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Vaidlustus

Rahandusministeerium · 21. jaanuar 2026
Viit
12.2-10/26-14/18-1
Registreeritud
21. jaanuar 2026
Dokumendi liik
Sissetulev kiri
Adressaat
MB Alpha biotica
Saabumis/saatmisviis
DVK/e-post
Funktsioon
12.2 RIIGIHANGETEALANE TEGEVUS
Sari
12.2-10 Riigihangete vaidlustusmenetluse toimikud
Toimik
12.2-10/26-14
Vastutaja
Angelika Timusk (Rahandusministeerium, Riigihangete vaidlustuskomisjon)

Failid

  • 📎MB_Alpha_biotica_Challenge_Procurement_294643.asice135 KB
  • 📎MB_Alpha_biotica_Challenge_Procurement_294643.pdf276 KB

Sisu (failidest)

FORMAL CHALLENGE / REQUEST FOR REVIEW (VAIDLUSTUS) Procurement: Purchasing rapid drug tests (Reference No. 294643) To: Police and Border Guard Board (Registry code 70008747) Contracting Authority: Police and Border Guard Board Procurement title: Purchasing rapid drug tests Reference No.: 294643 (Riigihangete Register) Tenderer: MB Alpha biotica Bid No.: 573937 (Part II) Decision date/time: 12.01.2026 15:09 Date of challenge: 21.01.2026 1. Subject of the challenge MB Alpha biotica hereby submits a formal challenge / request for review against the Contracting Authority’s decision dated 12.01.2026 15:09 rejecting MB Alpha biotica’s bid No. 573937 in Part II under procurement No. 294643. This challenge is filed within the statutory deadline. According to § 185 (2) and § 189 (1) of the Public Procurement Act, the decision may be contested before the Appeals Committee (Public Procurement Review Committee) at the Ministry of Finance within 10 days of becoming aware of the decision. We request the Contracting Authority to: 1) revoke the rejection decision regarding our bid in Part II and return our bid to the evaluation stage; and 2) provide a detailed written justification specifying the factual and legal grounds of the rejection. 2. Timeline and factual background 1) On 24.09.2025 at 13:57, MB Alpha biotica submitted its bid via the Riigihangete Register. 2) During the procedure, the Contracting Authority requested clarification regarding Section 2.2.2 of the technical specification: “Urine testing for the presence of narcotic, psychotropic or other intoxicating substances in a person's body must be possible in the ambient air temperature range of +2 to +30°C.” We provided the requested clarification and submitted additional manufacturer confirmation and supporting evidence. 3) Product samples were provided to the Contracting Authority. On 21.08.2025 at 15:57, the Contracting Authority’s representative confirmed by email: “We have received your package.” 4) On 12.01.2026 at 15:09, the Contracting Authority issued a decision rejecting our bid in Part II. The stated reason was that an “incorrect product user manual (IFU)” had been submitted and therefore the Contracting Authority was allegedly unable to verify the detection limits (CUT-OFF) required under Section 2.2.12 of the technical specification. 3. Contested reasoning in the rejection decision The rejection decision states: “The bidder has submitted an incorrect product user manual with the bid, which is why the contracting authority is not able to check the detection limits (CUT OFF) of the substances set out in Section 2.2.12 of the technical specifications in Annex 2. Therefore, MB Alpha biotica bid No. 573937 does not meet the requirements set out in the basic public procurement documents and must be rejected.” 4. Grounds for the challenge 4.1. CUT-OFF values are clearly provided in the manufacturer documentation (IFU / Technical Data Sheet) – the conclusion is factually incorrect The required detection limits (CUT-OFF) are clearly verifiable from the manufacturer documentation submitted by MB Alpha biotica. Together with this challenge we provide: IFU including the CUT-OFF table; IFU excerpt where CUT-OFF values are clearly visible; and a Technical Data Sheet excerpt confirming the panel and sensitivity values (ng/ml). Therefore, the statement that the CUT-OFF limits could not be checked is factually unfounded. 4.2. Technical Data Sheet confirms compliance with the temperature requirement (+2…+30°C) The manufacturer Technical Data Sheet explicitly confirms that “The test can be performed at a temperature of +2 – +30°C.” This directly confirms compliance with Section 2.2.2 of the technical specification. 