Following reports of the hospitalisation of female patients after an aesthetic treatment with a product containing botulinum toxin type A, the Institute for Medicines and Medical Devices of Montenegro (CInMED) wishes to inform the public that, at present, it has no confirmed information on the exact identity of the product administered, its batch number, origin, method of procurement, or the conditions under which it was stored and administered. Therefore, it cannot be asserted that the product in question was Dysport or that it was a falsified medicinal product. These circumstances need to be established through the appropriate investigation currently being conducted by other competent authorities.

Based on applications submitted by wholesalers and the accompanying documentation, during the period 2025–2026 CInMED issued import authorisations for the following medicinal products containing botulinum toxin type A:

• Dysport, powder for solution for injection, package size 2 × 500 units, Ipsen Biopharm Limited, United Kingdom. Batch numbers and expiry dates: 025729 (31 May 2027), 027576 (30 June 2027), 033747 (30 November 2027), 035057 (31 December 2027) and 038312 (31 March 2028);
• Bocouture, powder for solution for injection, package size 1 × 100 units, Merz Pharma GmbH & Co. KGaA, Germany. Batch number and expiry date: 533870 (November 2027);
• Xeomin, powder for solution for injection, package size 1 × 100 units, Merz Pharma GmbH & Co. KGaA, Germany. Batch number and expiry date: 436208 (31 August 2028);
• Xeomin, powder for solution for injection, package size 1 × 50 units, Merz Pharma GmbH & Co. KGaA, Germany. Batch number and expiry date: 437107 (30 April 2027).

The above-mentioned batches are within the legal distribution chain and may continue to be used in healthcare institutions.

Medicinal products containing botulinum toxin require appropriate conditions for storage, preparation and administration. Their distribution must take place through authorised wholesalers, pharmacies and healthcare institutions, and they must be administered by appropriately trained healthcare professionals exclusively within healthcare institutions.

CInMED is competent solely for the legal medicines supply chain. Where there is a suspicion that a product has been procured or administered outside that chain, the origin of the product, the manner in which it was procured and any potentially unlawful conduct are to be established by the competent state authorities, primarily the Police Administration, with the involvement of the competent inspectorates and other authorities in accordance with their respective powers.

As before, CInMED will cooperate with the competent authorities and, once the product has been identified and the necessary information or samples have been obtained, will undertake activities falling within its competence: verification of the product name and batch number, comparison against the import authorisations issued and available distribution data, and, where necessary, quality control testing.

CInMED calls on healthcare professionals and members of the public to report to CInMED any suspected quality defect or adverse reaction to a medicinal product.