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of May 25, 1993 No. 1456-XII

About pharmaceutical activities

(as amended on 27-04-2023)

The parliament of the Republic of Moldova adopts this law.

Chapter I Basic concepts

Article 1. Basic concepts

For the purpose of this law the following basic concepts are used in value:

pharmaceutical activities - the scientific and practical field of health care including activities for development of drugs, their standardization, registration, production, production, quality control, storage, informing on them, delivery and leave to their population and also on management of the pharmaceutical companies and organizations and their divisions which is performed only within the pharmaceutical company and organization, except for researches on development and testing of the drugs performed according to the current legislation;

primary package - the reservoir or any other form of packaging which is in direct contact with medicine;

secondary package - packaging into which the primary package is inserted;

approval - process of examination, approbation and registration of drugs, other pharmaceutical products and parapharmaceutical products;

the import permit of medicinal raw materials, materials, products, primary and secondary package - the permission issued by the Agency on drugs and medical products to the business entity licensed in pharmaceutical activities on production of the drugs intended for the person and preparation of the main dosage forms; the allowing document issued by the Agency on drugs and medical products for implementation of the foreign trade transactions (import) for a certain period of time and in certain limits;

examination - the process of complex research of medicine and documentation relating to it performed by group of specialists (druggists, pharmacologists, clinical physicians, etc.) as a result of which compliance (or discrepancy) documentation drugs, reliability of documentation and the data included in it are established;

approbation - the procedure of official recognition including preparation of the report and official confirmation by method of collective expert evaluation of results of examination of medicine therefore its registration is allowed or deviates;

registration - process of preparation and the edition by the Agency on drugs and medical products of the order, creation and issue of the registration certificate of medicine and entering of medicine into the State register of drugs therefore the admission of medicine on the market and its use in medical practice is allowed;

not approved medicine - medicine which did not pass the examination approbation and registration because of its non-presentation for this purpose, or approval of which was refused in accordance with the established procedure, or approval effective period expired;

the data protection period - the period during which the holder of data on preclinical testing and clinical trials has the right to forbid use of these data;

the period of market exclusivity - the period during which medicine generic cannot be entered on the market;

the first approval - for the first time the approval received anywhere in the world on original medicine;

preparation of drugs - pharmaceutical activities, other than production, performed on the basis of the established formula provided by specialized literature or the recommendation of doctors, organizations or bodies of health care, implemented in the drugstores having production department;

the main medicines - the drugs made in drugstores according to the main (individual) recipes and also in the form of pharmaceutical developments according to the repeating recipes;

the price of the producer - the goods price, namely the price of CIP (Carriage and Insurance Paid to - transportation and insurance are paid to [the called destination]) it agrees to the international commercial rules Inkoterms-2020, established by the Parisian Chamber of Commerce and Industry declared by the producer or his official representative for approval and inclusion in the National price catalog on drugs;

purchase price - the price of the producer specified in primary documentation converted into national currency (lei) on the official rate of Moldovan leu operating on the date of customs clearance taking into account the paid customs duties and costs for quality control of the purchased drugs, and also other charges established by the state;

the declared purchase price - the price of the medical products compensated or offered to compensation from funds of compulsory medical insurance which is formed of the price of the producer and costs for customs procedures declared by the supplier of medical products and transportation expenses it agrees to the international commercial rules Incoterms 2010 and Incoterms 2020 established by the Parisian Chamber of Commerce and Industry. The declared purchase price is converted into national currency (lei), by the annual average currency rate the current year established by National Bank of Moldova on the date of the statement;

production (production) of drugs - the pharmaceutical activities performed for the purpose of serial production of drugs, including at least one of stages of engineering procedure, including processes of packing, packaging and marking, quality control at production phases, quality control of ready-made product;

pharmaceutical safety - set of the measures directed to identification and the prevention of the potential hazards for health of the population caused by availability, inadequate quality, falsification of drugs, and also their misuse and/or use in the fraudulent purposes;

the obligation on rendering public service - the special requirements and obligations imposed on service providers in each sector of public services by legislature or bodies of public management authorized to regulate, authorize or manage the corresponding public service.

Article 2. Legislation on pharmaceutical activities

Pharmaceutical activities are regulated by this law and other legal acts concerning pharmaceutical activities.


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