Stakeholders and Informative Material

Stakeholders and Informative Material

List of Main Stakeholders

      • Licensed Veterinary Pharmacies.
      • Authorised Veterinary Wholesale Distributors.
      • Authorised Medicated Feed Mills, a​nd approved Medicated Feed distributors.
      • Good Manufacturing Practice (GMP) certificate  Holders . 

COMMISSION IMPLEMENTING REGULATION (EU) 2021/1904 of 29 October 2021 adopting the design of a common logo for the retail of veterinary medicinal products at a distance​

Persons  who can  to  supply  veterinary  medicinal  products may offer such products for sale at a distance only if a common logo, which includes a hyperlink to the Veterinary Medicines Unit ‘s website (specifically this webpage), is included in the website offering sale at a distance. 

The purpose of this logo is to  assist the public in finding out whether a  website offering such products for sale at a distance (e.g. over the internet) is authori​sed  by the Veterinary [ss7] fServices or such an activity. 

The common logo appearance is as follows (in English and Maltese):

VET Logo Maltese VersionVET Logo English Version 

Ordering of Veterinary Prescriptions / access to the electronic veterinary prescription

Veterinary Surgeons can order veterinary prescriptions by post using the form ‘Request for Veterinary Prescription Booklets’ EN | MT

The veterinary prescriptions hard copies will eventually be replaced with an electronic veterinary prescription. This is already functional and both prescribers and dispensers can request access to it. This can be done by filling in ‘An application form for access to the Veterinary Prescription’. EN | MT​ 

Veterinary Surgeons are encouraged to use only the electronic veterinary prescriptions. This may eventually become mandatory.  

The electronic veterinary prescription offers many advantages, not to mention improved traceability, decrease in errors, collection of data on use of antimicrobials,​ facility to keep records and better control on the use of veterinary medicinal products. This can be accessed from here

It is also included on the ‘maltapps​’ under ‘Environment, Energy, Agriculture & Fisheries’ 

Sales data of antimicrobials 

In accordance with Article 57(1) and (2) of Regulation (EU) 2019/63 and with the specific requirements set in Commission Delegated Regulation (EU) 2021/5784 and Commission Implementing Regulation (EU) 2022/2095 , Member States are to collect relevant and comparable data on the volume of sales of veterinary antimicrobial medicinal products and on the use of antimicrobial medicinal products used in animals per animal species, and to report collated data to the European Medicines Agency (EMA).

Pursuant to the above, Veterinary wholesale distributors, medicated feed traders and medicated feed mills herein referred to as ‘Data Providers, must provide the Veterinary Medicines Unit with all data relating to volume of sales of antimicrobials. This forms part of an ongoing global and EU/EEA projects for the reviewing of any developments in antimicrobial resistance (AMR) in relation with antimicrobial use. ​Eventually,  data on the use (not just sales) of antimicrobials will be collected. Data shall also be gathered from farm level and veterinary clinics/hospitals.

Each year, most often in December,  the Veterinary Medicines Unit sends to the Data Providers a form to fill in and gives a deadline before which the data must be submitted . The usual template of the form is this  ‘SalesData​’. This can change depending on the situation during the time the call for submission of data is made and any improvements thereof. This document will help stakeholders understand what is to be expected.

Eventually collection of data will be made on the use of antimicrobials rather than on sales, and include other stakeholder apart from wholesale distributors.

Annu​al data on the disposal of antimicrobials may also be requested.


Inspections are made by the Veterinary Medicines Unit to ascertain conformance with the set requirements. The Veterinary Medicines Unit may also conduct  joint inspections with other Units on any establishment where veterinary medicinal products are kept and/or used. 

Inspections can be of a routine nature or following an identifiable report. Reports are always treated with strict confidentiality. 

Some inspections may be conducted as audits to verify the reliability or veracity of data provided to the Veterinary Medicines Unit, such as data on the sales or use of antimicrobials.​

Stakeholders are encouraged to identify and report any activities they perceive as being irregular or illegal to the Veterinary Medicines Unit using the feedback form on the main menu. This can also used to submit complaints or suggestions. 

Collaborations with other interested partners

The Veterinary Medicines Unit keeps close contact with its stakeholders. These can be both local ones and also European or international ones. Local ones include the Malta Veterinary Association (MVE) and Veterinary Surgeon Council (VSC). It regularly undertakes projects with WOAH ( World Organisation for Animal Health) , European Medicines Agency (EMA) and Federation of Veterinarians of Europe (FVE). A Maltese language infographic about new important legal provisions in Regulation (EU) 2019/6 prepared in conjunction with FVE can be found in the FVE website.

