Legal requirements of oral medication in animal stocks in Germany

摘要

Oral medication of animal stocks can be administered via oral ready-to-use veterinary medicinal products or by using medicated feedingstuffs. The regulations contained in the German Drug Act (Arzneimittelgesetz - AMG) and the ordinances derived from the AMG are applicable to both types of medicinal product. The legal requirements relating to the manufacture, authorisation, marketing, dispensing and proper use of these medicinal products in respect of oral medication are dealt with in detail. Pursuant to Section 13 AMG, companies that manufacture medicated feedingstuffs require a manufacturing licence. To take into account the special features of these medicinal products, specific stipulations have been laid down regarding the manufacture and dispensing of medicated feedingstuffs by these companies. The use of medicated feedingstuffs is for various reasons in steep decline, while oral ready-to-use medicinal products are, according to reports on practice in the relevant sector, increasingly being used to treat animal stocks as well. When dispensing veterinary medicinal products, the veterinarian must comply with the state of the art and make sure that the animal keeper is able to use the drugs properly. In order to react to doubts regarding compliance with these legal requirements, recommendations for use of oral medication should be developed which provide veterinarians with an aid to assist them in deciding which type of drugs are most suited for the respective case, and what is to be complied with in their use. The recommendations for use are intended to facilitate the correct application of oral medication in respect of both types of veterinary medicinal product.