Acquisition of intended exclusively for the production of parenteral bags INFARMED - the Portuguese National Authority for Medicines and Healthcare Products (“Infarmed”) has recently adopted Decision 089/CD/2022, concerning the regulatory framework for the acquisition of medicines without a national Marketing Authorisation (“AIM”), intended exclusively for the production of parenteral bags ...
Regulation (EU) 536/2014 of the Parliament and of the Council of 16 April 2014 on clinical trials on medicinal products for human use introduced additional requirements for the labelling of investigational and auxiliary medicinal products, in particular, for unauthorised medicinal products, in order to eliminate divergences in approach among Member States ...
“Government efforts to manipulate markets and prices on consumer goods never work as intended, and in this case, would be counterproductive.” The waning days of summer signal the approaching midterm election season. Amid inflation, recession and voter discontent, it’s understandable that a group of congress members are anxious to put points on the board with a price-control scheme that they wrongly believe will lower prescription drug prices ...
On 31 August 2022, the UK COVID-19 Inquiry (“the Inquiry”) opened its second Module. Module 2 will examine the political and administrative decision making of the UK and devolved governments, with a particular focus on early 2020 ...
On February 24, a lot changed in Ukraine, and the judicial system was no exception. What new has the full-scale invasion of the Russian Federation brought to the resolution of legal disputes and what does the judiciary look like under martial law - we will consider further. The first months after the invasion Immediately after the Russian invasion, the courts took some time to recover from the shock ...
There are often many reasons cited as to why international arbitration should be the preferred method of dispute resolution for parties: it can be quicker, cheaper, the process is private, the award is final and the parties have more autonomy over the process. Whilst some of these factors are debatable (especially in highly complex commercial cases), the fact that parties to an arbitration can have more autonomy than in traditional court litigation is usually less controversial ...
SyCip Salazar Hernandez & Gatmaitan (SyCipLaw) Partners Ricardo Ma. P.G. Ongkiko (Head of the Firm's Litigation Department), Carlos Roberto Z. Lopez, and John Christian Joy A. Regalado authored the Philippine chapter of the latest Global Practice Guide (GPG) on International Arbitration published by Chambers and Partners ...
Dear valued clients, colleagues and friends, On 23 August 2022, the Malaysia Competition Commission (“MyCC”) launched a public consultation on the proposed renewal of a Block Exemption Order (“BEO”) in respect of liner shipping services covered under a VSA. The renewal application was made pursuant to Section 8 of the Competition Act as the earlier BEO granted expired on 6 July 2022. The press release by MyCC (“Press Release”) is accessible here ...
The United Arab Emirates (UAE), a sought-after destination by foreign businesses for establishing their regional offices, consists of multiple jurisdictions for incorporation/establishment of entities. Each Emirate of the UAE has its own licensing authority and, additionally, there are more than 40 free zones in the UAE. Each Emirate and each free zone can be regarded as a separate jurisdiction for the incorporation and establishment of entities ...
In July, the Antimonopoly Committee asked the Ministry of Strategic Industries to update the conditions for providing state aid to companies that develop, manufacture, repair, and service aviation equipment and engines. What to update and how, the committee wrote in recently adopted recommendations . Asters lawyer Olena Gadomska told Mind what the latter envisage, why AMCU is resorting to such changes and who they will affect ...
With regulations imposing mandatory vaccination for certain workers in the care sector being implemented to those same regulations being revoked some four months later, employers in this sector may well be confused as to what options are available to them ...
The decision will be relevant for parties seeking to bring claims in the BVI courts where there are competing jurisdictions and systems of law at play. Funders and ATE insurers will also find the decision of interest where they are considering the merits of funding cross-border claims involving BVI defendants. A copy of the judgment is available here. Background WWRT had commenced proceedings in the BVI against Carosan, a BVI company, and BK, a Ukrainian businessman ...
