Veterinary Medicines

Medicinal product is a product containing a substance or a combination of substances produced and intended for the treatment or prevention of diseases in humans or in animals, for diagnostic purposes, improvement or modification of physiological functions or for achieving other medically justified objectives.

Blood and blood components intended to be used in transfusion shall not, under the provisions of this Law, be cosidered medicinal products.

A finished medicinal product, under the provisions of the Law on Medicinal Products and Medical Devices, is a medicinal product marketed in a given strength, form and package, under a proprietary name or an international non-proprietary name (INN). A finished medicinal product with a special commercial name determined by the manufacturer is marked, dispensed or sold as a medicinal product with a proprietary name. A finished medicinal product can also be dispensed or marketed under its International Non-Proprietary Name (INN), defined by the World Health Organization, with the name of the manufacturer.

A magistral formula is a medicinal product prepared in the pharmacy according to a prescription (formula) for an individual patient-user.

A galenic formula is a medicinal product prepared in a galenic pharmacy laboratory, in accordance with the current pharmacopoeia or current magistral formulae and destined to be dispensed or sold to the patients-users served in a concerned pharmacy.

A veterinary medicinal product under the provisions of the Law on Medicinal Products and Medical Devices, is a medicinal product intended to be used on animals only.

A traditional medicinal product is a medicinal product that is not based on scientific principles, but is an expression of traditional or other therapeutic approaches (traditional herbal medicinal products and others).

A homeopathic medicinal product under the provisions of the Law on Medicinal Products and Medical Devices, is a medicinal product made of

products, substances or compounds representing the homeopathic raw materials, in accordance with a homeopathic manufacturing procedure and pursuant to the methods of the European Pharmacopoeia or the pharmacopoeias of other countries of European Union.

A premix is a pharmaceutical form of a veterinary medicinal product, intended to be mixed with animal feed or with water used to water the animals.

Pursuant to this Law, the term medicinal product shall also apply to: Medicinal product made from human or animal blood, Immunological medicinal product (sera, vaccines, specific and non-specific immunoglobulins, toxins, and allergens), Radiopharmaceutical medicinal products, finished medicinal product or a medicinal product prepared immediately before being used and containing one or more radionuclids intended for medical use.

National marketing authorizations for medicinal products are issued in Serbia. Since Serbia is not a member of the EU, in this phase of the development of pharmaceutical regulatory system for granting centralized authorization or marketing authorization based on mutual reckognition is not yet possible. Although Serbia is not yet a member of the EU, when marketing medicinal products, there is a possibility of reckognizing and accepting expert oppinions and performed clinical trials, in line with the Declaration of Helsinki, as well as the study on bioequivalence and bioavailability, with the applications processed in accordance with the internationally reckognized standards, and with medicinal products that have already been marketed.

When granting the marketing authorization for a medicinal product, the Medicines and Medical Devices Agency of Serbia keeps in sight the provisions of international agreements on the obligation of marketing good quality, safe and efficient medicinal products, the increase of marketed false medicinal products in the world and the need for cessation thereof, as well as the illegal marketing of the unregistered medicial products. The Agency issues the approval for marketing authorizations for unregistered medicinal products when it is medically indicated and legally permitted.