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

• issue a consent for import of unauthorised medicinal products in accordance with the Article 5 of this Law,
• issue approval for import and export of immunological medicinal products and medicinal products from the blood and plasma.

In accordance with Article 133 of the Law on medicines, 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 of medicinal products seated in Montenegro for the medicinal product they manufacture.

Documentation required for:

• issuance of the consent for import of unauthorised medicinal products in accordance with the Article 5 of this Law,
• 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.
• 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.