Controlled substances (drugs, precursors and medicines containing precursors)
- Document symbol
- G/LIC/N/3/MNE/8/Rev.1
- Original language
- English
- Published on
- 19/11/2024
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.
Institute for Medicines and Medical Devices (hereinafter: Institute) issues authorisations for the import of: medicines classified as drugs (hereinafter: drugs), precursors and medicines containing precursors. Authorisations are issued in accordance with the following legislation:
• Law on Medicines ("Official Gazette of Montenegro", No. 080/20);
• Law on control of manufacture and trade of substances that can be used in the manufacture of narcotic drugs and psychotropic substances ("Official Gazette of Montenegro", No.83/09 and No.40/11);
• Law about preventing of drug abuse ("Official Gazette of Montenegro", No.28/11 and No.35/13);
• Law on administrative procedure ("Official Gazette of Montenegro", No.056/14, No. 020/15, No. 040/16 and No. 037/17).
Purposes and Coverage of Licensing
Q2. Identify each licensing system maintained and state what products, appropriately grouped, are covered.
The Institute issues import licenses for the following products:
• controlled substances (drugs, precursors and medicines containing precursors).
Q3. The system applies to goods originating in and coming from which countries?
The system is related to the goods originating/coming from any country.
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?
There is an annual quota for drugs, precursors and medicines containing precursors, such as pseudoephedrine, ephedrine and norephedrine in terms of quantity at the national level that cannot be exceeded. This quota, for each calendar year, is determined by the International Narcotics Control Board in Vienna (INCB), and authorisations for the import of mentioned controlled substances are issued according to it.
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?
Issuance of import licenses is conducted in accordance with:
- Law on Medicines ("Official Gazette of Montenegro", No. 080/20);
- Law on control of manufacture and trade of substances that can be used in the manufacture of narcotic drugs and psychotropic substances ("Official Gazette of Montenegro", No. 83/09 and 40/11);
- Law about preventing of drug abuse ("Official Gazette of Montenegro", No. 28/11 and 35/13);
- Law on administrative procedure ("Official Gazette of Montenegro", No. 056/14, 020/15, 040/16 and 037/17).
Issuance of import licences is obligatory and there is no possibility not to issue the licence based on administrative discretion.
The Article 8 of Law on Medicines ("Official Gazette of Montenegro", No. 080/20) envisages that Government of Montenegro may determine alternative procedure and conditions for the issuance of marketing authorisation for a medicine.
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?
Information on permitted annual quotas for import of drugs are published on the website of the International Narcotics Control Board (https://www.incb.org/). Quotas are formed on the basis of needs for drugs, precursors and medicines containing precursors, such as pseudoephedrine, ephedrine and norephedrine individually on annual level that importers submit to the Institute. After processing these data, the Institute sends data to the Ministry of Health, which forward these data for the approval to the International Narcotics Control Board (INCB).
In cases where needs for controlled substances are increased in relation to the required annual quota, the Institute, through the Ministry of Health may, with an explanation, ask for an increase in quotas for certain drug, precursor and medicine containing precursors, such as pseudoephedrine, ephedrine and norephedrine.
All the information needed to obtain import authorisation for drugs (regulations, instructions and forms) the importer can find on the website of the Institute https://www.cinmed.me/.
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?
The amount of quotas is determined annually by the International Narcotics Control Board. Application for an import may be submitted by necessity, with the condition not to exceed the quota, and the validity period of import authorisation for drugs is six months and for precursors and medicines containing precursors is 30 days, which are intended for single import.
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.)
The Institute sends one copy of the import licence for drugs, precursors and medicines containing precursors to the Customs Administration, and after customs clearance of the goods, Customs returns this copy of the licence to the Institute, which contain details of the realisation of imported products. The amount that has not been imported is not counted into the allowed quota. One copy of import authorisations for drugs is intended for importer, and one for the competent authority of the exporting country.
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?
Applications may be submitted immediately after publishing quotas.
Q6.V. What are the minimum and maximum lengths of time for processing applications?
The period needed for processing applications and issuing licences for the import of drugs is up to 30 days but usually within seven days.
Q6.VI. How much time remains, at a minimum, between the granting of licences and the date of opening of the period of importation?
Import can be done immediately after obtaining import licence (date of issuance of the licence is stated on the licence).
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?
Processing of applications for import of drugs, precursors and medicines containing precursors is performed only by one administrative body - Institute for Medicines and Medical Devices.
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?
