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    <title>Fimea.fi news</title>
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    <description>Fimea.fi news</description>
    <pubDate>Mon, 13 Apr 2026 02:06:47 GMT</pubDate>
    <dc:date>2026-04-13T02:06:47Z</dc:date>
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      <title>Report lack of efficacy of a veterinary antiparasitic medicine</title>
      <link>https://fimea.fi/en/-/report-lack-of-efficacy-of-a-veterinary-antiparasitic-medicine</link>
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      <pubDate>Wed, 08 Apr 2026 08:13:00 GMT</pubDate>
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      <dc:date>2026-04-08T08:13:00Z</dc:date>
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      <title>Fimea published a clinical investigation plan template to support clinical investigations of medical devices</title>
      <link>https://fimea.fi/en/-/fimea-published-a-clinical-investigation-plan-template-to-support-clinical-investigations-of-medical-devices</link>
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      <pubDate>Wed, 08 Apr 2026 06:30:00 GMT</pubDate>
      <guid isPermaLink="false">https://fimea.fi/en/-/fimea-published-a-clinical-investigation-plan-template-to-support-clinical-investigations-of-medical-devices</guid>
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      <dc:date>2026-04-08T06:30:00Z</dc:date>
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      <title>Finns consider medicine counselling important </title>
      <link>https://fimea.fi/en/-/finns-consider-medicine-counselling-important-</link>
      <description />
      <pubDate>Thu, 12 Mar 2026 09:34:00 GMT</pubDate>
      <guid isPermaLink="false">https://fimea.fi/en/-/finns-consider-medicine-counselling-important-</guid>
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      <dc:date>2026-03-12T09:34:00Z</dc:date>
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    <item>
      <title>Up-to-dateness of registration information is the responsibility of the medical device operator</title>
      <link>https://fimea.fi/en/-/up-to-dateness-of-registration-information-is-the-responsibility-of-the-medical-device-operator</link>
      <description />
      <pubDate>Mon, 09 Mar 2026 12:45:00 GMT</pubDate>
      <guid isPermaLink="false">https://fimea.fi/en/-/up-to-dateness-of-registration-information-is-the-responsibility-of-the-medical-device-operator</guid>
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      <dc:date>2026-03-09T12:45:00Z</dc:date>
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      <title>Medical devices can also be handed over to patients outside the hospital</title>
      <link>https://fimea.fi/en/-/medical-devices-can-also-be-handed-over-to-patients-outside-the-hospital</link>
      <description />
      <pubDate>Mon, 09 Mar 2026 09:51:00 GMT</pubDate>
      <guid isPermaLink="false">https://fimea.fi/en/-/medical-devices-can-also-be-handed-over-to-patients-outside-the-hospital</guid>
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      <dc:date>2026-03-09T09:51:00Z</dc:date>
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    <item>
      <title>Fimea’s final accounts and annual report for 2025 have been published</title>
      <link>https://fimea.fi/en/-/fimea-s-final-accounts-and-annual-report-for-2025-have-been-published</link>
      <description />
      <pubDate>Fri, 27 Feb 2026 12:04:00 GMT</pubDate>
      <guid isPermaLink="false">https://fimea.fi/en/-/fimea-s-final-accounts-and-annual-report-for-2025-have-been-published</guid>
      <dc:creator />
      <dc:date>2026-02-27T12:04:00Z</dc:date>
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    <item>
      <title>Fimea.fi user survey is now open</title>
      <link>https://fimea.fi/en/-/fimea.fi-user-survey-is-now-open</link>
      <description />
      <pubDate>Tue, 24 Feb 2026 12:34:00 GMT</pubDate>
      <guid isPermaLink="false">https://fimea.fi/en/-/fimea.fi-user-survey-is-now-open</guid>
