- Contingency legislation covering regulation of medicines, medical devices and clinical trials in a no deal scenario—Human Medicines (Amendment etc) (EU Exit) Regulations 2019
- Original news
- What is the purpose of the Human Medicines (Amendment etc) (EU Exit) Regulations 2019? What is the scope of the Regulations?
- HMRs, among other things, implement EU directives relevant to the regulation of medicinal products into UK law. There are however a number of EU regulations that are currently directly applicable. How do the draft 2019 Human Medicines Regulations deal with those regulations?
- Marketing authorisations
- Paediatric investigation plans and studies
- Orphan medicinal products
- Advanced therapy medicinal products (ATMPs)
- Manufacturing and batch testing
- Parallel import licences and parallel distribution notices
- Do the draft 2019 Human Medicines Regulations provide clarity as to whether and how the upcoming reform to the EU regulatory frameworks governing safety features for medicines will apply in the UK?
- How do the draft 2019 Human Medicines Regulations ensure the continuity of supply of medicines for the UK?
- What will be the impact of the amended UK regulatory framework on the life sciences businesses?
Life Sciences analysis: As part of our series on contingency legislation covering regulation of medicines, medical devices and clinical trials in a no deal scenario, Julia Gillert and Els Janssens, associates at Baker McKenzie’s healthcare team, look at the Human Medicines (Amendment etc) (EU Exit) Regulations 2019.
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