List of Main
Stakeholders
- Licensed Veterinary
Pharmacies.
- Authorised
Veterinary Wholesale Distributors.
- AuthorisedMedicated Feed Mills, and 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 authorised by the Veterinary fServices or such
an activity.
The common logo appearance is as follows (in English and Maltese):
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 https://vetpres.gov.mt/
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.
Annualdata on the disposal of antimicrobials may also be
requested.
Inspections
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 alertmedicine@gov.mt. 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.
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.