Up-to-date information from the 09.12.-12.12.2024 meeting on new approvals, extensions of indication, newly published EPAR's and recently started procedures.

If a manufacturer expects that there will be interruptions in the supply of a medical device, it must report this to the competent authority in accordance with Article 10a of Regulation (EU) 2017/745 on medical devices (MDR) and Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR). You can find more information here: https://www.basg.gv.at/fuer-unternehmen/medizinprodukte/hersteller#c24702

Recall due to exceeding the active ingredient content

"Katinko Ointment" contained the declared substances methyl salicylate, menthol and camphor and is therefore to be classified as an illegal medicinal product.

"Aboniki Balm" contained the declared substances methyl salicylate, menthol, camphor and eucalyptol and is therefore to be classified as an illegal medicinal product.

"Robb Well Being" contained the declared substances methyl salicylate, menthol, camphor and eucalyptol and is therefore to be classified as an illegal medicinal product.

"Moove Pain Relief Specialist" contained the declared substances methyl salicylate, menthol and eucalyptol and is therefore to be classified as an illegal medicinal product.

Regulation 1234/2008/EC was amended by Delegated Regulation (EU) 2024/1701 and will enter into force on 1 January 2025.

"Hoe Hin White Flower Olie" contained the declared active substances methyl salicylate, menthol, camphor and eucalyptol and is therefore to be classified as an illegal medicinal product.

"EXS Delay Spray" contained the undeclared active ingredient lidocaine and is therefore to be classified as an illegal medicinal product.