Starting 01 March 2013, import of pharmaceuticals into Ukraine requires a separate import licence (the “Import Licence”). This requirement was introduced by Law of Ukraine No. 5038-VI, dated 04 July 2012 that amended accordingly Law of Ukraine on Pharmaceutical Products No. 123/96-ВР, dated 04 April 1996. (“Law”).
To implement the said provision of the Law, the Health Protection Ministry of Ukraine through its Order No, 143, dated 20 February 2013 adopted the relevant licence conditions (“Licence Conditions”) that became effective as of 01 March 2013.
Import Licence is issued by the State Agency of Ukraine for Pharmaceutical Products (“Agency”) to importers of pharmaceutical products who meet the following requirements:
- have sufficient material and technical resources;
- employ qualified personnel;
- have appropriate resources to conduct quality control of the pharmaceuticals that will be imported into Ukraine.
Compliance with the aforementioned requirements must be evidenced by the regular audit of activities relating to production or wholesale/retail trade of pharmaceuticals. If no such audit has been conducted before the importer applied for the Import Licence, the Agency conducts such an audit within the licence issuance period (i.e., 10 business days after submission of the licence application).
According to the Licence Conditions, no Import Licence is needed for import of:
- active pharmaceutical ingredients (API); and
- medicines imported as humanitarian aid or in connection activities of charitable organisations as provided by applicable Ukrainian laws.
Import Licence is issued for an indefinite term. State fee for obtaining this licence amounts approx. EUR 100.
The Law does not provide for any transition period for implementation of the Import Licence requirement. This means that currently all companies that import pharmaceutical products in Ukraine must suspend their import activities until they receive the relevant licence.
To prevent possible interruptions in supplies of imported pharmaceutical products in Ukraine, the Agency’s officers promised to promptly process all the licence applications submitted to them starting 01 March 2013.
Law of Ukraine On Amending Certain Laws of Ukraine on Licensing Of Import of Pharmaceuticals and Defining the Term "Active Pharmaceutical Ingredient”, No. 5038-VI, dated 04 July 2012;
Law of Ukraine on Pharmaceutical Products No. 123/96-ВР, dated 04 April 1996 (as amended);
Order of Health Protection Ministry of Ukraine On Adoption of Licence Conditions for Conducting Business Activities of Pharmaceutical Products Import No. 143, dated 20 February 2012