We use cookies to give you the best online experience. By using our website you agree to our use of cookies in accordance with our cookie policy. Learn more here.Close Me
On March 23, 2012 the Ministry of Healthcare of Ukraine
submitted the draft amendments to the resolution of the Cabinet of
Ministers of Ukraine No. 73 dd. 15.01.2012 and No. 376 dd.
26.05.2005 for public discussion. The amendments apply to the
registration procedure for medicinal products and medical
immunobiological preparations, namely as follows:
State registration of medical immunobiological preparations
will be confirmed by a bill of state registration of a medicinal
product (medical immunobiological preparation) instead of a
certificate, as it is now;
The right to apply for state registration will be granted to an
individual or a legal entity having the resources to implement
pharmacovigilance in Ukraine;
The Ministry of Healthcare will consider an application for
registration and after that refer it to the appropriate expert
establishment;
In addition to an application for state registration it will be
necessary to submit a copy of document confirming the compliance of
manufacturing conditions of a medicinal product with the Good
Manufacturing Practices approved in Ukraine;
The Ministry of Healthcare of Ukraine is entitled to decide on
the prohibition of turnover of a medicinal product by terminating
its registration certificate, if the medicinal product has not been
in the turnover for 3 years from the date of its registration;
Vaccines and toxoids shall be re-registered in accordance with
the re-registration procedure for medicinal products based on the
data on their effectiveness and safety, which were obtained from
their medical use.
The content of this article is intended to provide a general
guide to the subject matter. Specialist advice should be sought
about your specific circumstances.
To print this article, all you need is to be registered on Mondaq.com.
Click to Login as an existing user or Register so you can print this article.
Under the NHS reforms, CCGs now have responsibility for commissioning healthcare services to meet the reasonable needs of the persons for whom they are responsible.
The main purpose of this brief information note is to indicate the regulations of healthcare services and health insurances available for foreigners in Turkey
Leaders from some of the South West’s biggest and most successful industries have come together to draw a road map to the region becoming Britain’s agri-food sector ‘centre of excellence’.
Parallel to the harmonisation process of Turkish legislation with European Union law, the legal environment regarding veterinary products is also evolving in Turkey.
There have been specific rules governing the promotion of medicinal products in Turkey since the beginning of the 90’s.
Some comments from our readers… “The articles are extremely timely and highly applicable” “I often find critical information not available elsewhere” “As in-house counsel, Mondaq’s service is of great value”
