Belgium

As from 1 May 2019, new Belgian rules apply to the harmonisation of SPC, labelling and patient information leaflet.

The FAMHP clarifies the rules for harmonisation of SPC’s, labelling and patient information leaflets (PIL) in different countries. Marketing Authorisation Holders (MAH) and applicants can find all new rules on the FAMHP website.

Source: https://www.famhp.be/en/news/medicines_for_veterinary_use_new_belgian_rules_from_1_may_2019_for_the_harmonisation_of_spc

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