      <dc:creator />
      <dc:date>2026-02-24T12:34:00Z</dc:date>
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    <item>
      <title>Nordic pilot of medicine packages in English for small-scale hospital products will continue   </title>
      <link>https://fimea.fi/en/-/nordic-pilot-of-medicine-packages-in-english-for-small-scale-hospital-products-will-continue-</link>
      <description />
      <pubDate>Thu, 19 Feb 2026 12:08:00 GMT</pubDate>
      <guid isPermaLink="false">https://fimea.fi/en/-/nordic-pilot-of-medicine-packages-in-english-for-small-scale-hospital-products-will-continue-</guid>
      <dc:creator />
      <dc:date>2026-02-19T12:08:00Z</dc:date>
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      <title>Fimea and Tukija to speed up evaluation of national clinical trials</title>
      <link>https://fimea.fi/en/-/fimea-and-tukija-to-speed-up-evaluation-of-national-clinical-trials</link>
      <description />
      <pubDate>Wed, 11 Feb 2026 06:51:00 GMT</pubDate>
      <guid isPermaLink="false">https://fimea.fi/en/-/fimea-and-tukija-to-speed-up-evaluation-of-national-clinical-trials</guid>
      <dc:creator />
      <dc:date>2026-02-11T06:51:00Z</dc:date>
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      <title>Fimea prepares for the expansion of non-prescription medicine sales channels</title>
      <link>https://fimea.fi/en/-/fimea-prepares-for-the-expansion-of-non-prescription-medicine-sales-channels</link>
      <description />
      <pubDate>Mon, 02 Feb 2026 06:59:00 GMT</pubDate>
      <guid isPermaLink="false">https://fimea.fi/en/-/fimea-prepares-for-the-expansion-of-non-prescription-medicine-sales-channels</guid>
      <dc:creator />
      <dc:date>2026-02-02T06:59:00Z</dc:date>
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    <item>
      <title>Report on joint inspections at EU level published – Fimea participates in strengthening market surveillance in the EU</title>
      <link>https://fimea.fi/en/-/report-on-joint-inspections-at-eu-level-published-fimea-participates-in-strengthening-market-surveillance-in-the-eu</link>
      <description />
      <pubDate>Wed, 28 Jan 2026 12:51:00 GMT</pubDate>
      <guid isPermaLink="false">https://fimea.fi/en/-/report-on-joint-inspections-at-eu-level-published-fimea-participates-in-strengthening-market-surveillance-in-the-eu</guid>
      <dc:creator />
      <dc:date>2026-01-28T12:51:00Z</dc:date>
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      <title>More detailed instructions for the FAST-EU pilot on clinical drug trials published for sponsors</title>
      <link>https://fimea.fi/en/-/more-detailed-instructions-for-the-fast-eu-pilot-on-clinical-drug-trials-published-for-sponsors</link>
      <description />
      <pubDate>Wed, 21 Jan 2026 13:10:00 GMT</pubDate>
      <guid isPermaLink="false">https://fimea.fi/en/-/more-detailed-instructions-for-the-fast-eu-pilot-on-clinical-drug-trials-published-for-sponsors</guid>
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      <dc:date>2026-01-21T13:10:00Z</dc:date>
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    <item>
      <title>How does a professional user benefit from ensuring conformity?</title>
      <link>https://fimea.fi/en/-/how-does-a-professional-user-benefit-from-ensuring-conformity-</link>
      <description />
      <pubDate>Wed, 21 Jan 2026 11:55:00 GMT</pubDate>
      <guid isPermaLink="false">https://fimea.fi/en/-/how-does-a-professional-user-benefit-from-ensuring-conformity-</guid>
      <dc:creator />
      <dc:date>2026-01-21T11:55:00Z</dc:date>
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    <item>
      <title>Fimea has released a guideline page on using artificial intelligence in medical devices</title>
      <link>https://fimea.fi/en/-/fimea-has-released-a-guideline-page-on-using-artificial-intelligence-in-medical-devices</link>
      <description />
      <pubDate>Mon, 19 Jan 2026 12:00:00 GMT</pubDate>
