Commission Regulation (EC) No 1234/2008 of 24 November 2008 concerning the examination of variations to the terms of marketing authorisations for medicinal products for human use and veterinary medicinal products (Text with EEA relevance) (c. 1234)

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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.