Human and veterinary medicines, and medical devices
- 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: human and veterinary medicines, and medical devices. Authorisations are issued in accordance with the following legislation:
- Law on Medicines ("Official Gazette of Montenegro", No. 080/20);
- Law on Medical Devices ("Official Gazette of Montenegro", No. 024/19);
- Law on administrative procedure ("Official Gazette of Montenegro", No. 056/14, No. 020/15, No. 040/16 and No. 037/17);
- Rulebook on more detailed conditions for import of medical devices that are not registered ("Official Gazette of Montenegro", No. 073/22 and No. 126/22).
Purposes and Coverage of Licensing
Q2. Identify each licensing system maintained and state what products, appropriately grouped, are covered.
The Institute issues import licences for the following products:
• human and veterinary medicines; and
• medical devices.
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?
The purpose of issuing authorisations for the import of medicines and medical devices is not to limit the quantity or value of the import, but to check the documentation on the quality, safety and efficacy of products imported. Alternative methods for meeting the goals are not considered, because the issuance of import licences is in accordance with the national legislation which is to a great extent harmonized with the EU legislation in the area.
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 issuance of import licenses is conducted in accordance with:
- Law on Medicines ("Official Gazette of Montenegro", No. 080/20);
- Law on Medical Devices ("Official Gazette of Montenegro", No. 024/19);
- Law on administrative procedure ("Official Gazette of Montenegro", No. 056/14, 020/15, 040/16 and 037/17);
- Rulebook on more detailed conditions for import of medical devices that are not registered ("Official Gazette of Montenegro", No. 073/22 and 126/22).
The issuance of import licenses is obligatory and there is no possibility to issue the license 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 procedures 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?
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)?
The application for import for these products may be submitted at any time according to the opinion of the importer. The time-limit for issuing license is 30 days. This term is most often seven days, or if the goods have already arrived at the customs and at the request of the importer, it may be even shorter, i.e., be done by priority (providing all necessary documentation is still obligatory).
Q7.b. Can a licence be granted immediately on request?
In case of emergency, if the documentation is correct, the licence may be issued in less than 30 days or shorter than the average period (see answer to question a).
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 regarding the period of the year during which the application may be submitted and / or import be done.
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?
Processing of applications for import is performed only by one administrative body - Institute for Medicines and Medical Devices.
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 Medical Devices ("Official Gazette of Montenegro", No. 024/19);
- 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.
Import or marketing of medicines may be performed by legal persons seated in Montenegro, which possess wholesale authorisation (wholesalers), issued by the Institute or authority in charge of veterinary affairs for veterinary medicines.
Wholesale of medical devices may be performed by legal persons seated in Montenegro, which are registered in accordance with decision on wholesale registration by the Institute.
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; and
- Decision on the mode of payment and amount of fees for entering and removing medical devices, manufacturers and legal persons that market and import medical devices into and from the Register, as well as keeping the Register (Official Gazette of Montenegro No. 78/2009).
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 Institute's portal 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 medicines for human use:
- Application for import authorisation for a medicine for human use that does not have marketing authorisation on the form published on the portal of the Institute (www.cinmed.me).
- Table containing list of medicines to be imported completed in line with the Instruction for using excel table for import of medicines that do not have marketing authorisation, available on the portal www.cinmed.me in the section Human medicines/Import and export of medicines.
- Evidence that the medicine is authorised for marketing (marketing authorisation, or CPP certificate in English, or translated into Montenegrin language) from the competent authority of an European Union Member State, or a country that has the same, or similar requirements as the EU for issuance of marketing authorization (provided that the medicine is manufactured in line with Guidelines of Good Manufacturing Practice, i.e. it has a GMP certificate defined in item 5 of this Instruction), and which approved the packaging for which the application for import into Montenegro was submitted.
- Summary of Product Characteristics (SmPC) and Package Leaflet (PIL) approved by the competent authority of the country defined in item 3 (in English or translated into Montenegrin). It is also necessary to submit Mock-up, approved along with the SmPC and PIL or developed in line with approved labelling for immediate and outer packaging. If the mock-up is not available, it is necessary to submit photos of the packaging (photos of all sides of the packaging are required).
- Evidence from the competent authority that a medicine has been manufactured in accordance with Guidelines on Good Manufacturing Practice (GMP certificate issued by competent authority of one of the EEA Member States or countries that have signed mutual recognition agreements (MRA) with European Union Member States regarding GMP inspections).
- Batch release certificate in accordance with Internationally harmonised requirements for batch certification) for each batch the import of which is applied for.
