World Markets Sp. z o.o. — EU GMP NCR (EudraGMDP) Findings

During the inspection, despite the fact that, by decision of the President of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products No. UR/DZL/UD/0002/22 of 23 August 2022, authorisation No. 4617 for the medicinal product Liv.52 was suspended, it was confirmed that the medicinal product in question was being imported, certified and released. The above actions show signs of a violation of the provisions of the Polish Criminal Code, who states that whoever endangers the life or health of many people or property of significant value by producing or placing on the market medicinal products that do not meet the applicable quality standards shall be subject to imprisonment for up to 8 years. In addition it wasfound that the importer broke the Polish Pharmaceutical Law by failing to apply GMP requirements and failing to comply with the obligations of the holder of a manufacturing or importing authorisation for medicinal products. During the inspection 3 critical, 4 major and 2 others deficiencies were identified. The critical deficiencies concerned:  the certification and release for market (batches release) of 16 batches of the medicinal product Liv.52, composite product, tablets despite the suspension of the marketing authorisation number 4617;  lack of certification by a Qualified Person of the distributed batch number 112302613 of the medicinal product Liv.52 composite product;  there was no confirmation at the place of import, for the distributed batch number 112302613 of the medicinal product Liv.52, composite product, tablets, the Qualified Person had ensured that the batch was subjected to quality analysisin the territory of the Republic of Poland for the following parameters: product appearance, product form, TLC identity, active substances/markers (sum of flavonoids, mustard index,iron), average tablet weight, mass uniformity, pH, tablet disintegration time, drying weight loss, heavy metals (lead, cadmium, mercury, arsenic), compliance of packaging testing with the registry;  6 batches of the medicinal product Liv.52, composite product, tablets were marketed, despite the suspended marketing authorisation number 4617;  the organisation, location and size of the ‘Import warehouse’ room were not suitable for carrying out the operations for which it was intended, as they did not minimise the risk of mixing and any adverse impact on the quality of the product, owing to the lack of storage space, in an orderly manner, for the batch of the product, in quarantine status in the areas dedicated to: released products and products in preparation for shipment to wholesalers. Action taken/proposed by the NCA: Revocation of the manufacturing authorisation No. 231/0315/15 in Full Withdrawal, of current valid GMP certificate No. IWSF.405.112.2022.IP.1 WTC/0315_01_01/252 Withdrawal of Good Manufacturing Practice Certificate IWSF.405.112.2022.IP.1 expiry date passed on 22.07.2025 Recall of batches already released Recall of batches: 112302614, 112302613, 112301842, 112302503, 112300609, 112301841, 112302502, 112302504, 1123,01843, 112300610, 112203813, 112203288, 112202216, 112202215, 112203815, 112203814, 112203289, 112201909. Recall of next batches have been initiated: 112201908, 112203108, 112401596, 112401836, 112401837, 112402091, 112402090, 112401595, 112400913, 112400914, 112402269, 112402270, 112402271, 112402272