Authorisation Routes, Licensing Schemes and Medicated Feed

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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 five authorisation or registration routes and three licensing schemes to obtain a valid authorisation.

Flow diagram of Authorisation or Registration Routes and Licensing Schemes

Information about the Authorisation or Registration Routes

Information about the Licensing Schemes

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

Only products with active ingredients present in the List of Active Ingredients for Products to be authorised in accordance with Regulation 4(2) can be authorised through this route.

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 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.

Although applicants can propose a Distribution Category for the Veterinary Medicinal Products, the final decision remains that of the Veterinary Medicines Section. The Section 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 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.

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 Purposes 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.

For those products that hold a Marketing Authorisation the validity of that Marketing Authorisation is 5 years from the first issue thereof, after which it can be renewed indefinitely (no fees for renewal). The yearly administrative fee mentioned above still applies. The receipt number for the payment is indicated on the issued certificate.

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. If the annual administrative fee is not paid the product is considered as unauthorised.

In the case of Regulation 7 Registrations only, when Registration Holders apply for an annual extension they should enlist (not submit) 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 (Summary of Product Characteristics, Package Leaflet and labelling) of the product.

The request for extension sent through e-mail to veterinarymedicine@gov.mt should include the table below:

Name

Strength

Number

Extension period

For Regulation 7 only. Variations that effect SPC/PIL/Labelling. Yes/No. If yes list them

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.

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 Feed 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.

Blue copies of the prescription (Schedule II of S.L 437.47) for Medicated Feed (from medicated feed traders and local Medicated Feed Mills) should be sent to the relevant section of the Veterinary Regulations Directorate. Data from them are shared with the Veterinary Medicines Section.

List of Medicated Feeding Stuffs marketed in Malta (brought ready made)

List if Medicated Feeding Stuffs manufactured in Malta