Basic information
Outline of the system
A licence is necessary for companies who want to import medicinal products for (whole)sale. Personal imports from outside the EU/EEA-area are prohibited. However, the Norwegian Medicines Agency can permit an exception under special circumstances. In these cases, a licence is necessary. An import licence has to be applied for. In practice such licences are given when a shipment is stopped by the Customs, not in advance.
Product coverage
The licensing systems are the two mentioned above. The products covered are all medicinal products.
Nature of licensing
Automatic
If Automatic, administrative purpose
Non-Automatic
If Non-Automatic, description of the notified Non-Automatic Licensing regime
Products under restriction as to the quantity or value of imports
The overall purpose of the licensing system is to ensure that medicines sold on the Norwegian market have good quality, are effective and safe to use.
Questions for products under restriction as to the quantity or value of imports
There are no such restrictions.
The system applies to products originating from which country?
Companies' imports: from all countries inside EU/EEA-area an import license is necessary. From countries outside this area a manufacturing–licence is necessary. Imports of medicinal product not intended for medical use can be imported from all countries. Personal imports: a licence after exception is needed from countries outside EU/EEA-area.
Expected duration of licensing procedure
Legal requirements
Is the licensing statutorily required?
Medicinal Product Act No. 132 of 4 December 1992, §12 and §13, Regulation No. 1219 of 21 December 1993 regarding wholesaling, Regulation No. 1441 of 2 November 2004 regarding production and imports of medicinal products.
Does the legislation leave designation of products to be subject to licensing to administrative discretion?
The notion of a medicinal product is defined by the above regulation.
Is it possible for the government to abolish the system without legislative approval?
A legislative approval is necessary to abolish the system.
Eligibility of applicants
Is there a system of registration of persons or firms permitted to engage in importation?
Companies have to be registered in Norway.
What persons or firms are eligible to apply for a licence?
Everyone, both companies and individuals, are eligible to apply for an import licence.
Is there a registration fee?
There is no registration fee.
Is there a published list of authorized importers?
The Norwegian Medicines Agency publishes a list containing the companies which have an import licence, see https://legemiddelverket.no/english/import-wholesaling-and-retailing.
Contact point for information on eligibility
Ministry/Authority
Address
Telephone
Fax
E-mail address
Website
Contact officer
Submission of an application
Administrative body(ies) for submission of an application
Documentation requirements
What information is required in applications?
An application form is submitted at request. The company has to fill in the application form and eventually give additional information, if required.
What documents is the importer required to supply with the application?
Window of submission of an application
How far in advance of importation must application for a licence be made?
Are there any limitations as to the period of the year during which application for licence can be made? If so, explain
No.
Issuing the license
Can a licence be granted immediately on request?
Usually not, see Answer 29.
Can licences be obtained within a shorter time-limit or for goods arriving at the port without a licence
Applications from companies shall be handled within 90 days, but there is usually a much shorter time-limit. The 90-days deadline follows from the EU Directive 2001/83/EC, Art.78, which is incorporated into the Wholesale Regulation § 2. Goods arriving at the port without licence can under special circumstances be imported for the one case if it later will be given an import licence.
Applications from persons will be handled within one or a few days.
Which administrative body is responsible for approving application of licences?
The licence is given by the Norwegian Medicines Agency. The Customs control the imports.
Must the applications be passed on to other organs for visa, note or approval?
Are there any other conditions attached to the issue of a licence?
No.
Fees and other administrative charges
Is there any licensing fee or administrative charge?
No.
What is the amount of the fee or charge?
Is there any deposit or advance payment required associated with the issue of licences?
No.
Amount or rate?
Is it refundable?
What is the period of retention?
What is the purpose of this requirement?
Refusal of an application
Under what circumstances may an application for a licence be refused other than failure to meet the ordinary criteria?
If the company is not registered in Norway, the application will be refused.
Are the reasons for any refusal given to applicants?
The reason for a refusal will be given to the applicant.
Have applicants a right of appeal in the event of refusal to issue a licence?
Yes.
If so, to what bodies and under what procedures?
It is possible to appeal the decision to the Ministry of Health and Care Services under an administrative procedure. The applicant may also refer the matter to a court of law.
Importation
Are there any limitations as to the period of year during which importation may be made?
No.
What documents are required upon actual importation?
The importer has to present the import licence to the Customs.
Are there any other administrative procedures, apart from import licensing and similar administrative procedures, required prior to importation?
No.
Conditions of licensing
What is the period of validity of a licence? Can the validity be extended? How?
Normally the validity of a licence is five years. In certain cases the period can be shorter. The period of validity may be extended after an application for extension.
Is there any penalty for the non-utilization of a licence or a portion of a licence?
No.
Are licences transferable between importers? If so, are any limitations or conditions attached to such transfer?
No.
Foreign Exchange
Is foreign exchange automatically provided by the banking authorities for goods to be imported?
N/A.