Member States shall take all necessary measures to ensure that medicated feedingstuffs are issued directly to the stockfarmer or holder of the animals only by the manufacturer or distributor specially approved by the competent authority of the Member State of destination.

Furthermore, medicated feedingstuffs for the treatment of animals whose meat, flesh, offal or products are intended for human consumption may not be issued unless:

• they do not exceed the quantities prescribed for the treatment, in accordance with the veterinary prescription where this is provided for,

• they are not issued in quantities greater than one month's requirements as established in accordance with the stipulations of the first indent.

However, notwithstanding paragraph 1, Member States may in special cases authorize distributors specifically approved for that purpose to issue, on the basis of a veterinary prescription, medicated feedingstuffs in small quantities, prepacked and ready for use, and prepared, without prejudice to Article 8 (2) in accordance with the requirements of this Directive, provided that these distributors:

• comply with the same conditions as the manufacturer regarding the keeping of registers and the storage, transport and issue of the products concerned,

• are subject to special checking for the purpose, under the supervision of the competent veterinary authority,

• may supply only prepacked or prepackaged medicated feedingstuffs ready for use by the holder or stock-farmer that have on the packaging or containers instructions for the use of the said medicated feedingstuffs and, in particular, an indication of the withdrawal period.

The provisions of paragraph 2 shall not affect national rules on the legal ownership of the medicated feedingstuffs.