Veterinary Medicine Section

1.

The Mission Statement and Vision

2.

The Purpose of the Website

3.

List of Application Forms

4.

List of Reporting Forms

5.

List of Main Stakeholder

6.

FAQ  

7.

Contact Information

8.

Disclaimer

 

1.    The Mission Statement and Vision

The Veterinary Medicines and Animal Nutrition Section (VMANS) was set up with the purpose of regulating the placing on the market, distribution and use of veterinary medicinal products, thereby promoting responsible use of good quality, safe and effective veterinary medicinal products. A complete Mission Statement of the Section can be found here​.​




2.    The Purpose of the Website 

The information in this website is intended to increase predictability, to prevent arbitrary decisions, and to supply information which is not readily available elsewhere. 

It is hoped that the regulations and rules explained in this website are transparent, and that they are presented in a consistent, uniform, impartial and reasonable manner. 

Applicants can improve the quality of their submissions with a view to facilitating and speeding up the authorisation by following the instructions in this website.

The website is divided into a number of sections, where each section tackles a specific subject. These are in turn sub-divided into sub-sections with the aim of reflecting the different areas of interest of the various stakeholders. 

Some of the information and downloadable material may be found in more than one section. The following is a complete list of application forms and reporting forms available from the Veterinary Medicines and Animal Nutrition Section. However, individual application forms or reporting forms can be found again in their own distinct section.

A ‘Table of Misconceptions will help the reader understand better the concepts and explanations provided in this and the other sections of the website.

3.    List of Application Forms

Applicants can use the Application Forms found below for the different procedures. An acknowledgement note will be given upon the submission of each application form or a reporting form. 

These authorisation routes and licensing schemes can be found in the 'Flow Diagram of Authorisation Routes​  


 

1

Licensing of Veterinary Medicinal Products

1A

Application form for the Final National Stage for a Marketing Authorisation  authorised according to the DCP/MRP​

1B

Application form for an Authorisation in accordance with Regulation 7​

1C

Application form for an Authorisation in accordance  with Regulation 4(2)​

1D

Notification form for a product Authorised according to the Centralised Procedure

1E

Application form for an Acquisition License under the Cascade (ALC)

1F

Application form for a License to Import a Product Containing a Veterinary Medicinal Product for Research Purposes

2

Licensing of Premises and Activities

2A

Application form  for a Veterinary Wholesale Dealer​​

2B

Application form  to open and operate a Veterinary Pharmacy​

2C

Application form for bonded stores​​​
​2D ​Application form for Medicated Feed Mill​

3

Post Licensing Activities and Procedures

3A

Variation Notification form for variations of products Authorisation in accordance with Regulation 7

3B

Variation application form for products Authorisation in accordance with Regulation 4(2)

3C

Application form for the  renewal of an authorisation in accordance  with Regulation 4(2)

3D

Application form for the renewal of an authorisation in accordance  with Regulation 7​

3E

Application Form for the Withdrawal o​f a Veterinary Medicinal Products (for any type of Authorisation)​​

 

4.    List of Reporting Forms 

5.    List of Main Stakeholders

•    A list of  Veterinary Pharmacies can be found here
•    A list of  
Veterinary Wholesale Dealers can be found here
•    A list of  Medicated 
Feed Mills can be found here​

6. Frequently Asked Question on Veterinary Medicines and Animal Nutrition Section’s role and Registration Fees

1)    What Products are regulated by the Section?
2)    How are Veterinary Medicinal Products authorised?
3)    What products are not regulated by the section?
4)   Are Products that are not Veterinary Medicinal Products but are used for a medicinal purposes regulated and  controlled by the section?  
5)    How can I distinguish between a medicinal and a non-medicinal?
6)    What are Unauthorised Veterinary Medicinal Products?
7)    Why is Authorisation of veterinary medicinal products important?
8)    What other activities are undertaken by this section?
9)    How much would it cost to register veterinary medicinal products?

The answers to these questions can be found  in  FAQ

7.    Contact Information

More information about the activities that are regulated by this Section, and the responsibilities of each stakeholder, can be found in the section of this website named ‘Main Stakeholders’.  

For further information you may contact Mr. Stephen Spiteri at the Veterinary Medicines and Animal Nutrition Section or call on telephone number (00)356 2292 5375/6

You may also put your queries in writing and, either send an e-mail to 
Stephen Spiteri or else send a letter to the following address:

Stephen Spiteri - Principal Pharmacist
Veterinary Medicines and Animal Nutrition Section
Veterinary and Phytosanitary Regulation Division (VPRD)
Level 2, Administration Building
ABATTOIR STREET, ALBERTOWN, MARSA,
MRS 1123 - MALTA

You can lodge a complaint using the Complaint Form. This can be used:

•    if you feel aggrieved by a decision taken by this Section. 
•    if you have comments on the degree of navigability of this website. 
•    if you have suggestions of how things in this sector could be improved.

If you have any kind of suggestions to make or if you have comments on the degree of navigability of this website you can use the 'Suggestion for Improvement form I​'

8. Disclaimer

The information in this website is regularly reviewed and updated in line with the rapidly evolving legislative, regulatory and technical areas.                                                                      

The Veterinary Medicines and Animal Nutrition Section does not take responsibility of the concepts as understood, or misunderstood, by the reader. 

Existing approvals and on-going applications are affected by a decision taken by the Division and communicated through this website.

The information present in this website is not to be considered as professional consultancy material. Stakeholders are responsible for their own decisions in accordance with the existent legislation. 

The information and instructions contained in this website are mostly guidelines prepared by the Veterinary Medicines and Animal Nutrition Section for the benefits of its stakeholders. Interested parties are encouraged to refer to the legislation proper, i.e. Subsidiary Legislation 437.47 under Chapter 437, The Veterinary Services Act.

The word ‘Licence’, when in use, might not necessary construed as having a legal standing​.

This website was last updated on the: 09/08/2017

The reader can refer to:

Synonyms:

For the purposes of the information contained in this website, the following terms shall be considered as synonyms:

•   drugs, veterinary medicines, VMP, veterinary medicinal product and product 

•  this Section, Veterinary Medicines and Animal Nutrition Section, Maltese Agency for Veterinary Medicinal Products, Veterinary Services, Maltese National Competent Authority for Veterinary Medicinal Products  

•   registration, authorisation and approval of veterinary medicinal product 

•   VPRD, Division

References to:  the section granting ‘approvals’  and/or  ‘permits’  shall be construed as being  granted by the Director of the Veterinary Services mentioned in Chapter 437, The Veterinary Services Act.

All reference to Member States and to the European Union shall be taken as the European Union Member States and the States that have signed the European Economic Area agreement, namely Norway, Iceland and Liechtenstein.​​