EU\/EEA \u00b7 medicines and regulatory compliance \u00b7 updated procedural guidance<\/p>\n
In the update of 6 October, EMA clarifies how marketing authorisation holders should implement the results of the uniform assessment of periodic safety update reports \u2014 PSUSA. For centrally authorised medicines outside the specific procedure, variation type IA_IN, category C.3.a, can be used when the agreed text is implemented without adaptation and harmonised national translations are available. If the conditions are not met, the type IB, C.3.b route remains. This is a procedural guidance, not a new law. Regulatory and quality teams should check the classification of the planned variations, the evidence of identity of the text and the applicable deadline under the specific notification.<\/p>\n
USA HVAC Equipment and Testing Laboratories Final Rule<\/p>\n
The U.S. Department of Energy published a final rule on October 7 that removes Annex B for testing commercial air-heating furnaces and the associated Thermal Efficiency Two metric. The rule is effective December 7, 2026. The mandatory Annex A method and current energy efficiency requirements are maintained: the change does not repeal testing or demonstration of compliance. European manufacturers and exporters to the U.S. market, as well as their service laboratories, should review their specifications, testing contracts, and metrics used. It is particularly important that future declarations and test programs do not rely on the repealed additional method.<\/p>\n
EU\/EEA \u00b7 pharmacy and change management \u00b7 clarification of procedural requirement<\/p>\n
EMA updated on 6 October the guidance on changes to local representatives listed in the product information of centrally authorised medicines. Where the change only affects these representatives or their contacts, it can be implemented before notifying the Agency. However, it must then be communicated via the next amendment to the product information, or if no such amendment is foreseen, via a notification under Article 61(3). This is a clarification in Rev.119 of the Procedural Manual, not a general exemption from notification. Marketing authorisation holders should check the registers of changes, responsible parties and pending notifications to ensure that the regulatory trail is not lost following a change of contact.<\/p>\n
USA \u00b7 industrial safety and inspection \u00b7 consulting, T\u201314<\/p>\n
On October 21, the LPAC will consider PHMSA\u2019s proposal for risk-based determination of inspection intervals for tanks to pipelines for hazardous liquids. The deadline for advance written comments for the meeting is today, October 7; registration for virtual participation is until October 17. The draft provides for reference to the fifth edition of API 653 with amendments and corrections through July 2025. This is not yet a final rule. Inspection organizations, engineering providers, and operators with U.S. projects can review the evidence for the risk assessment and proposed intervals. Additional written comments after the meeting are accepted until November 20.<\/p>\n
USA \u00b7 measurements, testing and exposure assessment \u00b7 consultation, T\u201314<\/p>\n
The U.S. Department of Health and Human Services is accepting submissions through October 21 for information on assessing electromagnetic and radiofrequency exposures. The request, published on September 21, covers scientific evidence, measurement methods, and appropriate metrics, including specific absorbed power and power density. Today\u2019s notice is a two-week reminder of the deadline, not a new regulatory change. No new limits are being introduced and no final conclusion on health risk has been made. Laboratories, wireless equipment manufacturers, and exposure specialists may prepare technical opinions clearly describing the methodologies, limitations, and data quality under dossier HHS-OASH-2026-0397.<\/p>\n
United Kingdom \u00b7 packaging, traceability and certification \u00b7 consultation on draft regulations<\/p>\n
HMRC launched a technical consultation on 6 October on the recognition of chemically recycled plastic through mass balance for the purposes of the Plastic Packaging Tax. The draft links this approach to certification schemes, accredited certification bodies, site audits and chain-of-custody declarations. It is proposed that relevant records should be kept for at least six years. Submissions are being accepted until 21 December; the stated aim is to use the approach from 1 April 2027. Detailed rules have not yet been adopted. Manufacturers, packaging exporters and TIC organisations should assess future evidence of recycled content and audit competence, without assuming that an existing certificate will automatically cover the scheme.<\/p>\n
EU \u00b7 digital products and cyber compliance \u00b7 active baseline<\/p>\n
ENISA\u2019s guidance, updated on 3 October, describes an important limitation of the Cyber Resilience Act reporting platform. In the current version, the 72-hour notification counter counts 48 hours after the early warning was submitted. Therefore, the platform may show a delay before 72 hours have passed since the event was first reported. This does not change the legal deadlines or the requirement to report without undue delay. The topic is included as an initial operational baseline, not as a new act from today. Manufacturers should keep a reliable record of the time of notification and submissions and verify their internal notifications, rather than relying solely on the on-screen counter.<\/p>\n
