Full legal work in the pharmacy business is possible only with a license for pharmaceutical activities. Obtaining this document is not such a difficult, frightening procedure, if you treat it responsibly. The legislation lists the documents that must be submitted to the applicant for such an enterprise. After collecting the full package and sending it in the prescribed manner to the state institution, you can apply for a pharmaceutical license. Based on the document, you can officially work in the chosen direction.
Name of pharmacy business
Registration of a license for pharmaceutical activity begins with the provision of basic information about the applicant to the address of the responsible structures. For this, it is necessary to indicate in the documents the full name of the legal entity and the legal form selected for work. In the presence of an abbreviated name, this information is also announced. In addition, it is necessary to provide the official address where the company is located, the addresses of the premises where it is supposed to carry out activities subject to licensing.
A positive decision on a request for a pharmaceutical license can only be obtained by an entrepreneur who has provided a regnomer from the state register confirming the establishment of a legal entity. You also need to provide information on documentation confirming that information about the legal entity is officially entered into a specialized state registry. If the company has a phone number or e-mail, these contact details must be indicated in the application for a license for pharmaceutical activities.
IP: features of the pharmacy business
If an individual entrepreneur needs a license for pharmaceutical activity, he must provide his name, address of residence, and the place where he is supposed to work in the direction requiring a license. Necessarily recorded information on the identification documents and regnomer, confirming that an entry was made in the state registry on the registration of the entrepreneur.
At present, only those PIs are licensed for pharmaceutical activities, which, at the stage of filing a package of documents, provided data on documentation confirming inclusion in the Unified State Register of Enterprises, and it is necessary to clarify the address of the registration authority. If the IP has a phone number, email, this data is attached to the general package of documents.
What other documents will be required
When forming a set of documentation, you should indicate the TIN, identification information about the document confirming that the legal entity is registered with the tax authorities, and also officially note which type of activity is planned after obtaining the license. We will have to paint what services are supposed to be provided, back up all this with copies of constituent documentation. If the documents submitted to the address of the state institution are not certified by a notary, the originals will have to be attached for verification to confirm their truth.
Only such an enterprise will enter the register of licenses for pharmaceutical activities that can provide official justification for using the premises at the specified address. This may be a document declaring ownership or other grounds.You will have to attach papers confirming the availability of specialized equipment, pre-attend to the receipt of the conclusion of the SES on the compliance of the selected territory with the proposed type of activity.
Certification and work experience of specialists
Registration, re-issuance of a license for pharmaceutical activity requires the provision of official documentation confirming that the specialists are certified, have work experience in the chosen direction. Photocopies of pharmaceutical education documentation are required. Enough middle stage, although the highest is preferred.
In order for the documentation package to begin to be considered, state duty must be paid in advance. The fact of payment is confirmed by a receipt attached to the general list of documentation.
Manager Requirements
Obtaining an LLC license if it is assumed that the manager will be engaged in the wholesale, preservation, transportation, retail sale of medicines is possible only if this person has a specialized secondary or higher education in the field of pharmaceuticals. An alternative is a veterinary education of a similar level. It is necessary to take care of obtaining a certificate confirming the specialization and have three years (or more) work experience in the chosen direction.
To confirm the seniority, the head prepares an extract from the work book. The documentation may indicate that the person holds the position of Director General. In this case, you will have to additionally (in the appendix) indicate the job responsibilities, including the sale of medicines.
Obtaining a license and employees
Previously, it also happened that the term of the license for pharmaceutical activities is coming to an end, it is necessary to prepare a new document, but the current head of the enterprise does not have a specialized education. They solved the problem by inviting the staff responsible for the wholesale, storage, transportation, and retail sale of products to the staff. The responsibility of this (these) people included dispensing drugs, ensuring the correct conditions of the place where the medicines are in the warehouse. Currently, licenses are issued indefinitely.
A specialist must have a certificate confirming his education, knowledge and skills. It is necessary to invite not only the work of those who have an official document confirming the presence of specialized education of a higher or middle level. Otherwise, you can’t count on getting a license.
License term
The duration of the pharmaceutical license is currently unlimited. According to current legislation, you need to receive it only once.
Rules and Laws
In 2012, a new resolution was adopted, which substantially adjusted the practice of issuing specialized licenses for pharmaceutical enterprises. This area has become more streamlined, structured than before. Many also note that contradictory wordings were removed from the law. The 2012 decree continues the line of legislative change that was launched a year earlier. This document replaced paper approved in 2006 in the same direction. The resolution, published in January 2012, focuses on the perpetual validity of the license.
Pharmaceutical activity
The decree clearly lists activities classified as pharmaceutical. Here is a list of services, works related to this area. All of them require clearance. Two large groups have been identified: funds intended for veterinary medicine and those that are needed for medical use. Each category includes five types of activities:
- sale of goods (wholesale, retail);
- ensuring the safety of the product;
- transportation;
- vacation;
- production.
Where to apply for a license
Several state institutions responsible for issuing specific licenses have been identified. Individual entrepreneur, any legal entity interested in receiving a document, chooses the most convenient option for itself from the following three:
- executive power of the subject (if it is supposed to sell medical goods at retail);
- Federal Service for Veterinary Control, Phytosanitary Surveillance (if the company works with medicines for veterinary medicine);
- Federal service supervising social development, healthcare (if wholesale sales of medical supplies are supposed).
About requirements for pharmaceutical companies
All conditions that are established at the state level for enterprises seeking to obtain permission for activity in the pharmaceutical field are divided into two groups:
- applied to those wishing to issue a license;
- applied to those who already have a license.
The first should have qualified personnel, managers, premises for conducting activities. The second will have to provide data on the availability of premises, staff qualifications, as well as confirmation of compliance with legal requirements that relate to trade, handling, storage and other operations related to medicines.
How long to wait for a license
The current standards of legal acts establish deadlines and forms for the response of state institutions to petitions regarding the issuance of a license. Currently, the responsible structure has 45 days from the date of official registration of the fact of receipt of a package of documents from a potential license holder. The response to the request will be either a document (license), or a reasoned refusal with a list of points that caused such a decision. If the state authority made a negative decision, the enterprise (entrepreneur) has the right to correct the mistakes made and again send the package of documents, once again paying for the public service, as well as providing a receipt confirming this fact.
If the company is not ready to risk time and wants to get a license for the first time, you can contact the intermediary. In almost every region of the country, there are firms offering legal services in this area. Their employees explain what documents are required, form a complete package of documentation and submit it to government agencies, observing all the rules of the law. This usually does not shorten the deadlines, but it minimizes the risk of a negative decision upon request, which means that you do not have to pay the state fee again and lose some more time. However, this is true only when choosing a responsible, trustworthy intermediary. Do not choose the company with the lowest prices. First you need to study different market offers and explore what are the responses to the activities of enterprises. Only after this can you trust the fate of your company in the hands of private lawyers.