of January 15, 1996 No. 73
About approval of the Regulations on control of compliance of the immunobiological medicines applied in medical practice, to requirements of the state and international standards
According to the Law of Ukraine "About ensuring sanitary and epidemiological wellbeing of the population" and for the purpose of enhancement of system of testing and acceleration of implementation of new immunobiological medicines in medical practice the Cabinet of Ministers of Ukraine DECIDES:
1. Medical immunobiological supplies (further immunobiological products) are vaccines, anatoxins, immunoglobulins, serums, bacteriophages, other medicines, held for use in medical practice for the purpose of treatment, specific prevention, diagnostics of condition of immunity (in vivo).
Immunobiological products can be made as ready dosage forms, biological agents (active ingredients), bulk immunobiological medicines and medicines in krupnoobjemny packaging (in bulk), standard samples (the international sample, the state (industry) standard sample, standard sample of the company).
2. Determine that state registration of medical immunobiological supplies of national and foreign production is performed by the Ministry of Health, and examination of materials on medical immunobiological supplies which move for state registration (re-registration), and also examination of materials about modification of registration materials during action of the registration certificate on medicine (medical immunobiological supply), is carried out by the state company "State MZ Expert Centre".
3. To the ministries and departments, the Government of the Autonomous Republic of Crimea, local authorities of the state executive authority, the companies, organizations and the organizations irrespective of subordination and patterns of ownership to provide to Public service on medicines and
to control of drugs information on immunobiological medicines for control of their compliance to requirements of the state and international standards.
Disclaimer! This text was translated by AI translator and is not a valid juridical document. No warranty. No claim. More info
Database include more 50000 documents. You can find needed documents using search system. For effective work you can mix any on documents parameters: country, documents type, date range, teams or tags.
More about search system
If you cannot find the required document, or you do not know where to begin, go to Help section.
In this section, we’ve tried to describe in detail the features and capabilities of the system, as well as the most effective techniques for working with the database.
You also may open the section Frequently asked questions. This section provides answers to questions set by users.