Stakeholders and Informative Material

Stakeholders and Informative Material

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

 
 
 

Persons  approved  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 Section ‘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 approved by the Veterinary Medicines Section for 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’. ENMT​ 

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.


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 Section 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. ​

Each year, most often in December,  the Veterinary Medicines Section 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.

Yearly data on the disposal of antimicrobials may also be requested.



Inspections 

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

In addition the Veterinary Medicines Section collaborates closely with the Veterinary Regulation Directorate, specifically the Enforcement Unit, through a Memorandum of Understanding. This allows effective enforcement action in cases of serious breaches. 

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 Section, 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 Section using the feedback form on the main menu. This can also used to submit complaints or suggestions. 

Collaborations 


The Veterinary Medicines Section 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 OIE ( 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 Section 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 Section. 

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 Section 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 Section. 
 
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.  


Comment to the Veterinary Medicines Section 


Anyone can submits comments to the Veterinary Medicines Section by using the form Comments to the Veterinary Medicines Section EN | MT ​The form can also be used to submit suggestions for improvement or any complaint. 

 
Circular name​ ​​​​                                                                Issue Date
Common logo for the retail of veterinary medicinal products at a distance​ ​08/02/22
Access to the Electronic Veterinary Prescription  (e-VetPres)​ ​14/01/22
Proper use of Vaccine for Viral Hemorrhagic Disease in Rabbits ​ ​10/08/21
Veterinary Medicinal Products containing ‘’zinc oxide’’ to be administered orally to food​​ producing species                ​
​11/02/21​
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​ ​17/06/20
Counterfeit Seresto collar for dogs ​14/08/19
Medications for pigeons​ ​22/11/18
​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​ ​03/08/18
Data Collection on Antimicrobial Agents use ​14/12/17
Returned Veterinary Medicinal Products to the Veterinary Pharmacy​ ​16/12/16
​Veterinary Medicinal Products containing Lincomycin and spectinomycin for use in pigs and/or chickens ​​31/08/16
Banned Substances for Racing Pigeons as decided by the Malta Federation of Racing Pigeons  ​30/09/16
Rigward l-użu tal-antibijotici fuq tiġieġ tas-simna destinati għall-konsum minn nies u fuq tiġieġ tal-bajd​ ​09/11/15
Regarding the use of Antimicrobials (AM) on Poultry flocks destined for slaughter for human consumption and layers ​09/11/15
Prudent use of Antimicrobials ​​26/05/15
Sale of Veterinary Medicinal Products  by Wholesales Directly to Animal Keepers ​24/07/14
Record Keeping by the Veterinarian  ​05/12/13​
The prudent use of Flouroquinolones ​25/11/13
Prudent use of Veterinary Medicinal Products containing 3rd and 4th generation Cephalosporin ​ 08/04/12
Licensed Distributors of Veterinary Pharmaceuticals  ​                                                 14/12/04​
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Leaflets, Presentations and other Publications 


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. 
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