      <guid isPermaLink="false">https://fimea.fi/en/-/fimea-has-released-a-guideline-page-on-using-artificial-intelligence-in-medical-devices</guid>
      <dc:creator />
      <dc:date>2026-01-19T12:00:00Z</dc:date>
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    <item>
      <title>Manufacturers of medical devices must report serious incidents using a new form starting May 2026</title>
      <link>https://fimea.fi/en/-/manufacturers-of-medical-devices-must-report-serious-incidents-using-a-new-form-starting-may-2026</link>
      <description />
      <pubDate>Wed, 07 Jan 2026 08:03:00 GMT</pubDate>
      <guid isPermaLink="false">https://fimea.fi/en/-/manufacturers-of-medical-devices-must-report-serious-incidents-using-a-new-form-starting-may-2026</guid>
      <dc:creator />
      <dc:date>2026-01-07T08:03:00Z</dc:date>
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    <item>
      <title>Number of shortages at similar level to previous years</title>
      <link>https://fimea.fi/en/-/number-of-shortages-at-similar-level-to-previous-years</link>
      <description />
      <pubDate>Mon, 05 Jan 2026 06:46:00 GMT</pubDate>
      <guid isPermaLink="false">https://fimea.fi/en/-/number-of-shortages-at-similar-level-to-previous-years</guid>
      <dc:creator />
      <dc:date>2026-01-05T06:46:00Z</dc:date>
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    <item>
      <title>New decree on fees chargeable by the Finnish Medicines Agency entered into force on 1 January 2026</title>
      <link>https://fimea.fi/en/-/new-decree-on-fees-chargeable-by-the-finnish-medicines-agency-entered-into-force-on-1-january-2026</link>
      <description />
      <pubDate>Mon, 29 Dec 2025 13:22:00 GMT</pubDate>
      <guid isPermaLink="false">https://fimea.fi/en/-/new-decree-on-fees-chargeable-by-the-finnish-medicines-agency-entered-into-force-on-1-january-2026</guid>
      <dc:creator />
      <dc:date>2025-12-29T13:22:00Z</dc:date>
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    <item>
      <title>European Commission published new proposal for the Biotech Act</title>
      <link>https://fimea.fi/en/-/european-commission-published-new-proposal-for-the-biotech-act</link>
      <description />
      <pubDate>Tue, 23 Dec 2025 11:10:00 GMT</pubDate>
      <guid isPermaLink="false">https://fimea.fi/en/-/european-commission-published-new-proposal-for-the-biotech-act</guid>
      <dc:creator />
      <dc:date>2025-12-23T11:10:00Z</dc:date>
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    <item>
      <title>Amendments to the Act on the Secondary Use of Health and Social Data concerning clinical trials and investigations to enter into force on 1 January 2026</title>
      <link>https://fimea.fi/en/-/amendments-to-the-act-on-the-secondary-use-of-health-and-social-data-concerning-clinical-trials-and-investigations-to-enter-into-force-on-1-january-2026</link>
      <description />
      <pubDate>Fri, 19 Dec 2025 11:54:00 GMT</pubDate>
      <guid isPermaLink="false">https://fimea.fi/en/-/amendments-to-the-act-on-the-secondary-use-of-health-and-social-data-concerning-clinical-trials-and-investigations-to-enter-into-force-on-1-january-2026</guid>
      <dc:creator />
      <dc:date>2025-12-19T11:54:00Z</dc:date>
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      <title>The national medicines data repository will be named Farmasto, ushering in a new era of how authorities manage medicines data</title>
      <link>https://fimea.fi/en/-/the-national-medicines-data-repository-will-be-named-farmasto-ushering-in-a-new-era-of-how-authorities-manage-medicines-data</link>
      <description />
      <pubDate>Wed, 17 Dec 2025 09:06:00 GMT</pubDate>
      <guid isPermaLink="false">https://fimea.fi/en/-/the-national-medicines-data-repository-will-be-named-farmasto-ushering-in-a-new-era-of-how-authorities-manage-medicines-data</guid>
      <dc:creator />
      <dc:date>2025-12-17T09:06:00Z</dc:date>
