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License for pharmaceutical activity.
"Regulations on licensing of pharmaceutical activity"
Approved by Resolution of the Russian Federation Government on July 1, 2002 № 489.
1. These Regulations shall govern the licensing of pharmaceutical activities of legal entities.
2. The Pharmaceutical organizations caring out activities in wholesale trade of medicines and pharmaceutical institutions including retail and wholesale trade of medicines, as well as the manufacture of medicines.
3. Pharmaceutical Licensing by the Ministry of Health of Russia or the executive authorities of territorial entities of Russian Federation, which the Ministry has been transferred by agreement with their licensing authority for these activities (hereinafter - the licensing authority).
4. License requirements and conditions for the implementation of pharmaceutical activity are:
a) the applicant for a license (licensee), acting on its own, by right of ownership or on other legal grounds should be equipped with equipment, facilities and appliances necessary for the licensed activity;
b) compliance with the requirements of the technical reinforcement and equipment means the alarm and premises used for the implementation of pharmaceutical activity;
c) compliance with rules governing the storage and handling of drugs based on their physical-chemical, pharmacological and toxicological properties, as well as with drugs, possessing flammable and explosive properties;
d) ensuring quality standards for medicines in their possession, sale and manufacture;
e) compliance with the rules of the wholesale and retail trade in drugs, as well as rules for the preparation of medicines in pharmacology;
f) The heads of organizations, wholesalers and pharmacology, whose work is directly related to the reception, storage, release, manufacture and disposal of medicines should have higher pharmaceutical education, professional experience of at least 3 years and a specialist certificate;
pharmaceutical institutions specialists, involved directly in manufacture, storage, release and sales of medicines, should have higher or secondary pharmaceutical education and professional certification;
professionals ,working in wholesale pharmaceutical organizations, directly involved in receiving, storing and dispensing of medicines, should have higher or secondary pharmaceutical education and professional certification;
g)The advance professional training at least once in 5 years is required for all qualified employees, carrying out pharmaceutical activities
5. To obtain a license licensee shall submit to the licensing authority the following documents:
a) application for a license, stating:
- The names and organizational-legal form, location of the entity, as well as the location of its geographically separate units and facilities used for the implementation of the licensed activity;
- Licensed activities (listing the work to be undertaken by the licensee);
b) copies of all legal documents and a certificate of state registration of the applicant's license;
c) a copy of the certificate of applicant's license to the Tax Authority;
d) a document confirming payment of license fee for consideration by the licensing authority an application for a license;
e) a specialist certificate confirming compliance with the training manager of a legal entity, the head of the division of a legal entity licensed activity;
f) documents confirming the right of the applicant's license to use the premises for the licensed activity;
g) Copies of documents confirming the applicant's employees receive a license or higher secondary pharmaceutical education;
h) a copy of the conclusion from the sanitary-epidemiological department on the premises under the requirements for the implementation of the licensed activity,
6. All documents submitted for obtaining a license, shall be taken on an inventory, a copy of which indicating the date of receiving the documents the licensing authority forwarded (handed) to the license applicant.
Copies of documents are not notarized, shall be submitted with the presentation of the original documents.
It is not allowed to request other additional documents from the license applicant.
The Licensee is liable for the of false or distorted information, in accordance with Russian Federation legislation low.
7. The licensing authority, during licensing process, has the right to verify compliance with the license applicant's requirements and conditions.
8. The licensing authority decides to grant or to refuse to grant the license within 60 days of receipt of the application with all necessary documents.
9. Validity of licenses for pharmaceutical activities - 5 years.
10. In the case of loss of license the licensee has the right to duplicate it.
11. If a licensee has geographically separate units and facilities used for licensed activities, the licensing authority shall issue together with the license, the number of copies for each unit and facility, certified by the licensing authority.
12. Monitoring compliance with the license requirements and conditions is carried out under regulations the head of the licensing authority, which identifies the licensee, subject to verification, timing verification and the commission inspection.
Duration of inspection should not exceed 15 days. Scheduled inspections are carried out not more than once in 2 years.
Unscheduled inspections are conducted to confirm the elimination of the licensee identified during routine inspection of violations of licensing requirements and conditions, as well as in the case of the licensing authority concerned about the existence of such violations.
The licensee shall provide the conditions for conducting the audits, including providing the necessary information and documents.
The audit instrument is made with specific violations, which is signed by all members of the commission. Licensee (the agent) should be familiar with the results of inspection, and the act must be entered on the fact of acquaintance. If the licensee does not agree with the results of inspection, it has the right to reflect the opinion in the act. If the licensee refuses to see the results of inspection, the committee members record this fact in the act and assure him of his signature.
13. The licensing authority must, in 5-day period after the decision on granting, extending the validity period, reissue, suspend, renew or revoke a license in writing, notify the licensee, as well as relevant taxation entities.
14. The licensee shall notify in writing within 15 days to the licensing authority to change its location, as well as the location geographically separate units and facilities used for the licensed activity.
15. The licensee operates under a license granted to him by the licensing authority of specific territorially entity of Russian Federation may carry out this work in other territorially entity of Russian Federation with prior notification to them .
16. The licensing authority shall keep a register of licenses, which shall include:
a) The name of the licensing authority;
b) the licensed activities (listing the work performed);
c) the name and legal organizational form of the licensee, the code according to the national classifier of enterprises and organizations, taxpayer identification number, certificate number of state registration as a legal entity, its location, indicating the location geographically separate units and facilities used for the implementation of pharmaceutical activity ;
d) the date of the decision to grant the license;
e) license number;
f) The term of the license;
g) information on the license in the register of licenses;
h) information about the renewal of the license;
i) information about the reissue of the license;
g) the grounds and the date of suspension and renewal of licenses;
k) the basis and the date of revocation of license.
17. The licensing authority provisions the licenses based on the information from the register of licenses by the Federal Law "On licensing certain types of activities."
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