Consultation on Proposals for Legislative Changes to the Human Medicines Regulations 2012

Consultation opened on 17 December 2021. Closing date 14 January 2022.

Summary

The Department of Health wants your views on proposed changes to the Human Medicines Regulations 2012 which relate to the supply of medicines in accordance with Patient Group Directions.

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Consultation description

The Minister of Health in Northern Ireland, is seeking views on proposed changes to the Human Medicines Regulations 2012 (HMRs) that relate to the supply of medicines in accordance with Patient Group Directions (PGDs). 

For a PGD to be lawful, it must be developed and approved by a doctor (or dentist) and a pharmacist. It must also be approved by the agency that has commissioned the service. This agency must be specifically designated within the HMRs.  As the specific statutory functions in relation to PGDs
will become the responsibility of the Department of Health from 1st April 2022, following the pending closure of the Regional Board, the Department needs to be designated as a ‘Health Authority’ and an amendment to the Human Medicines Regulations is therefore being proposed.

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