ANNEX I: Extensions of marketing authorisations

Location:
Annex
Source:
Eur-Lex

1.

Changes to the active substance(s):

(a) replacement of a chemical active substance by a different salt/ester complex/derivative, with the same therapeutic moiety, where the efficacy/safety characteristics are not significantly different;
(b) replacement by a different isomer, a different mixture of isomers, of a mixture by an isolated isomer (e.g. racemate by a single enantiomer), where the efficacy/safety characteristics are not significantly different;
(c) replacement of a biological active substance with one of a slightly different molecular structure where the efficacy or safety characteristics are not significantly different, with the exception of the following:
  • changes to the active substance of a seasonal, pre-pandemic or pandemic vaccine against human influenza;
  • replacement or, upon agreement of the relevant authorities, addition of a serotype, strain, antigen or coding sequence or combination of serotypes, strains, antigens or coding sequences for a human coronavirus vaccine;
  • replacement or, upon agreement of the relevant authorities, addition of a serotype, strain, antigen or coding sequence or combination of serotypes, strains, antigens or coding sequences, for a human vaccine other than for human influenza or coronavirus that has the potential to address a public health emergency in the Union;

(d) modification of the vector used to produce the antigen or the source material, including a new master cell bank from a different source, where the efficacy/safety characteristics are not significantly different;

(e) a new ligand or coupling mechanism for a radiopharmaceutical, where the efficacy/safety characteristics are not significantly different;

(f) change to the extraction solvent or the ratio of herbal drug to herbal drug preparation where the efficacy/safety characteristics are not significantly different.

2.

Changes to strength, pharmaceutical form and route of administration:

(a) change of bioavailability;
(b) change of pharmacokinetics e.g. change in rate of release;
(c) change or addition of a new strength/potency;
(d) change or addition of a new pharmaceutical form;
(e) change or addition of a new route of administration ( 2 ).