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 websiteprovides 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.