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L'înformâtion et les sèrvices publyis pouor I'Île dé Jèrri

Medicines (Jersey) Law 1995: Application for a Manufacturer's Licence

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A decision made on 16 October 2018

Decision Reference: MD-HSS-2018-0048

Decision Summary Title :

Medicines (Jersey) Law 1995 – Application for a Manufacturer’s Licence

Date of Decision Summary:

11th October 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 a Manufacturer’s Licence

Date of Written Report:

11th October 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 a Manufacturer’s Licence

Decision(s):

The Minister granted a manufacturer’s licence to the Jersey Blood Service for a period of 3 years to provide for the manufacture of blood components up until 31st October 2021.

Reason(s) for Decision:

An application for a 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. An inspection of the Service by the Medicines and Healthcare Products Regulatory Agency has confirmed that the Jersey Blood Service is in general compliance with the EU Blood Directives and the Blood Safety and Quality Regulations.

Resource Implications:

None

Action required:

Minister to approve the application from the Jersey Blood Service for a manufacturer’s licence and sign and seal the licence.

Signature:

 

 

Position:

Minister for Health and Social Services

 

Date Signed:

 

 

Date of Decision (If different from Date Signed):

 

 

Medicines (Jersey) Law 1995: Application for a Manufacturer's Licence

STATES OF JERSEY

 

HEALTH AND COMMUNITY SERVICES DEPARTMENT

 

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

 

 

Issue

 

The Minister is requested to consider granting a manufacturer’s licence to the Jersey Blood Service (JBS) for a period of 3 years.

 

 

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.

 

On Expiry of the previous full licence on 31st January 2018 routine collection and production of blood components was temporarily suspended while an upgrade of facilities was undertaken. At that time an emergency licence was granted in order to provide resilience in the event that blood supplies from the UK were disrupted while the upgrade of facilities was undertaken. The current emergency licence expires on 31st October 2018.

 

The upgrade of facilities has now been completed and the service has subsequently been inspected by the Medicines and Healthcare Products Regulatory Agency (MHRA). This inspection has confirmed that the Jersey Blood Service is in general compliance with the EU Blood Directives and the Blood Safety and Quality Regulations. The service therefore complies with European and UK best practice regarding blood component manufacture.

 

Accordingly an application, in accordance with the Medicines (Applications for Manufacturer’s and Wholesale Dealer’s Licences) (Jersey) Order 1997, has been received from the Jersey Blood Service seeking a new manufacturers licence.

 

 

Recommendation

 

The Minister is recommended to grant a manufacturer’s licence to the Jersey Blood Service for a period of 3 years, expiring on 31st October 2021 with the condition that a further MHRA inspection is undertaken no later than 30th April 2021.

 

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