Law on drugs.

This Law regulates all necessary conditions for the production, trade (also international trade) and testing of medicines for human use and use in veterinary medicine, including measures to ensure quality, proper classification, safety and efficacy of such drugs or medicines, also competencies of bodies in the field of medicines, as well as other issues of importance for performing related activities. The production and sale of medicines is an activity of public interest. Veterinary medicines shall be tested in accordance with observed principles of veterinary ethics and general animal welfare protection. The production, trade, testing and control of medicines can be performed by authorized legal entities that fulfill the conditions prescribed by this Law and regulations adopted as for the purpose of implementation of this the same. In Montenegro, only a medicinal product that has a marketing authorization may be placed on the market. Market prohibitions are laid down in article 3 (paragraph 6 determines that it is prohibited to produce/trade with drugs which are intended to treat animals used for human consumption, and which are manufactured from substances that cannot be used to produce drugs for use in veterinary medicine). Topics covered in this Law are further regarding the good laboratory practice; withdrawal period which is the period of time that must elapse between the last administration of certain drug to animals, under normal conditions, until the treated animal and its products can be used for food, in order to protect human health and ensure that such produced food does not contain residues in quantities exceeding the maximum permitted concentrations; maximum residue level which is the maximum allowable drug concentration present in traces of foods and foodstuff obtained from treated animals; immunological veterinary medicinal product which is any medicinal product administered to animals in order to create their active or passive immunity or to diagnose the condition of their immunity.
The text is divided into thematic Chapters and a total of articles. Titles of main Chapters are as follows: I. Basic provisions; II. Jurisdiction; III. Drugs; IV. Drug permit; V. Drug testing for security documentations in the procedure of issuance of medicinal authorizations; VI. Drug production; VII. Drug trade; VIII. Drug quality assurance; IX. Drug labelling; X. Pharmacovigilance; XI. Drug advertising; XII. Inspection; XIII. Penalty provisions; XIV. Transitional and final provisions.