Begivenheder for udbudsgruppen

Begivenheder for udbudsgruppen

DatoBegivenhed
19-04-20242025 - NF2.1301.a Frist for spørgsmål
30-04-20242025 - NF2.1301.a Tilbudsfrist kl. 12.00
31-01-20252025 - NF2.1301.a Vedståelse af tilbud indtil
17-02-20252025 - NF2.1301.a Frist for optagelse i Lægemiddelstyrelsens medicinpriser.dk

 Spørgsmål og svar

Frist for spørgsmål: 19-04-2024

Pris
Spørgsmål: Forstår jeg rett så trenge ikke pris å være like i de ulike anbudene til de ulike markedene Dk/Is og marked Norge f.esk anbud x Dk/Is - pris 10 anbud y No - pris 20

Svar: Each lot number is a separate lot for the pharmaceutical indicated and is put up for tender independently of the other procurement numbers, as stated in the Tender Specifications section 5.1. The price offered under a lot number must apply for all countries covered by the Framework Agreement. The tender price under a lot number as primary supplier for Norway may be different to the tender price under the linked lot number as primary supplier for Denmark and Iceland, see the Tender Specifications section 8.1.

Minimumrabatt
Spørgsmål: Med tanke på at priser må gis inn i EURO, og det er litt umulig å si valutakursen i fremtiden, hva gjør dere om det som i dag var under 7% ikke er 7% når dere apneer og ser på tilbudet. Vil dette bli hjemmel for at dere kaster tilbudet? Vil dere evt da runde det til 7%?

Svar: When giving a bid on a lot number involving Norway, the prices cannot be higher than the maximum Pharmacy Purchase price minus 7 % Wholesaler fee (in Norwegian referred to as "maks AIP"), set by the Norwegian Medicines Agency, as stated in Appendix 7. If the prices does not comply with this at the time for the valuta conversion, the Supplier should contact the Contracting Authorities.

Vedlegg
Spørgsmål: Det er kun mulig å legge med 5 vedlegg, og dette blir for lite i forhold til hva vi trenger å legge med tilbudet. Hvordan kan vi få lagt med flere dokumenter? Kan dere endre dette?

Svar: If there are more than 5 files, they should be collected into a Zip file. On Amgros' Supplier and Tender Portal you can find the guide "User Guide to Submission of Offers" explaining how to create a zip-file. There is also a danish version: "Tilbudsgivning - via Amgros' Leverandør- og Udbudsportal"

manglende konkurranse i LOT
Spørgsmål: Dere viser til at dere ønsker å sikre levering ved å splitte markedene som tidligere har vært slått sammen. Noen av disse substansene har veldig lavt volum, så ved å splitte markedene, blir risikoen for å levere inn tilbud høy, da volumet en kan ende opp med å vinne er lavere enn miste produksjons volum. Dette var bedre i forrige anbud. I noen land er det bare 1 leverandør, så muligheten for å få en back up/ sikre levering forsvinner. Hvodan tenker dere at dette løses hvis dere ikke får tilbud der i den LOTB (der bare finnes 1 leverandør,) og den som vant substansen (LOT A), ikke har MT i landet for LOT B? Bakgrunnen for anbud forsvinner også der hvor det ikke finnes konkurranse?

Svar: After the submission deadline, we evaluate the offers received. If there are lot numbers for which no offer has been received, we will then take a decision on the further tendering procedure according to the Tender regulation.

LOT med kun 1 tilbyder
Spørgsmål: Det er flere LOT som bare har 1 tilbyder/et produkt som har MT. Hvis dere ikke får tilbud inn i dette anbudet, er dere åpen for en direkteavtale likevel, eller hva gjør dere?

Svar: After the submission deadline, we evaluate the offers received. If there are lot numbers for which no offer has been received, we will then take a decision on the further tendering procedure according to the Tender regulation.

Point 2.2.1.a Iceland
Spørgsmål: The application for exemption from labelling, leaflet etc. It is not entirely clear if the exemption applies to all package material or this is ONLY labelling and leaflet. And if the box has to have Iceland present?

Svar: Referring to the Appendix 6, Icelandic national requirements, section 2.2.1.a: “... Upon request from the Supplier or Marketing Authorization Holder the Icelandic Medicines Agency (IMA) can grant an exemption from Icelandic labeling and Patient Information Leaflets (PIL) for products that are not given directly to the patient for self-medication and therefore permit labeling and PILs to be in English or in a Nordic language (other than Finnish). Applications for exemptions from the Icelandic leaflet and / or Icelandic labeling on the packaging can be sent via e-mail to lyfjastofnun@lyfjastofnun.is. ...“ In the text above, "labeling on the packaging" refers to all packaging material.

