MOODY NEWS
MOODY NEWS is the daily regulatory overview of MG Global in partnership with ERPI. We monitor official sources in Bulgaria, the EU and international markets for changes in the accreditation, certification, notification, verification, validation and TIC sector.
The public section presents concise and action-oriented signals. Extended information — primary sources, applicability, timelines, impact assessment, and recommended actions — is available to MG Global clients and partners.
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MOODY NEWS — October 7, 2026.
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…
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MOODY NEWS — October 6, 2026.
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,…
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MOODY NEWS — October 5, 2026.
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…
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MOODY NEWS — October 4, 2026.
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…
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MOODY NEWS — October 1, 2026.
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…
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MOODY NEWS — September 30, 2026
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…
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