Pharmacy warehouse is a business entity that deals with the acquisition, storage, packaging and gathering, as well as wholesale of medicines and medical supplies. Due to the specific nature of its activities, a warehouse license requires a license for pharmacy activities.

 

The necessary permission is issued in authorized state bodies after passing the approved procedure. This process requires significant time and material costs, as well as the involvement of expert organizations for inspecting the compliance of warehouse premises with the requirements set forth in legislation.

 

Do you want to get a pharmacy license in the shortest time and with minimal hassle? Apply for help to the Center for Clinical Research "Promedika". We provide all the necessary services to obtain a license of a pharmacy organization at a minimum cost and with a 100% guarantee of the result.

 

Procedure for registration of a license

The procedure for obtaining a pharmacy license consists of the following steps:

1. preparation of premises for use as a pharmacy warehouse. A set of works aimed at creating the necessary conditions for storage and acquisition of medicines and medical products is being carried out;

 

2. examination of the object, in the process of which the conformity of the warehouse to the requirements of the current regulatory and legal acts is determined. The business owner provides technical documentation for the property (warehouse), as well as a certificate confirming his ownership, or a lease;

 

3. obtaining a sanitary and epidemiological certificate that gives the right to store pharmaceutical products and trade them. To obtain a license, it is necessary to provide the enterprise's registration documents for real estate (for placing a warehouse in it) or certified copies of this document, as well as a lease for a real estate object;

 

4. registration of a license for a pharmacy warehouse. In order to obtain the necessary document, the licensee must provide a full package of company registration documents and certificates on registration of the premises with tax authorities and state funds. Also, a certificate of registration in the statistical bodies with the relevant codes of activity and documentation for the real estate object are required.

When registering a license, it is important that the issuing authority verifies the ability of a legal entity or an entrepreneur to engage in pharmaceutical activities. In support of this, such documents are provided:

  • an extract from the register of fixed assets of the enterprise, which is necessary for the implementation of this type of activity;
  • copies of documents of employees of the enterprise, confirming their higher pharmaceutical education;
  • copies of valid dispensing certificates (including certificates from refresher courses);
  • documents confirming the employment relationship between the license recipient and employees of medical institutions that have a pharmaceutical education;
  • documents on your appointment as the head of the enterprise;

 

After registration of the necessary package of documents, the expert commission of the Department of Public Health or Federal Service for Supervision in Health Care conducts an on-site inspection. Based on its results, a license is issued personally to the head of the enterprise or to the person to whom the power of attorney is issued.

 

Order of service

Do you need a pharmacy license? The "Promedika" Center will help you to get it. Please contact our specialists by the telephone number listed on the website. They will provide consultations on the procedure for passing the procedures, the deadline, and also about how much the pharmacy license costs. We will save you from the hassle of licensing so that you can concentrate on developing your business.

For the primary analysis (scheme), cost and timing of registration of funds (LS),
Medical products (MI) and dietary supplements according to the rules of the Russian Federation
and the United Arab Emirates the manufacturer must provide the following data:

Medicine

1. Instructions for use


2. Detailed composition


3. Certificate copyGMP


4. Data on pre-clinical and clinical trials


5. The status of product registration in the country of production



Medical product

1. Description of the medical device


2. Copy of ISO certificate, CE certificate (or other similar documents)


3. Data on pre-clinical and clinical trials


4. The status of product registration in the country of production

 



BAA

1.Instructions for use


2. Full composition with percentage of components


3. A copy of the GMP certificate and / or ISO and / or HACCP


4. Data on pre-clinical and clinical trials


5. A copy of the safety certificate for product

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