In accordance with Law on Medicinal Products the Institute for medicines and medical devices shall:

• issue a consent for import of unauthorised medicinal products in the following cases:

  1) the medicinal product  is intended for a specific patient or group of patients,

  2)  medically justified needs for the protection of public health, based on the request of a health institution

  3)  in the event of an epidemic, epizootic, natural disaster or other emergency situations in accordance with this law

  4) the import of a donation or humanitarian aid medicinal product, including. a donation program in the EU,

  5) a medicinal product for scientific research,

  6) for compassionate use. 

• issue approval for import and export of immunological medicinal products and medicinal products from the blood and plasma.

In accordance with Article 114 of the Law on Medicinal Products, the import and export of medicine falls within the wholesale of medicines. Wholesale of medicines may be performed by:

1) wholesalers which have the wholesale authorisation issued by the Institute for medicinal products for human use or the competent authority for veterinary affairs for medicinal products for veterinary use; and

2) manufacturers established and authorised in Montenegro, for medicinal products covered by the manufacturing authorisation. 

Documentation required for issuance of the consent for import of unauthorised medicinal products, as well as issuance of the approval for import and export of immunological medicinal products and medicinal products from the blood and plasma shall be submitted to the Institute in accordance with Rulebook on more detailed conditions for the issuance of import authorization for a medicine that does not have marketing authorisation (“Official Gazette of Montenegro” No 19/24 and 34/24) and the instruction Required documentation for issuance of import authorisation for medicines that do not have marketing authorisation and import-export of blood products and immunological products.