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CHECKLISTS
This Checklist summarises the issues to consider when assessing active and passive sales, as well as restrictions of those sales, in EU vertical agreements under Article 101 TFEU and the EU Vertical Block Exemption Regulation 2022/720 (VBER 2022). For detailed information regarding the VBER 2022, see further: The Vertical Block Exemption Regulation 2022/720. NOTE—This Checklist assumes the starting point is a vertical agreement containing territorial, customer or online sales restrictions. It is aimed at guiding an assessment of whether the relevant sales activity is active or passive, whether the restriction falls within a permitted exception under VBER 2022 and, if not, whether further self-assessment under Article 101 TFEU is required. The availability of VBER 2022 also depends on the general conditions for the block exemption being met, including the market share thresholds and the absence of other hardcore restrictions. When does the distinction matter? The first question to consider is whether the agreement contains territorial or customer restrictions for which the distinction between active and passive sales is relevant. The distinction is critical
GLOSSARY
This term refers to the offence committed by the party that promises or gives the bribe.
PRACTICE NOTES
The Bribery Act 2010 (BA 2010) criminalises: • bribing another person (active bribery) • soliciting or accepting a bribe (passive bribery) • bribing a foreign public official, and • for a business or commercial organisation only, failing to prevent bribery The purpose of this Practice Note is to provide a general understanding of the active and passive bribery offences under BA 2010, ss 1, 2 and the offence of bribing a foreign public official under BA 2010, s 6; in short, the giving or receiving of bribes. It does not provide a summary of the corporate offence of failing to prevent bribery, which is covered in Practice Note: Failure to prevent bribery—the offence. This Practice Note should be read in conjunction with Practice Note: The Bribery Act 2010—an introductory guide. BA 2010 came into force on 1 July 2011. Conduct committed before the entry into force of BA 2010 is prosecuted under the old law, see Practice Notes: Corruption and common law bribery—pre-Bribery Act 2010 [Archived]
GLOSSARY
Generally, active devices refer to medical devices powered by electricity or any source of power other than that generated by the human body or gravity. Examples are examination lights, surgical microscopes, gas pressure regulators or blood pumps for heart-lung machines or devices for viewing diagnostic images such as ultrasound images. Under Regulation (EU) 2017/745 (EU MDR), ‘active device means any device, the operation of which depends on a source of energy other than that generated by the human body for that purpose, or by gravity, and which acts by changing the density of or converting that energy. Devices intended to transmit energy, substances or other elements between an active device and the patient, without any significant change, shall not be deemed to be active devices. Software shall also be deemed to be an active device’. UK legislation compounds the definition of an ‘active’ device with implantable devices.
GLOSSARY
Generally, active implantable medical devices (AIMDs) are powered devices (other than from the human body or gravity) that are inserted into a patient’s body partially or fully through a natural orifice or by surgical means, and are intended to remain in the patient’s body. For example, coronary pacemakers, cochlear hearing implants, infusion pumps or neurostimulators. The UK and EU legislative definitions differ and are as follows: The UK Medical Devices Regulations 2002 (MDR 2002), SI 2002/618, which implement Directive 90/385/EEC, the Active Implantable Medical Devices Directive in the UK, define AIMD as: ‘…a medical device which— • relies for its functioning on a source of electrical energy or a source of power other than that generated directly by the human body or by gravity; and • is intended to be totally or partially introduced into the human body (whether surgically or medically, including being introduced into a natural orifice) and which is intended to remain in the human body after completion of the surgical or medical procedure during which it is introduced, even if it is intended to administer a medicinal product or incorporates as an integral part a substance which, if used separately, would be a medicinal product.’ Under Regulation (EU) 2017/745, the Medical Devices Regulation (EU MDR), an active device and an implantable device are separately defined: ‘…active device means any device, the operation of which depends on a source of energy other than that generated by the human body for that purpose, or by gravity, and which acts by changing the density of or converting that energy. Devices intended to transmit energy, substances or other elements between an active device and the patient, without any significant change, shall not be deemed to be active devices. Software shall also be deemed to be an active device.’ ‘…implantable device means any device, including those that are partially or wholly absorbed, which is intended: • to be totally introduced into the human body, or • to replace an epithelial surface or the surface of the eye by clinical intervention and which is intended to remain in place after the procedure. Any device intended to be partially introduced into the human body by clinical intervention and intended to remain in place after the procedure for at least 30 days shall also be deemed to be an implantable device.’ Specific requirements for AIMDs are set out in Annex I of the EU MDR at Chapter 2, section 19.
GLOSSARY
Active investing involves continuous buying and selling of shares by the asset manager who needs to keep a frequent eye on market conditions. It is expensive in dealing fees, and needs to avoid being treated as trading by HMRC who might then charge tax on any profits.
GLOSSARY
An employee who is contributing (or has contributions made on their behalf) to a pension scheme.
GLOSSARY
Theperiod during which a member of a pension scheme is an active member.
GLOSSARY
A network in which the passive splitting point is replaced with an Optical Line Distribution unit which is a powered unit making it possible to have a higher bit rate on individual routes over longer distances than on a passive optical network.
GLOSSARY
Also referred to as a ‘drug substance’, this term refers to any substance or mixture of substances intended to be the biologically active ingredient (or ‘active substance’) contained in a final medicinal product and intended to provide pharmacological activity or other direct effects. It is internationally defined as: ‘…any substance or mixture of substances intended to be used in the manufacture of a drug (medicinal) product and that, when used in the production of a drug, becomes an active ingredient of the drug product. Such substances are intended to furnish pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment, or prevention of disease or to affect the structure and function of the body.’ Medicinal products are usually composed of several components: the primary biologically active ingredient(s) which form the active pharmaceutical ingredient (API) plus other non-active ingredients known as ‘excipients’. The procedure for optimising and compositing this mixture of components, often producing ‘pharmaceutical intermediate’ byproducts as synthesising the API, and excipients into a final medicinal product is referred to as drug ‘formulation’. APIs are legally required to be registered with drug regulatory authorities (eg MHRA, FDA, EMA) and manufactured in compliance with good manufacturing practice (GMP) regulations and licensed facilities.
GLOSSARY
Where a fund manager decides to invest more or less in a particular investment or class of investments than the investment represents in a benchmark or index.
GLOSSARY
The return of a portfolio relative to its investment benchmark.