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      <title>EU Council and Parliament reach an agreement on the pharma package</title>
      <link>https://fimea.fi/en/-/eu-council-and-parliament-reach-an-agreement-on-the-pharma-package</link>
      <description />
      <pubDate>Thu, 11 Dec 2025 12:45:00 GMT</pubDate>
      <guid isPermaLink="false">https://fimea.fi/en/-/eu-council-and-parliament-reach-an-agreement-on-the-pharma-package</guid>
      <dc:creator />
      <dc:date>2025-12-11T12:45:00Z</dc:date>
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      <title>​​​​​​​New study examined development needs of the regulatory competence of European medicines agencies</title>
      <link>https://fimea.fi/en/-/-new-study-examined-development-needs-of-the-regulatory-competence-of-european-medicines-agencies</link>
      <description />
      <pubDate>Thu, 11 Dec 2025 08:43:00 GMT</pubDate>
      <guid isPermaLink="false">https://fimea.fi/en/-/-new-study-examined-development-needs-of-the-regulatory-competence-of-european-medicines-agencies</guid>
      <dc:creator />
      <dc:date>2025-12-11T08:43:00Z</dc:date>
    </item>
    <item>
      <title>Maintenance break in the publication archive on 9 December 2025</title>
      <link>https://fimea.fi/en/-/maintenance-break-in-the-publication-archive-on-9-december-2025</link>
      <description />
      <pubDate>Mon, 08 Dec 2025 13:52:00 GMT</pubDate>
      <guid isPermaLink="false">https://fimea.fi/en/-/maintenance-break-in-the-publication-archive-on-9-december-2025</guid>
      <dc:creator />
      <dc:date>2025-12-08T13:52:00Z</dc:date>
    </item>
    <item>
      <title>New substances to be classified as narcotics</title>
      <link>https://fimea.fi/en/-/new-substances-to-be-classified-as-narcotics</link>
      <description />
      <pubDate>Thu, 04 Dec 2025 12:59:00 GMT</pubDate>
      <guid isPermaLink="false">https://fimea.fi/en/-/new-substances-to-be-classified-as-narcotics</guid>
      <dc:creator />
      <dc:date>2025-12-04T12:59:00Z</dc:date>
    </item>
    <item>
      <title>FAST-EU project accelerates the assessment of multinational clinical trials in Europe</title>
      <link>https://fimea.fi/en/-/fast-eu-project-accelerates-the-assessment-of-multinational-clinical-trials-in-europe</link>
      <description />
      <pubDate>Thu, 27 Nov 2025 11:39:00 GMT</pubDate>
      <guid isPermaLink="false">https://fimea.fi/en/-/fast-eu-project-accelerates-the-assessment-of-multinational-clinical-trials-in-europe</guid>
      <dc:creator />
      <dc:date>2025-11-27T11:39:00Z</dc:date>
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    <item>
      <title>Responsible use of antibiotics in veterinary medicine accomplished through long-term work</title>
      <link>https://fimea.fi/en/-/responsible-use-of-antibiotics-in-veterinary-medicine-accomplished-through-long-term-work</link>
      <description />
      <pubDate>Wed, 19 Nov 2025 07:00:00 GMT</pubDate>
      <guid isPermaLink="false">https://fimea.fi/en/-/responsible-use-of-antibiotics-in-veterinary-medicine-accomplished-through-long-term-work</guid>
      <dc:creator />
      <dc:date>2025-11-19T07:00:00Z</dc:date>
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    <item>
      <title>One in six bacterial infections worldwide is resistant to antibiotics – Finland has succeeded in combating antibiotic resistance</title>
      <link>https://fimea.fi/en/-/one-in-six-bacterial-infections-worldwide-is-resistant-to-antibiotics-finland-has-succeeded-in-combating-antibiotic-resistance</link>
      <description />
      <pubDate>Tue, 18 Nov 2025 06:32:00 GMT</pubDate>
      <guid isPermaLink="false">https://fimea.fi/en/-/one-in-six-bacterial-infections-worldwide-is-resistant-to-antibiotics-finland-has-succeeded-in-combating-antibiotic-resistance</guid>
      <dc:creator />
      <dc:date>2025-11-18T06:32:00Z</dc:date>
    </item>
    <item>
      <title>Information on exemptions granted for Nordic flex EN/EN packages will from now on be published on Fimea’s website</title>