Good Manufacturing Practice (GMP) Inspection and Manufacturing Import Authorisation (MIA)

Companies can contact the Veterinary Medicines Unit in case they would like to get information on the granting of a MIA or Good Manufacturing Practice (GMP) Inspections and certification thereof. 

Details information on the EU GMP can be found in Volume 4 of Eudralex, i.e. The Good Manufacturing Practice (GMP) Guidelines.  

Reporting Adverse Drug Reactions and Product Defect 

Any person can use the ‘Reporting Form for Adverse Drug Reactions and Product Defect’ EN | MT​ to pass on information of such cases to the Veterinary Medicines Unit. 

The form can also be used to report any perceived loss of efficacy, especially in the case of VMPs containing antimicrobials. 

Marketing Authorisation Holders (MAHs) or their local representatives are required to report to the Veterinary Medicines Unit any defect in a product or a suspected Adverse Drug Reaction, which might necessitate a recall or cause a restriction in supply of a veterinary medicinal product, including those manufactured solely for export. Apart from these any person can report a suspected Product Defect or a suspected Adverse Drug Reaction ​to the Veterinary Medicines Unit. 

The report can be sent to generic e-mail Reports can also be made by telephone. During Monday to Friday between 8:00 to 13:00, reporters can call on telephone number +356 2292 5367 or +356 2292 5588 . After these hours, reporters can call on +356 7992 5363.  

Animal Health Control Programme

In line with regulation 79(2) of Subsidiary Legislation 437.47—The Veterinary Medicinal Products regulation—as from 23rd April 2023 it has become mandatory for every registered or licensed establishment of food producing animals and for establishments where animals are kept for display to the public or for breeding purposes to have an appropriate animal health control programme designed and implemented under the responsibility of a professional registered wuth the Veterinary Surgeon Council.

The Guidelines for the Animal Health Control Programme​ / Linji gwida għall-Programm ta' Kontroll tas-Saħħa tal-Annimali​ can give more information regarding of what is expected from this programme. 

Comment to the Veterinary Medicines Unit 

Anyone can submits comments to the Veterinary Medicines Unit by using the form Comments to the Veterinary Medicines Unit EN MT ​The form can also be used to make a report, submit suggestions for improvement or any complaint.

Circular name​​                    ​Issue Date
Circular on Licensing of Vet Pharmacies​ ​                   23/03/23

Common logo for the retail of veterinary medicinal products at a distance​


Access to the Electronic Veterinary Prescription  (e-VetPres)​


Proper use of Vaccine for Viral Hemorrhagic Disease in Rabbits ​


Veterinary Medicinal Products containing ‘’zinc oxide’’ to be administered orally to food​​ producing species                          ​


Special Warnings on the Specifications of Products Administered to Animals

​ 04/11/20

Categorisation of antibiotics used in animals​ 

​ 04/08/20

Withdrawal of Veterinary Medicinal Products on the  Market​


Counterfeit Seresto collar for dogs


Medications for pigeons​


​On the potential risk for the consumer resulting from the use of Diethanolamine (DEA) as an excipient in veterinary medicinal products for food producing species​


Data Collection on Antimicrobial Agents use


Returned Veterinary Medicinal Products to the Veterinary Pharmacy​


​Veterinary Medicinal Products containing Lincomycin and spectinomycin for use in pigs and/or chickens


Banned Substances for Racing Pigeons as decided by the Malta Federation of Racing Pigeons 


Rigward l-użu tal-antibijotici fuq tiġieġ tas-simna destinati għall-konsum minn nies u fuq tiġieġ tal-bajd​


Regarding the use of Antimicrobials (AM) on Poultry flocks destined for slaughter for human consumption and layers


Prudent use of Antimicrobials


Sale of Veterinary Medicinal Products  by Wholesales Directly to Animal Keepers


Record Keeping by the Veterinarian 


The prudent use of Flouroquinolones


Prudent use of Veterinary Medicinal Products containing 3rd and 4th generation Cephalosporin

