Disposal of reliable information on medicinal products is a prerequisite for implementation of rational use of medicinal products.
In the procedure of marketing authorization issuance, as an integral part of the marketing authorization, ALIMS approves the Summary of Product Characteristics (SmPC) and Patient Leaflet (PIL). SmPC is the basic information for veterinary professionals on how to use a medicinal product in a safe and efficient manner. The Patient Leaflet (PIL), which contains information for the patient, is prepared in accordance with the SmPC content, in a form that is adapted for the patient. In addition to registration documentation, approved SmPCs and PILs, the basis for the provision of information on medicinal products is also a literature search.
Apart from information on a medicinal product pertaining to the approved indications, dosage of contraindication, adverse reactions and other information on medicinal products, which are an integral part of the SmPC, ALIMS also provides expert opinions on medicinal products regarding registration status of a medicinal product, status in relation to the documentation with which the medicinal product is registered (own research or bibliographic data), as well as on the existence of parallel medicinal products (medicinal products that have the same INN, expressed in the same pharmaceutical form, regardless of the dose).
A reference medicinal product is a medicinal product for which the marketing authorization has been issued in the Republic of Serbia or in the European Union member states based on full documentation on a medicinal product quality, safety and efficiency in accordance with the current requirements.
A generic medicinal product is a medicinal product with the same qualitative and quantitative composition of active substances and the same pharmaceutical form as the reference medicinal product, and whose biological equivalence in relation to the reference medicinal product has been proven through suitable investigations of biological availability. Different salts, esters, ethers, isomers, mixtures of isomers, complexes and derivatives of active substances are considered to be the same active substances of a generic medicinal product, unless they significantly differ in their safety or efficiency. Different forms of oral medicinal products with immediate release are considered to have the same pharmaceutical form of the generic medicinal product.
Veterinary Medical Devices
The Agency provides information on veterinary medical devices. Search for veterinary medical devices registered in the Veterinary Medical Device Registry can be conducted at the following link:
Search veterinary medical devices