On 23 December 2022, the Italian Medicines Agency (AIFA) published on its website an update concerning the procedures for submitting the Active Substance Master File, which is the document that the manufacturer of the active ingredient is required to submit to AIFA for the active substances contained in the medicine for which a marketing authorization has been applied for.
The UK government has published its response to the Women and Equalities Committee’s report on menopause and the workplace. While the response accepts some of the Committee’s proposals, it also confirms that the government does not propose any legislative changes or to produce a model menopause policy or trial menopause leave.
The first ever guidance on social media has been issued by the Prescription Medicines Code of Practice Authority (PMCPA) to help pharmaceutical companies apply the high standards demanded by the industry’s ABPI Code of Practice to all their online communications channels. The PMCPA Social Media Guidance 2023 has been produced in consultation with the Medicines and Healthcare Products Regulatory Agency, the ABPI, and pharmaceutical companies. It includes advice for companies to help them use social media in line with these rules and the rest of the Code, following a huge increase in PMCPA complaint cases during the COVID pandemic, and a consensus from the industry that the previous 2016 guidance on digital communications, which did not cover social media platforms, was outdated and unhelpful given today’s online climate.
The MHRA lifted some extra burden from the industry by extending the European Commission Decision Reliance Procedure (ECDRP) by 12 months until 31 December 2023. The ECDRP was introduced following Brexit and is available to medicines approved via the EU centralized procedure.
Before 31 December 2023, in situations where a Committee for Medicinal Products for Human Use positive opinion has been received, applicants can continue to submit their ECDRP Marketing Authorisation Application (MAA) or variations to MHRA, and MHRA will continue to review these applications via the current ECDRP process.
The MHRA also announced that from 1 January 2024, a new international recognition framework will be in place, which will have regard to decisions already made by the European Medicines Agency/European Commission and certain other regulators.
Following concerns expressed about the capacity of Notified Bodies to certify medical devices in accordance with the EU Medical Device Regulation within the transitional periods provided therein, on 6 January 2023 the European Commission adopted a proposal to extend the transitional periods under Article 120(3) of the MDR.
On 11 January 2023, Decree Law No. 4 on “Urgent provisions regarding the procedures for the repayment of the medical device expenditure ceiling overrun” was published in the Italian Official Gazette. Article 1 of the Decree extends to 30 April 2023 the deadline by which companies that supplied medical devices to NHS during the years 2015-2018 must pay the required payback amounts.
On 22 December 2022, the Court of Justice of the European Union ruled on Case C-530/20 concerning the interpretation of Articles 86, 87, and 90 of Directive 2001/83/EC on the advertising of medicinal products for human use.
Various new corporate income tax measures entered into force in Belgium as of 1 January 2023, the most impactful being a temporary increase of the minimum corporate tax base under the so-called “basket rule”. This measure will be in force until the European Minimum Tax Directive (Pillar Two) is implemented into Belgian legislation and takes effect (in principle as of 1 January 2024).
Baker McKenzie’s Sanctions Blog published the alert titled Ukraine introduces extensive sanctions packages against Russian media personalities on 20 January 2023. Read the article via the link here. Please also visit our Sanctions Blog for the most recent updates.
Belgium has finalized the basic banking service framework for companies, among others, by creating the long-awaited basic banking service chamber, as a result of which the new rules can now finally take effect.