PharmacovigilanceOfficial

Slovakia's ŠÚKL joins #MedSafetyWeek, urging patients and professionals to report side effects

🇸🇰 ŠÚKL · Mon 02 Nov 2026

The Slovak medicines authority is backing the 2–8 November global campaign with the message not to ignore side effects, and has restated how suspected reactions can be reported.

ŠÚKL, Slovakia's State Institute for Drug Control, is taking part in this year's #MedSafetyWeek, the global medicines safety awareness campaign running from 2 to 8 November 2026. Its message is that side effects should not be ignored and should be reported.

In its press release of 2 November, the authority called on patients and healthcare professionals to treat medicines with care and not to underestimate adverse effects. It stressed that early reporting, even of less serious symptoms, helps regulators identify risks quickly. Miroslava Gočová, head of ŠÚKL's pharmacovigilance department, said reports from both patients and health professionals play an important role in monitoring medicine safety. She added that a reporter does not need to be certain that a medicine caused the problem, because a suspicion alone is valuable.

ŠÚKL noted that the risk of side effects is higher at the start of treatment, when doses change, when several medicines are taken together, or when medicines are combined with certain foods or food supplements. It advised people to read the package leaflet and to consult a doctor or pharmacist if anything is unclear.

The organisers expect the 2026 edition to be the largest so far, with more than 130 organisations from over 120 countries taking part. Campaign messages will be shared in more than 60 languages, including Slovak.

Reports can be submitted through ŠÚKL's electronic form on its eSKADRA portal, by email to neziaduce.ucinky@sukl.sk, on a form sent by post to the institute's Bratislava address, or by phone. ŠÚKL asks reporters to give details of the patient, the suspected medicine, the reaction, relevant history and concomitant medicines, plus their own contact details in case follow-up is needed. The announcement introduces no new regulatory requirements.

What it means for your team

  • No new obligations arise for marketing authorisation holders; this is an awareness initiative promoting spontaneous reporting.
  • Companies with Slovak operations may wish to align their own patient and healthcare-professional communications with the campaign window and to point to ŠÚKL's reporting channels.
  • Reporting teams should be ready for a possible rise in spontaneous reports around the campaign, including for non-serious or uncertain suspected reactions.
  • Minimum case data are listed by ŠÚKL: patient identifiers, suspect product details, reaction details and a reporter contact. Good-quality follow-up information depends on them.

Official source: ŠÚKL ↗

Article written by VigiEye from the official source (ŠÚKL). AI-assisted; check the source before acting.

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