1 Since 1 July 2013, Notification Shall Also Be Given If the Medicinal Product Is Parallel

1 Since 1 July 2013, Notification Shall Also Be Given If the Medicinal Product Is Parallel

Send the form to: /
or
Läkemedelsverket
Swedish Medical Products Agency
Box 26
751 03 Uppsala
Sweden / Application for licence to parallel import medicinal products
Date:
Information regarding the medicinal product:
Name under which the product is to be marketed in Sweden
Strength / Dosage form
Package size(s)
Routes of administration
Parallel importer:
Company / Phone / E-mail
Address / P.O. Box
Postcode / City / Country
Contact person (any comments during the assessment of the application is sent to the E-mail address stated below):
Name / Company / Phone / E-mail
Local representative (if relevant):
Company / Phone / E-mail
Address / P.O. Box
Postcode / City / Country
1. General information about the product to be imported:
1.1 Exporting EU- or EEA state
1.1.2 Shall the notification procedure as described in section 9 LVFS 2012:19 take place? (Applies if the exporting state is Bulgaria, Estonia, Latvia, Lithuania, Poland, Romania, the Slovak Republic, Slovenia, the Czech Republic or Hungary)[1].
Yes
No
1.1.3 If yes, has notification been given to the concerned party 30 days before this application was submitted to the Medical Products Agency?
Yes
No
1.2 Name of product, strength and pharmaceutical dosage form in the exporting state
Name of the product
Strength / Dosage form
1.3 Marketing authorisation number of the marketing authorisation in the exporting state
1.4 Name and address of the holder of the marketing authorisation in the exporting state
Name / Address
1.5 Name and address of the manufacturer of the product (With manufacturer means the person on behalf of whom the qualified person decides on release for sale)
Name / Address
2. Information about the existing marketing authorisation in Sweden that covers the product (directly imported) which the applicant refers to:
2.1 Name of the product
Strength / Dosage form
2.2 Marketing authorisation number
2.3 Name and address of holder of the above mentioned marketing authorisation
Name / Address
2.4 The holder of the above marketing authorisation has been/will be notified according to section 8 LVFS 2012:19 prior to marketing of the parallel imported product
We have already notified
We will notify prior to marketing of the product
3. Describe differences between the directly imported product and that to be imported:
Notable differences e.g. concerning colour, break-mark, appearance, size. Also differences concerning pack sizes, type of packaging, and attached devices has to be stated.
4. Information about relabelling/repackaging:
4.1 Full details of the relabelling, and the repackaging procedure. Also consider: labelling, print, transport, storage and any attached devices.
4.2 Quality control
GMP and GDP is followed, instructions and routines for reception, storage, repackaging and batch release, transport and routines for withdrawal exist.
4.3 Name, address and manufacturing authorisation and, when appropriate, technical agreement of the company (ies) who carries (y) out the repackaging/relabelling. Also state whether the company (ies) carries (y) out only repackaging, only batch release or repackaging and batch release.
Name and address
Repackaging
Batch release
Repackaging and batch release
Manufacturing authorisation
Enclosed with previous application, still valid, sent (date):
Copy is enclosed
Technical agreement
Enclosed with previous application, sent (date):
Copy is enclosed
Member of the same group of companies, not necessary
5. Package data for the parallel imported product (repackaged/relabelled):
5.1 Package container
5.2 Shelf-life
5.3 Storage conditions
5.4 Shelf-life (after first opening of container)
5.5 Storage conditions (after first opening of container)
5.6 Shelf-life (after reconstitution)
5.7 Storage conditions (after reconstitution)
6. Enclosed drafts, or copies, of the:
Labelling on the immediate container of the product
Labelling on the outer container or carton
Package leaflet
7. Samples of all the containers and package sizes intended for importation from exporting state:
7.1 Samples enclosed
Samples will be sent by regular mail dated:
Photos replaces the samples and will be enclosed with the application (only applicable for narcotic medicinal products and cytostatic medicinal products)
7.2 Package size(s) / 7.3 Package container / 7.4 Batch no

Version 2018-04-041 (4)

[1] Since 1 July 2013, notification shall also be given if the medicinal product is parallel imported from Croatia, see Croatia´s accession treaty with EU.