Leveringen - 578906-2020

01/12/2020    S234

Noorwegen-Vadsø: Farmaceutische producten

2020/S 234-578906

Aankondiging in geval van vrijwillige transparantie vooraf

Leveringen

Rechtsgrond:
Richtlijn 2014/24/EU

Afdeling I: Aanbestedende dienst/instantie

I.1)Naam en adressen
Officiële benaming: Sykehusinnkjøp HF
Nationaal identificatienummer: 916879067
Postadres: Postboks 40
Plaats: Vadsø
NUTS-code: NO NORGE
Postcode: 9811
Land: Noorwegen
Contactpersoon: Ninja Elise Seippel
E-mail: ninja.elise.seippel@sykehusinnkjop.no
Telefoon: +47 98405239
Internetadres(sen):
Hoofdadres: https://permalink.mercell.com/143896216.aspx
Adres van het kopersprofiel: http://www.sykehusinnkjop.no/
I.4)Soort aanbestedende dienst
Publiekrechtelijke instelling
I.5)Hoofdactiviteit
Gezondheid

Afdeling II: Voorwerp

II.1)Omvang van de aanbesteding
II.1.1)Benaming:

Methylprednisolone Injections for National Reserves

Referentienummer: 2020/1868
II.1.2)CPV-code hoofdcategorie
33600000 Farmaceutische producten
II.1.3)Type opdracht
Leveringen
II.1.4)Korte beschrijving:

The government has decided that establish two levels of medicine reserves in Norway. A decision has been made in project B180 (National Reserves of Medicines), owned by Helse Vest RHF [the Western Norway Regional Health Authority] and managed by Sjukehusapoteka Vest HF, that a national reserve must be established for several selected medicines. This means that reserves must be developed as soon as possible. The time aspect is central to reserve considerations and in light of the ongoing SARA-CoV-2 pandemic.

The Voluntary ex ante transparency notice applies to injections Methylprednisolone, ATC code: H02AB04

II.1.6)Inlichtingen over percelen
Verdeling in percelen: neen
II.1.7)Totale waarde van de aanbesteding (exclusief btw)
Waarde zonder btw: 500 000.00 NOK
II.2)Beschrijving
II.2.3)Plaats van uitvoering
NUTS-code: NO01 Oslo og Akershus
II.2.4)Beschrijving van de aanbesteding:

Sykehusinnkjøp HF, medicines division (Sykehusinnkjøp), is procuring and obtaining tenders for health company financed medicines. Sykehusinnkjøp has been given a mandate to procure the medicine. Sykehusinnkjøp has previously announced and held an open tender contest for parenteral pharmaceutical special preparations ('LIS 2001c Parenteral Pharmaceutical Special Preparations’ the tender). The contest included the mentioned medicine, as the tender documentation annex 3 - 'Active Ingredients List' requested tenders for the active ingredient (the medicine or reasonable alternatives).

Sykehusinnkjøp therefore believes that there are grounds to make the procurement without a contest. The basis for the grounds are in accordance with the public procurement regulations, Section 13-4 a), c.f., Section 13-3.

Tenders were not received in the above-mentioned contest for the active ingredient in question (medicine or reasonable alternatives), and this part of the contest must therefore be marked as unsuccessful.

Sykehusinnkjøp has now examined which relevant medicines fulfil the regulatory requirements in Norway. If a medicine has a marketing licence in Norway, you cannot just procure an alternative medicine with a marketing licence in another country in the EU/EEA area. This is in the law on medicines, etc., Sections 8 and 10, sml. regulations on medicines chapter 2. This is further connected to Sykehusinnkjøp as a medicine intermediary having a right to its operations, c.f., the regulations on wholesaler operations with medicines, Section 33.

According to www.legemiddelsok.no there are no other companies that the Supplier that have a marketing licence for the medicine in Norway.

Sykehusinnkjøp has assessed that no other possible tenderers of the medicine will be able to fulfil the regulatory requirements in Norway (marketing licence in Norway), and be able to deliver so that the contract is fulfilled by the contracting authority's required date, and that there are no reasonable alternatives to the medicine.

It is, therefore, objectively impossible to hold an ordinary contest or a contest in accordance with the public procurement regulations, Section 13-3. The scope of the contract is not larger than necessary.

Based on this, Sykehusinnkjøp intends to enter into a contract between Helse Vest RHF and the Supplier for the procurement of the medicine.

Sykehusinnkjøp requests that those who have objections to this voluntary ex-ante transparency notice submit feedback before the waiting period, which is set to 10 days calculated from the day after the publication of the voluntary ex-ante transparency notice. If no objections are received, a contract will be signed after the waiting period has expired.

