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
(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