- When the import of an immunological medicine or a medicine derived from human blood and plasma is applied for; the following shall also be submitted: a) Certificate of analysis of one of the member laboratories of the Official Medicines Control Laboratory (OMCL) or countries that have signed an agreement with European Union Member States regarding the recognition of batch certification, for the same batch/es for which the manufacturer's certificate referred to in item 6 has been submitted; b) Manufacturing and control summary protocol (for vaccines), for the batch/es for which the certificates of analysis referred to in items 6 and 7(a) have been submitted.
- Justified application of the import proposer referred to in the Article 5 of the Law on Medicines ("Official Gazette of Montenegro", No. 80/20) on the form published on the portal of the Institute (www.cinmed.me) in the section Human medicines/Import and export of medicines.
- Pro-forma invoice, or invoice of the supplier.
Documentation required for obtaining authorisation for import of veterinary medicines:
- Cover letter;
- Table containing list of medicinal products to be imported;
- Evidence from the competent authority that a medicinal product has been granted marketing authorization in country of a manufacturer, European Union Member States, or in countries having the same standards for issuing marketing authorization;
- Evidence from the competent authority that a medicinal product has been manufactured in accordance with Guidelines on Good Manufacturing Practice (GMP certificate);
- Approved Summary of product characteristics and Package leaflet from one of countries referred to in item 3 (in English, or translated into Montenegrin) and Mock- up approved along with the summary and package leaflet, i.e., developed according to the approved text of the packaging (Labelling);
- Batch release certificate in accordance with Internationally harmonised requirements for batch certification for each batch of medicinal product to be imported;
- In case of import/export of immunological products a certificate of analysis for every batch is required, from a manufacturer and from one of the laboratories that are OMCL members, or countries that have signed agreements with European Union on recognition of batch certification;
- Pro-forma invoice, or invoice of the distributor;
- Evidence of payment of prescribed fees.
Documentation required for obtaining authorisation for import of medical devices:
Wholesaler shall submit the following documentation along with the application:
- Form for issuance of import authorization for medical devices that are not registered (available on CInMED portal);
- Justification, or statement of the proposer of an unregistered medical device import (available on CInMED portal);
- Declaration of conformity and/or certificate of conformity of an unregistered medical device or proof that equivalent safety and performance assessment has been carried out for unregistered medical device for which no conformity assessment was carried out by a notified body, i.e. a manufacturer seated in the EEA member state;
- Free sale certificate, or certificate issued by an authorized body ISO 13485 for class I medical devices, other in vitro diagnostic medical devices and class A in vitro diagnostic medical devices;
- Translation of instructions for use of unregistered medical device into Montenegrin and into languages that are in official use in Montenegro, signed by a medical doctor of appropriate specialty for the medical device that the patient uses independently;
- Pro-forma invoice of the supplier;
- Other information at the request of the Institute, in accordance with the Law.
- Certificate of conformity for an unregistered medical device shall not be submitted for medical devices of class I, Other-In vitro diagnostic medical devices and in vitro diagnostic medical devices of class A.
- Equivalent safety and performance assessment implies that a conformity assessment is carried out in a member state of the International Medical Device Regulators Forum.
- Justified proposal for import and the statement of the responsible person shall be submitted on forms published on the portal of the Institute.
Q11. What documents are required upon actual importation?
Documents required are related to the quantity of the imported products and the date of the import. For medicines and medical devices additional documentation upon import is not required.
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 following Decisions:
- 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; and
- Decision on the mode of payment and amount of fees for entering and removing medical devices, manufacturers and legal persons that market and import medical devices into and from the Register, as well as keeping the Register (Official Gazette of Montenegro No. 78/2009).
In line with 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:
- Fee for import licenses for human medicines that do not have marketing authorisation is €150;
- Amount of the fee for issuance of approval for the import of veterinary medicines that do not have marketing authorisation is, for:
|
Name of the service |
Price (€) | |
|
- up to 6 medicines - from 7 to 10 medicines - from 11 to 20 medicines - more than 20 medicines |
60,00 100,00 150,00 200,00 | |
In line with the Decision on the amount and payment method of the fees incurred by the performance of expert tasks in the area of medical devices (Official Gazette of Montenegro No. 35/23) fees for import authorisations for medical devices are listed as follows:
|
Import value |
Fees (EUR) |
|
up to 5 medical devices from 6 to 10 medical devices from 11 to 15 medical devices from 16 to 20 medical devices over 20 medical devices |
60 100 150 200 250 |
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?
Period of validity of an import license for medicines is until the end of the import of the quantities indicated in the import license and it is valid for a multiple import.
Period of validity of an import license for veterinary medicines is 3 months from the date of issuance and is valid for a multiple import.
Period of validity of an import license for medical devices is 3 months from the date of issuance and is valid for a multiple import.
Licenses could not be extended but request for a new license 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.