Public procurement notice: Voluntary Ex Ante Transparency Notice
Published: 2018-12-26
Buyer: Sykehusinnkjøp HF
Country: NO
Contract type: Supplies
Procedure: Contract award without prior publication
CPV classification: 33600000: Pharmaceutical products
Estimated value: 627000 NOK
Award criteria: Lowest price

Technical requirements: Additional contract with Macure Pharma after the tender competition LIS 1901 - Special pharmaceutical preparations ATC C01CE02, Milnicor.
Sykehusinnkjøp HF, Divisjon legemidler (LIS) is collecting tenders for medicines that are used by the Health Trusts. LIS has previously announced and held an open tender contest for special pharmaceutical preparations ('LIS 1901 Special Pharmaceutical Preparations'). The competition included active ingredients in accordance with the tender documentation´s annex 3, Active Ingredients List, including the active ingredient milrinon. 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).
The last section of point 4.3 of the framework agreement on the right to give notice on the contract, states that notice will be given on contracts for preparations that 'require certification exemption' with immediate effect, if an equivalent preparation with available marketing permission becomes available in the Norwegian market. There is now marketing permission for a medicine that includes the active ingredient milrinon (Milnocor from Macure 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 in point 4.3 will be used. The health trusts still, however, need the active ingredient in the contract period.
Based on this, LIS intends to enter into contracts between the health trusts and Macure Pharma APS, as LIS believes that there is the legal basis to enter into a contract with the mentioned supplier for Milrinon macure inf/inj 1 mg/ml (ATC-code no. C01CE02) as ad additional contract to LIS 1901 Special Pharmaceutical 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. See 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 those who have objections to this submit feedback before the waiting period, which is set to 10 days calculated from the day after notification of the decision. 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 held an open tender contest for special pharmaceutical preparations ('LIS 1901 Special Pharmaceutical Preparations'). The competition included active ingredients in accordance with the tender documentation, annex 3 - Active Ingredients List, including the active ingredient milrinon. 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).
The last section of point 4.3 of the framework agreement on the right to give notice on the contract, states that notice will be given on contracts for preparations that 'require certification exemption' with immediate effect, if an equivalent preparation with available marketing permission becomes available in the Norwegian market. There is now marketing permission for a medicine including the active ingredient milrinon (Milnocor from Macure 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.


Winner: Macure Pharma APS
Award value: 627000