Public procurement notice: Voluntary Ex Ante Transparency Notice
Published: 2019-01-24
Buyer: Sykehusinnkjøp HF
Country: NO
Contract type: Supplies
Procedure: Contract award without prior publication
CPV classification: 33600000: Pharmaceutical products
Estimated value: 4158600 NOK
Award criteria: Lowest price

Technical requirements: Supplementary contract with Öresund Pharma after the tender competition LIS 1907j injection and infusion preparations.
Sykehusinnkjøp HF, Divisjon legemidler (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 1907j injection and infusion preparations”). The competition included active ingredients in accordance with the tender documentation, annex 3 — Active Ingredients List, including the active ingredient carmustine. 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. There is now marketing permission for a medicine containing the active ingredient carmustine (Carmustine Obvius from Öresund Pharma APS). 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.
On this basis, LIS intends to enter into contracts between the health trusts and Öresund Pharma APS, as LIS believes that there is the legal basis to enter into a contract with the named supplier for Carmustine Obvius 100 mg (ATC code No. L01AD01) as a supplementary contract to LIS 1907j injection and infusion 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 requests that anyone who objects to this submits feedback before the waiting period expires, which is 10 days calculated from the day after notification of the decision (take note of the delay before the notice is published on Doffin/TED). If no objections are received, a contract will be signed after the waiting period has expired.
Sykehusinnkjøp HF, Divisjon legemidler (LIS) is collecting tenders for medicines that are used by the health trusts. LIS has previously announced and implemented an open tender competition for injection and infusion preparations (“LIS 1907j injection and infusion preparations”). The competition included active ingredients in accordance with the tender documentation, annex 3 — Active Ingredients List, including the active ingredient carmustine. 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).


Winner: Öresund Pharma ApS
Award value: 4158600