Stakeholders and Informative Material

​​​​​The ‘List of Main Stakeholders’ has been prepared for the benefit of all those who would like to refer to the authorised veterinary pharmacies, veterinary wholesale dealers, Good Manufacturing Practice operators and manufactures/traders of medicated feeding stuffs in Malta. 
 

List of Application Forms 

  • To open and operate a Veterinary Pharmacy EN | MT
  • To operate a Veterinary Wholesale Dealer Activity EN | MT
  • To open and operate a Medicated Feed Mill  EN | MT​

Ordering of Veterinary Prescriptions 


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


Sales data of antimicrobials 

 
Veterinary wholesale dealers and medicated feed mills must provide the Veterinary Medicines Section with all data relating to volume of sales of antimicrobials. This forms part of an ongoing exercise by the EU/EEA countries for the reviewing of any developments in antimicrobial resistance (AMR) in relation with antimicrobial use. ​


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. 
 
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. They can also used to submit complaints or suggestions. 


Good Manufacturing Practice (GMP) Inspection


Companies can contact the Veterinary Medicines Section in case they would like to get information on 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. 

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
Licensed Distributors of Veterinary Pharmaceuticals  ​14/12/04
​​​​​​​Prudent use of Veterinary Medicinal Products containing 3rd and 4th generation Cephalosporin ​08/04/12
The prudent use of Flouroquinolones ​25/11/13
Record Keeping by the Veterinarian ​05/12/13​
Sale of Veterinary Medicinal Products  by Wholesales Directly to Animal Keepers ​24/07/14
Prudent use of Antimicrobials ​26/05/15
Regarding the use of Antimicrobials (AM) on Poultry flocks destined for slaughter for human consumption and layers. ​09/11/15
Rigward l-użu tal-antibijotici fuq tiġieġ tas-simna destinati għall-konsum minn nies u fuq tiġieġ tal-bajd​ ​09/11/15
Banned Substances for Racing Pigeons as decided by the Malta Federation of Racing Pigeons  ​30/09/16
Veterinary Medicinal Products containing Lincomycin and spectinomycin for use in pigs and/or chickens ​31/08/16
Returned Veterinary Medicinal Products to the Veterinary Pharmacy​ ​16/12/16
Data Collection on Antimicrobial Agents use ​14/12/17
​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​
Medications for pigeons​  ​22/11/18​
Counterfeit Seresto collar for dogs ​                                                                                            ​  14/08/19
 
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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