Sanidad

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  05/09/2024

  China

  China enters new regulatory era with release of first draft Medical Devices Administration Law for Public Comment

  On 28 August 2024, China’s National Medical Products Administration (NMPA) released the draft of the Medical Devices Administration Law of the People's Republic of China for public comment with the deadline for feedback set for 28 September 2024.Unlike pharmaceutical products, for over two decades medical devices have not been governed by a national-level law from the National People's Congress, such as the Drug Administration Law, but by an administrative regulation, the Regulation on the Supervision and Administration of Medical Devices (i.e. "Medical Device Regulation"), and various separate...

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  02/09/2024

  Ukraine

  Ukraine tightens rules on labelling medicines

  On 21 August 2024, the Parliament of Ukraine adopted amendments to the Law on Medicinal Products as a part of an effort to align Ukrainian legislation with EU regulations, particularly Article 54 of Directive 2001/83/EC. These Amendments, however, introduce stricter rules than the EU legislation.Key provisions of the Amendments:1.    Prohibition on non-compliant labelling:The Amendments strictly prohibit the inclusion of any advertising information or references to entities other than the Marketing Authorisation Holder (MAH) or the manufacturer on the packaging of medicinal...

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  29/08/2024

  Ukraine

  Ukraine to Allow Limited Parallel Import of Medicines from 2025

  On 27 July 2024 a Law of Ukraine On Amendments to Certain Laws of Ukraine Concerning Parallel Import of Medicinal Products (the “Law”) came into force. The Law legalises limited parallel import regime for medicinal products as of 1 January 2025.The Law will bring the following key changes: From 1 January 2025, the parallel import of medicines into Ukraine will be lawful. At first, it will be possible to import medicines into Ukraine from EU countries, Iceland, Liechtenstein, and Norway only.It will be allowed to import medicines identical or similar to those registered in...

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  15/08/2024

  United Kingdom

  Labour’s proposal to introduce VAT on private school fees – what are the potential implications?

  A key tax plan of the Labour administration was to impose VAT on private school fees.  Now that the 2024 General Election is behind us and the Labour government are starting to settle into their tenure, what do we know about the proposal and how it will affect the various stakeholders? What are the proposed changes?Labour intends to introduce 20% VAT on education, including vocational training, and boarding services which are provided by private schools from 1 January 2025.  Private schools’ eligibility for charitable rates relief will also be removed. The proposed VAT...

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  14/08/2024

  England and Wales

  Closing the gaps to protect society’s most vulnerable– are you affected by proposed changes to regulation of Children’s Homes?

  The regulation of children's homes in the UK has undergone significant scrutiny and changes in recent years. In our previous articles, “Closing the gaps to protect society’s most vulnerable– are you affected by proposed changes to regulation of Children’s Homes?” (view here, here and here), which are a series of updates starting from July 2020, we discussed the government's efforts to tighten regulations and enhance the quality of care and accommodation provided to vulnerable children. These articles detailed the forthcoming introduction of new quality standards and...

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  13/08/2024

  Europe

  Antibody Appeals Uncovered

  Since the first approval of Muromonab-CD3 in 1986, antibodies have become progressively more common, frequently reaching a ‘blockbuster’ status. According to statistics provided by Statista in March, 5 out of 10 top-selling drugs were antibodies in 2023. Therefore, patents related to antibodies are now of considerable interest and significance to the pharmaceutical industry. They provide protection for commercially important inventions, spur further investment, and allow patients to benefit from these therapeutics. Our report provides a high-level analysis of the Board of Appeal decisions...

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