Regulatory framework for medicinal products

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Practice notes
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Practice notes
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Precedents
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Practice notes
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Precedents
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Practice notes
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Practice notes
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Most recent Regulatory framework for medicinal products content

Practice notes
An introduction to the regulation of medicinal productsEU and UK legal framework governing medicinal productsA complex array of requirements and...
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14th Sep
Practice notes
Post-Brexit transition period—the regulation of medicinal productsThis Practice Note considers the potential impact of the end of the transition...
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18th Aug
Practice notes
Introduction to borderline productsThis Practice Note provides an introduction to the concept of borderline products, how the regulatory status of...
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17th Aug
Practice notes
Manufacturing of medicinal products for human useManufacturers of medicinal products must comply with certain minimum standards in their production...
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10th Aug
Practice notes
The regulation of advanced therapy medicinal productsIP COMPLETION DAY: The Brexit transition period ended at 11pm on 31 December 2020. At this time...
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Produced in partnership with Geneviève Michaux of King & Spalding 9th Aug
Practice notes
Regulation of e-cigarettesIP COMPLETION DAY: The Brexit transition period ended at 11pm on 31 December 2020. At this time (referred to in UK law as...
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Produced in partnership with Jaspreet Takhar of Baker McKenzie 9th Aug
Practice notes
BiosimilarsIP COMPLETION DAY: The Brexit transition period ended at 11pm on 31 December 2020. At this time (referred to in UK law as ‘IP completion...
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Produced in partnership with Eleanor Denny, associate, and Claire Phipps-Jones, senior associate, of Bristows LLP 9th Aug
Q&As
Why are e-cigarettes subject to the Medicines and Healthcare Products Regulatory Agency regulatory procedures? Are e-cigarettes considered medical...
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31st Jul
Practice notes
Marketing authorisations in the EU—content and form of the application and other practical considerationsAs explained in the Practice Note: Marketing...
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31st Jul
Practice notes
Regulatory data protectionDirective 2001/83/EC (consolidated version 26.07.2019), the Pharmaceutical Code establishes a period of ‘data exclusivity’...
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Produced in partnership with Elisabethann Wright BL of Cooley (UK) LLP, Fabien Roy of Hogan Lovells, Jane Summerfield of Hogan Lovells and Richard Welfare of Hogan Lovells 31st Jul
Practice notes
Orphan medicinal productsOrphan medicinal products (OMPs) are medicines used to prevent, diagnose or treat rare medical conditions and diseases. Given...
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31st Jul
Practice notes
Unlicensed medicinal products and off-label use of medicinal productsThis Practice Note explores unlicensed medicinal products and the various ways...
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Produced in partnership with Peter Feldschreiber, 4 New Square, Lincolns’ Inn 31st Jul
Q&As
How are medicinal products derived from human blood and plasma regulated?A complex array of requirements and guidelines developed at both EU and EU...
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31st Jul
Q&As
What legislation and guidance is relevant to the good manufacturing practice (GMP) of medicinal products?Two directives laying down principles and...
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31st Jul
Q&As
Does a marketing authorisation holder (MAH) of a medicinal product need to collect information on individual cases of ‘off-label’ use if there is no...
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31st Jul
Practice notes
Marketing authorisations in the EU—regulatory procedures for approval of medicinal productsNo medicinal product may be placed on the market without...
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31st Jul
Practice notes
UK regulation of cannabis-based medicinal productsThe cannabis plant can be used to produce a wide range of products with versatile purposes from...
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31st Jul

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