License conditions

• A legal entity that carries out the wholesale distribution of medicines is obliged to have a person responsible for the storage and distribution of medicines (responsible person), as well as other appropriate staff depending on the scope of activity with education in the application of Good Practice guidelines in distribution.
• It must have a suitable space for the reception, accommodation and storage of drugs, as well as starting substances for production, under certain storage conditions, and a wholesale drug store that has a license to import drugs and a space with ensured quarantine conditions for products that are still in the quality control process ; space for shipping medicines, space for accommodation of returned, rejected, withdrawn, falsified or defective medicines; space for a wardrobe, sanitary facilities and office premises. The storage space, as a rule, should have at least 70 m2 and should be separated from the space for the wardrobe, sanitary rooms and office rooms.
• The premises of the wholesale drug store must be built of solid material, that the construction and size corresponds to the intended purpose, that the walls, floors and ceilings of flat and smooth surfaces are made of material that is not susceptible to cracking and shedding, that they can be quickly and easily cleaned or washed, as well as disinfect; that it has appropriate lighting, temperature, humidity and ventilation without harmful direct or indirect influence on the prescribed and safe reception, accommodation and storage of starting substances and/or medicines; as well as that the space and arrangement of equipment and devices meet the needs of unhindered performance of operational activities, without the risk and possibility of replacing or mixing different products.
• A wholesale drugstore that sells radiopharmaceuticals in bulk should have a storage space that, in addition to the aforementioned conditions, should meet the following conditions: the required level of hermetic sealing of windows, doors and other openings is provided; provided regular control of the level of radioactivity, in accordance with regulations regulating protection against ionizing radiation and radiation safety; provided regular cleaning and disinfection of the premises in the manner provided for in the regulations regulating protection against ionizing radiation and radiation safety, and that, if necessary, it can be easily decontaminated. A wholesaler does not have to have space to store radiopharmaceutical drugs that are labeled with radioisotopes that have a short half-life.
• The wholesale drug store in the area for storing medicines should implement a program of pest control and measures against wastage and damage, as well as mutual contamination of products, to be regularly cleaned, disinfected and controlled depending on its purpose, and to display in a visible place signs prohibiting smoking, eating and drinking , as well as other prohibitions that may affect hygienic conditions.
• The wholesaler should provide: appropriate access for receiving and shipping medicines; that the area for reception and the area for dispatching medicines are adequately separated from the storage area and protected from the weather; necessary security measures to prevent unauthorized persons from entering the storage area and an alarm system for continuous detection of unauthorized entry.
• The space for storing medicines should have the appropriate temperature and humidity, which the wholesaler regularly controls and keeps records of.
• The wholesaler should have appropriate equipment for receiving, placing and storing medicines in accordance with the conditions set by the manufacturer; has appropriate equipment for monitoring temperature and humidity, and establishes a preventive maintenance plan for space and equipment.
• For the transport of medicines, the wholesale drugstore should have at its disposal the appropriate type and sufficient number of its own means of transport or the means of transport of the person with whom it has concluded an agreement on the entrustment of transport operations, which should be adapted to the group and type of medicines, the planned volume of traffic and meet the storage conditions for those medicines.
• For the transport of certain types of medicines, means of transport should be equipped for special conditions of transport in accordance with the prescribed conditions of storage, i.e. transport (eg provision of a "cold chain" with available records of control and temperature monitoring).
• Transport of radiopharmaceuticals is carried out by appropriate means of transport that meet the conditions prescribed by the law regulating the transport of dangerous substances.
  The applicant submits the following documentation when submitting an application for obtaining a license for wholesale distribution of medicinal products for human use:

Special requirements for qualifications

• diploma from the Faculty of Pharmacy
• proof of completed training in the field of Good Practices in Distribution guidelines
• full-time employment contract
• confirmation from the Tax Administration about applying for employment insurance
• residence and work permit for a responsible person (only applicable for foreigners)
• extract from the marriage register (if applicable)
• proof of work experience (copy of work book and CV)
• the applicant's statement about the permanent availability (24 hours) of the responsible person with the specified contact information (mobile phone, email)

Fees

Issuance of a license for the sale of medicines in bulk: 800 EUR
GDP inspection: 800 EUR per day
Issuance of GDP certificate: 500 EUR
Sanitary approval: 36 EUR

Payment via internet banking

Hipotekarna banka
IBAN: ME25520420000000072389
Call number: invoice number or item number after issuing the invoice
Purpose: payment of compensation
User: INSTITUTE FOR DRUGS AND MEDICINE. ASSETS BULEVAR IVANA CRNOJEVICA 64A - PODGORICA

NLB Banka
IBAN: ME25530005030006098394
Call number: invoice number or item number after issuing the invoice
Purpose: payment of compensation
Beneficiary: INSTITUTE FOR DRUGS AND MEDICAL DEVICES

Competent authorities

Institute for Medicines and Medical Devices of Montenegro
Bulevar Ivana Crnojevića 64a, Podgorica
+382 (20) 310 280
+382 (20) 310 281
+382 (20) 310 580
info@cinmed.me
sladjana.marsenic@cinmed.me

Mail za slanje dokumentacije:

pisarnica@cinmed.me

Relevant regulations

Law on Medicines ("Official Gazette of Montenegro", No. 80/20),

Rulebook on the detailed conditions and the method of determining the fulfillment of the conditions for carrying out the trade of medicines for human use in bulk ("Official Gazette of the Republic of Montenegro", No. 45/21 of 29 April 2021),

Guidelines on Good Distribution Practice of Medicinal Products for Human Use (The Rules Governing Medicinal Products in the European Union, Volume 4 – Guidelines on Good Distribution Practice of Medicinal Products for Human Use), published on the CInMED website on October 12, 2020,

Compilation of Community Procedures on Inspections and Exchange of Information (Compilation of Community Procedures on Inspections and Exchange of Information),

Legal remedies

The possibility of a lawsuit within 30 days to the Administrative Court, Svetog Petra Cetinjskog 130, Podgorica.