vsd.gov.mt
vsd.gov.mt
The unit was set up with the purpose of regulating the placing on the market, retail, distribution, manufacturing and use of veterinary medicinal products. It promotes the responsible use of veterinary medicinal products that are of good quality, safe and effective.
The Veterinary Medicines Unit work in close collaboration with the European Medicines Agency (EMA)
The Veterinary Medicines Unit assesses or evaluates applications for the authorisation or registration of veterinary medicinal products to be placed on the Maltese Market. There are different authorisation/registration fees for these are nearly all incur a fee. Information about this can be found in the part of this website named ‘Authorisation for Veterinary Medicinal Products’.
The Veterinary Medicines Unit also assesses applications for the Authorisation for a Wholesale Distributor of Veterinary Medicinal Products, a Veterinary Pharmacy Licence, Medicated Feed Mill Authorisation and an authorisation for Manufacturer of Veterinary Medicinal Product.
These are nearly all incur a fee. Information about this can be found in the part of this website named ‘Opening a new Business’.
In addition, the Veterinary Medicines Unit vets postal parcels containing Veterinary Medicinal Products obtained for private use, conducts inspections on all stakeholders as part of its surveillance programme, oversees the service of the veterinary prescription (the electronic veterinary prescription and hard copies) and contributes extensively to awareness campaigns on the prudent use of veterinary medicinal products, especially antimicrobials.
The following Regulations were published in the Official Journal of the European Union on 7th January 2019 and started to be applied on 28th January 2022.
and
Information on Regulation (EU) 2019/6
The purpose of this EU Legislation is to increase the availability of veterinary medicinal products and medicated feeds , to reduce the administrative burden on enterprises, to improve the functioning of the internal market and to slow down the development of antimicrobial resistance.
The information in this website is regularly reviewed and updated in line with the rapidly evolving legislative, regulatory and technical areas.
The Veterinary Medicines Unit does not take responsibility of the concepts as understood, or misunderstood, by the reader.
The information present in this website is not to be considered as professional consultancy material. Stakeholders are responsible for their own decisions in accordance with the existent legislation and requirements.
Interested parties are encouraged to refer to the legislation proper. The most relevant legislation is as follows:
Apart from S.L 35.38, all other Subsidiary Legislations have been published under Chapter 437, Veterinary Services Act, as amended.
The amendments in the Veterinary Services Act through ACT No. XIV of 2022 published on the 28th October 2022 added the necessary vires to the minister to enact important legislation related with anything related with veterinary medicinal products. Amongst other important changes there are those related with enforcement action, collection of data on sales, penalties, the application for licences for veterinary pharmacies, managing pharmacist for veterinary pharmacies and alignment with regulation (EU) 2019/6 of the European Parliament and of the Council of 11th December 2018. Amendments have also been carried out in relation to the functions of the National Veterinary Laboratory, the responsibilities of the Director of Veterinary Services and the slaughter of food-producing animals.
All interested parties can find a list of all authorised veterinary products in the EU in the Union Product Database (UPD)
The Veterinary Medicines Unit gives its contribution in the National Strategy and Action Plan for the Prevention and Containment of Antimicrobial Resistance in Malta 2020 – 2028.
The European Sales and Use of Antimicrobials for Veterinary Medicine Working Group (ESUAvet) provides strategic guidance and recommendations to the European Medicines Agency (EMA) This guidance refers to the collection and analysis of data on sales volumes of veterinary antimicrobials and the use of antimicrobials in animals in the European Union (EU).
Through the Veterinary Medicines Unit, Malta actively participates in this working group and collects the mandatory data on the use and sale of antimicrobials.
A number of innovative systems have been established to support this task. A very important tool in this task is the, electronic veterinary prescription.
To support Member States in this task, 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.
The Unit is also the main liaison for participation as an affiliated entity in a joint action under annual work programme 2021 of the EU4Health Programme.
In this programme – co-funding (80%) is provided by the EU 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 tasked with overseeing certification for Good Manufacturing Practice (GMP) and good distribution practices (GDP) of veterinary medicinal product.