      <link>https://fimea.fi/en/-/information-on-exemptions-granted-for-nordic-flex-en-en-packages-will-from-now-on-be-published-on-fimea-s-website</link>
      <description />
      <pubDate>Fri, 14 Nov 2025 10:08:00 GMT</pubDate>
      <guid isPermaLink="false">https://fimea.fi/en/-/information-on-exemptions-granted-for-nordic-flex-en-en-packages-will-from-now-on-be-published-on-fimea-s-website</guid>
      <dc:creator />
      <dc:date>2025-11-14T10:08:00Z</dc:date>
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    <item>
      <title>Fimea invites experts in cancer treatment to comment on the high-risk medicines classification of cancer drugs between 5 and 25 January 2026</title>
      <link>https://fimea.fi/en/-/fimea-invites-experts-in-cancer-treatment-to-comment-on-the-high-risk-medicines-classification-of-cancer-drugs-between-5-and-25-january-2026</link>
      <description />
      <pubDate>Thu, 13 Nov 2025 06:31:00 GMT</pubDate>
      <guid isPermaLink="false">https://fimea.fi/en/-/fimea-invites-experts-in-cancer-treatment-to-comment-on-the-high-risk-medicines-classification-of-cancer-drugs-between-5-and-25-january-2026</guid>
      <dc:creator />
      <dc:date>2025-11-13T06:31:00Z</dc:date>
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    <item>
      <title>Infographic to support researchers in planning an investigation in accordance with Article 82 of the Medical Device Regulation</title>
      <link>https://fimea.fi/en/-/infographic-to-support-researchers-in-planning-an-investigation-in-accordance-with-article-82-of-the-medical-device-regulation</link>
      <description />
      <pubDate>Mon, 10 Nov 2025 09:08:00 GMT</pubDate>
      <guid isPermaLink="false">https://fimea.fi/en/-/infographic-to-support-researchers-in-planning-an-investigation-in-accordance-with-article-82-of-the-medical-device-regulation</guid>
      <dc:creator />
      <dc:date>2025-11-10T09:08:00Z</dc:date>
    </item>
    <item>
      <title>The #MedSafetyWeek campaign between 3 and 9 November 2025 promotes drug safety</title>
      <link>https://fimea.fi/en/-/the-medsafetyweek-campaign-between-3-and-9-november-2025-promotes-drug-safety</link>
      <description />
      <pubDate>Mon, 03 Nov 2025 07:00:00 GMT</pubDate>
      <guid isPermaLink="false">https://fimea.fi/en/-/the-medsafetyweek-campaign-between-3-and-9-november-2025-promotes-drug-safety</guid>
      <dc:creator />
      <dc:date>2025-11-03T07:00:00Z</dc:date>
    </item>
    <item>
      <title>A new symbol makes it easier to identify risk minimisation materials</title>
      <link>https://fimea.fi/en/-/a-new-symbol-makes-it-easier-to-identify-risk-minimisation-materials</link>
      <description />
      <pubDate>Thu, 30 Oct 2025 06:31:00 GMT</pubDate>
      <guid isPermaLink="false">https://fimea.fi/en/-/a-new-symbol-makes-it-easier-to-identify-risk-minimisation-materials</guid>
      <dc:creator />
      <dc:date>2025-10-30T06:31:00Z</dc:date>
    </item>
    <item>
      <title>Medicines Day 2026 focuses on over-the-counter products and reliable information</title>
      <link>https://fimea.fi/en/-/medicines-day-2026-focuses-on-over-the-counter-products-and-reliable-information</link>
      <description />
      <pubDate>Tue, 28 Oct 2025 06:32:00 GMT</pubDate>
      <guid isPermaLink="false">https://fimea.fi/en/-/medicines-day-2026-focuses-on-over-the-counter-products-and-reliable-information</guid>
      <dc:creator />
      <dc:date>2025-10-28T06:32:00Z</dc:date>
    </item>
    <item>
      <title>Introducing a dedicated website section for substances of human origin</title>
      <link>https://fimea.fi/en/-/introducing-a-dedicated-website-section-for-substances-of-human-origin</link>
      <description />
      <pubDate>Mon, 27 Oct 2025 12:17:00 GMT</pubDate>
      <guid isPermaLink="false">https://fimea.fi/en/-/introducing-a-dedicated-website-section-for-substances-of-human-origin</guid>
      <dc:creator />
      <dc:date>2025-10-27T12:17:00Z</dc:date>
