Denmark to end foreign-pack permission for Paracetamol AL 500 mg suppositories on 12 November
The Danish Medicines Agency will deactivate its section 29(2) permission for German-authorised Paracetamol AL "Aliud" suppositories because marketed Danish packs are available again.
The Danish Medicines Agency (DKMA) will deactivate on 12 November 2026 its permission to prescribe and dispense Paracetamol AL "Aliud" 500 mg suppositories under section 29(2) of the Danish Medicines Act. The reason given is that marketed Danish packs are available again.
The permission covered a product authorised in Germany, with Specific Pharma A/S named as the responsible importer. The active substance is paracetamol, and the listed indications are mild pain and fever reduction. The permission had been valid from 18 August 2026 and runs until 12 November 2026. The DKMA page was last updated on 9 November 2026.
While the permission was valid, pharmacies and hospital pharmacies could sell or dispense the foreign product on prescription. This was subject to the corresponding marketed Danish medicines being in supply failure. The DKMA noted that the full foreign product name must appear on the prescription.
For patients seeking reimbursement, a single-case reimbursement application had to be submitted for the foreign packs. Requests for the summary of product characteristics, or for the current availability of the foreign packs, were to go to the importer.
What it means for your team
- Prescribers and pharmacies should return to the authorised Danish packs once the permission lapses on 12 November 2026.
- Supply and market-access teams can treat this as a closed shortage episode for this product, based on the DKMA's statement that Danish packs are back on the market.
- Section 29(2) permissions are time-limited and tied to a supply failure, so they end when marketed alternatives return.
- Any open single-case reimbursement applications for the foreign packs were an importer and prescriber matter; questions on availability should go to Specific Pharma A/S.
Article written by VigiEye from the official source (DKMA). AI-assisted; check the source before acting.
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