EU guidance documents referred to in the Human Medicines Regulations 2012
Links to EU guidance, as it stood immediately before end of transition period.
This is EU guidance specifically referred to in the Human Medicines Regulations 2012 (HMRs), as these are due to be amended by the Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 and the Human Medicines (Amendment etc.) (EU Exit) Regulations 2020.
Before the end of the transition period, the Government is putting in place legislation to allow the continued sale of and access to medicines as well as to implement the Northern Ireland Protocol in relation to medicines regulation.
This will be done via amendments to the HMRs by the Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 and the Human Medicines (Amendment etc.) (EU Exit) Regulations 2020. The 2020 Regulations have been approved by Parliament and are now UK law.
The HMRs set out a comprehensive regime for the authorisation of medicinal products for human use; for the manufacture, import, distribution, sale and supply of those products; for their labelling and advertising; and for pharmacovigilance.
They also provide for enforcement powers for the authorisation and supervision of medicinal products for human use.
The amendments to the HMRs address the fact that the UK will no longer be part of the harmonised EU medicines network following the end of transition period.
However in Northern Ireland the EU regulations will continue to apply in accordance with the Northern Ireland Protocol. They replicate the current arrangements so far as possible in Great Britain but also make appropriate changes to reflect the fact that the MHRA will operate outside of the EU network while acknowledging the special provisions that will apply in respect of Norther Ireland.
Part of maintaining the current position involves continued reliance on EU guidance documents. Where existing EU law refers to various pieces of EU guidance, those references are inserted into the 2012 Regulations.
The relevant version of the EU guidance is the version as it stood immediately before the end of the transition period.
Those versions can be accessed below for reference in Great Britain (England, Scotland and Wales).
With regard to Northern Ireland, the relevant version of this guidance can be obtained from the EU websites.
Guidance on applications for marketing authorisations (MAs)
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Guidance on inspections
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Guidance on packaging and leaflets
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Guidance on Good Manufacturing Practice
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Guideline on similar biological medicinal products
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Guidelines for generic medicinal products for omitting bioavailability studies from an application
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Guidance for medical devices
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Guidelines for variations
Last updated 30 December 2020 + show all updates
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Provided links to versions of EU guidance documents, and updated the text to reflect that the 2020 Regulations have been approved by Parliament and are now UK law.
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First published.