4.3. Rejection is disproportionate even if the IFU version was disputed Even assuming the Contracting Authority considered the submitted IFU “incorrect”, rejection is disproportionate where essential information required for evaluation (CUT-OFF limits) is available and verifiable, and any potential discrepancy would be formal/technical and could be clarified without altering the substance of the bid. 4.4. The Contracting Authority had an objective possibility to verify compliance from the received product sample label The Contracting Authority confirmed receipt of the submitted samples. The product packaging label of the submitted sample clearly indicates the panel/cut-off values, including: AMP300 / MET300 / MDMA500 / COC100 / THC50 / MOP300 / OPI300 / BZO200 / FEN10 / KET100 / MTD200 / BAR300 / OXY300, and also contains product identification details (REF DMW-A1126-461, LOT SMP2025072502, expiry 2027-06). Accordingly, the Contracting Authority had an objective possibility to verify parameters from documentation and from the sample label. 4.5. Insufficient reasoning: the decision does not specify what exactly was “incorrect” The decision does not specify which part of the IFU was allegedly incorrect, why it was considered incorrect (version, model, product code, etc.), which specific substances/CUT-OFF limits were allegedly unverifiable, and whether the submitted IFU/Data Sheet/sample label information was taken into account. 5. Requests In light of the above, MB Alpha biotica requests the Contracting Authority to: 1) Revoke the decision rejecting MB Alpha biotica’s bid No. 573937 in Part II. 2) Return the bid to the evaluation stage and conduct a repeated evaluation, taking into account the provided IFU, Technical Data Sheet and other evidence regarding CUT-OFF values. 3) Provide a detailed written justification specifying: (i) on what exact basis the IFU was considered “incorrect”; (ii) which substances/CUT-OFF limits were allegedly unverifiable; and (iii) whether the submitted documents and the received sample label information were assessed. 6. Annexes Annex 1 – Rejection decision / notification (12.01.2026 15:09) Annex 2 – IFU (Instructions for Use) including the CUT-OFF table Annex 3 – IFU excerpt showing CUT-OFF values clearly Annex 4 – Technical Data Sheet excerpt confirming panel/cut-off values and operating temperature +2…+30°C Annex 5 – Photo of the submitted sample packaging label (panel/cut-off + REF/LOT/expiry) Annex 6 – Email confirmation of sample receipt (21.08.2025 15:57 – “We have received your package”) Annex 7 – Manufacturer confirmation and supporting document/photo regarding operating temperature (+2…+30°C) (if applicable) Signature Sincerely, Antanas Gabnys MB Alpha biotica COO +37067406560 [email protected] FORMAL CHALLENGE / REQUEST FOR REVIEW (VAIDLUSTUS) Procurement: Purchasing rapid drug tests (Reference No. 294643) To: Police and Border Guard Board (Registry code 70008747) Contracting Authority: Police and Border Guard Board Procurement title: Purchasing rapid drug tests Reference No.: 294643 (Riigihangete Register) Tenderer: MB Alpha biotica Bid No.: 573937 (Part II) Decision date/time: 12.01.2026 15:09 Date of challenge: 21.01.2026 1. Subject of the challenge MB Alpha biotica hereby submits a formal challenge / request for review against the Contracting Authority’s decision dated 12.01.2026 15:09 rejecting MB Alpha biotica’s bid No. 573937 in Part II under procurement No. 294643. This challenge is filed within the statutory deadline. According to § 185 (2) and § 189 (1) of the Public Procurement Act, the decision may be contested before the Appeals Committee (Public Procurement Review Committee) at the Ministry of Finance within 10 days of becoming aware of the decision. We request the Contracting Authority to: 1) revoke the rejection decision regarding our bid in Part II and return our bid to the evaluation stage; and 2) provide a detailed written justification specifying the factual and legal grounds of the rejection. 2. Timeline and factual background 1) On 24.09.2025 at 13:57, MB Alpha biotica submitted its bid via the Riigihangete Register. 2) During the procedure, the Contracting Authority requested clarification regarding Section 2.2.2 of the technical specification: “Urine testing for the presence of narcotic, psychotropic or other intoxicating substances in a person's body must be possible in the ambient air temperature range of +2 to +30°C.” We provided the requested clarification and submitted additional manufacturer confirmation and supporting evidence. 3) Product samples were provided to the Contracting Authority. On 21.08.2025 at 15:57, the Contracting Authority’s representative confirmed by email: “We have received your package.” 