Contact Information:

 Godwin Farrugia or Stephen Spiteri
Veterinary Medicines and Animal Nutrition Section, 
Veterinary Regulations Directorate, 
Abattoir Square, Albert Town Marsa, MRS 1123, Malta

 Telephone
+356 2292 5375/6

 Email

Authorisation/Registration Routes

1.     

Introduction

2.

The Five Authorisation Routes  

2.1

Centralised Procedure

2.2

Mutual Recognition/Decentralised Procedures,

2.3

National Procedures

2.4

Regulation 7

2.5

Regulation 4(2)

3.

Submission  of the Application Forms

4.

Time Frames for the Authorisation Routes

5.

Pricing Structure for all Authorisation Routes

6.

Post Authorisation Activities (General Instructions)

6.1

The Annual Authorisation Extension

6.2

The 5 yearly Authorisation Renewal

6.3

Variations to all types of Authorisation

6.4

Periodic Safety Update Reports ( PSURs)

6.5

Transfers of Marketing Authorisations 0r Authorisations

6.6

Withdrawal of the Veterinary Medicinal Product from the local Market

6.7

Certificate of Free Sale

7.

Contact Persons

1.    INTRODUCTION

Veterinary medicinal products marketed in Malta must have a Marketing Authorisation.

More detailed requirements for the authorisation of veterinary medicinal products can be found in the  Subsidiary Legislation 437.47, The Veterinary Medicinal Products Regulation which transposed Directive 2001/82/EC

Authorisation/registration can be achieved through five authorisation/registration routes and three licensing schemes. The authorisation/registration routes are described in this section and in its subsections.
  
Information on the licensing schemes can be found in another section named
Licensing Schemes.

All the Authorisation/registration routes entail an administrative fee of 60 Euro (but not the licensing schemes). Hard copies and/or electronic versions (CD, generic e-mail or Eudralink) should be submitted with each application. See the different authorisation/registration route or licensing scheme for the distinct requirements.

VMANS is moving on to a totally electronic means of submission. Only the most essential documents will be requested as hard copies.

Immunological Veterinary Medicinal Products (Vaccines)

Vaccines deserve a special mention. The manufacture, import, possession, sale, supply and/or use of certain vaccines may be prohibited in Malta, on the whole or part of its territory, pursuant to national legislation. Any person intending to manufacture, import, possess, sell, supply any immunological veterinary medicinal products must consult the Animal Health Section within the Veterinary and Phytosanitary Regulation Division on the current vaccination policies prior to the manufacture, import, possession, sale, supply and/or use.

In order for an individual to procure a vaccine from an EU/EEA it must be proven that the variant strain is present in Malta or at least in that particular farm. This is particularly important when there is no cross protection between the variant and the classical strain when there is no be benefit of using it blindly.

The VPRD suggest that if person who wants to use the vaccine suspects that that variant is present in the farm/Malta that person liaises with the company manufacturing the vaccine and sends the company swabs of the dead animal (suspected of contamination by the microbe) to do differential PCR.

The VPRD will request all the information as may be needed from both the company and the individual who wants to use the vaccine.




2.    THE FIVE AUTHORISATION ROUTES  

2.1 Centrally Authorised 

Click here for information about centrally-authorised authorization route.

A Community Marketing Authorisation which is granted by the European Commission through the Centralised Procedure in accordance with Regulation (EU) 726/2004.   The Marketing Authorisation obtained in this way is named a ‘Community Marketing Authorisation’ and is valid in all EU/EEA countries. 

2.2 MRP/DCP

Click here for information about MRP/DCP authorization route.   

A Marketing Authorisation which is granted by the Veterinary Medicines and Animal Nutrition Section through the Mutual Recognition or Decentralised Procedures, in line with S.L 437.47. 

2.3 Nationally Authorised Marketing Authorisation 

A Marketing Authorisation which is granted by the Veterinary Medicines and Animal Nutrition Section through the National Procedures, in line with S.L 437.47. It is the only way by which veterinary medicinal products from Third countries can be placed on the Maltese market. 

2.4 Nationally Registered in Accordance with Regulation 7   

Click here for information about Regulation 7 registration route​​.

