site.btaHealth Minister on Unqualified People Administering Medicinal, Cosmetic Products Intravenously
The intravenous administration of dietary supplements and cosmetic products, as well as of medicinal products that have not been authorized for use in Bulgaria - except for the permissible exceptions under the Medicinal Products in Human Medicine Act - and of those of unknown origin is prohibited, Health Minister Katya Ivkova said Friday during Question Time in Parliament. It is also prohibited for individuals without the appropriate medical qualifications to administer intravenous injections or infusions, whether in a medical facility or outside of one, she added.
Regarding the advertising of medicinal products, Minister Ivkova noted that it is regulated by law and by a regulation, with the legislation providing for strict control over the advertising of medicines. A medical professional or a person presenting themselves as a medical professional may not engage in direct or indirect advertising of medicines in print and electronic media, as well as on the internet. This provision is particularly important given the increasing number of cases where the images, names, and expert authority of doctors and other medical professionals are used to advertise products with purported therapeutic effects on social media and online platforms. Online advertising of prescription drugs is prohibited, with the exception of vaccination campaigns conducted in accordance with the law and approved by the competent authorities, Ivkova said.
The Bulgarian Drug Agency is a specialized body under the Minister of Health responsible for overseeing the quality, safety, and efficacy of medicines. Under current legislation, only natural and legal persons who have obtained the relevant authorization in accordance with the procedures and conditions of the Medicinal Products in Human Medicine Act are authorized to engage in wholesale and retail trade in medicinal products within the country. Online sales may only be conducted for non-prescription medicines by a person who has obtained authorization from the Bulgarian Drug Agency for the retail sale of medicinal products (pharmacy) or a registration certificate from the regional health inspectorate as a drugstore. An explicit ban has been introduced on the online sale of prescription drugs. Any offer, advertisement with the option for remote ordering, or sale of such medicinal products via websites, online stores, social media, or other online channels is in violation of current legislation, Minister Ivkova added.
A large proportion of inspections have uncovered advertisements for the sale of numerous prescription drugs; in most cases, there are no drugs authorized for use in Bulgaria under the published trade names, and for some of the substances, no marketing authorizations have been issued anywhere in the world, as they are still in the clinical trial phase.
/КТ/
Additional
news.modal.image.header
news.modal.image.text
news.modal.download.header
news.modal.download.text
news.modal.header
news.modal.text