Pharmaceutical Activity Licensing Unit is a structural subdivision of the State Medicines Control Agency under the Ministry of Health of the Republic of Lithuania, which performs pharmaceutical activity licensing process in the Republic of Lithuania. The unit performs:
- Licensing of pharmaceutical activity of legal entities (enterprises), i.e. issuance, changing, changing of information and data, suspension of validity of the licence, revocation of the suspension of validity of the licence and revocation of the licence for the activity of a pharmacy, manufacturer and wholesale distributor;
- Licensing of activities of legal entities (enterprises) related to narcotic and psychotropic substances of Schedules II and III, and (or) psychotropic substances of Schedule III, i.e. issuance of licences, changing of licences, suspension of validity of licence, revocation of suspension of licence and revocation of validity of licences;
- Licensing of the pharmaceutical activity of physical persons (pharmacists), i.e. granting, change, revocation of validity of licences, specification of licence data, supervision of improvement of Professional qualification;
- Entering of pharmacists‘ assistants (pharmacists technicians) into the list of Pharmacists‘ assistants (pharmacists technicians) (further – the List), i.e. entering of pharmacists‘ assistants (pharmacists technicians) into the List, change of data in the List, withdrawal from the List and entering data related to the improvement of professional qualification;
- Granting a stamp number for pharmaceutical specialists, i.e. for pharmacists and pharmacists‘ assistants (pharmacists technicians), as well as the change of stamp number details, and revocation of stamp number.
- Entering into the list of manufacturers, importers and distributors of active substances of authorized manufacturers, importers and distributors of the Republic of Lithuania (further - the List), elimination from the List, change and supplementation of data and information indicated in the request for entering into the List;
- Entering brokers of sale of medicinal products into the list of brokers authorized in the Republic of Lithuania (further – the List of Brokers), elimination of brokers from the List of Brokers, change or supplementation of data and information of the List of Brokers;
Granting of permissions to conduct manufacture of advanced therapy medicinal products for individual patients upon administration of physician, change of terms of such permissions or revocation of validity of such permissions.