A National Authorisation granted in accordance with Regulation 7 of S.L 437.47 in line with article 7 of Directive 2001/82/EC.  The applications are further classified into 4 types:

a.    Food Producing Animals
b.    Non-Food Producing Animals
c.    Herbal
d.    Homeopathics

2.5 Nationally Authorised in Accordance with Regulation 4(2)    

Click here for information about Regulation 4(2) authorization route.

A National Authorisation granted in accordance with Regulation 4(2) of S.L 437.47 in line with article 4(2) of Directive 2001/82/EC. This National Procedure is used for veterinary medicinal products which are administered to small non-food animals (but NOT cats and dogs) kept exclusively as pets. These animals are: aquarium animals, terrarium animals, cage birds, homing/racing pigeons, pet rabbits, small rodents and ferrets.

For ease of reference this route can be described as the ‘Exemption Scheme for Small Animals and Pets’.

The Flow Diagram of Authorisation Routes’ depicts all the available authorisation routes and licensing schemes.

Applicants can find more information on the Registration of Vet Medicine leaflet​

3.    SUBMISSION OF THE APPLICATION FORMS

In all cases application forms can be downloaded from this website and the original signed hard copy must be sent by post to:
 
Godwin Farrugia  
Veterinary Medicines and Animal Nutrition Section,
Veterinary Regulations Directorate,
Abattoir Square, Albert Town Marsa, MRS 1123, Malta.

The electronic copy can
: be sent to godwin.farrugia@gov.mt, or included on a CD/DVD which is enclosed with the application form with the rest of the supporting documentation. The electronic copy of the SmPCs must always be in editable word format.

Currently this section does  not make use of the Common European Submission Platform (CESP) for the exchange of information and submission of applications.

4.    TIME FRAMES FOR THE AUTHORISATION ROUTES  

The Veterinary Medicines and Animal Nutrition Section has a system to prioritise applications. The most urgent applications are dealt with in the shortest timescale.  The timescale for the review of application depends on the route of authorisation. The measure of urgency depends on the most pressing need in order to safeguard public or animal health, i.e. an application to process a rabies vaccine during a possible treat will be treated as more urgent than an application for an aquarium fish medicine.
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. 


After the authorisation is granted, the authorisation holder should be vigilant of the product on the market and watch out for any adverse drug reactions or product/batch defects. The Authorisation holder must also submit any proposed variations to the Veterinary Medicines and Animal Nutrition Section.

The time-frames (without considering clock-stops and breakdown sessions) for some of the Authorisation Routes  are:

Type of Authorisation:     Time Frame:

Regulation 7:         45 days
Regulation 4(2):     30 days
Notification for centrally Authorised Products:    10 days

The final time frame will ultimately depend on the time taken by the applicant to respond to VMANS ‘s queries.

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/assessment.

If no response is received after 6 months the applicant will be instructed to re-submit the application for the product in question.

5.    PRICING STRUCTURE

The fees for the registration and annual extension of  the Regulation 7, Regulation 4(2), MRP/DCP and Notification for centralised Products  are as follows: 

NOTE 1: The current fee  is € 60 annually for each product, pharmaceutical form or strength thereof.

VMP-A and all strengths thereof, e.g. 10mg/ml, 20mg/ml, 30mg/ml etc
3 applications /3 certificates for the 3 strengths/ 3 MA numbers, each number covers a product 3 x € 60 = € 180

NOTE 2: Different pack sizes of a same strength and volume would count as one product (e.g. pack size of 24 tabs or 48 tabs, pack size of 6 vials or 12 vials) and subject to one € 60 fee

VMP-A 10mg/ml X10ml  and all pack sizes thereof e.g. 10, 20, 30 etc.
one application / 1 certificate for all pack sizes/, 1 MA number, 1 x  € 60 for all  

NOTE 3: Dosage forms with variable volumes of a given strength would count as one product and subject to one € 60 fee if the target species of each volume is the same.

