Payment of administrative fee for the renewal authorisation of veterinary Medicinal Products

Overview

Online form that holders of any national Authorisations and registrations of veterinary medicinal products use to request renewal and pay the applicable fee.


This form is also used by Marketing Authorisation Holders and Notification Holders of Centrally Authorised Products to pay the applicable administrative fee for Marketing Authorisations and notifications of Centrally Authorised Products. This is not a renewal form for these products as Marketing Authorisations (not national authorisations) have an indefinite validity period.

What you'll get

In the case of Marketing Authorisations and Centrally Authorised Products Notification an acknowledgement is sent.

 

In the case of the below, the registration or authorisation documents are renewed and sent to the applicant:

 

  • Registration in accordance with regulation 8 of S.L 437.115 in line with Article 116 of Regulation (EU) 2019/6.
  • Authorisation in accordance with regulation 5 of S.L 437.115 in line with Article 5(6) of Regulation (EU) 2019/6.
  • Authorisation in accordance with Regulation 9 of S.L 437.115 in line with Articles 110, 112-114 of Regulation (EU) 2019/6.  (cascade authorisation).
  • Authorisation in accordance with S.L 6 of S.L 437.114 (research and development purpose).

Eligibility

Holders of any national authorisation or registration of veterinary medicinal products, Holders of Notifications for Centrally Authorised Products and Marketing Authorisation Holders.

How to apply

Fill in the online form and attach any necessary documents.
 

Documents required

 

  • Proof of payment.  
  • Latest Summary of product characteristics (SPC), where applicable.
  • Latest Package leaflets (PL), if applicable.
  • Latest Mock-ups of outer and immediate pack.
  • For products registered in accordance with Article 116 of Reg (EU) 2019, a list (not the actual variations applications) of those variations already approved (not pending or that have been submitted) in the country of source (if any) that changed the SPC, PL or Labelling from the date of the last renewal. The regulatory authority in Malta should have been notified of these variations as soon as the approval from the country of source was obtained through the applicable on-line form.
  • Only Notification for variation that change the SPC, PIL or labelling need to be submitted.
apply