Consultation Document - Amendments to the Human Medicines Regulations 2012 - Patient Group Directions following the closure of HSCBThe 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.