政府調達令和8年5月8日
医薬品等の電子申請ソフトウェア修繕業務（令和8年度）
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調達機関厚生労働省医薬・生活衛生局医薬安全評価課
品目医薬品、医療機器等の品質、有効性及び安全性の確保等に関する法律の改正施行に伴う医薬品等の電子申請ソフトウェア修繕業務
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医薬品等の電子申請ソフトウェア修繕業務（令和8年度）
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(3) Nature and quantity of the products to be required: Repair work of the Electronic Application Software for Pharmaceuticals etc. for an enforcement of revised Pharmaceutical and Medical Device Act, in FY 2026, 1 set
(4) Services period: From a contract day to March, 31, 2027
(5) Services place: The place specified by the Official in charge of disbursement of the procuring entity
(6) Date and time of the bidding briefing: 11:00 June, 5, 2026. The briefing will be held online. For details, please refer to the bidding documents.
(7) Qualifications for participating in the tendering procedures: Suppliers eligible for participating in the proposed tender are those who shall: (1) Not come under Article 70 of the Cabinet Order concerning the Budget, Auditing and Accounting. Furthermore, minors, Person under Conservatorship or Person under Assistance that obtained the consent necessary for concluding a contract may be applicable under cases of special reasons within the said clause (2) Not come under Article 71 of the Cabinet Order concerning the Budget, Auditing and Accounting (3) Are not being suspended from transactions by request of the officials in charge of contract (4) Have Grade “A”, “B”, or “C” on “offer of services etc.” in the Kanto-Koshinetsu Area in terms of qualification for participating in tenders by Ministry of Health, Labour and Welfare (Single qualification for every ministry and agency) in the fiscal years 2025, 2026 and 2027 (5) Prove to have no false statement in tendering documents (6) Prove neither the business condition nor credibility is deteriorating (7) Are enrolled in social insurance premiums (employee pension insurance, health insurance (administered by the National Health Insurance Association), seamen’s insurance, na-
tional pension, workers’ accident compensation insurance and employment insurance) and have no outstanding premium payments for the relevant systems (8) Have not received any administrative punishment for violating laws and regulations under the jurisdiction of the Ministry of Health, Labor and Welfare within the past year (9) Submit a pledge stating that you are not a person whose management is substantially controlled by an organized crime group or a person equivalent to that (10) Meet the qualification requirements which the Obligating Officer may specify in accordance with Article 73 of the Cabinet Order (11) Understand to be deemed to have pledged to strive to respect human rights in accordance with the “Guidelines for Respecting Human Rights in Responsible Supply Chains, etc.” (12) must be certified with either ISO9001: 2015 for quality management system or CMMI level 3 or higher for organizational capability maturity (13) Acquire any of the following: privacy mark certification, ISO/IEC27001 certification (international standard), or JIS Q 27001 certification (Japanese industrial standard) (14) The work place for this work and the data storage place shall be in Japan (15) must submit financial statements for the past three years to prove that the business is in a sound financial condition. In addition, the financial statements must be accompanied by a copy of the audit report issued by a certified public accountant or an auditing firm, and a copy of the results of the review by a tax accountant (16) Review the Procurement Specifications “11. (3) List of documents that potential bidders should review” within the specified period (17) have experience in help desk work related to systems that meet the following criteria: Systems that connect multiple locations of companies, government organizations, etc.
(8) How to bid: The bid amount will be the total price. Regardless of whether the bidder is a taxable entity with respect to consumption tax, etc. or a tax-exempt entity, the bidder must state in the bid document an amount equivalent to 110/100 of the estimated contract amount. This tender will be conducted through the electronic procurement system. However, those who have difficulty using the electronic procurement system will be allowed to submit paper tenders.
(9) Time-limit for tender: 11:00 June, 29, 2026
(10) Contact point for the notice: Tsujikawa Misaki Pharmaceutical Evaluation Division, Pharmaceutical Safety Bureau, Ministry of Health, Labour and Welfare, 1-2-2 Kasumigaseki Chiyoda-ku Tokyo 100-8916 Japan TEL03-5253-1111 (ext. 4202)
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