Notification for marketing authorisation holders regarding last revision date of product information within variation procedures for nationally authorised medicinal products
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...
Lasīt vairāk Zāļu valsts aģentūras vietnē