Italy \/ EU \u00b7 environment, laboratories and traceability \u00b7 notified project<\/p>\n
On 6 October, Italy notified in TRIS project 2026\/0540\/IT for a complete update of the rules on agricultural use and management of sewage sludge. According to the official notification, the technical annexes provide for updated quality indicators, limit values, analytical methods and frequency of controls, as well as stricter traceability. This is a project, not an operational change. The register indicates 7 January 2027 as the end of the waiting period, not as a mandatory implementation date. Operators, laboratories and suppliers active on the Italian market should review the future analytical scopes and the evidence along the chain; the specific parameters should be checked against the final text.<\/p>\n
Denmark \/ EU \u00b7 food, labelling and product evidence \u00b7 notified project<\/p>\n
The Danish Food Administration notified on 6 October draft 2026\/0542\/DK to amend the criteria for the voluntary Keyhole food label. The proposals include lower salt levels for various product groups and higher requirements for wholegrain content and fibre in bread. A 24-month transition period is foreseen, but this has not yet started by virtue of an adopted act. TRIS indicates an end to the waiting period on 7 January 2027. The label can also be used for imported products if the criteria are met. Exporters to Denmark should compare recipes, nutritional analyses and labels with the draft. The signal does not imply mandatory labelling or a new certification requirement.<\/p>\n
Published by MG Global in partnership with ERPI.<\/p>","protected":false},"excerpt":{"rendered":"
\u041d\u043e\u0432\u043e \u0440\u0430\u0437\u0432\u0438\u0442\u0438\u0435 EMA \u0443\u0442\u043e\u0447\u043d\u044f\u0432\u0430 \u043f\u043e-\u043b\u0435\u043a\u0438\u044f \u043f\u044a\u0442 \u0437\u0430 \u043f\u0440\u043e\u043c\u0435\u043d\u0438 \u0441\u043b\u0435\u0434 PSUSA \u0415\u0421 \/ \u0415\u0418\u041f \u00b7 \u043b\u0435\u043a\u0430\u0440\u0441\u0442\u0432\u0430 \u0438 \u0440\u0435\u0433\u0443\u043b\u0430\u0442\u043e\u0440\u043d\u043e \u0441\u044a\u043e\u0442\u0432\u0435\u0442\u0441\u0442\u0432\u0438\u0435 \u00b7 \u0430\u043a\u0442\u0443\u0430\u043b\u0438\u0437\u0438\u0440\u0430\u043d\u043e \u043f\u0440\u043e\u0446\u0435\u0434\u0443\u0440\u043d\u043e \u0443\u043a\u0430\u0437\u0430\u043d\u0438\u0435 \u0412 \u0430\u043a\u0442\u0443\u0430\u043b\u0438\u0437\u0430\u0446\u0438\u044f\u0442\u0430 \u043e\u0442 6 \u043e\u043a\u0442\u043e\u043c\u0432\u0440\u0438 EMA \u0443\u0442\u043e\u0447\u043d\u044f\u0432\u0430 \u043a\u0430\u043a \u043f\u0440\u0438\u0442\u0435\u0436\u0430\u0442\u0435\u043b\u0438\u0442\u0435 \u043d\u0430 \u0440\u0430\u0437\u0440\u0435\u0448\u0435\u043d\u0438\u044f \u0437\u0430 \u0443\u043f\u043e\u0442\u0440\u0435\u0431\u0430 \u0434\u0430 \u0438\u0437\u043f\u044a\u043b\u043d\u044f\u0432\u0430\u0442 \u0440\u0435\u0437\u0443\u043b\u0442\u0430\u0442\u0438\u0442\u0435 \u043e\u0442 \u0435\u0434\u0438\u043d\u043d\u0430\u0442\u0430 \u043e\u0446\u0435\u043d\u043a\u0430 \u043d\u0430 \u043f\u0435\u0440\u0438\u043e\u0434\u0438\u0447\u043d\u0438\u0442\u0435 \u0434\u043e\u043a\u043b\u0430\u0434\u0438 \u0437\u0430 \u0431\u0435\u0437\u043e\u043f\u0430\u0441\u043d\u043e\u0441\u0442 \u2014 PSUSA. \u0417\u0430 \u0446\u0435\u043d\u0442\u0440\u0430\u043b\u0438\u0437\u0438\u0440\u0430\u043d\u043e \u0440\u0430\u0437\u0440\u0435\u0448\u0435\u043d\u0438 \u043b\u0435\u043a\u0430\u0440\u0441\u0442\u0432\u0430 \u0438\u0437\u0432\u044a\u043d \u043a\u043e\u043d\u043a\u0440\u0435\u0442\u043d\u0430\u0442\u0430 \u043f\u0440\u043e\u0446\u0435\u0434\u0443\u0440\u0430 […]<\/p>\n","protected":false},"author":7,"featured_media":46333,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[1],"tags":[42],"class_list":["post-46459","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-news","tag-moody-news-daily"],"_links":{"self":[{"href":"https:\/\/mgglobal.eu\/en\/wp-json\/wp\/v2\/posts\/46459","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/mgglobal.eu\/en\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/mgglobal.eu\/en\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/mgglobal.eu\/en\/wp-json\/wp\/v2\/users\/7"}],"replies":[{"embeddable":true,"href":"https:\/\/mgglobal.eu\/en\/wp-json\/wp\/v2\/comments?post=46459"}],"version-history":[{"count":2,"href":"https:\/\/mgglobal.eu\/en\/wp-json\/wp\/v2\/posts\/46459\/revisions"}],"predecessor-version":[{"id":46461,"href":"https:\/\/mgglobal.eu\/en\/wp-json\/wp\/v2\/posts\/46459\/revisions\/46461"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/mgglobal.eu\/en\/wp-json\/wp\/v2\/media\/46333"}],"wp:attachment":[{"href":"https:\/\/mgglobal.eu\/en\/wp-json\/wp\/v2\/media?parent=46459"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/mgglobal.eu\/en\/wp-json\/wp\/v2\/categories?post=46459"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/mgglobal.eu\/en\/wp-json\/wp\/v2\/tags?post=46459"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}