Import Licensing Notification Portal

Q1. Give a brief description of each licensing system as a whole and, with respect to each, reply to the following questions as relevant, placing all of the material with respect to a given system in sequence together, and using cross references as appropriate when elements which have already been described are also present in another system.

The EU directives concerning medical devices have been ratified as part of EFTA’s treaty with the EU. National regulations have however not been set yet.
Therapeutic medicines are not subject to special import licences except when the active ingredients are narcotic drugs or psychotropic substances (see following, IV). They must however be registered according to the Pharmaceutical Act no. 93/1994 and Regulation on the registration of proprietary medicinal products and the issuing of marketing authorisations no. 465/1995 or Regulation on the registration of parallel imported medicinal products and the issuing of marketing authorisations no. 582/1995.

Q2. Identify each licensing system maintained and state what products, appropriately grouped, are covered.

Therapeutic substances and goods

Q3. The system applies to goods originating in and coming from which countries?

Q4. Is the licensing intended to restrict the quantity or value of imports, and if not, what are its purposes? Have alternative methods of accomplishing the purposes been considered and if so which? Why have they not been adopted?

Q5. Cite the law, regulation and/or administrative order under which the licensing is maintained. Is the licensing statutorily required? Does the legislation leave designation of products to be subjected to licensing to administrative discretion? Is it possible for the government (or the executive branch) to abolish the system without legislative approval?

Q6. For products under restriction as to the quantity or value of imports (whether applicable globally or to a limited number of countries or whether established bilaterally or unilaterally):

Q6.I. Is information published, and where, concerning allocation of quotas and formalities of filing applications for licences? If not, how is it brought to the attention of possible importers? Of governments and export promotion bodies of exporting countries and their trade representatives? Is the overall amount published? The amount allocated to goods from each country? The maximum amount allocated to each importer? How to request any exceptions or derogations from the licensing requirement?

Q6.II. How is the size of the quotas determined: on a yearly, six-monthly or quarterly basis? Are there cases where the size of quota is determined on a yearly basis but licences are issued for imports on a six-monthly or quarterly basis? In the latter case, is it necessary for importers to apply for fresh licence on a six-monthly or quarterly basis?

Q6.III. Are licences allotted for certain goods partly or only to domestic producers of like goods? What steps are taken to ensure that licences allocated are actually used for imports? Are unused allocations added to quotas for a succeeding period? Are the names of importers to whom licences have been allocated made known to governments and export promotion bodies of exporting countries upon request? If not, for what reason? (Indicate products to which replies relate.)

Q6.IV. From the time of announcing the opening of quotas, as indicated in I above, what is the period of time allowed for the submission of applications for licences?

Q6.V. What are the minimum and maximum lengths of time for processing applications?

Q6.VI. How much time remains, at a minimum, between the granting of licences and the date of opening of the period of importation?

Q6.VII. Is consideration of licence applications effected by a single administrative organ? Or must the application be passed on to other organs for visa, note or approval? If so, which? Does the importer have to approach more than one administrative organ?

Q6.VIII. If the demand for licences cannot be fully satisfied, on what basis is the allocation to applicants made? First come, first served? Past performance? Is there a maximum amount to be allocated per applicant and, if so, on what basis is it determined? What provision is made for new importers? Are applications examined simultaneously or on receipt?

Q6.IX. In the case of bilateral quotas or export restraint arrangements where export permits are issued by exporting countries, are import licences also required? If so, are licences issued automatically?

Q6.X. In cases where imports are allowed on the basis of export permits only, how is the importing country informed of the effect given by the exporting countries to the understanding between the two countries?

Q6.XI. Are there products for which licences are issued on condition that goods should be exported and not sold in the domestic market?

Q7. Where there is no quantitative limit on importation of a product or on imports from a particular country:

Q7.a. How far in advance of importation must application for a licence be made? Can licences be obtained within a shorter time-limit or for goods arriving at the port without a licence (for example, owing to inadvertency)?

Q7.b. Can a licence be granted immediately on request?

Q7.c. Are there any limitations as to the period of the year during which application for licence and/or importation may be made? If so, explain.

Q7.d. Is consideration of licence applications effected by a single administrative organ? Or must the application be passed on to other organs for visa, note or approval? If so, which? Does the importer have to approach more than one administrative organ?

Q8. Under what circumstances may an application for a licence be refused other than failure to meet the ordinary criteria? Are the reasons for any refusal given to the applicant? Have applicants a right of appeal in the event of refusal to issue a licence and, if so, to what bodies and under what procedures?

Q9. Are all persons, firms and institutions eligible to apply for licences: (If not, is there a system of registration of persons or firms permitted to engage in importation? What persons or firms are eligible? Is there a registration fee? Is there a published list of authorized importers?) a) under restrictive licensing systems? b) under non-restrictive systems?

Q10. What information is required in applications? Submit a sample form. What documents is the importer required to supply with the application?

Q11. What documents are required upon actual importation?

Q12. Is there any licensing fee or administrative charge? If so, what is the amount of the fee or charge?

Q13. Is there any deposit or advance payment requirement associated with the issue of licences? If so, state the amount or rate, whether it is refundable, the period of retention and the purpose of the requirement.

Q14. What is the period of validity of a licence? Can the validity of a licence be extended? How?

Q15. Is there any penalty for the non-utilization of a licence or a portion of a licence?

Q16. Are licences transferable between importers? If so, are any limitations or conditions attached to such transfer?

Q17. Are any other conditions attached to the issue of a licence? a) for products subject to quantitative restriction? b) for products not subject to quantitative restriction?

Q18. Are there any other administrative procedures, apart from import licensing and similar administrative procedures, required prior to importation?

Q19. Is foreign exchange automatically provided by the banking authorities for goods to be imported? Is a licence required as a condition to obtaining foreign exchange? Is foreign exchange always available to cover licences issued? What formalities must be fulfilled for obtaining the foreign exchange?