Pharmaceutical Law (1997)

The purpose of this Law is to regulate the activities of natural and legal persons in the field of pharmaceuticals, as well as to ensure the manufacture and distribution of medicinal products which are qualitative, medically appropriate and of an appropriate prophylactic, treatment and diagnostic level. The Ministry of Health shall be responsible for the supervision and control of the pharmacy system in the Republic of Latvia in the field of medicinal products for human consumption, but in the field of veterinary medicinal products – the Ministry of Agriculture. Supervision and control of the manufacture of medicinal products and the distribution of medicinal products to wholesalers and pharmacies shall be conducted by the Health Inspectorate of Latvia. The Food and Veterinary Service shall supervise and control the manufacture and distribution of veterinary medicinal products, as well as the use of medicinal products intended for human consumption on animals.
The Food and Veterinary Service shall, within the competence thereof, conduct the following functions: assess, classify and register veterinary medicinal products; establish and update the Veterinary Medicinal Product Register of the Republic of Latvia, grant registration numbers and codes for veterinary medicinal products, establish and maintain a data base regarding observed adverse reactions caused by veterinary medicinal products, regarding clinical investigation of veterinary medicinal products and observations of use thereof; organise collection of information, compile information and form statistics in the field of circulation of veterinary medicinal products using the information provided by veterinary medicinal product manufacturers, importers, distributors, practicing veterinarians and veterinary medical care institutions; ensure the quality control of veterinary medicinal products; ensure the co-operation with competent institutions of other countries in the field of assessment, registration and control of veterinary medicinal products; issue permits for importation, exportation and distribution of veterinary medicinal products, as well as of the veterinary medicinal products intended for clinical investigations, except the permits for importation, exportation and distribution of veterinary narcotic and psychotropic medicinal products; issue permits for distribution of veterinary medicinal products for veterinary medicinal products other than registered in the Republic of Latvia if veterinary medicinal products are necessary for treatment of a particular animal, treatment of particular animal disease or performance of medical manipulations and the medicinal products included in the Veterinary Medicinal Product Register of Latvia may not be used due to medical indications - on the basis of a written request of a practicing veterinarian and, if necessary, of an opinion of the Latvian Association of Veterinarians, veterinary medicinal products are necessary for provision of veterinary medical care in case of disaster, natural disaster or threats of spread of dangerous animal infectious diseases – on the basis of a decision of the State Chief Veterinary and Food Inspector; assess the conformity of veterinary pharmacies, veterinary medicinal product wholesalers, manufacturers (also foreign manufacturers) and importers, check the conformity of the qualification and experience of the responsible official with the requirements laid down in laws and regulations, and issue special permits (licences) for veterinary pharmaceutical activities. This requirement does not apply to the medicinal product manufacturers and importers referred to in Section 51.2 of this Law; issue permits for the importation into the Republic of Latvia of diagnostics for the needs of approbation and the acquiring, introduction and use of new methods; and assess the conformity of veterinary medicinal product manufacturers and importers with the requirements of good manufacturing practice and issue attestations of good manufacturing practice for veterinary medicinal products. This requirement does not apply to the medicinal product manufacturers and importers referred to in Section 51.2 of this Law.
The Law, among others, also provides for evaluation and registration of medicinal and pharmaceutical products; pharmacies; medicinal product wholesalers; manufacturing and importing of medicinal products and active substances and distribution of active substances; licensing and certification; liability for failure to observe the pharmacy law, taking of decisions and control; and suspension of the activity of subjects of pharmaceutical and veterinary pharmaceutical activity.