Authorisation Routes for Veterinary Medicinal Products and Medicated Feed

Authorisation Routes for Veterinary Medicinal Products and Medicated Feed


List of Registered or Authorised Veterinary medicinal Products in Malta​​


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 eight authorisation or registration routes. 

The Application Forms for the Authorisation or Registration Routes  

With a fee of €60/Year 
  • Notification for a Community Marketing Authorisation EN | MT

  • Final National phase for Marketing Authorisation through the Mutual Recognition /Decentralised Procedure (MRP/DCP)) EN | MT
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).​

  • ​​Registration of a Veterinary Medicinal Product in line Article 116 of Regulation  (EU) 2019/6 EN | MT

  • Authorisation of a Veterinary Medicinal Product in line with Article 5(6) of Regulation  (EU) 2019/6 EN | MT
Only products with active ingredients present in the List of Active Ingredients for Products to be authorised in accordance with Article 5(6) can be authorised through this route. 

      • Parallel Trade. Applicants can contact the Veterinary Medicines Section for guidance. The legal provisions of these can be found in Article 102 of (EU) Regulation 2019/6.​


        ​Without a fee
        • Cascade Approval   EN | MT
        • Approval to Procure Veterinary Medicinal Products for Research Purposes  EN | MT

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        Note on vaccines for all types of authorisation/licensing schemes: Applicants  are advised to inform themselves on the vaccination policies/programmes for certain diseases. When a vaccine is for a variant strain,  applicants must provide proof that the variant strain is actually present in Malta.  Applicants may be asked to send swabs or samples to appropriate laboratories to do differential Polymerase Chain Reaction (PCR) test to confirm presence of a variant strain. 

        Time frames for evaluation 


        The timeframe (excluding clock-stops and breakdown sessions) for the review of all National Applications Forms for veterinary medicinal products 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  product 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, with no possibility for refund.
        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 annual fee of  €60 for all authorisations or  registration that incur a fee As 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.
         
        The fee is applicable to all authorisation or registration routes 


         

        Post Authorisation Activities (General Instructions)

         

        Renewals for Market Authorisations

        For those products that hold a Marketing Authorisation the validity of that Marketing Authorisation is in accordance with Article 5 of Regulation (EU) 2019/6 The annual administrative fee of €60 still applies. The receipt number for the payment is indicated on the issued certificate.   

        Renewals for Registration in line with Article 116 and Authorisation in line with Article 5(6) of Regulation (EU) 2019/6 

        The validity of the Registration or Authorisation is one (1) year from the issue thereof 

        For the renewal a holders of the registration or authorisation are not requested to complete any standard application form; they are only required to send the request to the Veterinary Medicines Section through generic email at veterinarymedicine@gov.mt​ 

        Request for renewal should be sent up to two months before the authorisation or registration  expires. 

        It is the duty of the  registration or authorisation holder to maintain the validity of the authorisation of the product and make the request for renewal on time.  

        The annual administrative fee of €60  applies. This  should be paid simultaneously with the request for renewal.  The receipt number for the payment will indicated on the registration or authorisation document.   

        This requirement is for Article 116 registrations only.  The variations approved during the preceding year in the country of source should only be listed.  They should not be submitted. These should have been submitted soon after the variation was actually approved. 

        Registration Holders should ensure that the Veterinary Medicines Section always receives the updated Product Information (Summary of Product Characteristics, Package Leaflet and labelling) of the product.

        The request for renewal that is sent through e-mail to generic  veterinarymedicine@gov.mt​ should include the table below:​


         
         

        Name

        Strength

        Number

        Renewal period

        *List the Variations approved in the country of source that changed the SPC/PIL/Labelling. (if any)

         

        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/ Registrations’ EN | MT can be used to notify the VMS of notification of changes in the case of products authorised according to Article 116   or Article 5(6)  
         
         

        Periodic Safety Update Reports (PSURs)

         
        Until these remain valid as per Regulation (EU) 2019/6  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.

        Due to the withdrawal of the product all subsequent pending procedures associated with it will be considered as withdrawn. The Registration/Authorisation/Marketing Authorisation Holders should retain confirmation of withdrawal by the VMS with the formal documents relating to the product.


         

        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. 


        Medicated Feed 

        Medicated Feeds are not authorised/registered by the Veterinary Medicines Section, nevertheless the section should receive a copy of the ‘Accompanying Certificate in Respect of Medicated Feedingstuffs for Animals Intended for Trade’ (Schedule II of S.L 437.47) with accompanies each consignment that arrives in Malta. 

        There is no specific application form to manufacture a particular medicated feed but these must be manufactured in accordance with Regulation (EU) 2019/4 of the European Parliament and of the Council of 11 December 2018 on manufacture, placing on the market and use of medicated feed, amending Regulation (EC) No 183/2005 and repealing Council Directive 90/167/EEC  

        Regarding the prescription for medicated feed, if the electronic veterinary prescription is not used, the blue copies of the prescription (Schedule II of S.L 437.47) for Medicated Feed (from medicated feed distributors and local Medicated Feed Mills) should be sent to the Veterinary Medicines Section. 


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