Blood Components Manufacturer's Licence: Jersey Blood Service

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A decision made 24 January 2018:

Decision Reference: MD-HSS-2018-0001
Decision Summary Title :	Medicines (Jersey) Law 1995 – Application for renewal of Manufacturer’s Licence		Date of Decision Summary:	23rd January 2018
Decision Summary Author:	Chief Pharmacist		Decision Summary: Public or Exempt? (State clauses from Code of Practice booklet)	Public
Type of Report: Oral or Written?	Written		Person Giving Oral Report:
Written Report Title :	Medicines (Jersey) Law 1995 – Application for renewal of Manufacturer’s Licence		Date of Written Report:	23rd January 2018
Written Report Author:	Chief Pharmacist		Written Report : Public or Exempt? (State clauses from Code of Practice booklet)	Public
Subject: Medicines (Jersey) Law 1995 – Application for renewal of Manufacturer’s Licence
Decision(s): The Minister renewed the manufacturer’s licence to the Jersey Blood Service, on the same terms and conditions as the existing licence, for a period of 6 months to provide for the manufacture of blood components in emergency circumstances
Reason(s) for Decision: An application for the renewal of the manufacturer’s licence has been received from the Jersey Blood Service in accordance with the Medicines (Applications for Manufacturer’s and Wholesale Dealer’s Licences) (Jersey) Order 1997
Resource Implications: None
Action required: Minister to approve the application from the Jersey Blood Service for the renewal of the manufacturer’s licence and sign and seal the licence.
Signature:		Position:
Date Signed:		Date of Decision (If different from Date Signed):

Blood Components Manufacturer's Licence: Jersey Blood Service

STATES OF JERSEY

HEALTH AND SOCIAL SERVICES DEPARTMENT

Medicines (Jersey) Law 1995 – Jersey Blood Service Application for Renewal of Manufacturer’s Licence

Issue

The Minister is requested to consider renewing the manufacturer’s licence to the Jersey Blood Service (JBS) for a further period of 6 months.

Background

Article 9(2) of the Medicines (Jersey) Law 1995 requires that manufacturers of medicinal products be licensed. The preparation of products by the Jersey Blood Service (JBS) from blood collected from donors constitutes manufacture of a medicinal product, and consequently requires the JBS to be licensed as a manufacturer.

The current licence expires on 31st January 2018. On Expiry of the current licence routine collection and production of blood components is to be temporarily suspended while an upgrade of facilities is undertaken. During this period blood will be sourced from the UK. However, in order to provide resilience in the event that supplies are disrupted the ability to collect blood and produce blood components locally needs to be maintained.

An application, in accordance with the Medicines (Applications for Manufacturer’s and Wholesale Dealer’s Licences) (Jersey) Order 1997, has therefore been received seeking a renewal of the existing license on the same terms and conditions for a period of 6 months.

This is to enable the collection of blood and production of blood components to be undertaken in emergency circumstances should supplies from the UK be compromised while the planned upgrade of facilities locally is undertaken.

Recommendation

The Minister is requested to renew the manufacturer’s licence to the Jersey Blood Service for a period of 6 months to provide for the manufacture of blood components in emergency circumstances and subject to the same conditions provided for by the existing licence.