# EU guidance documents referred to in the Human Medicines Regulations 2012

Source: https://www.keypedia.com/records/uk_mhra_guidance/uk-mhra/8f84fc30-ed01-433c-86ef-9407e3b6926b
Type: Detailed Guide
Published: January 23, 2019
Updated: December 30, 2020

> The Medicines and Healthcare products Regulatory Agency (MHRA) and the UK Government have updated the Human Medicines Regulations (HMRs) 2012 to address the UK's regulatory framework following its exit from the European Union. These updates, facilitated by the 2019 and 2020 Amendment Regulations, ensure the continued sale and supply of medicines while implementing the Northern Ireland Protocol. Under this system, the MHRA operates independently of the EU network for Great Britain, whereas EU regulations remain applicable in Northern Ireland. To maintain stability, the UK continues to rely on EU guidance documents as they stood immediately before the end of the transition period for England, Scotland, and Wales. This specific document provides a general regulatory update rather than a report on a particular company or inspection; therefore, no specific violations or inspection dates are listed. The framework covers essential areas such as Good Manufacturing Practice (GMP), marketing authorizations, packaging, and pharmacovigilance. Regulated entities are required to adhere to the versions of guidance applicable to their specific region to ensure compliance with human medicine standards. For Great Britain, this involves referencing established pre-transition EU standards, while stakeholders in Northern Ireland must continue to follow current EU requirements as published on European Union websites.

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## Content

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) View all the files in this section Guidance on inspections View all the files in this section Guidance on packaging and leaflets View all the files in this section Guidance on Good Manufacturing Practice View all the files in this section Guideline on similar biological medicinal products View all the files in this section Guidelines for generic medicinal products for omitting bioavailability studies from an application View all the files in this section Guidance for medical devices View all the files in this section Guidelines for variations View all the files in this section