Medicinal products and devices
- Document symbol
- G/LIC/N/3/SVN/2
- Original language
- English
- Published on
- 25/10/2002
Outline of Systems
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.
Import of medicinal products which have a trafficking licence in the Republic of Slovenia is free. Import licence is required for certain products in accordance with the Medicinal Products and Medicinal Devices Act. The licensing is administered by the Agency of the Republic of Slovenia for Medicinal Products within the Ministry of Health.
Purposes and Coverage of Licensing
Q2. Identify each licensing system maintained and state what products, appropriately grouped, are covered.
The licensing covers products that are listed in Rules on the conditions and the procedure for obtaining a special authorisation for the import of medicinal products and devices.
Q3. The system applies to goods originating in and coming from which countries?
The system applies to goods originating in and coming from all 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?
The licensing is intended to monitor the trade with medicinal products and devices.
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?
The licensing system is based on:
- Medicinal Products and Medicinal Devices Act (OG No. 101/99, 70/00, 7/02, 13/02);
- Rules on the conditions and the procedure for obtaining a special authorisation for the import of medicinal products and devices (OG No. 72/00);
- Rules on medicinal devices (OG No. 82/00).
Procedures
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)?
How far in advance of importation must application for a licence be made?
It is up to the applicant to decide when to apply for a licence. The licence is issued within 30 days of receipt of application.
Can licences be obtained within a shorter time-limit or for goods arriving at the port without a licence
In some cases, it can be obtained within shorter time-period.
Q7.b. Can a licence be granted immediately on request?
In some cases, it can be obtained within shorter time-period.
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.
There are no limitations as to the period of the year during which applications for a licence and/or importation may be made.
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?
Which administrative body is responsible for approving application of licences?
An importer has to approach only one administrative body, i.e. Agency of the Republic of Slovenia for Medicinal Products.
Must the applications be passed on to other organs for visa, note or approval?
In the case of the imports of radio-pharmaceutical products approval of the Ministry of the Environment, Spatial Planning and Energy is also required.
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?
Under what circumstances may an application for a licence be refused other than failure to meet the ordinary criteria?
A licence is not refused if the ordinary criteria related to issuance are met.
Are the reasons for any refusal given to applicants?
The reasons for any denial are given to the applicant in writing.
Have applicants a right of appeal in the event of refusal to issue a licence? If so, to what bodies and under what procedures?
The refusal of issuing a licence can be appealed pursuant to the procedure provided by law.
Eligibility of Importers to Apply for Licence
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?
All persons with active licence for trafficking of medicinal products, issued by the Ministry of Health, are eligible to apply for an import licence.
Documentational and Other Requirements for Application for Licence
Q10. What information is required in applications? Submit a sample form. What documents is the importer required to supply with the application?
What information is required in applications?
The application should contain the following information:
- for medicinal product: name of medicinal product, pharmaceutical form, intensity, packaging, international non-proprietorial name (INN), quantity, customs tariff code;
- for medicinal device: manufacturer’s classification of device regarding potential risk for user, commercial name and description, quantity, customs tariff code;
- complete name and address of manufacturer;
- complete name and address of foreign supplier;
- complete name and address of importer;
- complete name and address of end user.
What documents is the importer required to supply with the application?
Other required documents are defined in the Rules on the conditions and the procedure for obtaining a special authorisation for the import of medicinal products and device.
Q11. What documents are required upon actual importation?
The import licence is required upon actual importation.
Q12. Is there any licensing fee or administrative charge? If so, what is the amount of the fee or charge?
There is a licensing fee in the amount of 4000 SIT.
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.
There is no deposit or advance payment requirement associated with the issuance of licences.
Conditions of Licensing
Q14. What is the period of validity of a licence? Can the validity of a licence be extended? How?
A licence is valid for 1 year. The validity can not be extended.
Q15. Is there any penalty for the non-utilization of a licence or a portion of a licence?
There is no penalty for the non-utilisation of a licence or a portion of it.
Q16. Are licences transferable between importers? If so, are any limitations or conditions attached to such transfer?
Licences are not transferable between importers.
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?
There are no other conditions attached to the issuance of a licence.
Other Procedural Requirements
Q18. Are there any other administrative procedures, apart from import licensing and similar administrative procedures, required prior to importation?
There are no other 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?
There is freedom of exchange operations.