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Health and Social Care

Volume 666: debated on Monday 14 October 2019

Draft Human Medicines and Medical Devices (Amendment etc.) (EU Exit)

The following are extracts from the debate on the draft Human Medicines and Medical Devices (Amendment etc.) (EU Exit) Regulations 2019.

Under just-in-time arrangements, drug companies would have a stockpile of a week’s supply, but now all drug companies have stockpiled six weeks’ worth of medications to be used in the UK, and I do not envisage a shortage of any drug that is required.

[Official Report, Sixteenth Delegated Legislation Committee, 7 October 2019, c. 8.]

Letter of correction from the Under-Secretary of State for Health and Social Care, the hon. Member for Mid Bedfordshire (Ms Dorries):

An error has been identified in my closing speech.

The correct information should have been:

Under just-in-time arrangements, drug companies would have a stockpile of a week’s supply, but now the vast majority of suppliers of prescription-only and pharmacy medicines from the EU have stockpiled six weeks’ worth of medications to be used in the UK, and I do not envisage a shortage of any drug that is required.

Companies will be required to operate a pharmacovigilance system from exit day. The master file is in the description of the pharmacovigilance system and the amending SI, which includes statutory contributions associated with a temporary exemption, to ensure supervisory capability of the companies, the QPPV and the MHRA.

[Official Report, Sixteenth Delegated Legislation Committee, 7 October 2019, c. 10.]

Letter of correction from the Under-Secretary of State for Health and Social Care, the hon. Member for Mid Bedfordshire (Ms Dorries):

An error has been identified in my closing speech.

The correct information should have been:

Companies are required to operate a pharmacovigilance system from exit day. The master file is the description of the pharmacovigilance system and the statutory conditions included in the amending SI should ensure supervisory capability of the companies, QPPV and the MHRA.