The Veterinary Medicines Unit forms part of the Veterinary Regulations Directorate (VRD) within the Animal Health and Welfare Department (AHWD) It was set up with the purpose of regulating the placing on the market, retail, distribution and use of veterinary medicinal products. It promotes the responsible use of good quality, safe and effective veterinary medicinal products.
The main roles of the Veterinary Medicines Unit are as follows:
1. Regulating the granting, withdrawal, suspension or revocation of authorisations/registrations of veterinary medicinal products in Malta.
2. Conducting inspections of veterinary wholesalers, veterinary pharmacies, medicated feed traders and medicated feed mills.
3. Issuing Good Manufacturing Practice (GMP) Certificates.
4. Providing advice to the Director General, AHWD and Director, VRD on practices and policies related to compliance with relevant EU Directives, namely Regulation (EU) 2019/6 on Veterinary Medicinal Product , Regulation (EU) 2019/6 on Medicated feeds , and Regulation (EU) 37/2010 in residues of pharmacological active substances in foodstuffs derived from animal origin.
5. Drafting reports, decisions and replies.
6. Determining the method of supply of veterinary medicinal products in Malta.
7. Participating in the elaboration of standards and policies related to veterinary medicinal products.
8. Implementing decisions of veterinary medicinal products which are required by the EU Commission.
9. Collecting information on the sale and use of veterinary medicinal products, particularly antimicrobial veterinary medicinal products.
10. Contributing to the EU medicines agencies network to optimise resources and knowledge-sharing in the network.
11. Representing the Veterinary Regulation Directorate and Animal Health and Welfare Department (AHWD) in relevant national, EU and international fora.
12. Proposing and drafting national legislation.
13. Participating in audits and benchmarking exercises of national, EU or international origin. 14. Liaison with foreign counterparts to make technical agreements is several areas as needed.
National Strategy and Action Plan for the Prevention and Containment of Antimicrobial Resistance in Malta 2020 – 2028
An important issue for the Veterinary Medicines Unit is the prudent use of antimicrobials. It therefore has a very active role in the national Strategy and Action Plan for the Prevention and Containment of Antimicrobial Resistance in Malta 2020 – 2028. Other national strategies may be interlinked with this strategy, such as the Animal Welfare Strategy. Here too, the Veterinary Medicines Unit is working closely with other units and Departments to achieve the goals in the strategies in which it is involved.
National Residue Control Plan
Another topic in which the unit is heavily involved is in the national plan for detecting residues of veterinary medicinal products in foodstuffs. In this area it collaborates extensively with the National Veterinary Laboratory.
ESVAC Project
Through the Veterinary Medicines Unit Malta participated for the first time in the European Surveillance of Veterinary Antimicrobial Consumption (ESVAC) and provided data on the sales of antimicrobial veterinary medicinal products for the year 2017
During the pastyears Malta has collected data on the sales of veterinary medicinal products containing antimicrobials of increasingly good quality. In 2012 it started providing the data to the WOAH according to its established form. In 2017 this was followed by sales data provided to ESVAC. During this journey it has learned a number of lessons that it intends to use in preparation for future submissions to ESVAC, given also that data on use of antimicrobials will soon have to be collected as well, even for non-food producing animals. As the challenges ahead are not small, the systems planned by the competent authority and tasks undertaken by it should be commensurate with them. A number of innovative systems have been established, e.g. electronic veterinary prescription, and new laws which could drive forward the ambitious targets have been proposed.
On the 28th June 2022 the EU Commission has issued a call for proposal for the ‘Implementation of the collection and reporting of data on sales and use of antimicrobials in animals for the period 2022-2027’ (SMP-FOOD-2022-AMRtool) for grants in the field of the Single Market Programme Regulation.
The call is managed the European Health and Digital Executive Agency (HaDEA)
On the 6/03/2023 the agreement with the EU Commission was signed. The funding will be 100% and will be about the recruitment of suitable staff members who can be tasked with the collection of data on sales and use of veterinary medicinal products containing antimicrobials.
Setting up and developing systems for data collection that are efficient and reliable are crucial to achieve national and European goals and monitor their progress. If such data is not collected properly any conclusions inferred from it would be misguiding and may also deviate the attempts to put in place the appropriate measures referred to in the ‘Strategy and Action Plan for the Prevention and Containment of Antimicrobial Resistance in Malta 2020 – 2028’. Misguided conclusions will lead to improper actions that paradoxically may do more harm than good.
EU4Health Programme
The Unit is also the main liason for participation of the Animal Health and Welfare Department as an affiliated entity in a joint action under annual work programme 2021 of the EU4Health Programme.
In this programme the AHWD receives direct co- funding to promote quality of medicines and to increase co-operation between the Member States and between the Union and Third countries through training, joint audits, re-assessments and inspections on good manufacturing (GMP) and good distribution practices (GDP.
The Veterinary Medicines Unit is the entity in Malta which is responsible for Good Manufacturing Practice (GMP) and other matters related with inspectorate services for veterinary medicinal products.