Contract notice
Section I: Contracting
authority
I.1) Name and addresses
Medicines and Healthcare Products Regulatory Agency (MHRA)
NIBSC, Blanche Lane, South Mimms
Potters Bar, Hertfordshire
EN6 3QG
UK
Telephone: +44 1707641000
E-mail: purchasing@nibsc.org
NUTS: UK
Internet address(es)
Main address: https://mhra.bravosolution.co.uk/web_mhra/login.html
I.3) Communication
Access to the procurement documents is restricted. Further information can be obtained at:
https://mhra.bravosolution.co.uk/web_mhra/login.html
Additional information can be obtained from the abovementioned address
Tenders or requests to participate must be sent electronically to:
https://mhra.bravosolution.co.uk/web_mhra/login.html
Tenders or requests to participate must be sent to the abovementioned address
I.4) Type of the contracting authority
National or federal agency/office
I.5) Main activity
Health
Section II: Object
II.1) Scope of the procurement
II.1.1) Title
Notified body and ISO13485:2016 certification body
II.1.2) Main CPV code
72225000
II.1.3) Type of contract
Services
II.1.4) Short description
The Medicines and Healthcare products Regulatory Agency is preparing to tender for a new Notified Body and ISO 13485 certificating body for one of its centre "National Institute for Biological Standards and Control (NIBSC)". NIBSC is a multi-disciplinary scientific establishment whose purpose is to safeguard and enhance public health by standardising and controlling biological substances used in medicines. One of its key roles is the production of reference materials including in vitro diagnostic devices (IVDs) and we are preparing to tender for a new Notified Body and ISO 13485:2016 certification body. We currently have 45 staff that are involved in the design and manufacture of 91 IVD products of which, 44 are currently Annex II List A and List B, and 47 are currently self-certified.
II.1.6) Information about lots
This contract is divided into lots:
No
II.2) Description
II.2.3) Place of performance
NUTS code:
UK
II.2.4) Description of the procurement
The Medicines and Healthcare products Regulatory Agency is preparing to tender for a new Notified Body and ISO 13485 certificating body for one of its centre "National Institute for Biological Standards and Control (NIBSC)". NIBSC is a multi-disciplinary scientific establishment whose purpose is to safeguard and enhance public health by standardising and controlling biological substances used in medicines. One of its key roles is the production of reference materials including in vitro diagnostic devices (IVDs) and we are preparing to tender for a new Notified Body and ISO 13485:2016 certification body. We currently have 45 staff that are involved in the design and manufacture of 91 IVD products of which, 44 are currently Annex II List A and List B, and 47 are currently self-certified.
II.2.5) Award criteria
Price is not the only award criterion and all criteria are stated only in the procurement documents
II.2.7) Duration of the contract, framework agreement or dynamic purchasing system
Duration in months: 36
This contract is subject to renewal: Yes
Description of renewals:
Couple of extensions.
II.2.9) Information about the limits on the number of candidates to be invited
II.2.10) Information about variants
Variants will be accepted:
No
II.2.11) Information about options
Options:
No
II.2.13) Information about European Union funds
The procurement is related to a project and/or programme financed by European Union funds:
No
Section IV: Procedure
IV.1) Description
IV.1.1) Type of procedure
Open procedure
IV.1.8) Information about Government Procurement Agreement (GPA)
The procurement is covered by the Government Procurement Agreement:
Yes
IV.2) Administrative information
IV.2.2) Time limit for receipt of tenders or requests to participate
Date:
03/07/2018
Local time: 13:00
IV.2.4) Languages in which tenders or requests to participate may be submitted
EN
IV.2.6) Minimum time frame during which the tenderer must maintain the tender
Tender must be valid until:
30/09/2018
IV.2.7) Conditions for opening of tenders
Date:
04/07/2018
Local time: 13:00
Section VI: Complementary information
VI.1) Information about recurrence
This is a recurrent procurement:
Yes
VI.4) Procedures for review
VI.4.1) Review body
Medicines and Healthcare Products Regulatory Agency
Potters Bar
UK
VI.4.2) Body responsible for mediation procedures
Medicines and Healthcare Related Products Regulatory Agency
South Mimms, Potters Bar, Herts
UK
Telephone: +44 1707641000
VI.4.4) Service from which information about the review procedure may be obtained
Medicines and Healthcare Related Products Regulatory Agency
South Mimms, Potters Bar, Herts
UK
Telephone: +44 1707641000
VI.5) Date of dispatch of this notice
04/06/2018