Type of document: Contract Notice
Country: United Kingdom
1. Title: CBRN/00282 – Supply of Pyridostigmine tablets
2. Awarding Authority:
Ministry of Defence
Ministry of Defence, Chemical, Biological, Radiological and Nuclear Delivery Team (CBRN DT), YEW 3a, #1342, MOD Abbey Wood
Bristol
England
BS34 8JH
Contact:
Email: alexandra.lashmar100@mod.gov.uk
Phone:
URL:
3. Contract Type: Products
4. Description: This Notice confirms commencement of Opportunity: CBRN/00282 Supply of Pyridostigmine Tablets. Details of the scope are set out below.
If you are interested in this opportunity, please register as a supplier on the Defence Sourcing Portal (). A Pre-Qualification Questionnaire (PQQ) for this opportunity has been published. Once registered, interested Suppliers must submit their response to the PQQ on the Defence Sourcing Portal. The link to the PQQ is set out in the attachments part of this notice.
IMPORTANT: the closing date to submit a PQQ response for this opportunity is 7 April 2021, 17:00. Any late submissions will NOT be considered.
Scope of Opportunity:
The UK Ministry of Defence (UK MOD) has a requirement for the production of Pyridostigmine Bromide tablets for oral consumption. The Chemical Biological Radiological Nuclear Team (CBRN) is seeking to appoint a manufacturer to produce these tablets for which it currently maintains the Marketing Authorisation (MA) on behalf of the Secretary of State for Defence.
The Supplier is to be responsible for:
1. Manufacture Pyridostigmine tablets, as per the technical specifications, on behalf of the UK MOD; the Marketing Authorisation Holder.
2. Develop protocols, compliant with ICH guidelines, to support stability studies for the life of the product.
3. Documentation and data, including a technical transfer summary report, to support license changes to ensure the manufacturer is named on the MA as the licensed manufacturer for the product.
4. Manufacture product in accordance with current Good Manufacturing Practice (cGMP) standards as defined by the International Conference on Harmonisation and regulated by the national competent Authority’s in Europe and Canada.
5. Storage of the finished product and all product movement between Qualified Person (QP) release and receipt will be carried out in accordance with the requirements of Good Distribution Practice (GDP) and the Guidelines on GDP on Medicinal Products for Human Use (2013/C 343/01) or as subsequently amended.
Initial quantity of requirement is estimated to be in the region of 140,00 to 200,000 tablets. Exact quantities to be confirmed at ITN stage. Quantities for Option years are not included within this range, and will also be confirmed at ITN stage.
The initial contract period will be 5 years, with the option to extend up to a further 5 years (total estimated contract duration is 10)
5. CPV Codes:
33661000 – Medicinal products for the nervous system
33140000 – Medical consumables
33000000 – Medical equipments, pharmaceuticals and personal care products
35113200 – Nuclear, biological, chemical and radiological protection equipment
33690000 – Various medicinal products
33661700 – Other nervous system medicinal products
85121200 – Medical specialist services
33190000 – Miscellaneous medical devices and products
6. NUTS Codes: UKK11
7. Main Site or Location of Works, Main Place of Delivery or Main Place of Performance: South West
8. Reference Attributed by the Awarding Authority:
tender_266737/930695
9. Estimated Value of Requirement: £4,000,000 to £7,000,000
10. Start Date: 20/09/2021
11. End Date: 20/09/2031
12. Closing Date: 07/04/2021
13. Other Information:
Additional Text
Please follow the link below to access the PQQ. If for any reason the link does not work, you may also search for the Opportunity once you have logged into the DSP. We suggest you search using the PQQ code or PQQ title:
PQQ Code: CBRN/00282-PQQ.
PQQ Title: TRN-lashmara-PQQ
If for any reason you are unable to access the PQQ, please contact the named contact within this notice.
Link to PQQ
Link to FT Contract Notice
For further information/documentation please visit: