Application Form for the Transfer of a Marketing Authorisation Holder for an Authorised* Product

e-form

Please note that submission must be sent electronically (through the Common European Submission Portal – CESP).

* When a Marketing Authorisation has already been issued by the Malta Medicines Authority

This application enables a company to take over responsibility from another company (different legal entity) where the application is in identical terms to the existing marketing authorisation.

DOCUMENTS WHICH HAVE TO BE SUBMITTED WITH THE APPLICATION FORM FOR A MARKETING AUTHORISATION TRANSFER FOR AN AUTHORISED PRODUCT:

Details of documents to be submitted : (Kindly indicate if submitted )

1. Legal document for Transfer (application form).

2. Proof of payment (as per current legal notice on fees).

3. Proof of establishment of the new Marketing Authorisation Holder (from official sources).

4. SmPC (Word format), Package Leaflet & Labelling bearing the new.

Marketing Authorisation Holder Name:

Address:

Marketing Authorisation Number of Malta:

5. A variation for a change in the PSMF summary (C.I. 8) and/or other relevant variations pertaining to the transfer (e'g' change in name of the medicinal product affected due to transfer) have been submitted.

6. Pharmacovigilance system master file (PSMF) : (Kindly indicate if submitted )

PSMF declaration*

*If the proposed MAH and the previous MAH belong to the same group of companies and the PSMF is going to be shared, a variation to the PSMF may not be required.

LI017/05 Appendix 1 Version 02

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1. DETAILS OF THE PROPOSED MARKETING AUTHORISATION HOLDER AFTER TRANSFER

Name and address:

Name and address of the applicant acting on behalf of the proposed Marketing Authorisation Holder, if different:

Name and address of the local representative for the product in Malta:

*A letter of authorisation for communication, signing, receipt of licences and/or any other activity is required for the applicant to act on behalf of the Marketing Authorisation Holder

2. DETAILS OF THE CURRENT MARKETING AUTHORISATION HOLDER

Name and address:

Name and address of the applicant acting on behalf of the current Marketing Authorisation Holder, if different:

Name and address of the new local representative for the product in Malta:

*A letter of authorisation for communication, signing, receipt of licences and/or any other activity is required for the applicant to act on behalf of the Marketing Authorisation Holder

3. DETAILS OF THE PRODUCT

Current MA Number:

Name of product:

Name of active substance(s):

Pharmaceutical form:

Strength(s):

*For bulk transfers, only one application form is required. Please include a list of products, including the strength, form and MA numbers.

LI017/05 Appendix 1 Version 02

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STATEMENT TO BE SIGNED BY THE EXISTING MARKETING AUTHRISATION HOLDER

REASON FOR TRANSFER APPLICATION

1. I hereby notify the Medicines Authority that

is to be transferred to

2. I request that an amended authorisation, reflecting this transfer and based on the original dossier and any ongoing or subsequent data submitted, be issued to

3. I confirm that the entire dossier for the product has been transferred to

This dossier includes all of the data in support of the original application together with all correspondence with the Medicines Authority concerning the product and all pharmacovigilance data both before and after the issue of the original MA.

4. I acknowledge our responsibilities in the event of any adverse reaction or quality defect associated with any remaining product bearing our name, address and MA number.

5. I acknowledge our responsibilities in the event of the necessity to recall from the market any remaining product bearing our name, address and MA number.

Signed:

Kindly fill in the Declaration form at the following link http://www.medicinesauthority.gov.mt/onlineapplications
A Declaration form should be submitted for each signatory.

Date:

Status of signatory:

Telephone No.:

E-mail address:

LI017/05 Appendix 1 Version 02

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STATEMENT TO BE SIGNED BY THE PROPOSED MARKETING AUTHORISATION HOLDER

REASON FOR TRANSFER APPLICATION:

1. I will have the sole responsibility for the product including obtaining approval for any changes subsequent to the grant of this product authorisation.

I have received the entire dossier for

from

2. This dossier includes all of the data in support of the original product authorisation application together with all correspondence with the Medicines Authority concerning the product and all Pharmacovigilance data both before and after the issue of the original product authorisation.

3. I have been assured by the current MA holder/applicant that, apart from the change of name and address of the product authorisation holder and the product authorisation number, the dossier on which the transfer is based is identical in every respect to that submitted by the original holder.

4. I confirm that I/we are established in the European Community and evidence of establishment in the EU has been provided with this application.

5. I confirm that I/we have adequate procedures in place to meet Pharmacovigilance obligations in accordance with current directives and regulations in force in the European Union and will act in compliance with them.

6. I confirm that I/we have established within my/our undertaking a scientific service in charge of information about the medicinal product within the meaning of the current Medicinal Products (Advertising) Regulations in force.

7. In case the drug substance of the medicinal product has an Active Substance Master File (ASMF), I will provide a new letter of access for the proposed MAH with the next update to the ASMF when the variation is submitted.

Signed:

Kindly fill in the Declaration form at the following link http://www.medicinesauthority.gov.mt/onlineapplications
A Declaration form should be submitted for each signatory.

Status of signatory:

Telephone No:

Email address:

Date:

8. Name of the person acting on behalf of the MAH if different:

* A letter of authorisation for communication, signing, receipt of licences and/or any other activity is required for the applicant to act on behalf of the Marketing Authorisation Holder.

LI017/05 Appendix 1 Version 02

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TO BE COMPLETED BY THE NEW PROPOSED MARKETING AUTHORISATION HOLDER

1. I confirm that I/we are established in the European Community and evidence of establishment in the EU has been provided with this application.

2. I confirm that I/we have adequate procedures in place to recall the medicinal product from the Maltese market.

3. I confirm that I/we have adequate procedures in place to meet Pharmacovigilance obligations in accordance with current directives and regulations in force in the European Union and will act in compliance with them.

4. I confirm that I/we have established within my/our undertaking a scientific service in charge of information about the medicinal product within the meaning of the current Medicinal Products (Advertising) Regulations in force.

5. I declare that healthcare professionals will be informed that a transfer has taken place when both the product containing the previous details of the MAH and product containing the new details of the MAH are marketed at the same time.

Signed:

Kindly fill in the Declaration form at the following link http://www.medicinesauthority.gov.mt/onlineapplications
A Declaration form should be submitted for each signatory.

Date:

Status of signatory:

Telephone No:

E-mail address:

6. Name of the person acting on behalf of the MAH if different:

Email address:

* A letter of authorisation for communication, signing, receipt of licences and/or any other activity is required for the applicant to act on behalf of the Marketing Authorisation Holder.

LI017/05 Appendix 1 Version 02

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