e-form

Application for the parallel importation of medicinal products

In case of renewal, include the PI number of the product to be renewed

1 DETAILS OF THE PROPOSED PARALLEL IMPORT LICENCE HOLDER (PARALLEL IMPORTER)

Name:

Address:

Country:

Telephone:

E-Mail:

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EudraGMDP Number of Wholesale Dealer’s Licence:

Person/ Company Authorised for Communication/ Signing of documents on behalf of the proposed Parallel Import Licence Holder (Annex I) (if applicable).

Name:

Address:

Country:

Telephone:

E-Mail:

Contact person in case of quality problems and defective batches:

Name:

Address:

24 hour contact number (phone/ mobile):

E-Mail:

Contact person for pharmacovigilance issues as relevant:

Name:

Address:

24-hour contact number (phone/ mobile):

Telephone:

E-Mail:

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2. DETAILS OF PRODUCT TO BE IMPORTED

3. INFORMATION ABOUT THE MARKETING AUTHORISATION IN MALTA
(REFERENCE PRODUCT)

Name of the product

Pharmaceutical form:

Strength:

Active Substance/s:

Amount of active substance/s per unit dose:

Proposed package size/s to be placed on the Market in Malta:

Source country:

Marketing Authorisation Holder
Name and Address

Marketing Authorisation Number (in the source country):

Name of the product

Pharmaceutical form

Strength

Name and address of the MAH

Marketing Authorisation Number (MA)

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4. DOCUMENTS/SAMPLE APPENDED TO THIS APPLICATION (tick as applicable)

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5. MANUFACTURER/S RESPONSIBLE FOR RELABELLING/ REPACKAGING OF THE PRODUCT

Name:

Address:

Country:

Telephone:

E-Mail:

Details of packaging operations to be carried out:

EUDRAGMP number of sites carrying out re-labelling operations:

Information on any other manufacturer should be given in the format: name, address and operations carried out.

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6. BASIS ON WHICH APPLICANT MAKES A PRESUMPTION OF ESSENTIAL SIMILARITY (AS DESCRIBED IN COMMUNICATION FROM THE COMMISSION COM (2003) 839 FINAL) BETWEEN THE LOCAL AND IMPORTED PRODUCT.

The applicant is to compare the product information of the product to be imported with that of the Maltese marketed product. If there are any significant differences, they are to be highlighted/pointed out on the proposed SPC and PL and justified.

Signature of
Applicant

Name and
Surname

Telephone number

Date

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7. Declarations for placing the parallel imported medicinal product on the Maltese market.

Name of the product, pharmaceutical form, and strength:

I hereby declare that:

1. The clinical particulars in the SmPC and package leaflet are in accordance with the currently marketed SmPC and package leaflet of the Maltese-market product.

2. My supplier will always keep me informed of any pharmacovigilance issues related to the product and that there is a system in place for handling pharmacovigilance issues as per the Parallel Importation of Medicinal Products Regulations.

3. The Marketing Authorisation Holder of the reference product marketed in Malta has been notified about the product being put on sale in Malta, one month prior to submitting the application to the Medicines Authority.

4. The product will be in line with the obligations as per the Medicines Act, 2003 and relevant subsidiary legislation.

5. All urgent safety measures, including the additional Risk Minimisation Measures, will be implemented in Malta before placing the product on the market.

6. Any quality defects and batch/product recalls shall be notified to the Medicines Authority, without unnecessary delay

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ANNEX I (if applicable) - Letter of authorisation for communication/signing on behalf of the proposed Parallel Import Licence Holder if applicable)

Name of the product, pharmaceutical form, and strength:

hereby authorise, until further notice,

whose business address is

to represent

and to undertake the following actions (tick as applicable):

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Name (In Block Letters) of the proposed Parallel Import Licence Holder:

Signature of the proposed Parallel Import Licence Holder:

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:

Name (In Block Letters) of the Person authorised to communicate/sign (as applicable) on behalf of the proposed Parallel Import Licence Holder:

Signature of person authorised to communicate/sign (as applicable) on behalf of the Authorisation Holder:

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:

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