Public procurement notice: Voluntary Ex Ante Transparency Notice
Published: 2019-04-19
Buyer: Sykehusinnkjøp HF
Country: NO
Contract type: Supplies
Procedure: Contract award without prior publication
CPV classification: 33600000: Pharmaceutical products
Estimated value: 115000 NOK
Award criteria: Lowest price

Technical requirements: LIS intends to enter a contract between the regional health trusts and Roche Norway, as LIS finds the legal right to enter a contract with the mentioned supplier of Valcyte powder and mixture, solution 50 mg/ml (ATC code J05AB14) as an additional contract to LIS 1901 pharmaceutical special preparations. The scope and length of the contract will follow the mentioned procurement (including access to extensions and notice), without a new competition being announced for this active ingredient/form of processing. Refer to the public procurement regulations, § 21-5, cf. § 21-2 first section, cf. § 13-4 letter b no. 3 (the monopoly is connected to the chosen supplier's marketing permission for the medicine in Norway).
Sykehusinnkjøp HF, Medicines Division (LIS) is collecting tenders for medicines that are used by the Health Trusts. LIS has previously announced and implemented an open tender contest for injection and infusion preparations (“LIS 1901 pharmaceutical special preparations”). The competition included active ingredients in accordance with the tender documentation's annex 3, the Active Ingredients List, including the active ingredient Valganciclovir. Tenders were only received for unregistered products for the mentioned active ingredient and a contract was subsequently signed (i.e., medicines without certification/marketing permission in Norway, which required a certification exemption).
In the Framework Agreement point 4.3 regarding termination, the last paragraph states that contracts for preparations with Requirements for exemption from authorisation’ will be terminated with immediate effect when there is a corresponding preparation with available marketing authorisation on the Norwegian market. A marketing permission has now been given for pharmaceuticals containing the active ingredient Valganciclovir (Valcyte from Roche Norway). Therefore it will no longer be possible to sell equivalent unregistered medicines in Norway, cf. the Medicines Act, chapter IV and the medicine regulations, chapter 2, and the right to give notice on the Framework Agreement point 4.3 will be used. The health trusts still, however, need the active ingredient in the contract period.
Based on this information LIS intends to enter a contract between the regional health trusts and Roche Norway, as LIS finds the legal right to enter a contract with the mentioned supplier of Valcyte powder and mixture, solution 50 mg/ml (ATC code J05AB14) as an additional contract to LIS 1901 pharmaceutical special preparations. The scope and length of the contract will follow the mentioned procurement (including access to extensions and notice), without a new competition being announced for this active ingredient/form of processing. Refer to the public procurement regulations, § 21-5, cf. § 21-2 first section, cf. § 13-4 letter b no. 3 (the monopoly is connected to the chosen supplier's marketing permission for the medicine in Norway).
LIS hereby asks suppliers with any objections thereof to submit feedback by the end of the waiting period that is valid until 2.5.2019. If objections are not made, a contract will be signed after the waiting period expires.


Winner: Roche Norge
Award value: 115000