Public procurement notice: Contract Notice
Published: 2020-04-10
Buyer: Ministry of Defence, ISTAR, Chemical, Biological, Radiological and Nuclear Delivery Team (CBRN DT)
Country: UK
Contract type: Services
Procedure: Negotiated procedure
CPV classification: 33000000 | 33600000: Pharmaceutical products | 33680000 | 35113200 | 85121200: Specialist medical services
Estimated value:  GBP
Submission deadline: 2020-05-11
Award criteria: The most economic tender

Technical requirements: Nuclear, Biological, Chemical and Radiological protection equipment, medical specialist services, pharmaceutical products, pharmaceutical articles, medical equipment, pharmaceuticals and personal care products. The Chemical Biological Radiological Nuclear Team (CBRN) have a requirement for the provision of a quality delivery partner to provide pharmaceutical services to the front line command. The contractor will hold all appropriate uk medical license(s) for the distribution of controlled drugs.
1) Provision of a qualified person (QP) to ensure activities carried out by the Authority are in compliance with Good Manufacturing Practice. (GMP), including:
(a) evaluations certification of batch records and certification of batches of in service medical countermeasures manufactured outside the EU and release to the UK for use by the authority (as the Market Authorisation Holder (MAH));
(b) undertake Good Manufacturing Distribution Practice (GMDP) audits of service providers and product manufacturers/suppliers on behalf of the authority;
(c) liaison with MHRA as necessary, including formal notification to Defective Medicines Reporting Centre (DMRC).
2) Qualified Person for Pharmacovigilance (QPPV) and nominated deputy, to provide on-going support as required for the provision of a fully compliant Pharmacovigilance service, including:
(a) review and comment on the in-house pharmacovigilance and provide medicine information on in-service pre-treatment sets and self administered post exposure treatment of Nerve Agent;
(b) liaison with other competent Authorities to ensure appropriate testing required as a result of registration is completed on behalf of the authority, within the relevant regulatory timelines;
(c) carry out safety monitoring for the products, compile periodic safety update reports and submit the reports to the relevant regulatory authorities.
3) Regulatory affairs consultant, provision of advice and services in order to ensure that the authority is compliant with EU and UK legislation. Notify the authority of any changes in legislation that may have an impact and provide advice on what must be implemented to ensure the market authorisations remain current and compliant;
4) Provision of a Responsible Person (RP) to ensure activities are carried in compliance with Good Distribution Practice (GDP)
(a) to be named as RP on the authorities WDA (Human and Veterinary) and Home Office Controlled Drugs License;
Both option periods to be individually taken up six months prior to the end of any potential contract period.
(c) where appropriate, a statement, covering the three previous financial years of the economic operator, of:
(ii) where appropriate, the turnover in respect of the work, works, goods or services which are of a similar type to the subject matter of the contract.

Eligibility requirements: (c) where appropriate, a statement, covering the three previous financial years of the economic operator, of: (i) the overall turnover of the business of the economic operator; and (ii) where appropriate, the turnover in respect of the work, works, goods or services which are of a similar type to the subject matter of the contract. This will be detailed in the ITN.
This will be detailed in the ITN.
This will be detailed in the ITN. This will be detailed in the ITN.