4) On 12.01.2026 at 15:09, the Contracting Authority issued a decision rejecting our bid in Part II. The stated reason was that an “incorrect product user manual (IFU)” had been submitted and therefore the Contracting Authority was allegedly unable to verify the detection limits (CUT-OFF) required under Section 2.2.12 of the technical specification. 3. Contested reasoning in the rejection decision The rejection decision states: “The bidder has submitted an incorrect product user manual with the bid, which is why the contracting authority is not able to check the detection limits (CUT OFF) of the substances set out in Section 2.2.12 of the technical specifications in Annex 2. Therefore, MB Alpha biotica bid No. 573937 does not meet the requirements set out in the basic public procurement documents and must be rejected.” 4. Grounds for the challenge 4.1. CUT-OFF values are clearly provided in the manufacturer documentation (IFU / Technical Data Sheet) – the conclusion is factually incorrect The required detection limits (CUT-OFF) are clearly verifiable from the manufacturer documentation submitted by MB Alpha biotica. Together with this challenge we provide: IFU including the CUT-OFF table; IFU excerpt where CUT-OFF values are clearly visible; and a Technical Data Sheet excerpt confirming the panel and sensitivity values (ng/ml). Therefore, the statement that the CUT-OFF limits could not be checked is factually unfounded. 4.2. Technical Data Sheet confirms compliance with the temperature requirement (+2…+30°C) The manufacturer Technical Data Sheet explicitly confirms that “The test can be performed at a temperature of +2 – +30°C.” This directly confirms compliance with Section 2.2.2 of the technical specification. 4.3. Rejection is disproportionate even if the IFU version was disputed Even assuming the Contracting Authority considered the submitted IFU “incorrect”, rejection is disproportionate where essential information required for evaluation (CUT-OFF limits) is available and verifiable, and any potential discrepancy would be formal/technical and could be clarified without altering the substance of the bid. 4.4. The Contracting Authority had an objective possibility to verify compliance from the received product sample label The Contracting Authority confirmed receipt of the submitted samples. The product packaging label of the submitted sample clearly indicates the panel/cut-off values, including: AMP300 / MET300 / MDMA500 / COC100 / THC50 / MOP300 / OPI300 / BZO200 / FEN10 / KET100 / MTD200 / BAR300 / OXY300, and also contains product identification details (REF DMW-A1126-461, LOT SMP2025072502, expiry 2027-06). Accordingly, the Contracting Authority had an objective possibility to verify parameters from documentation and from the sample label. 4.5. Insufficient reasoning: the decision does not specify what exactly was “incorrect” The decision does not specify which part of the IFU was allegedly incorrect, why it was considered incorrect (version, model, product code, etc.), which specific substances/CUT-OFF limits were allegedly unverifiable, and whether the submitted IFU/Data Sheet/sample label information was taken into account. 5. Requests In light of the above, MB Alpha biotica requests the Contracting Authority to: 1) Revoke the decision rejecting MB Alpha biotica’s bid No. 573937 in Part II. 2) Return the bid to the evaluation stage and conduct a repeated evaluation, taking into account the provided IFU, Technical Data Sheet and other evidence regarding CUT-OFF values. 3) Provide a detailed written justification specifying: (i) on what exact basis the IFU was considered “incorrect”; (ii) which substances/CUT-OFF limits were allegedly unverifiable; and (iii) whether the submitted documents and the received sample label information were assessed. 6. Annexes Annex 1 – Rejection decision / notification (12.01.2026 15:09) Annex 2 – IFU (Instructions for Use) including the CUT-OFF table Annex 3 – IFU excerpt showing CUT-OFF values clearly Annex 4 – Technical Data Sheet excerpt confirming panel/cut-off values and operating temperature +2…+30°C Annex 5 – Photo of the submitted sample packaging label (panel/cut-off + REF/LOT/expiry) Annex 6 – Email confirmation of sample receipt (21.08.2025 15:57 – “We have received your package”) Annex 7 – Manufacturer confirmation and supporting document/photo regarding operating temperature (+2…+30°C) (if applicable) Signature Sincerely, Antanas Gabnys MB Alpha biotica COO +37067406560 [email protected]
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