On 1 April 2022, the European Parliament’s Committee on Economic and Monetary Affairs (ECON) published a report setting out its proposed amendments to the draft regulation on information accompanying transfers of funds and certain crypto-assets (recast).
The draft report puts forward the following key proposals:
1. No exemptions based on the value of the transfer:
With respect to wire transfers, the Transfer of Funds Regulation requires a payment service provider to ensure that transfers of funds are accompanied by complete information on the originator and the beneficiary and to verify the information on their customer only if the transfers of funds exceeds EUR 1000, individually or as part of small linked transfers which together would exceed EUR 1000, except where the funds to be transferred are received in cash or anonymous electronic money or there are reasonable grounds for suspecting money laundering or terrorist financing. Due to the specific characteristics and risk profile of crypto-assets, the information obligation should apply to crypto-assets transfers, regardless of the value of the transfer. There are clear indications that crypto-asset activities associated with criminal activities and terrorism financing are often transfers of small value. Furthermore, crypto-assets and related technologies enable criminals to split high value transfers into small amounts across multiple wallet addresses in order to avoid detection of AML/CFT monitoring systems and to carry out illicit activities via structured transactions to a scale and global reach not available to wire transfers. In the view of the co-rapporteurs, the removal of a de minimis threshold for crypto-asset transfers would facilitate, rather than complicate, compliance and risk management by cryptoasset service providers. This is particularly relevant in light of the difficulty to identify linked transfers executed via multiple apparently unrelated wallet addresses as well as the high volatility of the valuation of most crypto-assets.
Patent protection for a newly introduced drug on the market lasts almost 20 years. During this time, no other company (except the one with the patent) has the right to produce it. When protection ends, the drug may be manufactured by other manufacturers who begin to compete with each other – such competing drugs are called generics.
The original and generic medicine may differ in name, manufacturer and price. However, the active substance contained in them, which is responsible for the action of the drug, and its amount will always be the same. Thanks to the guarantee of equally high production standards and constant monitoring of safety and effectiveness, patients can freely choose the product that best suits them in the pharmacy. The manufacturing process of generic drugs must follow the principles of Good Manufacturing Practice (GMP). Compliance with the GMP rules allows for the provision of good quality medical devices.
The Polish Public Procurement Office has issued recommendations regarding indications and requirements related to public procurement for IT systems.
The guidelines are divided into two volumes and together they provide a collection of information on public procurement of IT systems. The first volume presents recommendations and guidelines relating to preparatory activities prior to the commencement of a public procurement procedure for information systems, while Volume II is devoted to recommendations and guidelines relating to the description of the subject of a contract and preparation of a public procurement procedure for information systems.
KIELTYKA GLADKOWSKI KG LEGAL takes part in the project “Systemic Design and Sustainable Healthcare for MedTech Manufacturing (SysteMA)”. One of elements of the project is led by the Life Science Cluster in Krakow and the MedSilesia cluster. The latter became involved in activities to raise awareness and knowledge in the field of the circular economy.
The research is part of the EIT Manufacturing project SysteMA (Systemic Design and Sustainable Healthcare for MedTech Manufacturing), which focuses on the role of MedTech manufacturing towards the environmental, social, and economic sustainability of healthcare systems. The project aims to create online training courses on this topic, providing EU companies with actionable skills to improve the sustainability of their products and processes and seize new market opportunities.
