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Application for the renewal of a parallel import - Medicines Authority

By Joseph Burns,2014-11-21 22:54
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Application for the renewal of a parallel import - Medicines Authority

APPLICATION FOR THE RENEWAL OF A

PARALLEL IMPORT LICENCE

Medicines Authority 203 Level 3, Rue D'Argens, Gzira, GZR 1368 Malta. Tel. (+356) 23439000 Fax. (+356) 23439161 www.medicinesauthority.gov.mt Version 02 July 09

     11 DETAILS OF THE PARALLEL IMPORT LICENCE HOLDER (PARALLEL IMPORTER)

Name: _________________________________

     Address: _________________________________

     _________________________________

    Country: _________________________________ Telephone: _________________________________ Fax: _________________________________ E-Mail: _________________________________

    Name and address of the applicant, if different

Name: _________________________________

     Address: _________________________________

     _________________________________

    Country: _________________________________ Telephone: _________________________________ Fax: _________________________________ E-Mail: _________________________________

     Parallel Import Licence Holder’s trading style on labels and leaflet, if different

    ____________________________________________________________________________

    __________________________________________________

    2. PRODUCT DETAILS

Name of the product _____________________

    Pharmaceutical form _____________________

    Strength _____________________

    Medicines Authority 203 Level 3, Rue D'Argens, Gzira, GZR 1368 Malta. Tel. (+356) 23439000 Fax. (+356) 23439161 www.medicinesauthority.gov.mt Version 02 July 09

Active Ingredient/s Amount of active ingredient/s per unit dose

    _____________________________________________________________________

    _____________________________________________________________________

    _____________________________________________________________________

    _____________________________________________________________________

    Pack Size details _____________________

    Parallel Import Licence Number _____________________

    Date of expiry of the current licence _____________________

3. DOCUMENTS AND PACKAGING SAMPLES/MOCK UPS APPENDED TO THIS APPLICATION

     Summary of Product Characteristics (ANNEX C)

    Proposed label for immediate container and

    outer packaging (colour mock-ups) (ANNEX D)

    Label for immediate container and

    outer packaging of the original pack (colour mock-ups) (ANNEX H)

    Proposed patient information leaflet (ANNEX E)

    (colour mock ups)

    Patient information leaflet in country from

    which the product is to be imported (ANNEX F)

    Wholesale Dealer’s Licence (ANNEX G)

    Declaration by the applicant stating that his supplier will always

    keep him informed of any Pharmacovigilance issues related to the product requesting a parallel

    import licence (ANNEX I)

    Written declaration from the applicant stating that the marketing

    authorisation holder of the original product marketed in Malta has been notified about the

    repackaged product being put on sale in Malta, one month prior to submitting the application

    to the Medicines Authority. A copy of the letter sent to the Marketing Authorisation Holder

    should also be attached with the application form. (ANNEX J)

    Medicines Authority 203 Level 3, Rue D'Argens, Gzira, GZR 1368 Malta. Tel. (+356) 23439000 Fax. (+356) 23439161 www.medicinesauthority.gov.mt Version 02 July 09

    4. MANUFACTURER/S RESPONSIBLE FOR RE-LABELLING/RE-PACKAGING OF THE PRODUCT

Name: _________________________________

     Address: _________________________________

     _________________________________

    Country: _________________________________

    Telephone: _________________________________

    Fax: _________________________________

    E-Mail: _________________________________

Details of operations carried out

Re-labelling

    Re-packaging to change the number of blister strips in one outer carton

     Inserting a new leaflet

    Re-packaging the product

    in a new container

    or in a new outer carton

    Other

     ____________________________________________________________________________

     ____________________________________________________________________________

     ____________________________________________________________________________

     ____________________________________________________________________________

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

    Please supply a copy of the manufacturing authorisation of the above-mentioned manufacturer(s) responsible for re-labelling/re-packaging issued by the Competent Authority in the Member State (ANNEX B).

    Medicines Authority 203 Level 3, Rue D'Argens, Gzira, GZR 1368 Malta. Tel. (+356) 23439000 Fax. (+356) 23439161 www.medicinesauthority.gov.mt Version 02 July 09

    5. I CONFIRM THAT NO CHANGES HAVE BEEN MADE TO THE PRODUCT PARTICULARS OTHER THAN THOSE APPROVED BY THE MEDICINES AUTHORITY.

