The list of cases in which retail sale of medicinal products can be carried out outside of pharmacies has been expanded in Belarus. This is provided for by amendments to the Law "On Medicinal Products", which entered into force today, BELTA reports.
The list of cases in which retail sale of medicinal products can be carried out outside of pharmacies has been expanded in Belarus. This is provided for by amendments to the Law "On Medicinal Products", which entered into force today, BELTA reports.
Previously, retail sale outside of pharmacies was allowed only in rural settlements where there were no pharmacies. After the law entered into force, the retail sale of medicinal products is permitted at international thematic exhibitions, international sports, and cultural events, in the manner determined by the Ministry of Health.
The Law enshrines the provision on the Republican Formulary of Medicinal Products, which is established annually by the Ministry of Health to ensure the accessibility of medicinal products.
It is provided for the issuance of a registration certificate with a five-year validity period for a newly registered medicinal product, after which the drug must undergo a state registration confirmation procedure. Upon confirmation of state registration, an indefinite registration certificate is issued for the medicinal product. The document establishes cases where state registration (its confirmation) of a medicinal product, amendments to the registration dossier may be refused, as well as cases where the validity of the registration certificate may be suspended for up to six months or terminated.
A novelty of the law is the introduction of a pharmacovigilance system, which is a set of measures aimed at timely detection of all changes in the benefit-risk ratio of medicinal products and at minimizing the negative consequences of their use.
Industrial production of medicinal products is carried out in accordance with the requirements of Good Manufacturing Practice, approved by the Ministry of Health, based on a special permit (license) for pharmaceutical activities. Compliance of industrial production of medicines with the requirements of Good Manufacturing Practice is confirmed by a document issued by the Ministry of Health based on the results of inspections carried out in the manner and under the conditions determined by the Ministry of Health. In addition, the list of cases in which industrial production of medicinal products is prohibited has been expanded.
Information on medicinal products subject to prescription and over-the-counter sales, after their state registration and inclusion in the State Register of Medicinal Products of the Republic of Belarus, is posted on the website of the Ministry of Health.
The Law of the Republic of Belarus of November 17, 2014, introduces amendments and additions to the Law of the Republic of Belarus of July 20, 2006 "On Medicinal Products".
News of Belarus (BELTA)