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Reference substance samples for the quality control of medicinal products

You may import reference substance samples for the quality control of materials used in the manufacture of medicinal products free of customs duty and VAT.

The following criteria must be met to qualify for relief from customs duty and VAT:

  • the samples should be used for the quality control of materials used to manufacture medicinal products;
  • the reference substances should be approved by the World Health Organisation.

Approved for duty-free import

The consignee must be approved by Swedish Customs to import this type of goods duty free. The accountable manager should submit an application for authorisation for duty-free import, containing a description of the organisation’s activities, to Swedish Customs. Attach any supporting documents, such as organisation charts, annual reports and activity reports.

Swedish Customs will only authorise organisations that provide all necessary guarantees and whose accounts allow us to monitor their activities. Thus, submit information about the organisation’s record-keeping practices, as well a declaration stating that you are aware of the conditions for duty relief and that the organisation will comply with those conditions, in your application.

Remember to apply in time; the application must be authorised for duty-free import by the time your goods enter into free circulation.

Authorisations for duty-free import are valid for three years, counting from the date of authorisation.

Apply for duty and VAT relief

Apply for duty and VAT relief directly in the import declaration.

Note:

In case of simplified import declaration, the claim for duty relief must be made already in the simplified declaration. The data in data element 11 10 000 000 ‘Additional procedure’ must not differ between the simplified and supplementary declaration.

In case of entry in the declarant's records (EIDR), the claim for duty and VAT relief must already be made in the arrival notification. The entry in data element 11 10 000 000 ‘Additional procedure’ must not differ between the notification and the supplementary declaration in case of EIDR.

Ange följande koder för att ansöka om tull- och momsfrihet:

  • Dataelement 99 05 000 000 – Nature of transaction: 9
  • Dataelement 14 11 000 000 – Preference: 100
  • Dataelement 11 10 000 000 – Additional procedure: C18 + F45
  • Dataelement 12 03 000 000 – Supporting documents:
    • Enter document code 401G (authorised consignee decision) as the type and the authorisation number of the approval as the reference number.

VAT relief

Enter code F45 in data element 11 10 000 000 ‘Additional procedure’ to apply for VAT exemption. If you are registered for VAT, any VAT exemption is determined by the Swedish Tax Agency. Please observe that you must obtain duty relief in order to benefit from VAT exemption. This applies even if the goods are duty free (0%).

Find out more about VAT relief in the brochure VAT on imports (in Swedish) pdf, 1.4 MB.