Application for parallel importation or parallel trade

It is possible to submit an application to sell parallel imported/traded medicinal products both electronically and in paper format. We recommend the electronic application.

For applications regarding licences to sell a parallel traded veterinary medicinal product it is recommended to use our national application form below. A common EU-application form is also available on the HMA website.

Send a product sample of the medicinal product to the Swedish Medical Products Agency as a physical sample by regular mail. Enclose the form for the product sample together with the physical product sample. In the event of the product being classified as narcotics, cytostatics or if it is particularly toxic, the product sample shall be replaced by complete and high resolution images. There are guidelines on how to name medicinal products.

Electronic applications for parallel importation/trade

Electronic applications are sent by e-mail. If the e-mail is larger than 20 MB, EudraLink should be used. EudraLink is a file transfer service provided by EMA. Registration is required to use the service.

For multiple applications, one email per application is sent. New applications with multiple strengths/pharmaceutical forms from the same source Member State are sent in the same e-mail. In case of a withdrawal of the licence, the application may include several products sent in the same e-mail.

Use the following text in the subject line of the e-mail for the corresponding application:

• For a new application: ”P-HUM Nyansökan [Name of the parallel importer] [Name of the product]”
• For variations: ”P-HUM Ändringsansökan  [Name of the parallel importer] [Name of the product]”
• For a renewal: “P-HUM Förnyelseansökan [Name of the parallel importer] [Name of the product]”
• For a deregistration: ”P-HUM Avregistrering [Name of the parallel importer] [Name of the product]”

If the application includes several products, one product name followed by ”m.fl.” may be used, for example:

• “P-HUM Ändringsansökan [Name of the parallel importer] [One product name] m.fl.”

For veterinary medicinal products:
Replace P-HUM and Name of the parallel importer to P-VET and Name of the wholesale distributor.

For example:

• For a new application: ”P-VET Nyansökan [Name of the wholesale distributor] [Name of the product]”

Submit the electronic applications to RIC@lakemedelsverket.se

Application forms for creating a EudraLink account can be ordered from eudralink@ema.europa.eu

For general questions regarding electronic applications, e-mail eSubmission@lakemedelsverket.se

For support, see the checklist Elektronisk parallellimportansökan (Electronic application for parallel importation/trade) (in Swedish).

File format

Application documents must be submitted in PDF format. If possible, they should be created directly from electronic documents. The files should not have any security settings enabled in order for the content to be available for copying in text form. The application documents should be divided into separate files according to content.

A copy of the package leaflet should always be attached as a Word file. Regarding applications for variations, tracked changes must be visible.

File name

The files should be named so that they clearly state the content: 

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

Examples of clear descriptions:

• Application form
• Manufacturing authorisation
• Labelling outer package 60 tablets

The file name of the package leaflet must be entered in a standardised way. More information on this can be found under:

Paper applications

For applications submitted in paper format, the package leaflet is attached as a Word file on a CD or DVD.

The application shall only be submitted in one way, not as duplicates in different formats.

Use the same form as for an electronic application.

Comments and announcement of a decision

Any comments from the Swedish Medical Products Agency in a case, is sent to the e-mail address stated under “Contact person” in the application form.

A decision is sent to the e-mail address stated under “Parallel importer”/ “wholesale distributor” in the application form. Decisions are not signed.

Local representative

A local representative is the same as a registered representative.

• Announcement of a local representative/registered representative is submitted to the Swedish Medical Products Agency.
• The local representative is legally responsible.
• A definite distribution of responsibilities is regulated in an agreement between the parallel importer/wholesale distributor and the local representative.
• The local representative must hold a wholesale distribution authorisation.
• The Swedish Medical Products Agency sends all correspondence to the local representative, for example decision letters.
• Invoices will be sent to the local representative unless the parallel importer/wholesale distributor has notified that another billing address should be used.
• Matters relating to local representatives are handled by the Regulatory Unit at the Swedish Medical Products Agency.

Deviation texts in the labelling

A deviation text is a short supplementary text, which is indicated on the outer package of the parallel imported medicinal product and sometimes also on inner bags. It describes any differences regarding the name or the appearance (different colour, shape, embossing, marking, with/without score line) between the parallel imported/traded medicinal product and the corresponding medicinal product already authorised in Sweden.