VMP-A 10mg/ml and all volumes thereof e.g. 5ml for small  dogs, 10ml for medium dogs, 20ml for large dogs
3 applications /3  certificates for each  volumes, 3 MA numbers,  each number covers a product but  1 x € 60 or all

If the target species is different for any given volume, then that volume is subject to another € 60 fee


VMP-A 10mg/ml and all volumes thereof e.g. 5ml for small  dogs, 10ml for medium dogs, 20ml for large dogs, 20 ml for horses 
4 applications /4  certificates for each  volumes /, 4 MA numbers, each number covers a product but  2 x € 60 = € 120

NOTE 4: These fees do not include the prices for the assessment of a Full National Marketing Authorisation by the VPRD, if applicable.  The fees are applicable only to the registration of Veterinary Medicinal Products and not of assessments for the granting of a Marketing Authorisation.

NOTE 5: All fees are payable on invoice sent by post or e-mail to the applicant. 


NOTE 6:
These fees apply also to the preparation of Free Sale Certificates as well (see section 6.7)


The Veterinary and Phytosanitary Regulation Division Bank Account Number

 
Beneficiary: Veterinary and Phytosanitary Regulation Division

CENTRAL BANK OF MALTA
CASTILLE PLACE
VALLETTA , MALTA

MT55MALT011000040001EURCMG5001H

MALTMTMT

 
 
 

 

 

 

It is VMANS ‘s policy not to issue any refunds. However, money can be netted off with any future amounts due to the VMANS.

6.    POST AUTHORISATION ACTIVITIES (GENERAL INSTUCTIONS)

6.1 The Annual Authorisation/registration Extension

The Annual Authorisation Extension is carried out for all authorisation/registration routes and it entails an administrative fee of 60 Euro. The 60 Euro fee pertains to each and every veterinary medicinal product which is authorised/registered through any route. Upon payment, the terms of Marketing Authorisation are re-confirmed and the authorization/registration is extended for a period of one year.

Applicants are not requested to complete any standard application form; they are only required to notify this Section through a notification letter. Both  paper format or an e-mail are acceptable. For paper formats applicants may use Form IH​. Cheque are payable to the Veterinary and Phytosanitary Regulation Division (VPRD). Applicants  may also deposit the money to the VPRD bank account (above). An e-mail will be sent to the applicant  with the new Validity Period and referring to the receipt number present on the receipt after payment has been affected . The e-mail should be retained with the original authorisation.

The annual extension allows the continuing monitoring of the product on the Maltese market. Although there is no standard application form, the applicant is obliged to enlist all the variations that may have occurred during the one year period, and submit revised/updated Product Information if this is applicable.   

It is the duty of the authorisation holder to maintain the validity of the authorisation of the product and pay the annual fee on time. It is undesirable that this section keeps sending repeated reminders for payment to be affected on time. 

All fees are payable on invoice sent by post or e-mail to the applicant once the latter confirms the extension of the authorization and the procedure for extension can start.

Extension of Authorisation should not be confused with a Line Extension of a Marketing Authorisation. Please refer to the Table of Misconception.​

6.2 The 10 yearly or indefinite  Authorisation Renewal

Renewal is the re-evaluation of the risk/benefit ratio of the veterinary medicinal product. The applicant should provide this Section with a consolidated version of the file in respect of quality, safety, efficacy and environment risk assessment. All variations introduced since the registration or authorisation was first granted must be included with the application. If the risk/benefit ratio is still favourable, the registration for Regulation 7 and authorisation for Regulation4(2) are renewed for a period of 10 years.


After 10 years it is subsequently renewed for another 10 year period and so forth.

In the case of products which are granted a full Marketing Authorisation, once they are renewed after the first 5 year period, their authorisation becomes indefinite unless another risk/benefit assessment is required. The renewal application form for products which have a full Marketing Authorisation is different from the renewal used for products authorized through Regulation 7 of S.L437.47

There is no fee for renewal procedures carried out by the Veterinary Medicines and Animal Nutrition Section.  

Submissions can be made as hard copies or electronically  r
eplaced: godwin.farrugia@gov.mt  

Renewal of centrally authorised products is carried out by European Medicines Agency (EMA). All the documents are submitted to the agency directly by the Market Authorisation Holder (MAH).

Application forms for renewals can be downloaded from here. This section would need to be notified of the intention for renewal at least 1 month prior to the end of the authorization date.    

More information about the renewal and extension of products authorised  in accordance with  Regulation 7 and Regulation 4(2) is provided in the 
Instructive Leaflet on Renewals and Extensions of Authorisations.

