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State Medicines Control Agency of Lithuania

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Structure and contacts

About us
Contact information
Contacts

Services Legislation Marketing authorisation

Marketing authorization fees
E-submission
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

International cooperation
Report of baches and quantities of the medicinal product
Medicines consumption (2022)
Requirements applied for writing of prescriptions of other EU countries and dispensing of medicinal products
Brexit

Pradžia

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State Medicines Control Agency of Lithuania

Legal entity code

191351864

Address

Studentų g. 45A, Vilnius

Email

[email protected]

Ph. no

+370 5 263 9264

Data about the institution are collected and stored in the Register of Legal Entities.

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