Public procurement notice: Contract Notice
Published: 2019-11-05
Buyer: The Common Services Agency (more commonly known as NHS National Services Scotland) (‘NSS’)
Country: UK
Contract type: Supplies
Procedure: Open procedure
CPV classification: 33600000: Pharmaceutical products
Estimated value: 4800000 GBP
Submission deadline: 2019-12-16
Award criteria: Mixed

Technical requirements: All entities constituted pursuant to the National Health Service (Scotland) Act 1978 and any integrated joint boards established pursuant to the new Public Bodies (Joint Working) Scotland Act 2014.
This lot is for the supply of Thirty Seven (37) unlicensed imported medicines incorporating an over labelling and translation service to NHS Scotland.
This framework includes the option to extend for up to a total period of twenty four (24) months upon giving not less than three (3) months written notice, such notice to expire no later than the date the framework agreement is due to expire.
All entities constituted pursuant to the National Health Service (Scotland) Act 1978 and any integrated joint boards established pursuant to the new Public Bodies (Joint Working) Scotland Act 2014.
Supply of additional unlicensed imported medicines incorporating an over labelling and translation service to meet any future requirements as identified by the authority. The scope of these products is unknown at this stage.
The Authority intends to award this framework as an unranked multi-supplier framework with all framework participants who pass the selection criteria receiving the opportunity to participate in Lot 2, regardless if successful or unsuccessful on Lot 1. The mechanism for adding goods to this lot will be described in the ITT.
This framework includes the option to extend for up to a total period of twenty four (24) months upon giving not less than three (3) months written notice, such notice to expire no later than the date the framework agreement is due to expire.
Economic operators may be excluded from this competition if they are in breach of any situation referred to in Regulation 58 of the Public Contracts (Scotland) Regulations 2015.
The turnover of the potential framework participant(s) in relation to unlicensed imported medicines within its most recent full financial year must be equal or more than 2 000 000 GBP.
Confirmation that the turnover of the potential framework participant(s) in relation to unlicensed imported medicines into the UK within its most recent full financial year is equal or more than 2 000 000 GBP.
Confirmation of such should be included in the qualification envelope under Part 4B: economic and financial standing.
(a) all goods supplied under the framework agreement must be stored in and distributed from a site holding an MHRA wholesale distribution authorisation (WDA) valid for import and handling unlicensed relevant medicinal products issued by the MHRA and for import from outside of the EEA, a manufacturer's ‘specials’ licence (MS) valid for import;
(b) all goods submitted and classed as medical devices must carry a current and valid CE declaration of conformity, complying with Medical Device Directive 93/42/EEC at the date of submission;
(c) potential framework participants and/or sub-contractor(s) must offer a product overlabelling service to meet the NHS pharmaceutical quality assurance committee ‘Packaging and labelling for safety: unlicensed imported medicines — guidance for the overlabelling and provision of translated information’ guidance where original packaging is not in English;
(d) potential framework participants and/or any sub-contractor(s) must offer a translation service for the translation of the SPC, labels and PIL's. Translations must be performed to ISO 17100 for translation services standard or equivalent;

Eligibility requirements: Economic operators may be excluded from this competition if they are in breach of any situation referred to in Regulation 58 of the Public Contracts (Scotland) Regulations 2015.

Award value: 4800000