II.2.2) Additional CPV code(s)
II.2.3) Place of performance
II.2.4) Description of the procurement
The GDP Passport is an IEA solution to the EU Regulation to help ensure the safe handling, security and quality of medical products and medical devices are maintained throughout the supply chain.
European regulations require that pharmaceutical finished products, pharmaceutical active ingredients (APIs) and medical devices (all collectively referred to below as 'healthcare products') are transported, stored and handled according to Good Distribution Practice (GDP). The regulations also dictate that those responsible for contracting out transportation of these categories of products must ensure that they are being handled in accordance with GDP by their contractors. Consequently transport companies aspiring to win and retain healthcare contracts need to fully understand, and comply with, GDP. To this end, in 2009, the Irish Exporters Association launched the GDP Passport Scheme, which is a GDP quality system that meets the typical requirements of those seeking to contract out transportation of healthcare products.
The GDP Code of Practice is focused on providing training courses to all levels of personnel involved in the supply chain. The key to success is the full suite of standardised and certified training which is to be undertaken by all those engaged either directly by the manufacturer or indirectly by the service provider in distribution activities.
The GDP Passport Scheme is underpinned by a 'Code of Practice' which is regularly updated to keep it in line with current legislation and sector trends. The scheme provides an avenue for organisations to progress to commercially acceptable GDP compliance from a zero knowledge base, but it is equally helpful to those developing a current established, or partly established quality system.
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:
Review during the contract term
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:
II.2.11) Information about options
II.2.13) Information about European Union funds
The procurement is related to a project and/or programme financed by European Union funds: