Regulatory Work to Secure Licence Variation for anastrozole

  • NHS England

F14: Notice for changes or additional information

Notice identifier: 2022/S 000-001642

Procurement identifier (OCID): ocds-h6vhtk-02de26

Published 19 January 2022, 5:30pm



Section one: Contracting authority/entity

one.1) Name and addresses

NHS England

Quarry House

Leeds

LS2 7UE

Contact

Liz Fleetwood

Email

liz.fleetwood1@nhs.net

Country

United Kingdom

NUTS code

UKE - Yorkshire and the Humber

Internet address(es)

Main address

https://www.england.nhs.uk//

Buyer's address

https://www.england.nhs.uk//


Section two: Object

two.1) Scope of the procurement

two.1.1) Title

Regulatory Work to Secure Licence Variation for anastrozole

Reference number

C52236

two.1.2) Main CPV code

  • 85149000 - Pharmacy services

two.1.3) Type of contract

Services

two.1.4) Short description

This Tender is solely for the work involved to apply for and implement a major (type II) MHRA Marketing Authorisation variation to add a new clinical indication for anastrozole. The successful Bidder will be responsible for ensuring that all relevant MHRA conditions and documentation for the Marketing Authorisation variation are met and submitted within the time limits agreed with the Authority. In return the Authority will fund actual and reasonably incurred costs associated with obtaining this licence variation only.Full details can be found on the Atamis portal: https://health-family.force.com/s/Welcome Closing date for submissions is 31st January 2022 at 13:00


Section six. Complementary information

six.6) Original notice reference

Notice number: 2021/S 000-032170


Section seven. Changes

seven.1.2) Text to be corrected in the original notice

Section number

II.1.4.1

Place of text to be modified

Short description

Read
Text

This Tender is solely for the work involved to apply for and implement a major (type II) MHRA Marketing Authorisation variation to add a new clinical indication for anastrozole. The successful Bidder will be responsible for ensuring that all relevant MHRA conditions and documentation for the Marketing Authorisation variation are met and submitted within the time limits agreed with the Authority. In return the Authority will fund actual and reasonably incurred costs associated with obtaining this licence variation only.

Full details can be found on the Atamis portal: https://health-family.force.com/s/Welcome

Closing date for submissions is 7th February 2022 at 13:00

Section number

IV.2.2.1

Place of text to be modified

Deadline for EOI date

Instead of
Date

31 January 2022

Read
Date

7 February 2022

Section number

IV.2.7.1

Place of text to be modified

Tender opening date

Instead of
Date

1 February 2022

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Date

8 February 2022