Advice 1: How to obtain a license for a pharmacy

Pharmacy license is required entrepreneurs, carrying medicines and medical supplies. To obtain such a license can be subject to certain requirements that should be known to all who have decided to engage in such activity.
How to obtain a license for a pharmacy
The Federal law on licensing separate types of activity " stipulates that the trade of pharmaceuticals retail subject to mandatory licensing. The companies subject to this condition, are pharmacy organization: pharmacy stores, pharmacies and pharmacies.
The difference is that pharmacies and pharmacies can produce medications prescriptions according to the recipes without them – in the presence of the production Department. Pharmacies can only release finished products.
The license for the pharmacy in the Moscow region issued by the Ministry of health. In Moscow the issuance of licenses by the Department of health of the city. The terms of a license from the submission of documents may differ depending on the specific region. The license period is five years.
Be prepared to conduct on-site inspections, which are carried out by specialists of the health authority. Issued checks by the relevant act of examination.
Pharmacy license is issued with the address of a specific pharmacy. In addition to the constituent documents of the required documents for experts (pharmacists, pharmacists), including their employment record. Experience professionals may not be less than three years.
Accordingly should be the lease (sublease) of the premises, which is involved in licensing. Evidence of ownership by the lessor must also be presented in the documents. Licensing implies the conclusion of bodies of sanitary supervision.
Of course, the premise is that you want to use under the pharmacy operation must be equipped with special furniture and pharmacy refrigeration units. The area of the room must correspond to the type of a pharmacy.
The most common type of license is the license to pharmacy. Its area can be any. The main condition is the availability of the necessary spaces such as shopping facilities, storage room for drugs, a staff room, a WC, a room of acceptance. The minimum size of the area, allowing to place the named premises, approximately 20 square meters.
Pharmacy, in turn, may take only a few square meters and located in the shopping center, for example. It will be possible to implement only the ready products and personal hygiene products.
To obtain a pharmacy license without any problems and delays, you should seek the assistance of professional lawyers. Qualified professionals will be able to explain the procedure for obtaining a license, the licensing features of this kind of activity will help to prepare the necessary documents for license verification.

Advice 2 : How to obtain a license for pharmaceutical activity

Entrepreneur who chooses to engage in the manufacture of medicines according to recipes, not to do without special permission – licensed to pharmaceutical activities.
How to obtain a license for pharmaceutical activity
You will need
  • premises;
  • documents;
  • - the employees.
To obtain a license for pharmaceutical activity, follow the conditions necessary for obtaining a license. Buy or rent premises and equipment for the implementation of your firm's pharmaceutical activities.
If you manufacture prescription drugs – stick to the rules that are approved in accordance with the 17th article of the law "On medicines". If you are going to sell the drug through pharmacies, strictly careful not to sell worthless medicines; counterfeit medicines (counterfeiting), expired medicines. Upon detection of such drugs destroy them.
Make sure that your employees have secondary or higher education pharmaceutical orientation, and certificates specialist. Conduct refresher training of your employees at least once every five years.
Also, if you are a Manager-the license applicant and your activities are directly connected with the manufacture, purchase, storage, sale and destruction of drugs, you should have higher pharmaceutical education orientation. In addition, you need to work on speciality not less than three years.
If you meet all the requirements apply to Roszdravnadzor or its immediate management statement for the issuance of licenses for pharmaceutical activity. The application shall attach the following documents:
- copies of constituent documents of your pharmacy;
- documents which confirm payment of state duty in the amount of 300 rubles for consideration of an application for a license;
- leases of premises for your pharmacy with the sanitary-epidemiological conclusion on the compliance of the premises with the requirements of sanitary norms;
- documents on secondary or higher education, specialist certificates, documents of work experience, a degree (your staff).
Copies of documents not notarized, submit with the original. Within five days after the submission of documents to you, if done correctly, you will have a pharmaceutical license. For the license will pay 1000 rubles.
If you own five or more pharmacy chains, to obtain a license, regardless of where you run your business and where was your firm, contact a healthcare. Otherwise, for a license you need to contact the nearest regional office of the service.
Useful advice
In case you are refused to grant a license (for example, due to incomplete package of documents), you may appeal the decision to deny the local bankruptcy court.
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