What is a pharmaceutical license for retail and wholesale trade?

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In accordance with the requirements of the Federal Surveillance Service and current legislation in the field of healthcare, a pharmacy license is required for the wholesale or retail sale of medicines and other medical products.

Contents of the article:

• What is included in pharmaceutical activities
• License for wholesale and retail sale of medicines
• How to get a license

What is included in pharmaceutical activities

Pharmaceutical activities include

• Trade in medical goods;
• transportation and storage of medicines; prescription dispensing.

The sale of medicines and other goods is possible in retail trade, either through regular pharmacies, or in bulk. This is usually done by specialized warehouses, manufacturing companies or intermediaries. However, to carry out such activities, a special wholesale pharmaceutical license it should be noted that for retailers who have not presented a permit for wholesale trade in products from this region, it is impossible to participate in the supply of medicines and goods under government contracts, which makes it impossible to comply with Article 686 of the Decree. 07/06/2012.

License for wholesale and retail sale of medicines

In accordance with Law No. 54, transactions with medicines and medical products can be carried out in the following ways

1. Wholesale supplies are carried out by wholesale companies or manufacturers in accordance with established rules and requirements for the distribution, transportation and storage of medicines;
2. Retail trade is the activity of dispensing drugs in small quantities that correspond to a doctor’s prescription. Such activities are carried out by pharmacies, medical institutions, outpatient clinics, general family and medical practice centers and individual entrepreneurs.

To carry out pharmaceutical activities and sell medicines, a special license is required. To create wholesale supplies, the license must be appropriately labeled, allowing such products to be sold in large quantities.

How to get a license

To obtain a license for the wholesale or retail sale of medicines, you must contact special authorities. Today Roszdravnadzor (Federal Service for Surveillance in Healthcare) has the right to issue such licenses. They also handle licensing:

• Rosselkhoznadzor works in the field of botanical and veterinary supervision;
• Suborganizations of pharmacies of the state academy of sciences or federal bodies;
• Wholesale organizations selling medicines and medical equipment;
• Organizations working in the field of circulation of veterinary drugs;
• Executive authorities (departments, ministries, health councils).

The conditions and cost of obtaining a license depend on the type of document, the applicant’s availability of equipment and premises, and the qualifications of specialists and employees. The following licenses are available today

• Wholesale trade of goods for medical management;
• Storage of medicines and medical equipment;
• Transportation of medicines and other medical products;
• Retail trade of medicines, goods for medical use;
• Distribution of medicines;
• Product manufacturing; drugs for the medical industry.

Licenses do not expire, but some licenses may need to be renewed. These situations may be as follows.

• The company is reorganizing;
• The name of the company or its place of business changes;
• License forms are damaged or lost;
• The list of services has been changed or expanded.

The license is valid throughout the Russian Federation and is issued to wholesale and retail organizations, veterinary institutions, pharmacies, medical institutions and their divisions, wholesale warehouses, and manufacturers. In this case, the applicant must meet the following requirements

• Checking the location of activities (lease agreements, ownership of premises and buildings necessary for the provision of services);
• Certificate of the person responsible for organizational supervision of higher specialized education, 3 years of specialized or 5 years of professional 5 years of experience, permission to carry out pharmaceutical activities;
• Availability of higher/secondary veterinary education with work experience of at least 3 years (for institutions providing services in the field of veterinary medicine);
• The individual entrepreneur must also have a higher specialized education and work experience in this field of at least 3 years;
• Availability of a mobile company employee with higher or secondary education.

To obtain a license, the applicant must prepare and submit the following package of documents

• Executed application;
• Statutory documents (copy of the charter, composition agreement, certificate of state registration, statistical code, extracts from the unified state register of legal entities);
• Appointment of a responsible person (wardrobe) and presentation procedure;
• Lease agreements or ownership of premises, technical documentation;
• Sanitary conclusions of Rospotrebnadzor;
• Documents confirming the availability of special equipment for carrying out activities;
• Paid receipts (obligations are paid through the bank, and the document must be signed and certified with a wet seal).

The cost of obtaining such a license ranges from 210, 000 rubles, which depends on the type of document and other factors. The scale of government fees also varies. For example, during reorganization, obtaining a new license costs 750 – 750 rubles.