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To open and operate as Veterinary Pharmacy, Veterinary Wholesale Distributor, Medicated Feed Mill and Manufacturer of Veterinary Medicinal Product

​The Veterinary Medicines Section is responsible for the processing of application to open and operate Veterinary Pharmacies, Veterinary Wholesale Distributors, Medicated Feed Mills and Manufacturers of Veterinary Medicinal Product. To this end the section has prepared a number of Application Forms that applicant can use in order to start operating. Detailed explanations for each application can be found below. 


To operate as Veterinary Wholesale Dealer​


In order to carry out wholesale dealing activities in veterinary medicinal products a natural person or an entity must apply for a Wholesale Distribution Authorisation in accordance with Regulation 58(1) of  Subsidiary Legislation 437.47. 

Application forms are only on-line. Applicants can choose to submit their application in English or Maltese. 

Application to operate as Veterinary Wholesale Dealer  (In English)  (In Maltese​
 
There is no need to register and create an online profile. Once the Application Form is submitted it will be received in e-mail  veterinarymedicine@gov.mt  where it will  start to be processed. The applicant has also the possibility to print the completed application form or save it in PDF form. If applicants have any queries regarding their application they can send it to the e-mail given above.  

The Veterinary Medicines Section carries inspections to check if the applicant complies with the requirements. The applicant will be inspected when he applies for the authorisation as part of the evaluation of the application and then periodically based on risk assessment. If the application is positively evaluated a Wholesale Distribution Authorisation will be issued within 90 days from the date on which the Department receives the application. In case of delays the applicant will be informed accordingly by the section together with a valid reason. The authorisation  will have an indefinite validity period unless revoked or withdrawn. 

No fees currently apply for the acquisition of a Wholesale Distribution Authorisation. 


The following supporting documents must be submitted with the application form (scans are acceptable):

1. Site plan (1:250)                                                                                                  
2. Curriculum vitae of Responsible Person (RP) The RP is a person qualified in pharmacy with a minimum qualification of a Bachelor ‘s degree in Pharmacy 
3. Standard Operating Procedures (SOPs)                                    
4. Premises plan (1:100)                                                                              
5. Proposed layout of storage and dispatching areas                       
6. Police conduct of applicant      
7. Planning authority permit for a store                                                
8. Malta Financial Services Authority (MFSA) Licence,   (if the applicant is a limited company)                                ​9. Memorandum and articles of company (If the applicant is representing a company), if applicable


To open and operate a Veterinary Pharmacy​


In order to retail  veterinary medicinal products in Malta a natural person or an entity can apply for a Veterinary Pharmacy Approval and be in line with Article 59 of Subsidiary Legislation 437.47. 

Application forms are only on-line. Applicants can choose to submit their application in English or Maltese. 

Application to operate as a Veterinary Pharmacy   (In English)  (In Maltese​)

There is no need to register and create an online profile. Once the Application Form is submitted it will be received in e-mail  veterinarymedicine@gov.mt  where it will  start to be processed. The applicant has also the possibility to print the completed application form or save it in PDF form. If applicants have any queries regarding their application they can send to the e-mail given above.  

The Veterinary Medicines Section carries inspections to check if the applicant complies with the requirements. The applicant will be inspected when he applies for the approval as part of the evaluation of the application and then periodically based on risk assessment. If the application is positively evaluated a Veterinary Pharmacy Approval  will be issued within 45  days from the date on which the Department receives the application. In case of delays the applicant will be informed accordingly by the section together with a valid reason. The approval will have an indefinite validity period unless revoked or withdrawn. 

No fees currently apply for a Veterinary Pharmacy Approval. 

The following supporting documents must be submitted with the application form (scans are acceptable):

1. Site plan (1:250)                                                                                                
2. Curriculum vitae of Managing Pharmacist. The Managing Pharmacist is a person qualified in pharmacy with a minimum qualification of a University Bachelor degree in Pharmacy                                                                  
3. Standard Operating Procedures (SOPs)                                                     
4. Premises plan (1:100)                                                                                           
5. Proposed layout of storage areas and dispensing area                 
 6. Police conduct of applicant,                                                                              
7. Planning authority  Permit for a shop                                                        
8.Malta Financial Services Authority (MFSA) License (if the applicant is a limited company)                                    9. Memorandum and articles of company (If the applicant is representing a company).    


To open and operate a Medicated Feed Mill



To manufacture medicated feeding stuff a natural person or an entity must first apply for a Medicated Feed Mill Approval in accordance with Regulation 4  of Subsidiary Legislation 437.73

Application forms are only on-line. Applicants can choose to submit their application in English or Maltese. 

Application to operate as a Medicated Feed Mill   (In English)  (In Maltese​

There is no need to register and create an online profile. Once the Application Form is submitted it will be received in e-mail  veterinarymedicine@gov.mt  where it will  start to be processed. The applicant has also the possibility to print the completed application form or save it in PDF form. If applicants have any queries regarding their application they can send it to the e-mail given above.  

