How to get a license for pharmaceutical activities

How to get a license for pharmaceutical activities

If you want to do business in the pharmaceutical direction, you can not do without a special license. To get it, you must comply with the strict requirements of the Ministry of Health and do a number of certain actions.

1
Decide exactly what kind of activity you are going to do. You can open a pharmacy or pharmacy point. The discovery of the pharmacy involves the sale of drugs, vitamins and personal hygiene products. In the pharmacy item sell prescription medicines or without a doctor's prescription. For different activities, it is necessary to obtain different licenses.

2
A prerequisite for obtaining a license is the presence of room and equipment. You can purchase the premises in the property or rent it. The pharmacy institution should take at least 18 sq.m., but if it is located on the territory of therapeutic or preventive complex - at least 8 sq.m. The room there should be a trading room, a cash register, a reception station, a bathroom, a room for employees, a room for drugs, a reception area and unpacking. If you open a pharmacy point, there must be a room for making medicines.

3
It is also important to equip the room with furniture, racks with a glass windows and a refrigerator. Note that in the future the surface of the furniture will be subject to frequent rubbing and processing disinfectant, so pick up options with a steady material. Check carefully, whether all the requirements are observed - the place will be examined by the Commission of Rospotrebnadzor. Complete sanitary and epidemiological verification and make a conclusion that the services provided comply with the rules. Also get a conclusion in the state fire service authorities.

4
I hide the head, several provisions or pharmacists and a cleaner. Each employee (except the cleaner) should have a sanitary book and a secondary or higher formation of a pharmaceutical focus. Before getting a job in a pharmacy, provisions and pharmacists should get the experience of at least three years. They should be fairly qualified to provide visitors to competent consultations and select the necessary or alternative versions of medicines.

5
Some categories of drugs should be stored separately from each other. These include narcotic drugs and poisonous substances. For each category, select a separate zone. Especially "strong" drugs must be in a metal safe.

6
Contact Roszdravnadzor. Take a copy of a certificate of registration of an individual entrepreneur, a copy of the rental agreement or certificate of ownership, a copy of the passport of the pharmacy warehouse, employment records and diplomas of hired people, a sanitary and epidemiological conclusion on compliance with the requirements of sanitary standards, the conclusion of fire service authorities, as well as copies constituent documents of the organization. Just in case, look at the full list of required documents on the official website - www.roszdravnadzor.ru.. All documents must be notarized and comply with state standards. You will be asked to write a statement and pay the state duty. If everything goes successfully, within a few months you will receive a license for a period of five years.

The discovery process of the pharmacy is quite complicated and requires considerable investments, but in the future this business promises considerable incomes. Before discovery, it is very important to do high-quality training, which is why the license is associated with such strict requirements.

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