice notes
IP COMPLETION DAY: 11pm (GMT) on 31 December 2020 marks the end of the Brexit transition/implementation period entered into following the UK’s...
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Produced in partnership with Jaspreet Takhar of Baker McKenzie 29th Mar
Practice notes
11 pm (GMT) on 31 December 2020 marked 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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17th Mar
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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13th Feb
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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13th Feb
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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24th Dec
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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22nd Dec

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