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State Medicines Control Agency of Lithuania
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Authorisation procedures
LT RMS
Zero – Day procedure
Summary product characteristic, labelling, package leaflet
Variation procedures
Transfer of marketing authorisation holder
Parallel import
Common procedures
Areas of special competence
Scientific-regulatory advice
National requirements in MRP/DCP
Baltic package procedure
Health technology assessment
Information to the applicants
Information for healthcare specialists or patients organisations
Clinical trials
Pharmacovigilance
International Cooperation
Licensing of pharmaceutical activity
Licensing of Pharmaceutical Activity of Legal Entities (enterprises)
Licensing of activity related to narcotic and psychotropic substances of Schedule II and III, or psychotropic substances of Schedule III
Sizes of state fees
Applications for obtaining a licence
Statistical data
Supervision of manufacturing and distribution
Suspected quality defects in medical products
Good manufacturing practice
Good distribution practice
Rapid alerts
Submission and examination of complaints concerning the activities of the Agency
Quality and information security policy
Assessment of the quality of services provided to persons/customers
Important information
Report of baches and quantities of the medicinal product
Medicines consumption (2024)
Requirements applied for writing of prescriptions of other EU countries and dispensing of medicinal products
Topics, on which Agency employees provide consultations
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Last updated: 28-11-2023
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