Paragraph 12 Extension of time limits
This paragraph applies in relation to veterinary medicinal products that —
are intended for administration to food producing species, and
contain a new active substance that was not authorised in the Community by 30th April 2004.
If a person submits an application for a marketing authorisation for a product on or after 30th October 2005, and within 5 years of the original marketing authorisation being granted, the marketing authorisation is extended to include additional food-producing species, the ten-year period provided for in the paragraph 11(3) shall be extended by one year for each additional food producing species added to the marketing authorisation.
The total period shall not exceed 13 years.
The extension shall be granted only if the marketing authorisation holder originally applied for determination of the maximum residue limits for the active substance.