Belgica De Weerd B.V. — EU GMP NCR (EudraGMDP) Findings

Routine GMP inspection was performed on 29 January and 26 February 2026 . Two critical, four major and three other deficiencies were defined. The two critical deficiencies were regarding the following: 1. The quality of the certified veterinary medicines cannot be assured concerning the results of the ongoing stability studies. A high number of out of specifications on ongoing stability were reported of which at least four exceed the internal specifications of Belgica de Weerd, the rationale to not recall these batches and inform the authorities was insufficient. The rationale for accepting the out-of-specification results on the ongoing stability batches does not account for the spectrum of action of the antibiotic, the safety, therapeutic window, the synergistic effect of the different active ingredients and the development of antimicrobial resistance. This poses a risk to animal safety and public health. Also, Belgica de Weerd uses specifications for the amount of active ingredient during on-going stability of 90%-110% of the label claim. In the rationale for these limits the spectrum of action of the antibiotic, the safety, therapeutic window, the synergistic effect and the development of antimicrobial resistance of these limits are not accounted for. These limits are set for all products without a rationale to account for the different product composition of these products. In the risk assessment for an OOS on ongoing stability it is stated that it does not apply to the batches on the market, while a stability batch is representative for batches on the market. This poses a risk to animal safety and public health in the market. 2. Belgica de Weerd does not comply to GMP annex 16 and can not sufficiently assure the quality of the certified products on the market. The QP could not make clear against which specifications in the registration dossier the batches were certified since the QP had no access to the registration dossiers. This poses a critical compliance risk. The batch documentation does not comply to the release specifications in the registration dossier for several products and a variation for the change in contract manufacturing organization was not submitted to the competent authorities, while the batches produced by the new CMO were released to the market. After withdrawal of the GMP certificate of the contract manufacturer the QP continued to release the produced batches. Action taken/proposed by the NCA: Withdrawal, of current valid GMP certificate No. NL/V 23/0006 The competent authority is not granting a new GMP certificate because of GMP NC which was determined by the Dutch Inspectorate during the inspection in February 2026. This decision has been sent to the company by means of an official decision on the 29th of July 2026. Following this decision, a NCS will be issued by the Dutch NCA in EudraGMDP, whereby the current GMP certificate,will be withdrawn from EudraGMDP. Recall of batches already released The concerned products are only National registrated in The Netherlands (NL) and Romania (RO). If the concerned medicinal products are potentially critical, the marketing authorization holder (MAH) must report this to the competent authorities. The competent authority may determine whether a particular VMP is critical for the market and, based on a risk assessment, can be released to the market if shortages occur. This information is not yet available for the Dutch market. If the concerned VMP’s are assessed as critical, a recall will not be initiated.