Labelling and package leaflet

Proposals for labelling

Each time a proposal for labelling is submitted, it needs to be complete. A part of the outer package, for example one label or one side of the package, is not accepted. Proposals for labelling for an over-labelled package must contain labels for all package sides and a picture of the over-labelled package. Exceptions are made if there has been a change of either the outer labelling only or the inner labelling only which can be divided on different dates.

For electronic applications, the files should be named so that they clearly state the content:

Name strength dosage form the source Member State's code clear description.pdf

For variation applications, please state the ASP number on the labelling proposals.

Package leaflets

Format and versions

Package leaflets for parallel imported or traded medicinal products are managed the same way as package leaflets for other types of medicinal products.

This means that:

• The package leaflet is submitted in Word-format.
• For variations, the parallel importer’s/wholesale distributor’s previous version of the package leaflet is submitted with the function ”tracked changes” activated.
• The file name of the package leaflet is stated in a standardised way.
• Header and footer cannot be used for information regarding, for example, source Member State and ASP number.
• The approved package leaflet is assigned a date by the Swedish Medical Products Agency.
• The approved package leaflet is sent electronically to the company together with the decision letter.
• The approved package leaflet is published in Läkemedelsfakta (Medical Products Facts) at the Swedish Medical Products Agency’s website.

File name

The file name of the package leaflet is stated in a standardised way:

Name strength dosage form OTC the source Member State's country code PL.docx

• The file names are in English.
• Do not use commas between the different sections.
• Current strengths should always be included even if they are not specified in the file name of the package leaflet for the product already authorised in Sweden.
• OTC is only stated if the package leaflet applies to a non-prescription medicinal product.
• PL (Package Leaflet) is stated at the very end of the file name, even when the package leaflet refers to a medicinal product from Poland (which also has PL as a country code).

For guidance, use the name of the package leaflets in Läkemedelsfakta (Medical Products Facts).

Combined package leaflets

A combined package leaflet for different strengths/dosage forms is approved if:

• The direct imported medicinal product or the veterinary medicinal product already authorised in Sweden has a combined package leaflet for the strengths/dosage forms in question.
• The parallel imported/traded medicinal product has the strengths/dosage forms in question stated in the package leaflet approved from the current source Member State.

A combined package leaflet with a combined approval is not accepted for medicinal products from different source Member States. If the package leaflet is identical for new applications from different source Member States submitted at the same time, this may be stated in the cover letters of the applications.