Hungary – Laboratory reagents – JTKI AKA beszerzés

The procurement of services necessary for the laboratory tests to be carried out by the Applied Research Department (AKA) laboratories, in accordance with the specifications defined in the KKD, will be carried out under a framework agreement with 7 lots. The tenderer undertakes to commit to calling off 100% of the framework amount for all lots, depending on the ordered quantity and the unit prices of that quantity. The distribution of the framework amount per lot is as follows:

1. Lot: 6 944 136 HUF

2. Lot: 2 783 160 HUF

3. Lot: 2 352 330 HUF

4. Lot: 174 000 HUF

5. Lot: 174 000 HUF

6. Lot: 720 000 HUF

7. Lot: 438 600 HUF

Requirements for the offered product:

The requirements for the products to be offered are detailed in the procurement documents.

The tenderer (AT) may only offer product(s) that meet the following:

- legally marketable in the Member States of the European Union;

- new (factory new, unused, not a demo unit);

- manufactured in accordance with the harmonised standards of the European Union (or equivalent solution in case of deviation) and the essential requirements of the directives.

AKA draws the attention of AT that the tender price must include:

- the costs of packaging and transporting the device (product) to be delivered.

Regarding validity, the tenderer stipulates that only products with a minimum of 12 months of usable life from the date of delivery to the expiry date will be accepted. If the total usable life (from manufacture to expiry) is shorter than this, then the time from delivery to expiry must exceed 50% of the total usable life.

Performance deadline: 90 calendar days (early completion accepted)

Within the framework of the TECHNICAL OFFER, AT must attach (1) the price listed on the Price List, completed according to the template defined by AK, as a Commercial Offer. The name, item number, and manufacturer of the offered product must be listed in the Commercial Offer by the tenderer. The net unit price offered by AT, as well as the name, item number, and manufacturer of the offered product, will be treated as basic data by AK. The omission of attaching the TECHNICAL OFFER to the offer submitted before the deadline will result in the INVALIDITY of the offer. This does not apply if the values defined as basic data in the TECHNICAL OFFER can be clearly and unambiguously determined in other parts of the offer. (see KKD 8.3.)

Within the framework of the TECHNICAL OFFER, AT must attach (x) the product description supervised by the manufacturer or distributor (in copy) for the offered product. The product description supervised by the manufacturer or distributor must contain at least the name of the product, the name of the manufacturer, the place of origin of the product, as well as its technical parameters, characteristics, and all data and information from which the product's compliance with the technical requirements specified in the procurement documents can be determined. If the product description is not in Hungarian, a copy of the non-Hungarian language document and its Hungarian language translation must also be attached. By product description supervised by the manufacturer or distributor, AK means a document summarising the functional and technical parameters of the product issued by the direct manufacturer of the given product, or the representative authorised for distribution, or in the case of a non-EU manufacturer, by the manufacturer or EU-authorised representative for distribution (EC REP). AK does not expect certification by the manufacturer or distributor, i.e. any product description/prospectus originating from the manufacturer or distributor is sufficient.

The compliance of the offered product(s) with in vitro diagnostic medical devices must be proven according to Section 9 (2) of Government Decree 16/2012. (II.16.)

Within the framework of the OFFER, AT must attach, in a separate document, the indivisible delivery units of the products to be delivered to the buyer.