The Veterinary Medicines Section carries inspections to check if the applicant complies with the requirements. The applicant will be inspected when he applies for the approval as part of the evaluation of the application and then periodically based on risk assessment. If the application is positively evaluated a Medicated Feed Mill Approval will be issued within 45  days from the date on which the Department receives the application. In case of delays the applicant will be informed accordingly by the section together with a valid reason  The approval will have an indefinite validity period unless revoked or withdrawn. 

No fees currently apply for a Veterinary Pharmacy Approval. 


The following supporting documents must be submitted with the application form (scans are acceptable):

1. Site plan (1:250)                                                                                                  
2. Curriculum vitae of Technical Person                                                                                 
3. Standard Operating Procedures (SOPs)                                              
4. Premises plan (1:100),                                                                                  
5. Hazard Analysis and Critical Control Points plan (HACCP plan),                                                                            6. Planning authority permit for the applicable type of building                                                  
7. Drawings of the medicated feed line,                                                         
8. Memorandum and articles of company (if applicable),                   
9.  Malta Financial Services Authority (MFSA) License (if company is a limited company)


To open and operate a Manufacturing Plant for Veterinary Medicinal Products​


To manufacture or batch release veterinary medicinal products in Malta a natural person or an entity must apply for a Manufacturing Authorisation in accordance with Regulation 38(1) of Subsidiary Legislation 437.47. 

The form to do so can be requested from veterinarymedicine@gov.mt​ .It is available in English or Maltese. The completed form can then be posted to Veterinary Medicines Section, Animal Health and Welfare Department (AHWD)Level 2, Abattoir Street, Albertown,  Marsa MRS 1123, Malta. It can also be handed directly to an officer of the Veterinary Medicines Section by appointment by calling + 00356 2292 5375. If applicants have any queries regarding their application they can send to the e-mail given above or call on telephone number  
+ 00356 2292 5375.

If the application is positively evaluated the Wholesale Distribution Authorisation will be issued within 90 days from the date on which the Department receives the application. An inspection by the Veterinary Medicines Section will be conducted. In case of delays the applicant will be informed accordingly by the section together with a valid reason The authorisation will be entered in EudraGMP.

The applicable fees depend on the scale of manufacture, size of the manufacturing plant and on the pharmaceutical form being manufactured. The fee may also depend on whether or not a Good Manufacturing Practice (GMP) inspection needs to be conducted by the Animal Health and Welfare Department.


The following supporting documents must be submitted with the application. 

1. Site Master File 
2. Curriculum vitae of Production Manager  
3. Curriculum vitae of Quality Control Manage
4. Certificate of Registration issued by MFSA (for private & public companies only) 
5. Planning Authority permits for the applicable type of building 
6. Good Manufacturing Practice (GMP) certificate 
7. Curriculum vitae of Qualified Person  (QP)

The Manufacturing Authorisation reflects the status of the manufacturing site at the time of the inspection noted above and should not be relied upon to reflect the compliance status if more than three years have elapsed since the date of that inspection. However, this period of validity may be reduced or extended using regulatory risk management principles by an entry in the Restrictions or Clarifying remarks field. 

The authenticity of the authorisation may be verified in EudraGMP. If it does not appear, the Manufacturing Authorisation Holder should contact the Veterinary Medicines Section.           


More Information on the Qualified Person 


In accordance with Regulation 46 of S.L 437.47​ the Qualified Person shall be in possession of a diploma, certificate or other evidence of formal qualifications awarded on completion of a university course of study, or a course recognised as equivalent by the territory of Malta, extending over a period of at least four years of theoretical and practical study in one of the following scientific disciplines - pharmacy, medicine, veterinary science, chemistry, pharmaceutical chemistry and technology,
biology.

However, the minimum duration of the university course may be three and a half years where the course is followed by a period of theoretical and practical training of at least one year and includes a training period of at least six months in a pharmacy open to the public, corroborated by an examination at university level. The course shall include theoretical and practical tuition bearing upon at least the following basic subjects:

(a) experimental physics,
(b) general and inorganic chemistry,
(c) organic chemistry,
(d) analytical chemistry,
(e) pharmaceutical chemistry, including analysis of
medicinal products,
(f) general and applied biochemistry (medical),
(g) physiology,
(h) microbiology,
(i) pharmacology,
(j) pharmaceutical technology,
(k) toxicology,
(l) pharmacognosy (study of the composition and effects of the active principles of natural substances of plant and animal origin).                


​Ways to leave comments or seek to redress complaints for all applications​



If applicants need to redress any complaints, no reply  or lack of satisfaction regarding their application they can do so using any one of the following ways: 

1. Leave comments in the ‘Feedback webpage’   

2.leaving comments on an on-line form ‘Comments to the Veterinary Medicines Section ( English)  (Maltese​)  

3. Call on landline +00 356 2292 5375/5367

4. Write to: Veterinary Medicines Section, Animal Health and Welfare Department (AHWD)
Level 2, Abattoir Street, Albertown,  Marsa MRS 1123, Malta 



​This page was last updated on:  31/08/2020


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