Law on medicines.

This Law here regulates the conditions for the production, sale and testing of medicines for human use and for use in veterinary medicine, including measures aimed to ensure the quality, safety and efficiency of such medicines, among related competence of designated authorities in the field of medicines or drugs, as well as other issues of importance for the performance of this activity.
The text is divided into fourteen main thematic Chapters and a total of 227 articles. Titles of these Chapters are as follows: I. General provisions; II. Competences; III. Drugs; IV. Medicine licence; V. Drug testing to provide documentation in the procedure of issuance of drug licenses; VI. Production of medicines; VII. Trade with drugs; VIII. Medicine quality assurance; IX. Labelling; X. Pharmacovigilance; XI. Advertising medicines; XII. Control; XIII. Penalty provisions; and XIV. Transitional and final provisions.
The provisions of this Law apply to medicinal products intended for marketing that are manufactured industrially or by a manufacturing process that includes an industrial process. If the product according to its definition and characteristics can be considered a medicine and another product at the same time to which the provisions of other regulations may be applied, the provisions of this Law shall anyway apply. The production and sale of medicines is an activity of public interest according to this Law. The production, distribution, testing and control of medicines can be carried out by legal entities that meet the conditions prescribed hereby and in deriving regulations adopted n the basis of this text. In Montenegro, a medicine that has a medicine license issued by the European Commission can be in circulation and use, in in accordance with this Law. The production, i.e. the sale of medicines, is prohibited: 1) when a license for the drug or approval for procurement, i.e. import of the drug, has not been issued; 2) produced by a legal entity that does not have a license for production; 3) when are not marked in accordance with the provisions of this Law; 4) when the expiration date indicated on the package has expired; 5) when the incorrectness was determined in terms of their prescribed quality; 6) when result falsified; 7) when intended for treatment of animals used for human consumption, and when produced from substances which may not be used for the production of medicines for veterinary use. Medical deriving waste and other additional technical and procedural matters are competences of the the Institute that was established by the Ministry (see articles 9-26). The institute and the holder of the license for the drug organize a system of pharmacovigilance, with the aim of protecting human and animal health by collecting and evaluating information related to the safety of drug administration, as well as other information that can be significant for the assessment of the benefit-risk ratio of the medicinal product in circulation. With the system of pharmacovigilance, the Institute evaluates all data related to the safety of drug use, considers the possibilities to reduce and prevent risks and, if necessary, take appropriate measures in accordance with this Law. The system of pharmacovigilance of veterinary drugs enables the collection and evaluation of information obtained in connection with suspected adverse effects of veterinary drugs under approved conditions of use in animals and adverse effects in humans associated with the use of these drugs, lack of expected efficacy, unapproved use, investigation of validity of the withdrawal period and possible environmental impacts related to the use of such veterinary medicinal products.