II.2.5)Gunningscriteria
Prijs
II.2.11)Inlichtingen over opties
Opties: neen
II.2.13)Inlichtingen over middelen van de Europese Unie
De aanbesteding houdt verband met een project en/of een programma dat met middelen van de EU wordt gefinancierd: neen
II.2.14)Nadere inlichtingen

Afdeling IV: Procedure

IV.1)Beschrijving
IV.1.1)Type procedure
Gunning van een opdracht zonder voorafgaande bekendmaking van een oproep tot mededinging in het Publicatieblad van de Europese Unie in onderstaande gevallen
  • De aanbesteding valt buiten het toepassingsgebied van de richtlijn
Verklaring:

Sykehusinnkjøp HF, medicines division (Sykehusinnkjøp), is procuring and obtaining tenders for health company financed medicines. Sykehusinnkjøp has been given a mandate to procure the medicine. Sykehusinnkjøp has previously announced and held an open tender contest for parenteral pharmaceutical special preparations ('LIS 2001c Parenteral Pharmaceutical Special Preparations’ the tender). The tender includes the named medicine, as the tender documentation Appendix 3 - 'Active Ingredients List' tenders were requested for the active substance (the medicinal product or reasonable alternatives).

Sykehusinnkjøp therefore believes that there are grounds to make the procurement without a contest. The basis for the grounds are in accordance with the public procurement regulations, Section 13-4 a), c.f., Section 13-3.

Tenders were not received in the above-mentioned contest for the active ingredient in question (medicine or reasonable alternatives), and this part of the contest must therefore be marked as unsuccessful.

Sykehusinnkjøp has now examined which relevant medicines fulfil the regulatory requirements in Norway. If a medicine has a marketing licence in Norway, you cannot just procure an alternative medicine with a marketing licence in another country in the EU/EEA area. This is in the law on medicines, etc., Sections 8 and 10, sml. regulations on medicines chapter 2. This is further connected to Sykehusinnkjøp as a medicine intermediary having a right to its operations, c.f., the regulations on wholesaler operations with medicines, Section 33.

According to www.legemiddelsok.no there are no other companies that the Supplier that have a marketing licence for the medicine in Norway. Sykehusinnkjøp has assessed that no other possible tenderers of the medicine will be able to fulfil the regulatory requirements in Norway (marketing licence in Norway), and be able to deliver so that the contract is fulfilled by the contracting authority's required date, and that there are no reasonable alternatives to the medicine.

It is, therefore, objectively impossible to hold an ordinary contest or a contest in accordance with the public procurement regulations, Section 13-3. The scope of the contract is not larger than necessary.

Based on this, Sykehusinnkjøp intends to enter into a contract between Helse Vest RHF and the Supplier for the procurement of the medicine.

Sykehusinnkjøp requests that those who have objections to this voluntary ex-ante transparency notice submit feedback before the waiting period, which is set to 10 days calculated from the day after the publication of the voluntary ex-ante transparency notice. If no objections are received, a contract will be signed after the waiting period has expired.

IV.1.3)Inlichtingen over de raamovereenkomst
De aanbesteding betreft het sluiten van een raamovereenkomst
IV.1.8)Inlichtingen over de Overeenkomst inzake overheidsopdrachten (GPA)
De opdracht valt onder de GPA: ja
IV.2)Administratieve inlichtingen

Afdeling V: Gunning van een opdracht/concessieovereenkomst

Opdracht nr.: 1
V.2)Gunning van een opdracht/concessieovereenkomst
V.2.1)Datum van de beslissing tot gunning van de opdracht:
24/11/2020
V.2.2)Inlichtingen over inschrijvingen
De opdracht is gegund aan een groep ondernemers: neen
V.2.3)Naam en adres van de contractant/concessiehouder
Officiële benaming: Pfizer AS
Nationaal identificatienummer: 915213596
Plaats: Oslo
NUTS-code: NO01 Oslo og Akershus
Land: Noorwegen
De contractant/concessiehouder wordt een mkb-bedrijf: neen
V.2.4)Inlichtingen over de waarde van de opdracht/het perceel/de concessieovereenkomst (exclusief btw)
Aanvankelijk geraamde totale waarde van de opdracht/het perceel/de concessieovereenkomst: 500 000.00 NOK
Totale waarde van de opdracht/het perceel/de concessie: 500 000.00 NOK
V.2.5)Inlichtingen over uitbesteding

Afdeling VI: Aanvullende inlichtingen

VI.3)Nadere inlichtingen:
VI.4)Beroepsprocedures
VI.4.1)Beroepsinstantie
Officiële benaming: Øst-Finnmark tingrett
Postadres: Postboks 54
Plaats: Vadsø
Postcode: 9811
Land: Noorwegen
Internetadres: https://www.domstol.no/Enkelt-domstol/ost-finnmark-tingrett/
VI.4.2)Voor bemiddelingsprocedures bevoegde instantie
Officiële benaming: Klagenemda for offentlige anskaffelser
Postadres: Postboks 439 Sentrum
Plaats: Bergen
Postcode: 5805
Land: Noorwegen
E-mail: postmottak@kofa.no
Internetadres: http://www.kofa.no
VI.5)Datum van verzending van deze aankondiging:
26/11/2020