Company code 191351864
Žirmūnų str. 139A, Vilnius, Lithuania
E-mail: vvkt@vvkt.lt,
Phone: +370 5 263 92 64
Fax: +370 5 263 92 65






Licences for activity with narcotic and psychotropic substances

Legal entities intending to produce, import, export, medicinal products containing narcotic and psychotropic substances included into Schedules II or III, or engage into manufacturing activity of such medicinal products, or wholesale or retail sale activity, are obliged to obtain additional licence for activity with narcotic and (or) psychotropic substances.

 

Licences for activity with narcotic and (or) psychotropic substances are granted by the State Medicines Control Agency under the Ministry of Health of the Republic of Lithuania (hereinafter – SMCA) following the Law of the Republic of Lithuania on Control of Narcotic and Psychotropic Substances and the Decision No 887 of the Government of the Republic of Lithuania of 13 July 2011 „Regarding amendment of the Decision No 1630 of the Government of the Republic of Lithuania of 28 December 1995 „Regarding confirmation of rules for granting licences to manufacture, to import into the Republic of Lithuania, to export from the Republic of Lithuania, to engage into wholesale and retail sale with narcotic and psychotropic substances“.

 

 

Types of licences:

To manufacture narcotic and psychotropic substances of Schedules II and III (this licence is also obligatory for enterprises importing narcotic and psychotropic medicinal products from third countries);

To manufacture psychotropic substances of Schedule III (this licence is also obligatory for enterprises importing psychotropic medicinal products from third countries);

To engage in wholesale, import and export of narcotic and psychotropic substances of Schedule II and III;

To engage in wholesale, import and export of psychotropic substances of Schedule III;

To engage in retail sale with narcotic and psychotropic substances of Schedule II and III;

To engage in retail sale with psychotropic substances of Schedule III.

 

 

Requirements for obtaining a licence

 

Enterprises which plan to engage in pharmaceutical activity with narcotic and (or) psychotropic medicinal products are obliged to possess premises for safe storage of such medicinal products. Requirements for establishing premises for manufacture and storage of narcotic and psychotropic substances are confirmed by the Order No 342/482 of the Ministry of Interior Affairs and the Ministry of Health of the Republic of Lithuania of 25 August 1998 „Regarding confirmation of the description of the special requirements applied for premises in which narcotic and (or) psychotropic substances of Schedules II and III are manufacture, stored and where the wholesale or retail sale takes place“.

Last Update: 2011-09-14 15:29:17