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Czech regulator seeks supplier of paediatric ferrous sulfate drops or syrup via special programme

🇨🇿 SÚKL · Tue 10 Nov 2026

SÚKL has called for proposals for a Specific Treatment Programme covering oral ferrous sulfate heptahydrate for neonates and young children, as no suitable product is marketed in the Czech Republic.

The Czech State Institute for Drug Control (SÚKL) has invited interested parties to submit a proposal for a Specific Treatment Programme for a medicine containing ferrous sulfate heptahydrate in an oral form, either drops or syrup, that can be given to neonates and young children. The call was published on 10 November 2026 by the authority's Department of Medicines Availability.

SÚKL describes the situation as one of extraordinary need. No medicine with this active substance in oral drop or syrup form is currently available on the Czech market with an indication for treating iron-deficiency anaemia in neonates and young children.

The authority estimates the volume required by assuming supply for 100 to 150 patients per year.

Under the procedure, a legal or natural person submits the proposed programme to the Ministry of Health, which must give its consent, and to SÚKL, which issues an opinion. The source cites Section 49 of Act No. 378/2007 Coll. on Medicines. An unregistered medicinal product may be used, distributed and dispensed in the manner set out in the programme only after the Ministry of Health has given written consent.

By way of general context, specific treatment programmes are a national route for making unauthorised medicines available where no authorised alternative meets patients' needs.

What it means for your team

  • Companies with an oral ferrous sulfate drop or syrup suitable for neonates and young children have a defined route to supply the Czech market without a marketing authorisation.
  • Proposals go to the Ministry of Health for consent and to SÚKL for an opinion; use, distribution and dispensing may begin only after written ministerial consent.
  • The stated demand is small, at 100 to 150 patients a year, which suppliers should weigh when assessing commercial viability.

Official source: SÚKL ↗

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

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