vsd.gov.mt
vsd.gov.mt
This section of the website explains how to obtain: an Authorisation for a Wholesale Distributor of Veterinary Medicinal Products, a Veterinary Pharmacy Licence, Medicated Feed Mill Authorisation and Authorisation for Manufacturer of Veterinary Medicinal Product.
The Veterinary Medicines Unit is responsible for the processing of application to the open and operate Wholesale Distributors of veterinary medicinal products, Veterinary Pharmacies, and Manufacturers of Veterinary Medicinal Product.
The Unit is co-responsible for the processing of application to open and operate a Medicated Feed mill.
To this end the Unit has prepared a number of Application Forms that applicants can use in order to start operating. Detailed explanations for each application can be found below.
The following Regulations were published in the Official Journal of the European Union on 7th January 2019 and have been in force since 28th January 2022. They are being referred to frequently in this page.
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
and
Regulation (EU) 2019/6 of the European Parliament and of the Council of 11 December 2018 on veterinary medicinal products and repealing Directive 2001/82/EC
In order to carry out wholesale distribution activities in veterinary medicinal products a natural person or an entity must apply for a Wholesale Distribution Authorisation in accordance with Regulation 23 of Subsidiary Legislation 437.115 on Veterinary Medicinal Products in line with Article 99 of Regulation (EU) 2019/6.
There is no need to register and create an online profile. Once the Application Form is submitted it will be received in e-mail [email protected] where it will start to be processed. The applicant has also the possibility to print the completed application form or save it in PDF form. If applicants have any queries regarding their application they can send it to the e-mail given above.
The Veterinary Medicines Unit carries inspections to check if the applicant complies with the requirements. The applicant will be inspected when he applies for the authorisation as part of the evaluation of the application and thereafter the wholesale distributor will be inspected periodically based on risk. If the application is positively evaluated a Wholesale Distribution Authorisation will be issued within 90 days from the date on which the Unit receives the application. In case of delays the applicant will be informed accordingly by the Unit together with a valid reason.
The current fee for the acquisition of a Wholesale Distribution Authorisation is Euro 465 as per the schedule of Subsidiary Legislation 35.38. The Authorisation is valid for 3 years.
The following supporting documents must be submitted with the application form (scans are acceptable):
In order to open and manage a veterinary pharmacy in Malta a natural person or an entity must apply for a Veterinary Pharmacy Licence in accordance with Regulation 3 of S.L 437.116 in line with Article 62 of Chapter 437, The Veterinary Services Act.
There is no need to register and create an online profile. Once the Application Form is submitted it will be received in e-mail [email protected] where it will start to be processed. The applicant has also the possibility to print the completed application form or save it in PDF form. If applicants have any queries regarding their application they can send to the e-mail given above.
The Veterinary Medicines Unit carries inspections to check if the applicant complies with the requirements. . If the application is positively evaluated a Veterinary Pharmacy Licence will be issued within 45 days from the date on which the Unit receives the application. In case of delays, the applicant will be informed accordingly by the Unit together with a valid reason. The current fee for a Veterinary Pharmacy Licence is Euro 350 as per the schedule of Subsidiary Legislation 35.38. The Licence is valid for 5 years.
The following supporting documents must be submitted with the application form (scans are acceptable):
Thereafter the veterinary pharmacy will be periodically inspected based on risk.
To manufacture medicated feeding stuff a natural person or an entity must first apply for a Medicated Feed Mill Authorisation in accordance with Subsidiary Legislation 437.114 on Medicated Feeds and Article 13 of Regulation (EU) 2019/4.
There is no need to register and create an online profile. Once the Application Form is submitted it will be received in a generic e-mail [email protected] where it will start to be processed by the unit . The Veterinary Medicines Unit will inform the section of the Food Safety and Security Authority (FSSA) in charge of feeds of the outcome of the assessment. The FSSA will then do its own assessment and can also decide whether or not to proceed to a joint inspection.
An Authorisation is issued following a positive outcome of a joint inspection.
The applicant has also the possibility to print the completed application form or save it in PDF form. If applicants have any queries regarding their application they can send it to the e-mail given above.
No fees currently apply for a Medicated feed Mill Authorisation.
The following supporting documents must be submitted with the application form (scans are acceptable):
To manufacture or batch release veterinary medicinal products in Malta the entity must apply for a Manufacturing Authorisation in accordance with Regulation 12(2) of Subsidiary Legislation 437.115 in line with Articles 88 to 98 of Regulation (EU) 2019/6.
The legislation provides a complete list of the documents that need to be submitted with the application form.
The form to do so can be requested from [email protected] .It is available in English or Maltese. The completed form can then be scanned to [email protected] or posted to 15, Regent Buildings, Floor 2, Anton Cassar St. (previously race course street) Marsa, MRS 2996.
It can also be handed directly to an officer of the Veterinary Medicines Unit by appointment by calling +356 23397043. If applicants have any queries regarding their application they can send to the e-mail given above or call on telephone number +356 23397043.
If the application is positively evaluated the Authorisation will be issued within 90 days from the date on which the Unit receives the application.. In case of delays the applicant will be informed accordingly by the Unit together with a valid reason The authorisation will be entered in EudraGMP.
The applicable fees depend on the scale of manufacture, size of the manufacturing plant and on the pharmaceutical form being manufactured. The fee may also depend on whether or not a Good Manufacturing Practice (GMP) inspection needs to be conducted. . For a comprehensive list of fees applicant should refer to the schedule of Subsidiary Legislation 35.38.
The Manufacturing Authorisation reflects the status of the manufacturing site at the time of the inspection noted above and should not be relied upon to reflect the compliance status if more than three years have elapsed since the date of that inspection. However, this period of validity may be reduced or extended using regulatory risk management principles by an entry in the Restrictions or Clarifying remarks field.
The authenticity of the authorisation may be verified in EudraGMP. If the authorisation does not appear there, the Manufacturing Authorisation Holder should contact the Veterinary Medicines Unit.
Companies can contact the Veterinary Medicines Unit in case they would like to get information on the granting of a Manufacturing Authorisation or Good Manufacturing Practice (GMP) Inspections and certification thereof.
In accordance with Article 97 of Regulation (EU) 2019/6 the Manufacturing Authorisation Holder shall have permanently at his disposal the services of at least one Qualified Person (QP) who fulfils the conditions laid down in legal provisions related with manufacturing. The Qualified Person (QP) shall have the following qualifications:
After selecting a suitable QP but before his employment, the relevant details of the QP should be sent to the Veterinary Medicines Unit for a final verification.
If an applicant wishes to address any complaint, non-response or dissatisfaction with their application, they may do so using one of the following methods: