Internet address(es):

Main address: http://ssi.dk

Pandemic Influenza Vaccine.

Statens Serum Institut (SSI) is a public enterprise under the Danish Ministry of Health. On behalf of the Ministry, SSI will conduct a procurement of a pandemic influenza vaccine. The purpose of this tender is to ensure the needed stock of influenza vaccines in the event of an influenza pandemic during the contract period. The contract (Advance Purchase Agreement) regards reservation of the supplier's production capacity and the contract will contain an option for delivery of pandemic influenza vaccine in the event of an influenza pandemic called by the WHO during the contract period. Denmark will need an option for delivery of up to 2 100 000 immunizations.

Reference is made to section II.1.4) above.

The procurement will be conducted as a competitive dialogue according to the Danish Act on Public Procurement (act no 1564 of 15.12.2015 — available at: www.retsinformation.dk) cf. § 55(4), cf. § 67. By documenting the fulfilment of the qualification criteria listed below, suppliers will be qualified and invited to further participation in the dialogue. The dialogue will be conducted with separate meetings with all qualified suppliers, in order to establish the solutions the market operators are able to provide and the terms of which they are able to fulfil an Advanced Purchase Agreement. The dialogue will be declared closed, when SSI is able to set the terms and conditions for the procurement and contract. Subsequent to the dialogue, SSI will conduct a tender competition between all qualified suppliers, based on the results of the dialogue and SSI's assessments.

Before the dialogue, SSI conducted market consultations with a view to preparing the procurement and informing economic operators of the procurement plans and requirements.

All relevant documents regarding the market consultations as well as the dialogue can be found here: http://www.ssi.dk/Service/OmSSI/Juridisk%20information/Indkoeb/Vaccineudbud.aspx

Up to 72 months.

The contract includes option for delivery of pandemic influenza vaccine of up to 2 100 000 immunizations to Denmark.

The tenderer shall commit to offering a contract to Iceland, Greenland and the Faroe islands on the same terms as Denmark, however variations in certain terms may be accepted in consequence of differences in number of doses, conditions of supply, etc.

With regard to Section II.1.5) please note that SSI is not at present able to estimate the value of the contract. SSI will neither make a dialogue payment for the candidates as remuneration for their participation in the dialogue, nor a tender payment for each tender as remuneration for a compliant or successful tender.

It is not required that the candidate is registered in a commercial register or a trade register.

The candidate must use the European Single Procurement Document with the following information:

— A list of the applicant's principal deliveries of influenza vaccines effected within the last 3 years with indication of amounts, dates and recipient. Furthermore, the ESPD must include information about the applicant's principal deliveries of pandemic vaccines effected and delivered within the last 10 years.

This is to be stated in the ESPD, Part IV, Section C, Technical and professional ability, under the item ‘For public supply and public services contracts: Delivery of the deliveries of the type specified’.

If the applicant relies on the ability of other entities, this must be stated in the ESPD, part II, section C, cf. section VI.3) The other entity/entities must each fill in a separate ESPD with the information required. If the applicant is part of a consortium, this must be stated in the ESPD, Part II, section A, and each of the participating economic operators must fill in a separate ESPD with the information required.

In the selection phase, SSI will select the applicants with the best and most relevant references on the abovementioned supplies.

The supplier/tenderer must have the necessary permits from the competent authorities in the EU to produce and engage in trade of medicinal products.

The supplier/tenderer must have a registered approval for a prototype pandemic influenza vaccine (mock up) in compliance with the CHMP Guideline on dossier structure and content for pandemic influenza vaccine marketing authorization application by the time of submitting the final tender.

Concerning ESPD:

Applicants must complete and submit the ESPD together with the application as a temporary proof of the conditions mentioned in s. 148, para 1, (3) of the Procurement Act. See the website of the Danish Competition and Consumer Authority, which contains more specific instructions for completing the European single procurement document. SSI is obliged to exclude a tenderer from participation in the tendering procedure if the tenderer is subject to the mandatory grounds for exclusion set out in ss.135 and 136 of the Procurement Act. Information on exclusion grounds must be stated in the ESPD, Part III ‘exclusion grounds’ in section A, B and C. Attention is drawn to the fact that certain optional grounds for exclusion in the Directive on Public Procurement (Directive 2014/24/EU of the European Parliament and of the Council) is made mandatory in s. 136 of the Procurement Act. Reference is furthermore made to the Danish Competition and Consumer Authority's guide to the European single procurement document regarding correct completion of the form.

SSI reserves the right to initiate a ‘self-cleaning’ procedure if relevant, see s.138 of the Procurement Act.

Before SSI makes its decision regarding award of the contract, supporting evidence of the information stated in the European single procurement document must be provided, see ss.151 and 152 of the Procurement Act. Further information about this is to be found in the procurement documents.

The contract will be valid for minimum 4 years from the date of signing. The option for renewal for up to 72 months (Section II.2.7)) will be a topic for the dialogue with the suppliers. The contract will be valid throughout the contract period regardless of whether a pandemic occurs within the contract period. Should a pandemic occur before the end of the contract period, the contract may be extended with the time necessary in order to complete the vaccination and meet a possible 2^nd wave.

Pursuant to Danish Act on The Complaints Board for Public Procurement (act No 492 of 12.5.2010 with subsequent amendments — available at: www.retsinformation.dk), the following time limits for filing a complaint apply.

Complaints regarding a candidate not being pre-qualified must be filed with The Complaints Board for Public Procurement within 20 calendar days starting the day after the contracting authority has sent notification to the candidates involved, cf. § 171(2) of the Danish Act on Public Procurement (act No 1564 of 15.12.2015 — available at: www.retsinformation.dk) or § 2(1) of the Danish Act on The Complaints Board for Public Procurement, provided that the notification includes a short account of the relevant reasons for the decision.

Other complaints must be filed with The Complaints Board for Public Procurement within 45 calendar days after the contracting authority has published a contract award notice in the Official Journal of the European Union (with effect from the day following the publication date).

The complainant must inform the contracting authority of the complaint in writing at the latest simultaneously with the lodge of the complaint to The Complaints Board for Public Procurement stating whether the complaint has been lodged in the standstill period, cf. § 6(4) of the Act on The Complaints Board for Public Procurement. If the complaint has not been lodged in the standstill period, the complainant must also state whether it is requested that the appeal is granted delaying effect, cf. § 12(1) of the said Act.

Internet address:http://www.kfst.dk