Poland - Miscellaneous medicinal products

Description

1.The subject of the contract is the task entitled: "Supply of drugs for the clinical trial "LAMAinDiab" - lisdexamphetamine vs methylphenidate for pediatric patients with ADHD and type 1 diabetes - randomized crossover clinical trial "2.CPV codes: 33690000-3 Miscellaneous medicinal products, 33600000-6 Pharmaceutical products, 33692000-7 Medicinal solutions.3.The subject of the contract is the successive supply of the following medicinal products (lisdexamphetamine dimesylate, methylphenidate hydrochloride) for the implementation of the non-commercial clinical trial "LAMAinDiab - lisdexamphetamine vs methylphenidate for pediatric patients with ADHD syndrome and type 1 diabetes randomized crossover clinical trial, in accordance with the principles of good clinical practice, good manufacturing and supply practice (GCP, GMP, GDP.-Lisdexamphetamine dimesylate, hard capsules for oral administration-Methylphenidate hydrochloride, prolonged release tablets for oral administration in different dosages
1.The subject of the contract is the task entitled: "Supply of drugs for the clinical trial "LAMAinDiab" - lisdexamphetamine vs methylphenidate for pediatric patients with ADHD and type 1 diabetes - randomized crossover clinical trial "2. CPV codes: 33690000-3 Miscellaneous medicinal products, 33600000-6 Pharmaceutical products, 33692000-7 Medicinal solutions.3.The subject of the contract is the successive supply of the following medicinal products (lisdexamphetamine dimesylate, methylphenidate hydrochloride) for the implementation of the non-commercial clinical trial "LAMAinDiab - lisdexamphetamine vs methylphenidate for pediatric patients with ADHD syndrome and type 1 diabetes randomized crossover clinical trial, in accordance with the principles of good clinical practice, good manufacturing and supply practice (GCP, GMP, GDP.-Lisdexamphetamine dimesylate, hard capsules for oral administration-Methylphenidate hydrochloride, prolonged-release tablets for oral administration in various dosagesThe contract includes the delivery of drugs to four study sites in Poland, as designated by the Contracting Authority. The Contractor will receive the drug delivery addresses from the Ordering Party one month in advance at the indicated e-mail address. The first delivery should take place within 1.5 months from the clinical trial start date (may not coincide with the contract date). The supplier will be informed by the Purchaser's representative via e-mail about the start of the study. Deliveries of the drug will be executed according to partial orders placed by an authorized representative of the Purchaser at the e-mail address and telephone number indicated by the Contractor. The maximum lead time for a partial order is 15 working days (reducing the lead time is one of the evaluation criteria). In addition, the order includes the collection and disposal of unused medicinal products and all packages returned to the doctor by patients, which are subject to records (so-called compliance), due to the status of the investigational medicinal product.The Contractor is obliged to provide a list containing information about the contents of a given package and assigned batch numbers.The Contractor must have a license to trade in medicinal products GIF, in accordance with the Pharmaceutical Law.

Opportunity closing date

07 June 2022

Value of contract

to be confirmed