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Registration of the medicine

MAKROMED LLC provides professional consulting services on registration, re-registration and registration of changes in registration requirement documents of medicines in the Republic of Azerbaijan.Services are provided by experienced and highly qualified pharmacists. State registration is essential for the import and sale of medicines in the Republic of Azerbaijan. State registration, re-registration and registration of changes in registration documents of medicines regulated by the Resolution of the Cabinet of Ministers of the Republic of Azerbaijan No. 108 of July 13, 2007 is carried out by the Analytical Expertise Center (AEC) of the Ministry of Health of the Republic of Azerbaijan.
Medicines that require state registration are grouped as follows:
- Original medicines ;
- Generic medicines;
- Homeopathic medicines;
- Medicines that are registered but the form and dosage have been changed.
- Medicines that are already registered but are presented in newer and more effective combinations
Available records are provided with a written shipping form and dosage.
Upon completion of the registration process, a Registration Certificate for the medicinal product is submitted and the registered medicinal product is included in the state register. Only after registration it is feasible to sell the medicines  in the country area. By contacting MAKROMED, you can get the advice and assistance you need in the documentation process and state registration procedure.
Term of Execution of Medicines Registration Process
In accordance with the Resolution of the Cabinet of Ministers No. 108 of July 13, 2007;

Description of the procedures
 		 Execution time
Time of execution Conclusion of the contract (Preliminary expertise ) 5 days

Payment of the fee (Preliminary expertise )

15 bank work days

 
Preliminary examination 15 days
Replies of manufacturing company to the queries or remarks of experts related with registration documents (if any ) 90 days
Conclusion of the contract (Specialized expertise ) 5 days
Tax payment  (Specialized expertise ) 60 bank work days 

 
Specialized expertise   210 days
Specialized expertise  (Re- registration ) 90 days
Specialized expertise  (Registartion of the changes ) 90 days
Replies of manufacturing company to the queries or remarks of experts related with registration documents (if any ) 90 days
Decision of the Expert Council 10 days
Additional specialized expertise (if it needed) 30 days
Replies of manufacturing company to the queries or remarks of experts related with registration documents (if any ) 90 days
Latest decision of the expert  council 15 days
İssuance of registration Card 15 days

***Delays in the registration process may occur due to objective reasons.
***The above periods don’t include the inspection of production enterprise.

Our pharmacists work on the basis of a planned scheme of operations to solve current problems that may arise at all stages of the documentation and registration process.

It is inevitable to registrate changes in the registration documents of edicines in the below-mentioned cases.
 1.Update the instructions  for  use of medicines;
 2.Changes in the composition of  additional excipients on the medicine;
 3. If the information on the production area of ​​the medicinal product changes;
 4. To improve the quality of medicines, to change the method of quality control;