Naudingos nuorodos
Notice to the Applicants

Updated Product information template for nationally authorised medicinal products, Statements for use in Section 4.6 “Pregnancy and lactation” of SmPC and template of label / package leaflet for the homeopathic medicinal product authorized under the simplified registration procedure


Please be informed that update of template of label / package leaflet for the homeopathic medicinal product authorized under the simplified registration procedure has been approved by the order of Director of the State Medicines Control Agency under Ministry of Health of the Republic of Lithuania on 2 September 2021 No. (1.72E)1A-1124. Update of template of Product information  for nationally authorised medicinal product and Statements for use in Section 4.6 “Pregnancy and lactation” of SmPC approved on 6 September 2021 by the order of Director of the State Medicines Control Agency under Ministry of Health of the Republic of Lithuania No. (1.72E)1A-1135. New templates for granting marketing authorisations should be used from 3 September 2021 and 7 September 2021 respectively. 

For already authorised medicinal products, information could be updated in any regulatory procedure that affects these product information annexes, to comply with the revised template(s). Marketing authorisation holders for medicinal products with no regulatory procedures affecting the product information annexes could submit a dedicated type IB/C.I.(z) variation application to comply with the revised template(s).