​ 08/04/12

Licensed Distributors of Veterinary Pharmaceuticals 

​                                                 14/12/04​


      ​                                          ​          


Leaflets, Presentations and other Publications 

o  Summaries of the main points on the current legal framework related with the veterinary prescription, wholesale distribution of veterinary medicinal products and veterinary pharmacies

o Guidelines on the Prescribing and Dispensing of Veterinary Medicinal Products, including Antimicrobials, by veterinary surgeons

o   Guidelines on the Prescribing and Dispensing of Veterinary Medicinal Products and the Good Use of Antimicrobials for Wholesale dealers, Pharmacists and Medicated Feed Mills/Traders/Distributors​ 

o   Guidelines on the Prescribing and Dispensing of Veterinary Medicinal Products and the Good Use of Antimicrobials​​

o   Presentation on new Regulation (EU) 2019/6​

o   Presentation on LN 179 of 2021

o   User Guidelines on LN 179 of 2021

o   Summary of Provisions related with antimicrobials in LN179/2021​

o   Presentation on antimicrobial resistance intended for students​​

o   Presentation about the revision of the EU Legislation on Veterinary Medicinal Products

o   Annual meeting with wholesaler dealers and pharmacies 2018 (a presentation)

o   Common  animal diseases  guidebook for pharmacists and  pet owners

o   Presentation on the essential aspects of EU GMP

o   Food Safety & antibiotic residues on food animals (presentation prepared by Dr Gabriella Fumia)

o   L-Użu tal-Medicini fir-Razzett Razzett​

o   Guidelines for the proper management of medicinal product administered in farms

o   Nisġet Artna Ħarifa 2021​​  (Artikolu: Il-Bijosigurtà u Sanità fir-Razzett)

o   Linji Gwida għar-Raħħala dwar ir-Riċetti Veterinarji, d-Dispensa tal-Mediċina Veterinarja u l-Użu tal-Antibijotiċi​ 

o  Nisġet Artna Rebbiegħa 2021​  (Artikolu: L-Iżvilupp u t-Trasmissjoni tar-Reżistenza għall-Antibijotiċi mill-Batterja

o   Nisġet Artna Xitwa 2020​ ​(Artikolu: L-Użu tal-Antibijotiċi fl-Annimali) 

o   L- Użu tal-Antibijotiċi  fir-Razzett​

o   Fuljett fuq il-Mediċina Veterinarja

o   Fuljett fuq-il-Programm tas-Saħħa tal-Annimali​

o   Miżuri ta' bijosigurtà

o   Presentation about the Electronic Veterinary Prescription

o   Preżentazzjoni dwar Prodott Mediċinali Veterinarju

o   Preżentazzjoni il-Programm tas-Saħħa tal-Annimali​​

o   Nisġet Artna  Sajf 2022  (Artikolu: Programm xieraq ta’ kontroll tas-saħħa tal-annimali)

o   Nisġet Artna  Xitwa 2021 ( L Artikolu: Liġi Ġdida tal-UE Rigward il-Mediċina Veterinarja)​

o   Nisġet Artna  Ħarifa 2022 (L Artikolu: IL-Ġestjoni tal-Prodott Mediċinali u l-Għalf Medikat fl-Irziezet​

o   Distribution obligations of wholesalers and veterinary surgeons 

o   Nisġet Artna Xitwa 2022 (L Artikolu: Ir-riċetta veterinarja elettronika)

o   Nisget Artna Rebbiegha2023 (L-Artikolu: l-Impenn tad-Dipartiment tas-Saħħa u t-Trattament Xieraq tal-Annimali kontra r-Reżistenza għall-Antimikrobiċi

o   Information regarding RVHD Vaccines​

o   Newsletter 1. Ir- Reżistenza għall-Antibijotiċi mill-Batterja fl-annimali li jaffetwa l-bniedem ukoll

o Nisġet Artna Sajf 2023 (L Artikolu: Ġbir ta' Dejta ta' Bejgħ u Użu tal- Antimikrobiċi

oNisġet Artna Ħarifa 2023.  (L Artikolu: il Trattament Xieraq tal Annimali u r Reżistenza għall Antibijotiċi)​

o  Nisġet Artna Xitwa 2023.  (L Artikolu: L-użu tat-tilqim biex jitnaqqas l-użu ta’ Antibijotiċi )​

Biosecurity in the Farm

Biocheck.ugent® is a risk-based scoring tool to evaluate the quality of biosecurity of a herd.

The stakeholders can make  use of this freely  available tool (courtesy of Belgium) which may help them in their improvement of the biosecurity state  and by doing so improving the general animal health situation thus reducing antimicrobial usage. 

It has been developed by the Veterinary Epidemiology Unit of Ghent University, under the supervision of Prof. Dr Jeroen Dewulf and with technical support provided by Steven Bruneel.

The link to the questionnaire and the accompanying scoring system can be found in this website     biocheck.ugent ​ 

Good biosecurity in the farm reduces the incidence of diseases in the farm. This reduces the use of antimicrobials and the negative consequences that heavy use of these products may have, e.g. antimicrobial resistance.