Pharmaceutical News and Updates
01 January 2021
New guidance & information for industry from MHRA
MHRA have updated guidance to be followed from 1st January for pharmaceutical industry and organisations. This replaces previously published guidance on what to do from the end of the Brexit transition period.
Guidance & Information
__________________________________________________________________________________________________
31 December 2020
Responsible Person (Import)
A wholesale dealer in Great Britain may only import Qualified Person (QP) certified medicines from the European Economic Area (EEA) if certain checks are made by a "Responsible Person (import) (RPi)". Guidance has been published by the MHRA which describes:
_________________________________________________________________________________________________
15 June 2020
Medicines that cannot be exported from UK
MHRA have updated the list of medicinal products that cannot be exported from the UK or hoarded. The list of products can be found here.
__________________________________________________________________________________________________
09 May 2020
Annex 1 draft consultation
The deadline for the EudraLex Volume 4, Annex 1 on Manufacture of Sterile Medicinal Products second targeted consultation period has been extended until 20 July 2020. Targeted organisations representing relevant stakeholders are invited to take part and comment on the draft.
The Annex 1 consultation document and details on how to submit a contribution can be found here.
__________________________________________________________________________________________________
01 April 2020
MHRA flexibilities during Coronavirus pandemic
MHRA have provided guidance on industry flexible approaches to regulations during the Coronavirus / Covid-19 pandemic.
Details of the flexibilities can be found on the MHRA website here.
__________________________________________________________________________________________________
23 March 2020
MHRA GxP Inspections
Due to the Coronavirus pandemic, MHRA have announced a risk-based prioritisation of GxP inspections.
To read the full MHRA blog by David Churchwood click here.
__________________________________________________________________________________________________
New guidance & information for industry from MHRA
MHRA have updated guidance to be followed from 1st January for pharmaceutical industry and organisations. This replaces previously published guidance on what to do from the end of the Brexit transition period.
Guidance & Information
__________________________________________________________________________________________________
31 December 2020
Responsible Person (Import)
A wholesale dealer in Great Britain may only import Qualified Person (QP) certified medicines from the European Economic Area (EEA) if certain checks are made by a "Responsible Person (import) (RPi)". Guidance has been published by the MHRA which describes:
- How to apply to be a RPi
- How to verify the QP certification of a medicine has been carried out in the EEA
- How to verify that biological products (vaccines and medicines derived from human blood or plasma) have an independent batch release certificate.
_________________________________________________________________________________________________
15 June 2020
Medicines that cannot be exported from UK
MHRA have updated the list of medicinal products that cannot be exported from the UK or hoarded. The list of products can be found here.
__________________________________________________________________________________________________
09 May 2020
Annex 1 draft consultation
The deadline for the EudraLex Volume 4, Annex 1 on Manufacture of Sterile Medicinal Products second targeted consultation period has been extended until 20 July 2020. Targeted organisations representing relevant stakeholders are invited to take part and comment on the draft.
The Annex 1 consultation document and details on how to submit a contribution can be found here.
__________________________________________________________________________________________________
01 April 2020
MHRA flexibilities during Coronavirus pandemic
MHRA have provided guidance on industry flexible approaches to regulations during the Coronavirus / Covid-19 pandemic.
Details of the flexibilities can be found on the MHRA website here.
__________________________________________________________________________________________________
23 March 2020
MHRA GxP Inspections
Due to the Coronavirus pandemic, MHRA have announced a risk-based prioritisation of GxP inspections.
To read the full MHRA blog by David Churchwood click here.
__________________________________________________________________________________________________