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S.L. 437.47 · Veterinary Medicinal Products (S.L. 437.47)

S.L. 437.47 Art. 4BSamples and demonstration packs of veterinary medicinal products.

TITLE II

In KraftAmtlicher Text

(1)Veterinary medicinal products may be exempted from the provisions in regulations 5 to 8 if it can be demonstrated that the products are veterinary samples or demonstration packs distributed to veterinary surgeons or pharmacists by veterinary wholesale distributors.

(2) The products referred to in sub-regulation (1) may be used under the following conditions:

(a) they are distributed for free to persons authorised to receive them or are exhibited during conferences or similar activities which are held for intended for veterinary surgeons and/or pharmacists;

(b) they bear a label printed "Free sample/Demonstration pack – Not for sale";

(c) the unit pack should not contain more than:

(i) 50 units for capsules/tablets;

(ii) 10 units for injections and spot-ons

(iii) 300g for powders

(iv) 3L for liquids

(v) 5 units for intra-mammary tubes

(vi) any other measurement as established by the Veterinary Services for all other Pharmaceutical forms

(d) the information provided with the samples shall not be promotional in nature;

(e) the maximum period of time the authorised veterinary wholesale dealer can procure a product from a Member State of the European Union as a free sample is one (1) year from the first consignment thereof;

(f) if any product authorised in accordance with the provisions of sub-regulation (1) is administered to a food producing animals, that animal is excluded permanently from the food chain.

Änderungsgeschichte
  • Amended by L.N. 179 of 2021