An entrepreneur who decides to engage in the manufacture of prescription drugs cannot do without a special permit - a license that allows him to engage in pharmaceutical activities.
It is necessary
- - premises;
- - documentation;
- - staff.
Instructions
Step 1
To obtain a pharmaceutical license, please fulfill the conditions required to obtain a license. Buy or rent premises and equipment for your company to carry out pharmaceutical activities.
Step 2
If you manufacture prescription drugs - follow the rules that are approved in accordance with the 17th article of the Law "On Medicines". If you are going to sell medicines through pharmacies, make sure that worn-out medicines are not sold; counterfeit medicines (fakes), expired medicines. If you find such drugs, destroy them.
Step 3
Make sure your employees have a secondary or university degree in pharmaceuticals and are certified as a specialist. Provide professional development for your employees at least once every five years.
Step 4
Also, if you are a license applicant manager and your activity is directly related to the manufacture, purchase, storage, sale and disposal of drugs, you must have a higher education in pharmaceuticals. In addition, you must have worked in your specialty for at least three years.
Step 5
If you meet all the necessary requirements, submit to Roszdravnadzor or its nearest department an application for a pharmaceutical license. Attach the following documents to your application:
- copies of constituent documents of your pharmacy;
- documents confirming the payment of a state duty in the amount of 300 rubles for considering an application for a license;
- lease agreements for premises for your pharmacy with a sanitary and epidemiological conclusion on the compliance of the premises with the requirements of sanitary standards;
- documents on secondary or higher education, certificates of a specialist, documents on work experience in the specialty (you and your employees).
Step 6
Please submit copies of documents not certified by a notary together with the original. Within five days after submitting the documents to you, if everything is done correctly, you will have a pharmaceutical license. For the license itself, pay 1000 rubles.