If the demand for licences cannot be completely fulfilled i.e. if a small amount is missing for fulfilling an annual quota, the applicant which did not import his stated year demand takes precedence over others for obtaining import licence for a certain drug, precursor or medicines containing precursors such as pseudoephedrine, ephedrine and norephedrine (see answer to question I). Applications for import are processed according to the date of receipt, chronologically. The new importer who obtained wholesale licence for marketing of drugs and precursors must submit annual demand for drugs before submitting an application for import.
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?
Import licences are always needed, regardless of the fact that exporting countries issues export licences. Import licences are not 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?
There have been no such cases so far. Legal provisions provide that the procedure for approving the import of drugs, precursor or medicines containing precursors is identical regardless of whether the product will be marketed in Montenegro or exported to other countries (which requires a special export license).
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?
An application for a license may be rejected due to inadequate documentation on the product or the applicant and in other cases in accordance with relevant laws. Reasons for rejection of any kind are given to the applicant in the form of an appropriate legal act.
In case of rejection, the applicants have the right to appeal to the Administrative Court, in accordance with:
- Law on Medicines ("Official Gazette of Montenegro", No. 080/20);
- Law on control of manufacture and trade of substances that can be used in the manufacture of narcotic drugs and psychotropic substances ("Official Gazette of Montenegro", No. 83/09 and No. 40/11);
- Law about preventing of drug abuse ("Official Gazette of Montenegro", No. 28/11 and No. 35/13);
- Law on administrative procedure ("Official Gazette of Montenegro", No. 056/14, No. 020/15, No. 040/16 and No. 037/17).
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?
There is a system of registration of legal persons that may perform import and marketing. Legal persons that import and market drugs and precursors additionally require a separate authorisation for wholesale of drugs or precursors.
Fees for issuance of licenses for the import and wholesale of all these products are defined by:
- Decision on the payment method and amount of fees for the exercise of competences of the Institute for Medicines and Medical Devices that are determined by the law.
A list of all legal persons that are authorised to perform import and marketing on the basis of authorisations issued by the Institute, is published on the website of the Institute https://www.cinmed.me/ and is regularly updated.
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?
The portal Institute https://www.cinmed.me/ contains all the data that must be listed on the application for import all product groups.
Documentation required for obtaining authorisation for import of narcotic drugs is consisted of the following:
- Completed Application form for issuance of the import, export and transit authorisation for drugs (available on the CInMED web portal);
- User's (applicant's) statement of the purpose;
- Pro forma or forma invoice;
- Batch release certificate in accordance with Internationally harmonised requirements for batch certification for each batch of the medicine whose import is required.
Documentation required for obtaining authorisation for import of precursors and medicines containing precursors is consisted of the following:
- Completed Application form for issuance of the import, export and transit authorisation for precursors and medicines containing precursors (available on the CInMED web portal);
- User's (applicant's) statement of purpose;
- Pro-forma invoice or forma invoice;
- End user's statement of purpose of precursors, in accordance with the Rulebook on the form and content of statement of end user on the purpose of precursors ("Official Gazette of Montenegro", No. 4/2015) (applies only to precursors);
- Batch release certificate in accordance with Internationally harmonised requirements for batch certification for each batch of the medicine whose import is required.
Q11. What documents are required upon actual importation?
Upon actual importation, additional documentation is required only for the products belonging to the group of controlled substances i.e. drugs and precursors and medicines containing precursors. Documents required are related to the quantity of the imported products and the date of the import.
Q12. Is there any licensing fee or administrative charge? If so, what is the amount of the fee or charge?
The fees for issuing import licenses are defined by:
- Decision on the payment method and amount of fees for the exercise of competences of the Institute for Medicines and Medical Devices that are determined by the law.
In line with this Decision, fees for issuance of approval for import, transit or export of medicines containing drugs and import, transit, export or transport of precursors, in accordance with the regulations governing these areas, is 80€.
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.
No.
Conditions of Licensing
Q14. What is the period of validity of a licence? Can the validity of a licence be extended? How?
The period of validity of an import licence for drugs is 6 months and is valid for a single import.
Period of validity of an import licence for precursors and medicines containing precursors is 30 days and is valid for a single import.
Licences could not be extended, but a request for a new licence can be submitted.
Q15. Is there any penalty for the non-utilization of a licence or a portion of a licence?
No, there is not a 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?
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?
No other conditions attached.
Other Procedural Requirements
Q18. Are there any other administrative procedures, apart from import licensing and similar administrative procedures, required prior to importation?
No.