MOODY NEWS

Ново развитие MyHealth@EU: правилата за идентификация влизат в сила ЕС · Електронно здравеопазване · Приет регламент — влизане в сила На 12 октомври 2026 г. влиза в сила Регламент за изпълнение (ЕС) 2026/2099 за идентификацията и удостоверяването при трансграничен обмен на електронни здравни данни. Основното прилагане започва на 26 март 2027 г.; две разпоредби за…

New development UKAS withdraws first decisions for ISO 14001:2026 on 30 October United Kingdom · accreditation and environmental management · updated transition rule In an update dated 7 October, UKAS is moving the first group of decisions for the transition to ISO 14001:2026 from 30 November to 30 October 2026. The change affects UKAS-accredited systems certification bodies…

New development EMA clarifies easier path for changes after PSUSA EU/EEA · medicines and regulatory compliance · updated procedural guidance In the update of 6 October, EMA clarifies how marketing authorisation holders should implement the results of the single assessment of periodic safety update reports — PSUSA. For centrally authorised medicines outside the specific procedure…

New development Large combustion plants: notification without unnecessary delay Bulgaria · industrial emissions and monitoring · entry into force From October 6, the amendments to Decree No. 173 in the ordinance on emissions from large combustion plants are applied. In the monitoring section, a requirement has been added for the operator to notify and take the measures required by the Regional Inspectorate for Environmental Protection, Environment and Water,…

Upcoming deadlines MyHealth@EU: one week until the entry into force of the EU authentication rules · digital health and conformity assessment · adopted regulation - reminder T–7 On 12 October, Implementing Regulation (EU) 2026/2099 on identification and authentication for cross-border exchanges of health data through MyHealth@EU enters into force. Its substantive application starts on 26…

New development Pressure equipment: new standards and limited presumption of conformity EU · pressure equipment · adopted act - harmonised standards On 2 October, the European Commission published Implementing Decision (EU) 2026/2211, which updates the harmonised standards under Directive 2014/68/EU for pressure equipment. The changes cover boilers, refrigeration systems, qualification of welding operators…

New development Proof of country of melting and pouring of steel EU · steel and customs compliance · Start of application of adopted act From 1 October 2026, Implementing Regulation (EU) 2026/1963 requires evidence of the country of initial melting and pouring of covered steel imports. The main document is the Mill Test Certificate with…

New development Chlorpyrifos enters the EU persistent organic pollutants regime · Chemicals and supply chains · Entry into force Delegated Regulation (EU) 2026/1423, which includes chlorpyrifos in Annex I to the persistent organic pollutants regime, enters into force on 30 September. This is a new legal step of an already published act, not a new…

New development Explicit requirement for laboratory quality control for titanium dioxide Bulgaria · environment and laboratories · adopted act Amendment to Regulation No. 3 of May 22, 2013, promulgated on September 29, adds an explicit requirement for a quality assurance system for laboratory analyses in the monitoring of titanium dioxide production installations…

New development New outbreak in Plovdiv region: zones updated until October Bulgaria / EU · poultry farming and veterinary control · adopted decision The Implementing Decision (EU) 2026/2187 published on 28 September updates the zones for highly pathogenic avian influenza following a new outbreak in Plovdiv region. A protection zone is foreseen for Momino Selo and Glavatar until 18…