The Veterinary
Medicines Unit is responsible for the processing of application to open and
operate Veterinary Pharmacies, Veterinary Wholesale Distributors, Medicated
Feed Mills and Manufacturers of Veterinary Medicinal Product. To this end the Unit
has prepared a number of Application Forms that applicant 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
To operate as Veterinary Wholesale Dealer
In order to carry out
wholesale dealing activities in veterinary medicinal products a natural person
or an entity must apply for a Wholesale Distribution Authorisation in
accordance with Regulation 58(1) of Subsidiary Legislation 437.47 on Veterinary Medicinal
Products and Article 99 of 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.
Application forms are
only on-line. Applicants can choose to submit their application in English or
Maltese.
Application to operate
as Veterinary Wholesale Dealer (In English) (In Maltese)
There is no need to
register and create an online profile. Once the Application Form is submitted
it will be received in e-mail veterinarymedicine@gov.mt 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 then
periodically based on risk assessment. 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 authorisation will have an indefinite validity period
unless revoked or withdrawn.
No fees currently apply
for the acquisition of a Wholesale Distribution Authorisation.
The following
supporting documents must be submitted with the application form (scans are
acceptable):
1. Site plan
(1:250)
2. Curriculum vitae of
Responsible Person (RP) The RP is a person qualified in pharmacy with a minimum
qualification of a Bachelor ‘s degree in Pharmacy
3. Standard Operating
Procedures (SOPs)
4. Premises plan
(1:100)
5. Proposed layout of
storage and dispatching areas
6. Police conduct of
applicant
7. Planning authority
permit for a store
8. Malta Financial
Services Authority (MFSA) Licence, (if the applicant is a limited
company)
9. Memorandum and articles of
company (If the applicant is representing a company), if applicable
To open and operate a Veterinary Pharmacy
In order to
retail veterinary medicinal products in Malta a natural person or an
entity can apply for a Veterinary Pharmacy Licence and be in line with Article 62 of
Chapter 437, The Veterinary Services Act and Regulation 59 of Subsidiary
Legislation 437.47 on Veterinary Medicinal Products.
Application forms are
only on-line. Applicants can choose to submit their application in English or
Maltese.
Application to operate
as a Veterinary Pharmacy (In English) (In Maltese)
There is no need to
register and create an online profile. Once the Application Form is submitted
it will be received in e-mail veterinarymedicine@gov.mt 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. The applicant will be inspected when he applies for the Licence as part of the evaluation of the application and then periodically based on
risk assessment. 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 Licence will have an indefinite validity period unless
revoked or withdrawn.
No fees currently apply
for a Veterinary Pharmacy Licence.
The following
supporting documents must be submitted with the application form (scans are
acceptable):
1. Site plan
(1:250)
2. Curriculum vitae of
Managing Pharmacist. The Managing Pharmacist is a person qualified in pharmacy
with a minimum qualification of a University Bachelor degree in Pharmacy
3. Standard Operating
Procedures (SOPs)
4. Premises plan
(1:100)
5. Proposed layout of
storage areas and dispensing area
6. Police conduct
of applicant,
7. Planning
authority Permit for a shop
8.Malta Financial
Services Authority (MFSA) License (if the applicant is a limited company)
9. Memorandum and articles of company
(If the applicant is representing a company).
To open and operate a Medicated Feed Mill
To manufacture
medicated feeding stuff a natural person or an entity must first apply for a
Medicated Feed Mill Authorisation in
accordance with Regulation 4 of Subsidiary
Legislation 437.73 on Medicated Fees and 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
Application forms are
only on-line. Applicants can choose to submit their application in English or
Maltese.
Application to operate
as a Medicated Feed Mill (In English) (In Maltese )
There is no need to
register and create an online profile. Once the Application Form is submitted
it will be received in e-mail veterinarymedicine@gov.mt 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 then periodically based on risk assessment. If the
application is positively evaluated a Medicated Feed Mill Authorisation 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 Authorisation will
have an indefinite validity period unless revoked or withdrawn.
No fees currently apply
for a Medicated feed Mill Authorisation .
The following
supporting documents must be submitted with the application form (scans are
acceptable):
1.
Site plan (1:250)
2.
Curriculum vitae of Technical Person
3.
Standard Operating Procedures (SOPs)
4.
Premises plan (1:100),
5.
Hazard Analysis and Critical Control Points plan (HACCP plan),
6. Planning authority permit for the applicable type of
building
7.
Drawings of the medicated feed line,
8.
Memorandum and articles of company (if applicable),
9.
Malta Financial Services Authority (MFSA) License (if company is a limited
company)
To open and operate a Manufacturing Plant for Veterinary
Medicinal Products
To manufacture or batch
release veterinary medicinal products in Malta a natural person or an entity
must apply for a Manufacturing Authorisation in accordance with Regulation 38(1) of Subsidiary
Legislation 437.47 and with Articles 88 to 98 of 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.
The form to do so can
be requested from veterinarymedicine@gov.mt .It
is available in English or Maltese. The completed form can then be scanned to veterinarymedicine@gov.mt and posted to Veterinary
Medicines Unit, Animal Health and Welfare Department (AHWD)Level 2, Abattoir
Street, Albertown, Marsa MRS 1123, Malta. 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 Manufacturing Authorisation will be issued
within 90 days from the date on which the Unit receives the application.
An inspection by the Veterinary Medicines Unit will be conducted. 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 by the
Animal Health and Welfare Department.
The following
supporting documents must be submitted with the application.
1. Site Master File
2. Curriculum vitae of Production
Manager
3. Curriculum vitae of Quality Control
Manage
4. Certificate of Registration issued by
MFSA (for private & public companies only)
5. Planning Authority permits for the
applicable type of building
6. Good Manufacturing Practice (GMP)
certificate (if already available)
7. Curriculum vitae of Qualified
Person (QP)
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 it does not appear, the
Manufacturing Authorisation Holder should contact the Veterinary Medicines Unit.
More
Information on the Qualified Person
In accordance with
Article 97 of Regulation (EU) 2019/6 the manufacturer hall 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:
1. hold
a university degree in one or more of the following scientific
disciplines: pharmacy, human medicine, veterinary medicine, chemistry,
pharmaceutical chemistry and tech nology, or biology
2. have
acquired practical experience over at least two years, in one or more
undertakings which are authorised manufacturers, in the activities of
quality assurance of medicinal products, of qualitative analysis of
medicinal products, of quantitative analysis of active substances and the
checking necessary to ensure the quality of veterinary medicinal products.
The duration of practical experience required in the first subparagraph
may be reduced by one year where a university course lasts for at least
five years and by a year and a half where the university course lasts for
at least six years
3. The
holder of the manufacturing authorisation, if a natural person, may assume
the responsibilities of a Qualified Person.
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 clearance.
Ways to leave comments or seek to redress complaints for all
applications
If applicants need to
redress any complaints, no reply or lack of satisfaction regarding their
application they can do so using any one of the following ways:
1. Leave comments in
the ‘Feedback webpage’
2.leaving comments on
an on-line form ‘Comments to the Veterinary Medicines Unit ( English) (Maltese)
3. Call on landline +356
23397043
4. Write to: Veterinary
Medicines Unit, Animal Health and Welfare Department (AHWD) Level 2, Abattoir
Street, Albertown, Marsa MRS 1123, Malta
This
page was last updated on: 20/06/2023