vsd.gov.mt
vsd.gov.mt
Introduction
Veterinary medicinal products must obtain the relevant authorisation before they are placed on the market in Malta.
• List of authorised veterinary medicinal products as of 4th February 2025
• Flowchart of Authorisation or Registration Routes
Without a fee/ 1 year
• Registration of samples or demonstration packs
With a fee of €180/3 years
• Registration of a Veterinary Medicinal Product in accordance with regulation 8(1) of S.L 437.115 in line with Article 116 of Regulation (EU) 2019/6
• National Marketing Authorisation.
• Authorisation to obtain Veterinary Medicinal Products for Research and Development Purposes
With a fee of €60/ year
With a fee of €300/ 5 years
• Notification for a Community Marketing Authorisation (centrally authorised products)
• Authorisation of a Veterinary Medicinal Product in accordance with regulation 5 of S.L 437.115 line with Article 5(6) of Regulation (EU) 2019/6
• Registration of product for Parallel Trade.
• Registration of a homeopathic product
With a fee of €1,000/ 5 years
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 €180 Euro / 3 years per certificate for their issuance.
Although applicants can propose a Distribution Category for the Veterinary Medicinal Products, the final decision remains that of the Veterinary Medicines Unit that classifies the Distribution Category of the veterinary medicinal products in accordance with the criteria for the Distribution Category based on S.L 437.115
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.
Any person intending to manufacture, import, possess, distribute, sell, supply and use (including veterinary surgeons for cascade) this veterinary medicinal product must first consult the relevant Member State’s competent authority (FSSA) on the current vaccination policies, as these activities may be prohibited in a Malta on the whole or part of its territory pursuant to national legislation.
For example, it must be ascertained that Vaccination does not induce production of antibodies against nucleoprotein or neuraminidase, and therefore a DIVA (Differentiation of Infected from Vaccinated Animals) strategy can be implemented.
Although veterinary medicinal products can be registered or authorised without actually being marketed in Malta, this does not apply to live vaccines. Live vaccines can only be registered or authorised only if they can be allowed to be marketed in Malta.
The timeframe (excluding clock-stops and breakdown sessions) for the review of applications forms is 45 days. Applications Forms are evaluated in the order they are received while some applications are prioritised. 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 authorisation is the combination of the time needed for the evaluation 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.
Payments are done in the following banks account:
Beneficiary | Veterinary Services Directorate |
Bank Name | Central Bank of Malta |
Bank Address | Castille Place, Valletta, Malta |
Name of Account Holder | Cashier Malta Government |
Bank Code | 01100 |
Account number | MT55MALT011000040001EURCMG5001H |
SWIFT/BIC Code | MALTMTMT |
VAT Number (if required) | MT22004702 |
The fee covers the cost for any post-authorisations procedures
For those products that hold a Marketing Authorisation (Centralised, National, DCP and MRP) the validity of that Marketing Authorisation is according with Article 5 of Regulation (EU) 2019/6, i.e. it is indefinite unless certain conditions apply. However, the Marketing Authorisation is still subject to the applicable administrative fee.
Payments should be made at least two months but preferably not more than six months before they are due. The proof of such payment (usually a bank transfer statement) is a mandatory document that is submitted as part of the application form.
It is the duty of the registration or authorisation holder to pay for the first authorisation/registration and the subsequent administrative fees The registration or authorisation holder form must submit a new application when the period covered by the previous administrative approaches.
Variations for national Marketing Authorisations and DCP/MRPs/Subsequent Recognition must be submitted in line with Regulation (EU) 2019/6 and the EU wide standard application forms. The fee is included in the administrative fine, thus there are no fees associated with the application forms for these variations.
Variations for centrally authorised products are submitted to EMA and not the Veterinary Mediicnes Unit.
‘Notification of Changes’ (rather than variations) is the term used to describe the changes to products registered in accordance with Article 116.
For ‘Notification of Changes’ and variations to the other types of authorisation (namely all except free sale certificates and cascade authorisation) the ‘Changes in National Registration and National Authorisation’ should be used.
The fee is included in the administrative fine, thus there are no fees associated with these applications.
An application form for the ‘Withdrawal of a Veterinary Medicinal Product’ 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 is not the same as 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 wholesaler 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 Unit with the formal documents relating to the product.
Should the authorisation/registration holder decide to withdraw a veterinary medicinal product, the on-line application form for withdrawal must be used.
Provided that all pending payments of previous years are settled and that accounts are in order, applicants can make a request to the Directorate to have any remaining payment in excess of 1 year netted off from future submissions of applications for the authorisation/registration of veterinary medicinal products.
The request must be clear and the correct reference to the particular veterinary medicinal products in question must be made.
The pro-rate amount of payment to be netted off will be calculated according to the ‘Desired Date of Withdrawal’ on the application form; which cannot pre-date the submission date of the Withdrawal Application form.
As mentioned above, this possibility is being provided after the first year of authorisation/registration
The registration/authoriation of a veterinary medicinal product remains valid irrespective of whether a renewed registration/authorisation certificate is issued before or after the expiry date of the period covered by the administrative fee. Therefore, if an applicant submits a new application and it has not yet been processed by the Veterinary Medicines Unit, it should still be considered as valid.
It is the duty of the registration or authorisation holder to pay the applicable fee and submit a new application form when the end of the validy period of the previous administrative fee approaches.
If a new application for is not submitted and the applicable fee is not paid the registration/authorisation will still be considered as valid and subject to the applicable fee/s
A registration/authorisation will no longer be valid only if and when it is withdrawn by the applicant by submitting a Withdrawal Application Form, or if it is permanently revoked or its renewal refused for justifiable regulatory reasons by the Veterinary Services Directorate.