As all court cases do, the Supreme Court's landmark decision in West Virginia v. EPA last month addressed a specific question: whether the Environmental Protection Agency had the statutory authority to shut down power plants and reshape significant parts of the energy sector in its effort to reduce emissions. The answer was a plain and simple no. Equally clear was the court's argument, which has implications for administrative actions well beyond this case ...
Proposal for a regulation of the European Parliament and of the Council on standards of quality and safety Current regulatory framework and scope of application The EU regulatory framework on substances of human origin (“SoHO”) is reflected in Directives 2002/98/EC for blood and 2004/23/EC for tissues and cells ...
On 21st July 2022, the COVID-19 Inquiry was opened. Module 1 will consider the extent to which the risk of a Coronavirus pandemic was properly identified and planned for and whether the UK was ready for that eventuality. In broad terms, the module will look at the UK’s preparedness for whole-system civil emergencies, including resourcing, the system of risk management and pandemic readiness ...
On June 21, 2022, the government adopted Resolution No. 702 , which regulates the procedure for receiving partial unemployment benefits. From now on , self-employed persons and employees who have lost part of their income can count on assistance from the state. However, it should be noted that it is not the employee, but the employer who should seek help ...
Ohio’s “Heartbeat” Bill became law in Ohio when the U.S. District Court, Southern District of Ohio lifted its long pending injunction after the Supreme Court overturned Roe v. Wade ...
On July 19, 2022, the Court of Claims ordered that the current Improved Workforce Opportunity Wage Act (minimum wage) and Michigan Paid Medical Leave Act (paid leave) are void and reinstated the original ballot initiatives. However, employers do not need to overhaul their policies just yet because the ruling is stayed until February 19, 2023. Pending the outcome of appeal, these changes may not go into effect at all ...
In light of the sanctions imposed, ALRUD experts have prepared an Overview of Russian Counter-Sanctions measures that have been taken in response to the actions of unfriendly countries since 24 February 2022. The overview focuses on: Russian counter-sanctions measures Liability Prospects for foreign business Recent trends in litigation and arbitration Assumptions and limitations The review is updated on an ongoing basis. Follow the link to learn more ...
Daniil Lozovsky, Senior Attorney of the Competition/Antitrust Practice, and Grigory Viktorov, Junior Attorney of Competition/Antitrust Practice prepared an article “The new foreign direct investments regime in Russia” in Mergers & Acquisitions Expert Guide 2022 published by the Corporate LiveWire magazine. The article is aimed at informing the readers on the new FDI regime, the corresponding legal basis and the related matters ...
On 21 July 2022, Baroness Heather Hallett issued an opening statement in respect of the COVID-19 Inquiry ('the Inquiry'). As Chair, Baroness Hallett expressed her determination to “run the Inquiry as thoroughly and as efficiently as possible” and “to undertake and conclude the work of this Inquiry as speedily as possible so that lessons are learned before another pandemic strikes ...
Chloe, the assistance cat, has hit the headlines of several newspapers over the past few weeks, following her owner (Mr Fenn) bringing a claim under the Equality Act 2010 against Sainsbury’s supermarkets after they refused Chloe’s entry to the store. Mr Fenn has autism; a consequence of his autism is that he experiences sensory overload in busy places such as the supermarket and he states that Chloe helps him to focus ...
Impact on the activity of the pharmaceutical industry At the end of 2021, two laws were published to regulate the general framework for the prevention of corruption in the activity of companies: (i) Decree-Law 109-E/2021 of 9 December, which establishes the general rules for the prevention of corruption (“RGPC”) and (ii) Law 93/2021 of 20 December, which creates rules to protect whistleblowers (“RJPDI”) ...
Even though Belgium is lagging behind when it comes to enacting specific legislation, companies doing business in Belgium should be aware of the risk of being held accountable for human rights violations or environmental pollution up or down their value chain. Human rights violations are a ‘hot’ topic and businesses are confronted with ethical challenges in this respect ...
