J1/806/2026 – Medicines Exceptional Use Authorisation (AUE)
About This Opportunity
TranslatedThis tender, identified as J1/806/2026, concerns the Medicines Exceptional Use Authorisation (AUE) process. The objective is to establish or maintain a framework for the exceptional authorisation of medicines. This typically involves procedures and criteria for granting temporary access to medicinal products that are not yet authorised in the relevant jurisdiction but are deemed necessary for treating patients with serious or life-threatening conditions for whom no satisfactory alternative treatment exists. The scope of this tender likely includes the development, implementation, or management of the administrative and regulatory processes required for evaluating and approving these exceptional use applications. Key requirements may involve defining the eligibility criteria for both patients and medicines, establishing timelines for application review and decision-making, and ensuring compliance with national and international pharmaceutical regulations. The tender is relevant to the pharmaceutical sector and public health administration, aiming to ensure that critically ill patients can access potentially life-saving treatments under specific, controlled circumstances. Further details regarding the specific geographical scope, duration of the contract, and expected deliverables would be outlined in the full tender documentation. This initiative underscores a commitment to patient welfare by providing a pathway for accessing innovative or urgently needed therapies when standard treatment options are unavailable or inadequate.
This is a supplies contract in the health and medical services and legal services sectors, with a focus on Pharmaceuticals and Legislative Drafting. Located in Portugal, Europe, this opportunity is open to firms and consortiums, with an estimated budget of EUR 3,498.
Published through base_gov_pt, a national government procurement portal. Public procurement tenders follow the country's national bidding regulations and may have specific eligibility and documentation requirements for the supply of goods in the health and medical services sector. Supply contracts typically require bidders to demonstrate product compliance with technical specifications, delivery capacity, and relevant certifications. This contract has already been awarded. The information is published for transparency and market intelligence purposes.
Description
Original language: PortugueseThis tender, identified as J1/806/2026, concerns the procurement of medicines under the Exceptional Use Authorization (AUE) framework within Portugal. The contracting authority, operating through the public procurement portal BASE, is seeking to establish agreements for the supply of pharmaceuticals that require special authorization for their distribution and use. This process typically involves medicines that are not yet authorized for general market access but are deemed essential for specific patient populations or clinical situations where no alternative treatments are available or suitable.
The procurement is expected to cover a range of pharmaceutical products, necessitating detailed technical specifications, quality assurance documentation, and robust supply chain management plans from prospective bidders. Suppliers will likely need to demonstrate their capacity to comply with stringent regulatory requirements, including adherence to Good Distribution Practices (GDP) and specific Portuguese pharmaceutical legislation. The tender will evaluate proposals based on criteria that typically include the quality and efficacy of the proposed medicinal products, the reliability of the supply chain, pricing, and the ability to meet the unique logistical and regulatory demands associated with AUE medicines. This initiative underscores Portugal's commitment to ensuring access to critical treatments for its citizens, even when those treatments fall outside standard authorization pathways.
Data provenance
This notice is sourced from base_gov_pt and was originally published on March 5, 2026. Last refreshed 28 days ago. Original language: Portuguese. BidsFactory mirrors official procurement notices and links back to the source for full legal text.
About Unidade Local de Saúde da Região de Leiria, EPE
Unidade Local de Saúde da Região de Leiria, EPE has issued 540 procurement notices on BidsFactory, including 8 currently open and 434 awarded contracts. Activity concentrates in Health & Medical, General Supplies & Services, and Information & Communication Technology. All notices are published for Portugal. Notices are distributed via base_gov_pt and TED - Tenders Electronic Daily (EU). Most recent publication: July 14, 2026.
Frequently asked questions about this tender
What type of contract is this?
This is a Supplies contract in the Health & Medical sector. The classification helps bidders match the opportunity to their qualifications and registered scope of supply.
What is the estimated budget?
The estimated contract value is Up to €3,498. Bidders should ensure their proposals are consistent with this range and account for any local taxes and contract execution costs.
Where will the contract be performed?
The contract is for delivery in Portugal. Foreign bidders should review local registration, taxation, and any in-country presence requirements before submitting.
How can I submit a bid?
Visit base_gov_pt to access the full notice, required documents, and submission instructions provided by the contracting authority.
Is this tender still open?
No — the contract has already been awarded to Pharmade, Lda. The award notice is archived on BidsFactory for transparency and market intelligence.
Who is the contracting authority?
This notice was issued by Unidade Local de Saúde da Região de Leiria, EPE in Portugal. The authority is responsible for evaluating bids, awarding the contract, and managing performance.
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