For renewal application forms go to the main page.

Important: The annual administrative fee must not be confused with the 10-yearly renewal.

6.3 Variations

All variation application types for all authorisation routes can be sent electronically  to godwin.farrugia@gov.mt . No fees are due as these are included in the annual fee of the products.

The differences between the variations of each authorisation route are described in this document entitled, Variations for each Authorisation Type​.​

For variation application forms go to the main page.

6.4 Periodic Safety Update Reports (PSURs)

PSURs for product authorised through Regulation 7 of S.L 437.47 are not necessary.  PSURs of centrally authorised products are evaluated by EMA. There is no need to submit PSURs for products authorised nationally under the exemption scheme for small animals and pets (i.e. product authorised through Regulation 4(2) of S.L 437.47).

PSURs submissions can be submitted electronically on
 Eudralink stephen.spiteri@gov.mt.

6.5 Transfers of Marketing Authorisations or Authorisations

For full National Marketing Authorisations a Transfer Application Form can be downloaded here,  and once completed sent to:

Godwin Farrugia,
Veterinary Medicines and Animal Nutrition Section,
Abattoir square, Albert Town, Marsa MRS1123

The applicants are advised to contact
stephen.spiteri@gov.mt for Transfer Applications in the case of all the other types of Authorisations (except for centralised products)

6.6 Withdrawal of the Veterinary Medicinal Product from the Market

The withdrawal procedure described in this section can be used for all types of authorisation routes. A Withdrawal Application form can be downloaded from here. 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 (variations, etc.) should still continue to be honoured.

If the reasons for withdrawal are of commercial nature, the application form and procedure are sufficient.  However, if safety issues are involved, the authorisation holder may initiate a batch recall or discontinue the product altogether (see the section related to product/batch recalls).   
                                                                                       
It is recommended that the withdrawal application form is submitted before the payment of an annual administrative fee since no refunds are possible afterwards. The transfer of the validity period of the withdrawn product onto a new product can, however, be considered.   

The withdrawal application form can be sent electronically to
godwin.farrugia@gov.mt. The hard copy can also be sent by post and addressed to Godwin Farrugia.   

It is important that the ‘proposed date of withdrawal’ is clearly marked on the application form, and that this does not precede the withdrawal application form submission date.

If the product is not officially withdrawn, for all intents and purposes, it is still on the Maltese market.

The applicant must exhaust the stock of the veterinary medicine within 6 months from the desired date of Withdrawal. If any remaining stock remains this should not be distributed. 

The applicants can re-market the product any time after the withdrawal, i.e. the authorisation can be re-instated with the same VET/ES/VMA number. A new application form is not required but a letter of intent and the relevant fees must be sent to this Section. This letter can be submitted electronically through e-mail to 
godwin.farrugia@gov.mt or through a paper copy. This section should also be notified of any variations which might have occurred during the ‘missing period’.

6.7 Certificate of Free Sale

REQUEST AND ISSUE OF A CERTIFICATE OF FREE SALE (FSC)

1. Request for FSC submitted by the applicant, including details (product info, destination, etc)
2. Draft of FSC generated by VMANS and sent to the applicant for review of content entered/layout; invoice for administrative fee. For the Fee Structure please refer to section 5.
3. Draft resent to VMANS to be finalised and official certificate issued payment of € 60.00 as administrative fee.
4. Applicant takes the FSC from VMANS to The Malta Chamber of Commerce, Enterprise and Industry for authentication payment of administrative fee to MCCEI

(The Service is normally available at the Malta Chamber from 8 a.m. to 4 p.m. every day. It takes about ten minutes to process a certificate and payments should be made at the same time.)

5. The MCCEI details are as follows:
Manager - Statutory Affairs and Administration
The Malta Chamber of Commerce, Enterprise and Industry
Exchange Buildings,
Republic Street,
Valletta VLT1117, MALTA.

Tel: 003562203 2319 Fax: 003562124 5223
http://www.maltachamber.org.mt/

7.    CONTACT PERSONS

Those who may wish to know more on the authorization routes explained in this section may contact Stephen Spiteri on stephen.spiteri@gov.mt.mt or godwin.farrugia@gov.mt  or call on telephone number 00356 2292 5375/6