Tidligere felles marked
Spørgsmål: Dere sier at dere har gått fra å ha helle lot for alle land til å dele markedet i 2, dette for å sikre leveranse. Hvordan mener dere dette blir sikret ved å gå fra et volum som var ok for å levere tilbud, til at det det nå ikke er et interessant volum for å lever tilbud? Blir ikke hensikten med felles nordisk anbud, sikre leveranser, ved å kunne tilby et større volum litt borte? Nå blir markedene for små, til å de er av interesse for å send inn tilbud, og med tanke på hvor mange som ahr MT på aktuelle SKUer.

Svar: This time we have chosen to have a split market tender on most of the Nordic tenders. We want to attract and keep more suppliers of small generic products in the Nordics to ensure supply. If we only have 1 winner for a product in all three countries for the entire agreement period of 2 years plus the possibility of 2 times extensions by up to 12 months, we can create a monopoly situation in the Nordics if 1 supplier gets all the consumption. We try to avoid this by having a split market. This puts us in a better position in any shortage situation. We continuously evaluate the Nordic agreements and will take this input into account in future tenders.

Information regarding joint tender 1301
Spørgsmål: 1- Are we obliged to apply seperately for these 2 groups (Iceland & Denmark + Norway)? 2- Regarding Iceland market, can we participate in tender with cefalosporins that are registered in Denmark? 3- Can we limit our application for Denmark and Iceland only to Denmark. 4- We have applied for an exemption for the norwegian packages for the Icelandic market, taking this into account, can we sell norwegian packages in Iceland through this tender? (I ask that, because Norway is not in the same group with Iceland). 5- Do we have to offer the product registered in Denmark for this tender for all countries? Or we have to offer each country with their own registered products?

Svar: 1. If you wish to offer a product for both markets (Iceland & Denmark + Norway), you must give in an offer on each of the respective lot numbers. Note that the two lot numbers will be linked, see tender specifications section 3.1 and 10.5 2. You can participate in the tender with the Danish registered product for lot numbers for Denmark and Iceland. See Appendix 3 to the framework agreement. Please note that if you get award a framework agreement the product must be registered in the countries/country included in the agreement no later than 17 February 2025. See Framework Agreement section 2.7. 3. It is not possible only to give Denmark an offer and not Iceland. 4. If you are not able to deliver Icelandic packages you can apply for an exemption. See Appendix 6 to the Framework Agreement section 2.2.1.a. 5. It is not a requirement to have a marketing autorisation on the product on the time of submission of the offer. The product must be registered in the countries/country included in the agreement and be included in medicinpriser.dk/ Farmalogg/ Lyfjaverðskrá no later than 17 February 2025. See Framework Agreement section 2.7.

Price per unit
Spørgsmål: In the tender specification 8.2 and 10.2 we find the messages different in 8.2 and 10.2. Can you help to clarify that price / mg does not have to be the same for a 1g strength and a 2 g strength - but it is ok that 1x1g is priced as X and 1x2g i priced as fore example X*1,3 - and does not need to be twice the price of a 1g.

Svar: When several strengths are indicated by several lines under a lot number, it is not a requirement that the tenderer's prices for different strengths are determinated so that the price pr unit is the same, as mentioned in the Tender Specifications section 8.2. So the price pr unit for a pharmaceutical with the strength of X mg does not have to be the same as a pharmaceutical with the strength of Y mg.

tidliger felles lot for alle land
Spørgsmål: Noen av substansene er tidligere i et felles anbud, men nå er det blitt splittet på 2 markedet. Noen har små volumer som kan bli en utfordring ved at de er splittet i 2 markeder - her anbefaltes det å gå tilbake til 1 marked/1 felles lot for alle land - for å sikre tilbud/avtale

Svar: On the basis of a specific assessment, we have chosen to split the markets to ensure security of supply.

5.6 Estimated consumption
Spørgsmål: 5.6 Estimated consumption In the list of products, the Contracting Authorities have under "quantity per unit" indicated an es-timate of purchase under the framework agreement. The estimate corresponds to the historical consumption of the pharmaceuticals put up for tender for a corresponding purchase period as that of this procedure - Kan dere bekrefte at est volum er for hele avtaleperioden, 3 år? - estimert volum er veldig langt unna det volumet som har gått i markedet, hvor og når er volumene tatt fra, og evt hva er grunnen til endringen, da dette ikke er samsvarer med markedstall?

Svar: The estimated volume in this tender corresponds to the historical consumption of the pharmaceuticals for the ordinary contract period for 2 years, from 1 april 2025 througt 31 March 2027.

MAH
Spørgsmål: Behöver produkt ha MAH för Island, eller funkar det att den är ok för DK?

Svar: If you do not have a marketing authorisation in Iceland, you must apply for this. See the Framework Agreement section 2.2 and 2.2.1. For further information about the procedure in Iceland see Appendix 6.

 Informationer

Her er det muligt at se informationer, herunder udbudsmateriale, om det valgte udbud.

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