Good day! Of course, I will help you understand this resolution.
1. **Essence of the Law:** This Resolution of the Cabinet of Ministers of Ukraine defines the procedure for maintaining state registers in the field of medicinal products. It establishes the rules for the formation and maintenance of the State Register of Medicinal Products, the State Register of Medicinal Products Imported into the Territory of Ukraine in Parallel, and the State Register of Medicinal Products Placed on the Market that are Imported into the Territory of Ukraine. This is important for ensuring transparency and control over the circulation of medicines in Ukraine.
2. **Structure of the Law:**
* The resolution consists of several parts.
* Three procedures for maintaining separate registers of medicinal products are approved.
* Transitional provisions are defined regarding the commencement of operation of the new registers and the assignment of powers to the State Service on Medicinal Products and Drug Control until the establishment of a new central body.
* Amendments are made to the previous Resolution of the Cabinet of Ministers of Ukraine No. 411 of March 31, 2004 “On Approval of the Regulations on the State Register of Medicinal Products”.
* A list of Resolutions of the Cabinet of Ministers of Ukraine that have become invalid is defined.
3. **Main provisions of the Law:**
* **State Register of Medicinal Products:** Defines the mechanism for the formation and maintenance of the register, the procedure for entering information on registered medicines, changes to registration dossiers and exclusion of information from the register.
* **State Register of Medicinal Products Imported in Parallel:** Establishes the rules for maintaining the register and the procedure for entering information on permits for parallel import of medicines.
* **State Register of Medicinal Products Placed on the Market:** Regulates the procedure for maintaining the register, the procedure for entering information on series of medicines being imported, and persons responsible for placing medicines on the market.
I hope this has helped you to better understand this piece of legislation!
