16-05-2024
Attention Holders of Wholesale Distribution and Manufacturing Licenses
Following Article 30(5) of the Law on Pharmacy of the Republic of Lithuania, by order No. (1.72E)1A-512 of the Director of the State Medicines Control Agency under the Ministry of Health of the Republic of Lithuania (hereinafter referred to as SMCA) dated April 26, 2024, persons holding a wholesale distribution or manufacturing license issued by another institution authorized in another European Economic Area state and wishing to carry out wholesale distribution of medicinal products to healthcare institutions and (or) pharmacies in the Republic of Lithuania are required to notify their intended supply of medicinal products.
Please find the form in Lithuanian and English here https://e-tar.lt/portal/lt/legalAct/b4105e4005f611efbcbfb318996800a8
Please send the completed form by email to [email protected]
Persons holding a wholesale distribution or manufacturing license issued by a competent authority of an EEA state and listed in the list of persons who have submitted a notification of the intended supply of medicinal products, as specified in Article 30, Section 5 of the Law on Pharmacy, must submit reports to the SMCA regarding:
- The quantity of registered medicinal product packages sold to pharmacies during the reporting month;
- The quantity of registered medicinal product packages sold to personal healthcare institutions during the reporting month. The submission of data is regulated by the SMCA order No. (1.4)1A-1046 of October 16, 2012. Data must be submitted in the format specified in point 6 of this order, by the 10th day of the following month, via email to [email protected]
Please find the Order of SMCA here https://e-seimas.lrs.lt/portal/legalAct/lt/TAD/TAIS.435425/asr