Authorisation Routes and Licensing schemes

Introduction

 
Veterinary medicinal products must obtain the relevant authorisation before they are placed on the market in Malta. 

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Applicants can choose from five authorisation or registration routes and three licensing schemes to obtain a valid authorisation.  

The Application Forms for the Authorisation or Registration Routes and Licensing Schemes  

  • Community Marketing Authorisation EN | MT
  • Final National phase for Marketing Authorisation through the Mutual Recognition /Decentralised Procedure (MRP/DCP)) EN | MT
  • Registration of a Veterinary Medicine in line with Regulation 7 of Subsidiary Legislation 437.47 EN | MT
  • Authorisation of a Veterinary Medicine in Line with Regulation 4(2) of Subsidiary Legislation 437.47 EN | MT
  • Parallel Import Licence (non-applicable) 
  • Cascade Licence  EN | MT
  • Licence to Procure Veterinary Medicinal Products for Research Purposes  EN | MT
  • For a National Marketing Authorisation forms applicants can refer to the European Medicines Agency website

Applicants can find more information of on how to fill in the Application Forms from here ​

The Coordination Group for Mutual Recognition and Decentralised Procedures - Veterinary  CMDv website provides a lot of information about the Mutual Recognition /Decentralised Procedure (MRP/DCP). 

In case of Parallel Importation applicants can contact the Veterinary Medicines Section for guidance. 


Time frames for evaluation 


The timeframe (without considering clock-stops and breakdown sessions) for the review of all National Applications Forms is 45 days. Applications Forms are evaluated in the order they are received although we still take into account our system of prioritisation. For example, an application to process a vaccine of a new confirmed viral strain of a food-producing animal take precedence over  an application for a veterinary medicinal  medicine for aquarium fish.
It is essential that the applicants fill in the forms correctly and that all the supporting documents are provided. Failure from doing so will only delay the determination of an application. 
The time to grant a certification will ultimately be the combination of the time needed for the evaluation/assessment together with the time necessary for the applicant to respond to questions raised during evaluation.
If no response is received after 6 months of a query sent by the Veterinary Medicines Section the application will be considered as withdrawn.
After the authorisation is granted, the authorisation holder must be vigilant of the product on the market and watch out for any adverse drug reactions or product/batch defects. 
Post-authorisation obligations, such as variations, should be continued to be followed throughout the life-cycle of the product.
    

Fees


Currently there is one administrative fee of  €60 for all initial authorisations or authorisations and extensions thereof.  As explained above Licensing Schemes do not incur any fees. The Information Sheet about the Pricing Structure of the Veterinary Medicines Section gives comprehensive information about the applicable fees and conditions of payment for those applications were a fee is applicable.
 
Licensing schemes (Parallel Import, Licence for Research and Cascade Licence) are currently free of charge.

 

Post Authorisation Activities (General Instructions)

 

The Annual National Extension

 
The Annual Extension is applicable to all national authorisation/registration routes and it entails an administrative fee of  60. It is a national requirement. The 60 fee pertains to each and every veterinary medicinal product which is authorised/registered through any route. Upon payment, the authorisation/registration is extended for a period of one year.
 
Applicants are not requested to complete any standard application form; they are only required to send the request to the Veterinary Medicines Section through email at veterinarymedicine@gov.mt​
 
Applicants can send the request for extension up to two months before the certificate expires.
 
It is the duty of the authorisation holder to maintain the validity of the authorisation of the product and pay the annual fee on time. 

In the case of Regulation 7 Registrations only, when Registration Holders  apply for an annual extension they  should  enlist all the variations that have been approved in the country of source during the preceding year. Registration Holders should ensure that the VMS always receives the updated Product Information (PI) of the product.

 

Variations

 
The document ‘Variations for Each Authorisation or Registration Type can guide authorisation/registration holders when it comes to the appropriate procedures to use for the different types of authorisations or registrations.

The form ‘Notification for Changes in National Authorisations, licenses and Registrations’ EN | MT can be used to notify the VMS of notification of changes in the case of products authorised according to Regulation 7 and Regulation 4(2) of S.L 437.47. 
 
 

Periodic Safety Update Reports (PSURs)

 
PSURs for DCP/MRP and National Marketing Authorisations can only be submitted on  the Eudralink  address given to the company by the Veterinary Medicines Section.  
 
PSURs of centrally authorised products should be sent to the European Medicines Agency (EMA).


Withdrawal of the veterinary medicinal product from the market


An application form for the ‘Withdrawal of a Veterinary Medicinal Product’ EN | MT​ authorised  or registered in any route must be used to inform the Veterinary Medicines Section of the intention of the holder to withdraw the product/s from the Maltese market. 

Withdrawal of a product must not be confused with a product that is authorised but it is not marketed. In the latter case the relevant fees and post-licensing obligations (e.g. variations) should still continue to be honoured. 

The ‘Proposed Date of Withdrawal’ marked on the application form must not precede the withdrawal application form submission date. 

If the product is not officially withdrawn by means of this application form, it will be considered as being still on the market and subject to the relevant fees.  

The distributor must exhaust the stock of the veterinary medicine within 6 months from the ‘Proposed Date of Withdrawal’

Registration/Authorisation/Marketing Authorisation Holders are still required to abide by their post-marketing and pharmacovigilance duties until all stocks available in veterinary pharmacies are exhausted.​

 

 

Free Sale certificates


The Veterinary Medicines Section can also issue Free Sale Certificates for Veterinary Medicinal Products that are registered/authorised or manufactured in Malta. 

For further details applicants can contact the Veterinary Medicines Section. 



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