    </item>
    <item>
      <title>Language requirements to be simplified for common Nordic packages for hospital products</title>
      <link>https://fimea.fi/en/-/language-requirements-to-be-simplified-for-common-nordic-packages-for-hospital-products</link>
      <description />
      <pubDate>Wed, 22 Oct 2025 08:00:00 GMT</pubDate>
      <guid isPermaLink="false">https://fimea.fi/en/-/language-requirements-to-be-simplified-for-common-nordic-packages-for-hospital-products</guid>
      <dc:creator />
      <dc:date>2025-10-22T08:00:00Z</dc:date>
    </item>
    <item>
      <title>Fimea designates a third notified body under the IVD Regulation in Finland, strengthening Finland’s status as one of the leading EU countries by the number of notified bodies</title>
      <link>https://fimea.fi/en/-/fimea-designates-a-third-notified-body-under-the-ivd-regulation-in-finland-strengthening-finland-s-status-as-one-of-the-leading-eu-countries-by-the-number-of-notified-bodies</link>
      <description />
      <pubDate>Tue, 21 Oct 2025 06:10:00 GMT</pubDate>
      <guid isPermaLink="false">https://fimea.fi/en/-/fimea-designates-a-third-notified-body-under-the-ivd-regulation-in-finland-strengthening-finland-s-status-as-one-of-the-leading-eu-countries-by-the-number-of-notified-bodies</guid>
      <dc:creator />
      <dc:date>2025-10-21T06:10:00Z</dc:date>
    </item>
    <item>
      <title>Attention medical device operators: check the information submitted to the register by 31 December 2025</title>
      <link>https://fimea.fi/en/-/attention-medical-device-operators-check-the-information-submitted-to-the-register-by-31-december-2025</link>
      <description />
      <pubDate>Mon, 20 Oct 2025 12:00:00 GMT</pubDate>
      <guid isPermaLink="false">https://fimea.fi/en/-/attention-medical-device-operators-check-the-information-submitted-to-the-register-by-31-december-2025</guid>
      <dc:creator />
      <dc:date>2025-10-20T12:00:00Z</dc:date>
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    <item>
      <title>Nearly half of Finns with chronic conditions find medication therapy a burden</title>
      <link>https://fimea.fi/en/-/nearly-half-of-finns-with-chronic-conditions-find-medication-therapy-a-burden</link>
      <description />
      <pubDate>Mon, 20 Oct 2025 06:00:00 GMT</pubDate>
      <guid isPermaLink="false">https://fimea.fi/en/-/nearly-half-of-finns-with-chronic-conditions-find-medication-therapy-a-burden</guid>
      <dc:creator />
      <dc:date>2025-10-20T06:00:00Z</dc:date>
    </item>
    <item>
      <title>There’s still time to sign up for the information session for marketing authorisation holders on 30 October</title>
      <link>https://fimea.fi/en/-/there-s-still-time-to-sign-up-for-the-information-session-for-marketing-authorisation-holders-on-30-october</link>
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      <title>Medicines are not sweets: read the package leaflet and follow the instructions</title>
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      <title>Media visibility and costs of new medicines under examination – what does the media highlight?</title>
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      <title>Watch out for fake online pharmacies – be careful where you shop</title>
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      <title>Fimea’s E-service can now be accessed in one place</title>
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      <title>Fimea to investigate the conformity of software-based medical devices</title>
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      <title>Marketing authorisation for Litalgin products cancelled for safety reasons in summer 2024 – these products should no longer be used</title>
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      <title>2024 annual report on the supervision of the quality and safety of substances of human origin has been published</title>
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