Global Regulatory Monitor
Regulatory News, Week 3 · 2026/8

• 1.2] Non-sterile products; [
• 1.2.1] Non-Sterile Products (processing operations for the following dosage forms); [
• 1.2.1.1] Capsules, hard shell; [
• 1.2.1.8] Other solid dosage forms All other solid dosage forms not otherwise specified; [
• 1.2.1.13] Tablets; [
• 1.2.2] Batch certification; [
• 1.5] Packaging; [
• 1.5.1] Primary packaging; [
• 1.5.1.1] Capsules, hard shell; [
• 1.5.1.8] Other solid dosage forms All other solid dosage forms not otherwise specified; [
• 1.5.1.13] Tablets; [
• 1.5.1.17] Other non-sterile medicinal products Including powders and labelling of primary containers; [
• 1.5.2] Secondary packing; [
• 1.6] Quality control testing; [
• 1.6.3] Chemical/Physical

An inspection of the site was conducted from 05 to 08 May 2026. Two critical deficiencies and three major deficiencies from GMP were raised. The critical deficiencies concerned the failure to implement a comprehensively designed and correctly implemented PQS incorporating GMP and QRM, evidenced by the failure to ensure that robust and reliable batch control procedures were in place, as well as the failure of the Qualified Persons to ensure that each individual batch had been manufactured and checked in compliance the requirements of the MA and GMP. This Statement of Non Compliance does not include the manufacture of critical products. Such products should be agreed in writing with individual National Competent Authorities.

Action taken/proposed: suspension In part Withdrawal of current valid GMP certificates: UK MIA 322 INSP GMP 322/14798-0030[H] Prohibition of supply: Only batches of critical products can be supplied to UK markets while this statement of non-compliance remains in force.

• 1.1] Sterile Products; [
• 1.1.3] Batch certification; [
• 1.2] Non-sterile products; [
• 1.2.1] Non-Sterile Products (processing operations for the following dosage forms); [
• 1.2.1.1] Capsules, hard shell; [
• 1.2.1.5] Liquids for external use; [
• 1.2.1.6] Liquids for internal use; [
• 1.2.1.8] Other solid dosage forms All other solid dosage forms not otherwise specified; [
• 1.2.1.12] Suppositories; [
• 1.5] Packaging; [
• 1.5.1] Primary packaging; [
• 1.5.1.1] Capsules, hard shell; [
• 1.5.1.2] Capsules, soft shell; [
• 1.5.1.5] Liquids for external use; [
• 1.5.1.6] Liquids for internal use; [
• 1.5.1.8] Other solid dosage forms All other solid dosage forms not otherwise specified; [
• 1.5.1.11] Semi-solids; [
• 1.5.1.13] Tablets; [
• 1.5.1.17] Other non-sterile medicinal products Pessaries, Powders; [
• 1.5.2] Secondary packing; [
• 1.6] Quality control testing; [
• 1.6.3] Chemical/Physical; 2. IMPORTATION OF MEDICINAL PRODUCTS; [
• 2.1] Quality control testing of imported medicinal products; [
• 2.1.3] Chemical/Physical; [
• 2.2] Batch certification of imported medicinal products; [
• 2.2.1] Sterile Products; [
• 2.2.1.1] Aseptically prepared; [
• 2.2.1.2] Terminally sterilised; [
• 2.2.2] Non-sterile products; [
• 2.2.4] Other Importation Activities; [
• 2.2.4.6] Other Importation of QP-certified IMPs from country on approved list

An inspection of the site was conducted from 05 to 08 May 2026. Two critical deficiencies and three major deficiencies from GMP were raised. The critical deficiencies concerned the failure to implement a comprehensively designed and correctly implemented PQS incorporating GMP and QRM, evidenced by the failure to ensure that robust and reliable batch control procedures were in place, as well as the failure of the Qualified Persons to ensure that each individual batch had been manufactured and checked in compliance the requirements of GMP.

Action taken/proposed: suspension in full Withdrawal of current valid GMP certificates: UK MIA(IMP) 322 INSP IMP 322/14798-0031[I]

• 1NON-COMPLIANT MANUFACTURING OPERATIONS
• 1.2Non-sterile products
• 1.2.2Batch certification

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.

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.

The Dutch NCA is not intending to take measures on the manufacturer's authorization in order to allow the release of critical products. For more information about the inspection results and details please see the Supervisory Risk Assessment (SRA).

Verify whether your product is affected.Consult your healthcare provider prior to discontinuing use of the affected product, or if you have any health concerns.Contact the recalling firm if you have any questions about the recall.Report any health product related side effects to Health Canada.Report any other health product safety complaints to Health Canada.

Verify if your product is affected.Consult your healthcare provider prior to discontinuing use of the affected product, or for any health concerns.Contact the recalling firm if you have any questions about the recall.Report any health product related side effects to Health Canada.Report any other health product safety complaints to Health Canada.

Verify if your product is affected. If the lot number and expiry date are missing, your product may be affected by this recall.Consult your healthcare provider prior to discontinuing use of the affected product(s), or for any health concerns.Contact the recalling firm if you have any questions about the recall.Report any health product related side effects to Health Canada.Report any other health product safety complaints to Health Canada.

Lot # DLHU0031, Exp Date: 06/30/2027.

Lot #: 19260937A, Exp. Date February 2028; 19261225A, 19261185A, Exp. Date March 2028; 19261664A, 19261682A, Exp. Date April 2028.

Lot #: 3241653, Exp 4/30/2027