The Veterinary Medicines Section is the National Competent Authority (NCA) in Malta for veterinary medicinal products and 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 Veterinary Medicines Section forms part of the Veterinary Regulations Directorate (VRD) within the Animal Health and Welfare Department (AHWD).
The main roles of the Veterinary Medicines Section are as follows:
- Regulating the granting, withdrawal, suspension or revocation of authorisations/registrations of veterinary medicinal products in Malta.
- Conducting inspections of veterinary wholesalers, veterinary pharmacies, medicated feed traders and medicated feed mills.
- Issuing Good Manufacturing Practice (GMP) Certificates.
- 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.
- Drafting reports, decisions and replies.
- Determining the method of supply of veterinary medicinal products in Malta.
- Participating in the elaboration of standards and policies related to veterinary medicinal products.
- Implementing decisions of veterinary medicinal products which are required by the EU Commission.
- Collecting information on the usage of veterinary medicinal products, particularly antimicrobial veterinary medicinal products.
- Contributing to the EU medicines agencies network to optimise resources and knowledge-sharing in the network.
- Representing the Animal Health and Welfare Department (AHWD) in relevant national, EU and international fora.
- Proposing national legislation.
- Participating in audits and benchmarking exercises of national, EU or international origin.
An important issue for the Veterinary Medicines Section is the prudent use of antimicrobials and veterinary medicinal products residues in foodstuffs
Through the Veterinary Medicines Section 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 past 11 years 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.
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.
The Veterinary Medicines Section has a very active role in the national strategy against the rising threats of antimicrobial resistance and deep involvement in the national residue plan.