Basic information
Outline of the system
Institute for Medicines and Medical Devices (hereinafter: Institute) issues authorisations for the import of: human and veterinary medicines, 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; 020/15; 040/16 and 037/17).
Product coverage
The Institute issues import licences for the following products:
• Human and veterinary medicines; and
• Medical devices.
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 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.
Questions for products under restriction as to the quantity or value of imports
No applicable.
The system applies to products originating from which country?
The system is related to the goods originating/coming from any country.
Expected duration of licensing procedure
Legal requirements
Is the licensing statutorily required?
The issuance of import licences 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).
Does the legislation leave designation of products to be subject to licensing to administrative discretion?
The issuance of import licences is obligatory and there is no possibility not to issue the licence based on administrative discretion.
Is it possible for the government to abolish the system without legislative approval?
Article 8 of the Law on Medicines ("Official Gazette of Montenegro", No.080/20) envisages that the Government of Montenegro may determine alternative procedures and conditions for the issuance of marketing authorisation for a medicine.
Eligibility of applicants
Is there a system of registration of persons or firms permitted to engage in importation?
There is a system of registration of legal persons that may perform import and marketing.
What persons or firms are eligible to apply for a licence?
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.
Is there a registration fee?
Fees for issuance of licences for the import and wholesale of all these products are defined by:
- Decision on the manner of payment and amount of fees for issuance of authorisations, certificates and approvals for manufacture and marketing of medicines ("Official Gazette of Montenegro", No.22/13 from 17 May 2013); 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).
Is there a published list of authorized importers?
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.
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
Ministry of Health - Institute for Medicines and Medical Devices
Documentation requirements
What information is required in applications?
Please see Exhibit II
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 and veterinary use:
1) Cover letter;
2) Table containing list of medicines to be imported/exported;
3) Invoice or pro-forma invoice from a supplier;
4) Batch release certificate in accordance with Internationally harmonised requirements for batch certification for each batch the import of which is applied for;
5) In case of import/export of blood products and 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, or from the National laboratory of the Institute for Medicines and Medical Devices of Serbia (ALIMS);
6) Manufacturing and control summary protocol (for vaccines only), for batch(es) for which certificates are submitted;
7) Justified request of the health institution, i.e. opinion of medical specialist on the need for import of the particular medicine – for the first import or at the request of the Institute;
8) Proof of payment of prescribed fees.
• Documentation required for obtaining authorisation for import of medical devices:
1) Cover letter;
2) Application for authorisation with information on imported medical devices;
3) Letterheaded statement of the applicant for import of medical devices justifying the reason for not submitting application for entry into the register of medical devices kept by the Institute; in case that the application has been submitted, please state the date of submission of the documentation for entry into the register and number under which it is filed in the Institute;
4) Letterheaded statement of the healthcare institution (healthcare professional) justifying the import of specific medical devices. If a similar medical device is entered in the Institute’s register, the reason why the medical device that has already been entered into the register cannot be used shall be given;
5) Supporting certificates for each product from the list:
- Manufacturer's Declaration of Conformity (DoC);
- EC certificates, except for medical devices of Class I and In Vitro – Others;
6) Invoice or pro-forma invoice from a supplier;
7) Proof of payment of prescribed fees.
Window of submission of an application
How far in advance of importation must application for a licence be made?
The application for import for these products may be submitted at any time according to the opinion of the importer.
Are there any limitations as to the period of the year during which application for licence can 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.
Issuing the license
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).
Can licences be obtained within a shorter time-limit or for goods arriving at the port without a licence
The time-limit for issuing licence is 30 days. This term is most often 7 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).
Which administrative body is responsible for approving application of licences?
Processing of applications for import is performed only by one administrative body - Institute for Medicines and Medical Devices.
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 other conditions attached.
Fees and other administrative charges
Is there any licensing fee or administrative charge?
Yes.
What is the amount of the fee or charge?
The fees for issuing import licences are defined by Decisions adopted by the Government:
- Decision on the manner of payment and amount of fees for issuance of authorisations, certificates and approvals for manufacture and marketing of medicines ("Official Gazette of Montenegro", No.22/13 from 17 May 2013); 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 those decision fees for import licences for medicines and medical devices are determined based on the total value of the requested import:
Import value Fees (EUR)
up to 5 000 EUR 60
from 5 000 up to 50 000 EUR 125
from 50 000 up to 250 000 EUR 250
from 250 000 up to 500 000 EUR 500
from 500 000 up to 1.000 000 EUR 1.000
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?
An application for licence may be rejected due to inadequate documentation on the product or the applicant and in other cases in accordance with relevant laws.
Are the reasons for any refusal given to applicants?
Reasons for rejection of any kind are given to the applicant in the form of an appropriate legal act.
Have applicants a right of appeal in the event of refusal to issue a licence?
In case of rejection, the applicants have the right to appeal.
If so, to what bodies and under what procedures?
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; 020/15; 040/16 and 037/17).
Importation
Are there any limitations as to the period of year during which importation may be made?
There are no limitations regarding the period of the year during which the application may be submitted and / or import be done.
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.
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?
Period of validity of an import licence for medical devices is 3 months from the date of issuance and is valid for a multiple import. Period of validity of an import licence for medical devices is 3 months from the date of issuance and is valid for a multiple import.
Licences cannot be extended, but a request for a new licence can be submitted.
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.
Are licences transferable between importers? If so, are any limitations or conditions attached to such transfer?
Licences are not transferable between importers.
Foreign Exchange
Is foreign exchange automatically provided by the banking authorities for goods to be imported?
N/A.