Tenders Are Invited For Pharmaceutical Products - Drug Delivery Task 1 - Tofersen R-R D/Injection. - Nationa ... in Poland

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Pharmaceutical Products - Drug Delivery Task 1 - Tofersen R-R D/Injection. - National Health Fund Drug Program. The Ordering Partys Requirements Regarding The Subject Of The Order: 1) The Offered Medicinal Product Must Have Approvals, Certificates And Be Registered In Accordance With The Legal Provisions Requiring Approvals, Certificates And Registration, 2) The Offered Medicinal Product Must Be Placed On The Market In Accordance With The Requirements Of The Pharmaceutical Law Act Of September 6, 2001, Uniform Text (Journal Of Laws Of 2025, Item 750, As Amended). 3) The Medicinal Product Offered Must Comply With The Standards Or Technical Specifications Applicable To This Product; 3.4. The Ordering Party Allows The Use Of Equivalent Products, I.E. With Chemical, Physical And Quality Parameters Not Worse Than Those Specified In The Swz - Only In Relation To Products Whose Origin Has Been Determined By The Ordering Party By Indicating Trademarks, Patents Or Origin. The Ordering Party Allows For The Possibility Of Offering Equivalent Products Specified In The Swz, I.E. Pharmaceutically And Therapeutically Equivalent And Reimbursed By The National Health Fund. Pharmaceutical Equivalence Defines The Situation In Which Compared Drugs Contain The Same Amount Of Medicinal Agent In The Same Dosage Form, Meeting The Same Comparable Standards And Which Are Intended For Administration By The Same Route; Pharmaceutical Equivalence Does Not Determine Therapeutic Equivalence, As Differences In The Supplementary Substances And Production Process May Cause Differences In The Dissolution And Bioavailability And, Consequently, In The Action Of The Pharmaceutical Agent. Therapeutic Equivalence - Two Agents Are Therapeutically Equivalent If They Are Pharmaceutically Equivalent And If, When Administered At The Same Dose, Their Effects In Terms Of Both Efficacy And Safety Are As Expected On The Basis Of Appropriate Studies. The Ordering Partys Requirements Regarding The Subject Of The Order Are Specified In Annex No. 2B To The Swz. If The Contractor Applying For The Contract Offers, By Indicating In The Price Form, The Subject Of The Order Equivalent To That Specified In The Tor, He Is Obliged - In Order To Confirm That The Offered Deliveries Meet The Ordering Partys Requirements Specified In The Tor - To Provide A Description Of Each Of The Equivalent Solutions In The Price Form (Trade Name, International Name, Number Of Pieces In The Package Of The Offered Product). The Ordering Party Agrees To Change The Form Of Oral Forms, I.E. Pricing: - Instead Of Tablets - Coated Tablets, Ampoules - Vials; - Instead Of Coated Tablets - Tablets, Capsules Or Dragees - Instead Of Capsules - Coated Tablets, Tablets Or Dragees - Instead Of An Injector - A Pre-Filled Syringe - Instead Of A Pre-Filled Syringe - An Injector. Instead Of Tablets, Coated Tablets Or Slow-Release Capsules - Tablets, Coated Tablets Or Capsules And Modified Release And Vice Versa. An Equivalent Solution Means A Solution Enabling To Achieve The Effect Intended By The Ordering Party And S

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