Effective from 1st July 2014, it will no longer be permissible to import prescription medicinal products for personal use via shipments (e.g. mail, the Internet etc.) into Norway. Furthermore, such shipments may be seized and destroyed by the Customs.
Import of prescription medicinal products is generally not allowed without an approval from the Norwegian Medicinal Agency, cf. Section 13 of the Medicines Act. However, personal import via shipments (e.g. mail order and the Internet) of medicinal products has to a certain extent been allowed from countries in the EEA (European Economic Area), i.e. EU and Iceland, Lichtenstein (and Norway).
The vast majority of medicinal products which is imported via shipment by private citizens have either been falsified medicines or illegal medicines. Acknowledging that such import involves serious threats to the public health, the Norwegian Ministry of Health and Care Services issued in 2012 a consultative document proposing amendments to the current legislation. The proposal included severe restrictions on import of medicinal products for personal use. A general ban on the import of prescription drugs/medicinal products via shipments was proposed, as well as allowing the Customs to seize and destroy falsified or illegal medicinal products.
The proposal was approved by the Norwegian Parliament in February this year and sanctioned 23rd May. The amended legislation will enter into force 1st July 2014.
Following this date, medicinal products that are imported in violation of section 13 of the Medicines Act and appurtenant Regulations may be seized and destroyed. Upon withholding the medicines, the recipient shall be notified that the medicines will be considered seized and destroyed, and given the opportunity to respond within a given deadline.
If no response is received within the deadline, the medicines may be seized and destroyed without further procedure. If a response is received by the recipient, the general rules concerning individual administrative decisions of the Public Administration Act shall apply, thus it will be possible to appeal the decision. However, the amendment also include a paragraph which gives the Ministry necessary legal basis to adopt a Regulation to exempt appeals on such decisions. Such an exemption will be considered at a later point, if the number of appeals deems it necessary.
While the amendment aims to hinder the personal import of falsified and illegal medicines, the amendments also include a general ban on the personal import of prescription medicinal products via shipments.
Previously, in accordance with section 3-2 of the Regulation on manufacturing and import of medicinal products, private citizens could (via shipment) import for personal use medicinal products from an EU or EFTA member state on certain limitations. Import (via shipment) from outside the EU/EEA was not allowed.
The limitations were that the import of the medicinal products did not exceed three months of use during a three month period. Furthermore, the recipient had to document that the medicinal products where for personal use and was legally obtained. In the case of prescription medicinal products, a prescription from an authorized physician were required.
When the amendments enter into force, all personal import of prescription medicinal products (via shipments) will be prohibited. In cases where there are differences in the prescription status in Norway and the country of origin, the Norwegian status shall apply.
Concerning OTC-products, an absolute ban on personal import via shipments was discussed, but in accordance with decision C-322/01 of the European Court of Justice (DocMorris) this was not proposed. Thus, import of OTC-products will be possible, if the following conditions are met:
- the product has status as an OTC-product in Norway
- the amount do not exceed three months of use during a period of three months
- the medicinal product has a Marketing Authorisation in Norway
- the importer is able to document that the products are for personal use and have been legally obtained in the country of origin
- the shipment contains documentation which shows that the seller can legally sell and export the medicinal products.
Products legally obtained in a member state on the basis of prescription of a physician, as well as OTC-products not fulfilling the requirements above, may be seized and destroyed by customs if imported for personal use via shipments.
The amendment concerns only personal import via shipments, not import upon personal entry. In such cases, the limitations are a reasonable amount not exceeding one year of use when entering from countries in the EEA, and not exceeding three months of use when entering from other countries. Upon personal entry, it is necessary for the importer to document that the medicines are for personal use and are legally obtained.
For drugs that are classified as either narcotic substances or performance enhancing drugs, special rules/specific limitations apply.