VMVT secures victory in court against veterinary medicines company Amber Aid Medical UAB
The State Food and Veterinary Service (VVVT) has proved before the Supreme Administrative Court of Lithuania (SCA) that the requirement of UAB „Amber Aid Medical“ to register more than 40 veterinary medicines in the Veterinary Register (the "Register"), was probably a fictitious one in a possible attempt to evade the duty to pay the State a fee of more than 65 thousand Euros.
The story started back in January 2023, when UAB „Amber Aid Medical“ (the Company) approached the VMVT and asked to enter 41 veterinary medicinal products into the Register. This would be the last step in the authorisation of new veterinary medicinal products to be placed on the market. However, before a veterinary medicinal product can be entered in the Register, a number of procedures have to be carried out at the VMVT, such as: registration of the application for the veterinary medicinal product and the payment of the state fee in the VMVT's data systems and the assessment of the application for the veterinary medicinal product via the Common European Submission Portal (CESP). Only after these procedures have been completed, the decision of the VMVT to register the medicinal product shall be taken, which shall be formalised by a publicly published order of the Director of the VMVT. However, no information on these procedures was found in the data systems of the VMVT. Therefore, the Company's application for the final marketing authorisation procedure was rejected by the VMVT as being without legitimate grounds.
Later on, the Company tried to prove in the legal proceedings that it had allegedly submitted the required documents to the OHIM, and even provided the number of the allegedly received OHIM order for the registration of the medicinal product. However, no such document number existed in the register of legislation or in the OHIM document management system.
„To clarify the situation, the company presented the certificates of registration of veterinary medicinal products, allegedly signed by the then Director of the VMVT. According to the Company, it had also submitted the applications for the registration of veterinary medicinal products on a USB stick and handed them over to the Head of the Veterinary Medicines and Feed Division of the VMVT, who was at that time in charge of the procedure for the registration of these medicinal products. However, the documents and the decisions were not actually recorded anywhere. Thus, all the factual evidence confirmed that no registration procedure for veterinary medicinal products actually took place. The public information published by the VMVT clearly states that the documents for the registration of veterinary medicinal products must be submitted via the official portals. It should be in the interest of the responsible company to make sure that the procedure is carried out properly, which was not the case in this case," said Gitana Veitienė, Adviser to the Legislative and Law Enforcement Division of the VMVT.
It should be noted that both former employees of the VMVT mentioned in this story were suspected by the STT in November 2022 of having committed acts of a corrupt nature in relation to the activities of VMVT. Coincidentally, the Company came to the attention of the SFO a few months after these events.
„Registration of veterinary medicinal products – is a long, responsible and investment-intensive process. After all, they are used to treat animals. Therefore, the medicine has to be tested, evaluated, approved and a fee has to be paid to the state for the whole process. I do not know whether it is a coincidence or not, but I find it unusual that the Company rushed to pay the state fee for the registration of 41 medicines only a few days after the arrest of two former employees of the VMVT for suspected corruption. It is also unclear why the amount paid was as much as 8 times less than what was actually due. And these actions were followed by a request for final procedures to be carried out by the IMS. I consider the court's clarification that, despite the improper actions of the former OHIM staff, the company was also found to have failed to carry out its legitimate duties, to be a significant, rule-based case law finding.I am grateful to the focused team of the VMVT and to the specialists responsible for the registration of veterinary medicinal products, who reacted promptly to suspicions of possible corruption," said Audronė Mikalauskienė, Director of the VMVT, about the successful litigation.
The LWVAT, hearing the Company's appeal, upheld the decision of the Court of First Instance and found that the Company had not provided sufficient evidence to prove the validity of its claims. The Court stressed that, according to the legislation, the OHIM has the right and the duty to carry out only those actions which are expressly provided for by the legislation.
Audronė Mikalauskienė said that the Authority sees this court precedent as an important step in ensuring the correct execution of veterinary medicinal products registration procedures and in preventing malpractice.
