Licensing of activity related to narcotic and psychotropic substances of Schedule II and III, or psychotropic substances of Schedule III

Common licensing requirements for activity related to substances included into Schedules II and III

The right to manufacture, import, export, engage in wholesale and retail sale with substances included into Schedules II and III have only legal entities possessing the licence granted according to the order set forth by the Law on control of narcotic and psychotropic substances. Type of granted licence gives the right to engage in activity related with medicinal products containing substances of Schedule I, and narcotic and psychotropic substances of Schedule II and III, or activity related to psychotropic substances belonging to Schedule III.

Licences granted for the following types of activity:

1. to manufacture medicinal products which contain substances of Schedule I, narcotic and psychotropic substances of Schedule II and III;
2. to engage in wholesale, import and export of medicinal products containing substances of Schedule I, and narcotic and psychotropic substances of Schedule II and III;
3. to engage in retail sale of medicinal products containing substances of Schedule I, and narcotic and psychotropic substances of Schedule II and III;
4. to manufacture psychotropic substances of Schedule III;
5. to engage in wholesale, import and export of psychotropic substances of Schedule III;
6. to engage in retail sale of psychotropic substances of Schedule III.

Legal entity willing to obtain a licence of indicated type of activity must possess the license of the following type of pharmaceutical activity granted according to the Law on Pharmacy of the Republic of Lithuania:

a)      manufacturing licence when legal entity wants to obtain licence indicated in points 1 or 4;

b)      wholesale distribution licence when legal entity wants to obtain licence indicated in points 2 or 5;

c)      licence for pharmacy activity when legal entity wants to obtain licence indicated in points 3 or 6.

Licences to engage in activity related to medicinal products containing substances of Schedule I, and narcotic and psychotropic substances of Schedule II and III, or activity related to psychotropic substances belonging to Schedule III are granted by the State Medicines Control Agency under the Ministry of Health of the Republic of Lithuania by following the Law on control of narcotic and psychotropic substances of the Republic of Lithuania and by following the Resolution No. 1630 of the rules Government of the Republic of Lithuania of 28 December 1995 „On the approval of the rules of licensing of activity related to medicinal products containing substances of Schedule I, and narcotic and psychotropic substances of Schedule II and III, and approval of the order of granting permissions for the activity of scientific research related to substances included into the Schedule I of narcotic and psychotropic substances“.

Legal entity planning to engage in pharmaceutical activity with narcotic and psychotropic substances of Schedule II and III, or activity related to psychotropic substances belonging to Schedule III must install premises for safe storage of such substances following the Order No. V-1429 of the Minister of Health of the Republic of Lithuania of 29 December 2014 „Regarding the approval of the description of requirements applied for the premises in which narcotic and psychotropic substances included into Schedule II or III are stored while conducting their manufacture, wholesale or retail sale“.

The Resolution No. 1458 of the Government of the Republic of Lithuania of 15 December 2000 „Regarding approval of concrete State fee and the rules of payment and return of such fee“ sets forth State fees and their sizes for the services provided by the State Medicines Control Agency under the Ministry of Health of the Republic of Lithuania.a