For example:

• ”The tablet is round and embossed with XX”
• ”The blister pack is labelled both X and Y”

The deviation text is also stated in Läkemedelsfakta (Medical Products Facts) under the tab Registreringsinformation (Registration Information).

The text ”Inga avvikelser” (”No deviations”) is not stated on the outer package but in Läkemedelsfakta. It then states that the appearance is equal to the corresponding medicinal product already authorised in Sweden. However, there may still be differences in the composition compared to the direct imported medicinal product for human use, but the product is considered therapeutically equivalent. Information on the composition of a medicinal product can be found in its package leaflet.

Logotypes in the labelling

The logotype of the marketing authorisation holder for the direct imported medicinal product or the veterinary medicinal product already authorised in Sweden may be visible if it corresponds to the parallel imported/traded medicinal product’s manufacturer and if it is not too prominent. The logotype itself cannot be of a character that would indicate advertising.

Labelling of the immediate packaging

The immediate packaging (the packaging in direct contact with the medicine) is labelled so that a fast and adequate traceability is enabled. Since several parallel imported medicinal products with the same name and batch number may be on the market, not only information about the medicinal product name and the batch number is needed, but also information regarding the parallel importer/wholesale distributor. Traceability is important, since it, in case of a complaint or adverse drug reaction report, can prove that the product was handled incorrectly at the distribution stage, meaning that an error occurred at the parallel importation stage.

A blister pack is labelled with:

• the medicinal product name
• strength
• dosage form
• generic name
• parallel importer/wholesale distributor
• expiry date
• batch number

The medicinal product name, strength and dosage form are labelled on the same side of the blister pack. For blister packs, the parallel importer/wholesale distributor may be stated with name only.

Jars, bottles and such with more space, are fully labelled in accordance with the requirements for the outer package. There are exceptions for small medicinal containers.

The requirements for labelling the immediate packaging also applies, for example, to blister packs packaged in aluminium bags and vials that are sterile packaged and can be used several times after the sterile packaging is broken. It is not allowed to break sterile packaging when repackaging/re-labelling parallel imported/traded medicinal products.

Labelling of the outer packaging (and not the immediate packaging) only applies if:

• the medicinal product is to be used immediately after opening of the outer packaging and is then to be discarded
• the immediate packaging is to be stored in the outer packaging for the whole period of use.

Splitting a blister pack

It is not allowed to split unperforated blister packs due to the risk of getting too close to the tablet or capsule, which could cause a deterioration in the quality of the medicine. Splitting a perforated blister pack is only allowed if the original batch number is visible on every single part.

Bundling of packages

Bundling of packages is not allowed. Bundling means that several packages are joined together to create one big package without making a new outer package. Bundling is not appropriate for public health reasons. If the product from the source Member state cannot be obtained in the package sizes intended to be marketed in Sweden, the medicinal product should be repackaged in a new outer package.

The reason for bundling not being allowed is that the pharmacy label must remain after opening the package. When using a shrink film or something similar it will be discarded, and the pharmacy label will thereby disappear.

Each subsidiary pack may not be labelled with the same Nordic article number, barcode or package size as the outer package. When the outer package is labelled with its own Nordic article number, barcode and package size, the corresponding information for the subsidiary packs may be visible through or displayed on the side of the outer package which could result in the wrong package size being dispatched.

Bundled packages should not be able to be disassembled so that information in a foreign language that contradicts the Swedish labelling becomes visible, or that text that is not in accordance with the Swedish Medical Products Agency’s Provisions becomes visible.

The only type of multiple pack for medicinal products in the non-institutional care allowed by the Swedish Medical Products Agency is therefore a multiple pack where each subsidiary pack is provided with complete labelling and then placed in a completely labelled outer package.

A licence to sell

When a medicinal product has received a licence to be sold, a decision and an assessment report are sent to the parallel importer or wholesale distributor. The assessment report should be overseen by the parallel importer or the wholesale distributor to make sure all information is correct and that there are no misunderstandings regarding, for example, the repackaging procedure.