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Denmark to end foreign-pack permission for Paracetamol AL 1000 mg suppositories on 12 November

🇩🇰 DKMA · Mon 09 Nov 2026

The Danish Medicines Agency is inactivating its section 29(2) exemption for German-authorised Paracetamol AL 'Aliud' suppositories, as marketed Danish packs are available again.

The Danish Medicines Agency (DKMA) will inactivate, with effect from 12 November 2026, the permission to prescribe and dispense Paracetamol AL 'Aliud' 1000 mg suppositories under section 29(2) of the Danish Medicines Act. The agency says the step follows the return of marketed Danish packs.

The exemption had been in place since 20 May 2026 and was set to run until 12 November 2026. The foreign product is authorised in Germany, and Specific Pharma A/S was named as the responsible importer. The permission covered mild pain and fever reduction, the indications listed for the product.

While the permission applied, pharmacies and hospital pharmacies could sell or dispense the product against a prescription, in line with the stated indications. The corresponding Danish products were required to be in supply failure. DKMA's page was last updated on 9 November 2026.

The notice also restates the conditions that applied to the foreign packs. The full product name had to appear on the prescription. Patients needing reimbursement had to have a single-case reimbursement application made for the foreign packs. Requests for the summary of product characteristics, or for the current availability of the foreign packs, were to be directed to the importer.

By way of context, section 29(2) exemptions allow Denmark to cover shortages of authorised medicines with products authorised abroad, and they are normally withdrawn once domestic supply is restored.

What it means for your team

  • Prescribers and pharmacies should return to the authorised marketed Danish packs once the permission lapses on 12 November 2026.
  • Any prescriptions or stock planning built on the German-authorised packs should be reviewed ahead of the cut-off date.
  • Importers and supply-chain teams should note that the shortage justification for this exemption has ended, according to DKMA.
  • Market-access teams should remember that single-case reimbursement applied only to the foreign packs, not to the returning Danish products.

Official source: DKMA ↗

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

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