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The Ministry of Health of the Republic of Moldova is approved on July 13, 1999

REGULATIONS ON THE PROCEDURE FOR ISSUE OF LICENSES FOR IMPLEMENTATION OF PHARMACEUTICAL ACTIVITIES

I. PURPOSE OF THE PROVISION

This provision determines legal, organizational and economic bases of issue of licenses for the right of implementation of pharmaceutical activities for the purpose of ensuring strict observance of the standards and qualification requirements necessary for implementation of this type of activity, ensuring protection of interests and safety of the personality, society and the state, and is developed according to the Law on licensing of separate types of activity of N332-XIV of March 26, 1999 (Monitorul Oficial al Republicii Moldova, N62-64 of June 17, 1999), the Law on pharmaceutical activities of N1456-XII of May 25, 1993, changed and added with the Law on modification and amendments in the Law on pharmaceutical activities of N1460-XIII of January 28, 1998 and the Law on N1409-XIII medicines of December 17, 1997.

II. LICENSE FOR THE RIGHT OF PHARMACEUTICAL ACTIVITIES

The license for occupation pharmaceutical activities is the document certifying capability and right of its owner to perform this type of activity under the conditions providing quality and efficiency of medicines and the rendered services.

III. LICENSE FORM AND CONTENT

1. The license represents the form which sample is provided in appendix N 1, being integral part of this provision.

2. In the license are specified:

a) the body which issued it - the Ministry of Health of the Republic of Moldova;

b) series, number and date of issue;

c) business entity: the name, legal address, date and number of state registration, fiscal code - for the legal entity;

surname, name (if necessary middle name), these identity certificates (series, number, the residence), fiscal code - for physical person;

d) type of activity on which implementation litsenziyafarmatsevtichesky is issued;

e) conditions of implementation of pharmaceutical activities;

f) license effective period.

3. The license is signed by the Minister of Health and certified by seal the Ministries of Health.

4. Forms of licenses are documents of the strict reporting.

Acquisition, accounting and storage of forms of the license are assigned to body, authorized to grant licenses.

IV. LICENSE COVERAGE

1. The license is valid in all territory of the Republic of Moldova.

2. The license can be valid also outside the country according to international agreements, one of the parties of which is the Republic of Moldova.

V. LICENSE EFFECTIVE PERIOD

The license for implementation of pharmaceutical activities is granted for a period of 5 years.

VI. RIGHT TO THE LICENSE

1. Physical persons and legal entities, both the local, and foreign, registered as subjects entrepreneurships in the Republic of Moldova in the procedure established by the law have the right to the license.

2. For implementation of pharmaceutical activities with use of narcotic, psychotropic and poisonous drugs only the state companies have the right to the license.

VII. DOCUMENTS NECESSARY FOR RECEIPT OF THE LICENSE

For receipt of the license the business entity represents:

a) the statement (appendix N 2) in which it is specified:

- the name, the organizational legal form, legal address and fiscal code - for legal entities; surname, name (if necessary middle name), these identity certificates (series, number, the residence) and fiscal code - for physical persons;

- specific type of pharmaceutical activities for which the license is requested;

b) the charter (for the legal entity) or the decision on organization (for physical person);

c) the registration certificate in the State registration chamber under the Ministry of Justice;

d) the conclusion of the Ministry of Health according to appendix N 3, being integral part of this provision.

e) the certificate issued by the relevant tax authorities by which lack of debts on taxes and other obligatory payments in the budget and social fund is confirmed;

f) balance and the report on financial results (if the company existed).

VIII. REQUIREMENTS TO THE SUBMITTED DOCUMENTS

3. All documents specified in Article 7, are represented in the original or in the notarized copy.

4. It is forbidden to request the documents which are not provided by this provision or other regulations.

IX. BODIES, AUTHORIZED TO GRANT LICENSES FOR IMPLEMENTATION OF PHARMACEUTICAL ACTIVITIES

The licensing right for implementation of pharmaceutical activities belongs to the Ministry of Health or organization given it appropriate authority.

X. COMMISSION ON LICENSING FOR IMPLEMENTATION OF PHARMACEUTICAL ACTIVITIES

1. The commission on licensing for implementation of pharmaceutical activities (further - the Commission) consists of seven specialists in the field of pharmaceutical activities. The staff of the Commission, including the chairman, the vice-chairman and the secretary, is appointed by the order on the Ministry of Health.

2. Enters competence of the commission:

a) consideration of the applications, verification of the documents submitted by the applicant and decision making about licensing or about refusal in licensing;

b) control of compliance of activities of owners of licenses to the conditions specified in the license;

c) decision making about suspension of action of the license;

d) record keeping:

- acceptance, registration and accounting of statements and the documents submitted by applicants;

- accounting of the issued, suspended and cancelled licenses;

- accounting of the documents constituted by results of checks of activities of owners of the license;

e) maintaining and storage of protocols of commission sessions.

3. The commission keeps the register of business entities - owners of the license and ensures safety of the documents submitted by business entities during the entire period of action of the license.

XI. WORK OF THE COMMISSION

1. The commission chairman will organize its work, determines the place and time of holding meetings, provides accomplishment by the Commission it to function.

2. Commission sessions are convoked as required, but at least once a month. About the place and time of commission session it is reported not later than 3 days before holding meeting.

3. Commission session is competent if at it there is more than a half of members of the commission.

4. Decisions of the Commission are made by a simple majority vote her members who are present at meeting and drawn up by the relevant protocols signed by the chairman and the secretary of the Commission.

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