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1. **Essence of the Law:**
This resolution amends the procedure for state registration of medicinal products in Ukraine, in particular, it simplifies the procedure for registering medicines that are already registered in countries with high quality standards, such as the USA, Great Britain, Switzerland, Japan, Australia, Canada and EU member states, as well as those purchased through international organizations. Also, the resolution defines the specifics of registration of medicines purchased by specialized organizations, and establishes cases when the fee for state registration is not paid.
2. **Structure and main provisions:**
The resolution introduces changes to the Procedure for State Registration (Re-registration) of Medicinal Products, approved by постановoyu of the Cabinet of Ministers of Ukraine No. 376 dated May 26, 2005. The main changes concern:
* Simplifying the procedure for submitting an application for registration (the possibility of submitting in electronic form).
* Excluding the requirement for mandatory purchase of medicines that have already been purchased.
* Clarification of the list of documents for registration of medicines purchased by authorized organizations.
* Establishing clear deadlines for checking registration materials.
* Determining the grounds for refusal of state registration of such medicinal products.
* Making changes to the maintenance of the State Register of Medicinal Products.
* Establishing grounds for cancellation of state registration of a medicinal product, in particular, if production is carried out on the territory of the aggressor state.
* Exemption from paying the fee for state registration of certain categories of medicinal products.
3. **Key provisions for use:**
* **Electronic submission of documents:** Applicants can now submit documents for registration of medicinal products in electronic form, which greatly simplifies the process.
* **Simplified procedure for medicines from countries with high standards:** Medicinal products already registered in the USA, Great Britain, Switzerland, Japan, Australia, Canada and EU member states undergo a simplified registration procedure.
* **No registration fee:** There is no fee for registration of medicines purchased by authorized organizations and already registered in the above-mentioned countries.
* **Cancellation of registration of medicines produced in the aggressor country:** Medicinal products manufactured in Russia or Belarus are subject to cancellation of registration.
* **Validity period of the registration certificate:** A registration certificate is issued for a medicinal product purchased by a person authorized to make purchases in the field of health care for a period of five years with the possibility of re-registration.
These changes are aimed at ensuring quick access of patients to high-quality and effective medicinal products, especially those purchased at the expense of the state budget.