    I CONFIRM THAT THE CLINICAL PARTICULARS IN THE SmPC AND PACKAGE LEAFLET ARE IN ACCORDANCE WITH THE CURRENTLY MARKETED SPC AND PACKAGE LEAFLET OF THE

    ORIGINATOR (MALTESE-MARKET) PRODUCT.

    I HEREBY APPLY FOR THE RENEWAL OF THE PARALLEL IMPORT LICENCE.

    3I DECLARE THAT FEES HAVE BEEN PAID. (ATTACH PROOF OF PAYMENT ANNEX A)

    Signature of applicant _______________________________________

    Name in Block Letters _______________________________________

    Capacity in which signed _______________________________________

    Telephone number _______________________________________

    Fax number _______________________________________

Date _______________________________________

    Medicines Authority 203 Level 3, Rue D'Argens, Gzira, GZR 1368 Malta. Tel. (+356) 23439000 Fax. (+356) 23439161 www.medicinesauthority.gov.mt Version 02 July 09

EXPLANATORY NOTES

1 Name as mentioned on the wholesale dealer’s licence

    2 The ECJ has defined “repackaging” as including operations such as “removal of blister packs from original external packaging and their insertion into new external packaging” or “addition to the packaging of new user instructions or information or the fixing of self-stick labels” (ECJ,

    11 July 1996, MPA Pharma GmbH vs Rhone Poulenc Rorer GmbH (C-232/94) and BMS vs

    Paranova A/S (C-427/93, C-429/93, C-436/93) and joined cases C-71/94, C-72/94, C-73/94) 3 Payment of the relevant fee is to be made at: (when executing the payment the amounted should be remitted in full, net of all bank charges)

Bank Details - HSBC Malta plc.

    Gzira Branch

    Malta

    Account No. - 039-011176-002

    Swift Code - MMEBMTMT

    IBAN - MT78MMEB44392000000039011176002

    4 Parallel importers are required to ensure that there is a clear audit trail from the supplier in the source country. In the event of a recall of a batch of the parallel imported medicinal product in the source country, it is imperative that the importer is informed by the supplier so that the importer can take appropriate action. The Medicines Authority requires a declaration by the wholesale dealer that his supplier is going to keep him informed of any Pharmacovigilance issues. In addition, there should be a Standard Operating Procedure that covers the respective responsibilities of the supplier and importer. This will be requested in the course of inspections of manufacturers and wholesalers. 5 As per Communication from the Commission COM (2003) 839 final

    Medicines Authority 203 Level 3, Rue D'Argens, Gzira, GZR 1368 Malta. Tel. (+356) 23439000 Fax. (+356) 23439161 www.medicinesauthority.gov.mt Version 02 July 09

ANNEX A

Proof of Payment

Medicines Authority 203 Level 3, Rue D'Argens, Gzira, GZR 1368 Malta. Tel. (+356) 23439000 Fax. (+356) 23439161 www.medicinesauthority.gov.mt Version 02 July 09

    ANNEX B

    Copy of the manufacturing authorisation of the manufacturer(s) responsible for re-labelling/re-packaging issued by the Competent Authority in the

    Member State mentioned in Section 5 of the application form

    Medicines Authority 203 Level 3, Rue D'Argens, Gzira, GZR 1368 Malta. Tel. (+356) 23439000 Fax. (+356) 23439161 www.medicinesauthority.gov.mt Version 02 July 09

ANNEX C

Summary of Product Characteristics

Medicines Authority 203 Level 3, Rue D'Argens, Gzira, GZR 1368 Malta. Tel. (+356) 23439000 Fax. (+356) 23439161 www.medicinesauthority.gov.mt Version 02 July 09

    ANNEX D

    Proposed Label for Immediate Container and Outer Packaging

    (colour mock ups)

    Medicines Authority 203 Level 3, Rue D'Argens, Gzira, GZR 1368 Malta. Tel. (+356) 23439000 Fax. (+356) 23439161 www.medicinesauthority.gov.mt Version 02 July 09

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