Publication date: June 13, 2023
– analysis of the legality of the online supply chain under Polish pharmaceutical law
In recent years, the growing interest in the medical use of cannabis has opened up new opportunities in the pharmaceutical industry. In Poland, where the sale of cannabis only for the medical purposes is strictly regulated, the introduction of medical cannabis to the market is associated with legal and administrative challenges, and at the same time opens up prospects for new solutions for patients with various diseases. This case study analyses the process of introducing the sale of medical cannabis in Poland and its impact on the online pharmaceutical industry. It also points to the legal problems of the medical cannabis sales system from the perspective of the common phenomenon of the need for Polish patients to order medicine online and teleconsultations.
Market and legal conditions for the product in the online channel
Before 2017, cannabis was illegal in Poland for both medical and non-medical use. However, in 2017, the Polish parliament passed a law that allows the use of medical cannabis under the supervision of a doctor for patients suffering from certain diseases.
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Publication date: June 06, 2023
Pursuant to Art. 7 (2) of the Act on package travel and linked travel arrangements, there is an obligation to conclude an insurance contract in a specific amount. This provision provides that statutory obligations are fulfilled by tour operators and entrepreneurs facilitating linked travel arrangements by:
1) conclusion of a bank guarantee or an insurance guarantee in accordance with the template form and the provisions specifying the minimum amount of the guarantee sum or
2) conclusion of an insurance contract for travelers inaccordance with the form template and the provisions specifying the minimum amount of the sum insured, or
3) concluding a contract for a travel escrow account in accordance with the model of this contract and accepting travellers’ payments only to this account, if they provide package travel or facilitate the purchase of linked travel arrangements provided only on the territory of the Republic of Poland;
4) making timely payments of contributions in the due amount to the Tourist Guarantee Fund.
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Publication date: June 06, 2023
Biosimilars
Biosimilar medicines, also known as biosimilars, are used in medicine to treat severe and chronic conditions such as cancer, diabetes and autoimmune diseases. Biosimilars – true to their name, they are similar to existing biological reference drugs. They are produced using living organisms or their cells, such as proteins, antibodies and other biological substances. These pharmaceuticals are also produced using biological processes but are not identical to the original reference medicines.
Biosimilars must meet certain criteria to be approved by the relevant regulatory authorities. They must be similar in quality, efficacy and safety to reference medicines. This means that they must have similar biological properties, such as action, mode of action and side effects, to those of the reference drugs.
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Publication date: May 30, 2023
On 30 May 2023 KIELTYKA GLADKOWSKI takes part in the event organised by the International Law Section of American Bar Association, ESG for Food and Ag Businesses in 2023 and Beyond: Part I – Navigating Emerging ESG Trends & Regulations.
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Publication date: May 29, 2023
On May 31, 2023 KIELTYKA GLADKOWSKI will take part in Chainalysis Links Amsterdam 2023. The topics discussed will be, among others, Digital Asset Regulation Across EMEA in 2023. Global Head of Public Policy Caroline Malcolm together with policymakers and regulators from across EMEA will discuss the latest rules for digital assets and their implementation, upcoming DeFi regulation, and what it all means for industry players as 2023 gets underway.
There will be analysis of the complexities of crypto taxation. The speakers will touch on several topics including information reporting by exchanges, criminal enforcement, crypto seizures, multilateral collaboration, and the work of the Joint Chiefs of Global Tax Enforcement (J5). The participants will also analyse the topic of How Law Enforcement is Organizing to Combat Crypto Crime. The special panel will also be devoted to The Intersection of Crypto and War: A View from Ukraine. Valeria Kennedy, Director of Investigations at Chainalysis, and Yevhenii Panchenko, Head of Operational Analysis, Ukrainian Police will discuss the role cryptocurrency is playing in Ukraine’s fight against financial crime.
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