Line Extension

Line Extention

All changes listed in Annex I of Variation Regulation 1234/2008 are considered line extensions:


 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/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:


(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)

 

(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.


    3. Other changes specific to veterinary medicinal products to be

        administered to food-producing animals: change or addition of target species.

 

A line extension can either result in a new marketing authorisation number or be integrated into the existing marketing authorisation.

 

AGES MEA processes the latter within the scope of the life cycle, which is why the marketing authorisation number remains the same.


Line extensions resulting in new marketing authorsation numbers are recorded and charged as corresponding new applications for marketing authorisation.

Those remaining within the scope of the life cycle are covered by our annual fee.

 

regulatory requirements:

 

For every line extension, use the application form for a new application for marketing authorisation.

The MRP number in the decentralised sector contains “…/X”.


In the application form, select “line extension” and the respective extension sub-category.


Please state in your cover letter, whether the line extension should be integrated into the existing marketing authorisation and therefore not result in a new marketing authorisation number, including a short justification.

 

After examination of the documentation, the decision on the issue is incumbent on the agency.

Created: 27.11.2015

© Austrian Federal Office for Safety in Health Care
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