Slovenia asks wholesalers to import cefaclor suspensions after supply disruption
JAZMP has called on wholesalers to temporarily bring in two strengths of cefaclor oral suspension from other EU states, with bridging quantities set for six months.
Slovenia's medicines agency JAZMP has called on pharmaceutical wholesalers to arrange the temporary import of cefaclor granules for oral suspension from other EU member states. The request follows information the agency received about a disruption to supply.
The products concerned are cefaclor 125 mg/5 ml and cefaclor 250 mg/5 ml granules for oral suspension. The notice sets the expected bridging quantities for a period of six months, or until medicines holding a regular marketing authorisation become available again.
Wholesalers must submit an application for temporary import under the third indent of the third paragraph of Article 20 of the Medicinal Products Act (Official Gazette RS, No 17/14, as amended). JAZMP notes that both products appear on Slovenia's List of Essential Medicines for human use (Official Gazette RS, No 67/17).
The agency also asks wholesalers to encourage the manufacturer to obtain a regular marketing authorisation in Slovenia. It wants wholesalers to report as soon as possible on whether they can source the products for temporary import.
What it means for your team
- Wholesalers active in Slovenia should assess promptly whether they can source both cefaclor strengths from other EU markets and tell JAZMP.
- Any temporary import requires a formal application under Article 20 of the Medicinal Products Act, so regulatory teams should prepare submissions.
- Because the medicines are on the essential list, the agency is treating continuity of supply as a priority.
- Manufacturers without a Slovenian marketing authorisation for these products may face pressure from wholesalers to obtain one.
Article written by VigiEye from the official source (JAZMP). AI-assisted; check the source before acting.
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