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.
The Application Forms for the Authorisation or Registration Routes
- 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 Unit for guidance. The legal provisions of these can be found in Article 102 of (EU) Regulation 2019/6.
Without a fee
- Approval to Procure Veterinary Medicinal Products for Research Purposes EN | MT
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 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
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 Unit 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 Unit 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 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 Unit.
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 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.
Medicated Feed
Medicated Feeds are not authorised/registered by the Veterinary Medicines Unit, 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 Unit.