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ANNEX I U.K.Extensions of marketing authorisations

1. Changes to the active substance(s): U.K.

(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/safety characteristics are not significantly different, with the exception of:

• changes to the active substance of a seasonal, pre-pandemic or pandemic vaccine against human influenza;

• replacement or addition of a serotype, strain, antigen or combination of serotypes, strains or antigens for a veterinary vaccine against avian influenza, foot-and-mouth disease or bluetongue;

• replacement of a strain for a veterinary vaccine against equine influenza;

(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: U.K.

(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(1).

3. Other changes specific to veterinary medicinal products to be administered to food-producing animals: change or addition of target species. U.K.

(1)

For parenteral administration, it is necessary to distinguish between intra-arterial, intravenous, intramuscular, subcutaneous and other routes. For administration to poultry, respiratory, oral and ocular (nebulisation) routes used for vaccination are considered to be equivalent routes of administration.