Dear marketing authorisation holders,
Taking into account questions and comments received from marketing authorisation holders' (MAH) for indication of correct last revision date in product information within variation procedures for medicinal products authorised via national registration procedure, as well to encourage harmonized approach, the dates shall be indicated as follows (in section 10 of the Summary of Product Characteristics and section 6 of the Package Leaflet (hereinafter - PI)):
- Type IA variations – implementation date of Type IA variation should be stated as the last revision date of PI. The MAH is responsible for indicating the correct date in PI;
- Type IB and Type II variations - the date will be amended by the Agency during the review process of the national PI. This will be the date of alignment of PI within Agency.
Possible exception:
If changes are related to the transfer of MAH and transfer affects change of the name of the medicinal product – date should be agreed nationally (for example, indicating the date of MAH Transfer in product information).
The format of the date shall be according to the QRD template. In cases where the date will be entered by Agency, the template "MM/YYYY" shall be applied.
This practice shall aplly to variations for medicinal products authorised via national procedure, and will be applied from the 5 March 2024.
Nevertheless, in order to reduce administrative burden and to encourage faster and more convenient information flow in cases where MAH will be willing to implement/clarify/correct date of the product information after approval of variation procedure, please proceed within next PI updates. Please note that applications of corrigendums will not be accepted.
Please be reminded that since October 2020 Baltic agencies have already established a harmonised approach regarding last revision date in PI for medicinal products authorised via mutual recognition or decentralised procedures (for more information, please visit: https://www.zva.gov.lv/en/news-and-publications/news/notification-marketing-authorisation-holders-updated-after-comments-received).
