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. 

Applicants can choose from eight authorisation or registration routes. 

·        Flow diagram of Authorisation or Registration Routes and Licensing Schemes​

·        Information about the Authorisation or Registration Routes for which there is currently an applicable fee

·        Information about  the Authorisation or Registration Routes for which there is currently no applicable fee

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. 

A report on the changes in the authorisation status of Veterinary Medicinal Products in line with Article 5(6) of Regulation (EU) 2019/6 for 2021-2022

·        National Marketing Authorisation. Applicants can refer to the European Medicines Agency website​

·        Parallel Trade. Applicants can contact the Veterinary Medicines Unit 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

Although applicants can propose a Distribution Category for the Veterinary Medicinal Products, the final decision remains that of the Veterinary Medicines Unit. The Unit classifies the Distribution Category of the veterinary medicinal products in accordance with the criteria for the Distribution Category . as per Regulation 60 (8) of S.L 437.47.​

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 live or in some cases attenuated 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 Unit 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 Unit 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)

Market Authorisations (National/DCP/MRP) Annual Administrative fee

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, i.e. it is indefinite unless certain conditions apply. However, the the Marketing Authorisation is still subject to an annual administrative fee of €60. The receipt number for the payment is indicated on the issued certificate.  Payments can be made through this form​

Payments should be made  at least   two months but preferably not more than six months before they are due.

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 

Request for renewal should be sent at least two months but preferably not more than six months before the authorisation or registration  expires . These can be made through the following on-line form Renewal of authorisation​. 

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 on-line submission for a renewal.  The receipt number for the payment will indicated on the registration or authorisation document.   

The following instructions are only applicable for the on-line form for the renewals of for Article 116 registrations.  

  • 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 Unit always receives the updated Product Information (Summary of Product Characteristics, Package Leaflet and labelling) 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/ 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)  

The form can also be used for applicants to propose a change in the distribution category of a veterinary medicinal product. In addition to this variation form, during renewal,  the on-line form for renewal can also be used for this purpose, i.e. to propose a change in the distribution category. Applicants can choose from the two, depending which is the most suitable at that point in time.


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 Unit 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 Unit 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 Unit. 

The legal basis for this is Article 98 of Regulation (EU) 2019/6

Free sale certificates are subject to a fee of 60 Euro per certificate for their issuance.

Medicated Feed 

Medicated Feeds are not authorised/registered by the Veterinary Medicines Unit, nevertheless the unit  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 Unit. 

 


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