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It is registered

Ministry of Justice of Ukraine

July 11, 2014

No. 799/25576

ORDER OF THE MINISTRY OF HEALTH OF UKRAINE

of May 8, 2014 No. 314

About approval of the Procedure for maintaining the State register of medicines of Ukraine

(as amended of the Order of the Ministry of Health of Ukraine of 18.12.2015 No. 876)

According to Articles 3, 9 and 26 Laws of Ukraine "About medicines", Item 5 of the Regulations on the State register of medicines approved by the resolution of the Cabinet of Ministers of Ukraine of March 31, 2004 No. 411, order:

1. Approve the Procedure for maintaining the State register of medicines of Ukraine which is applied.

2. To provide to department concerning quality of the medical and pharmaceutical care (T. Donchenko) in accordance with the established procedure provision of this order on state registration in the Ministry of Justice of Ukraine.

3. To impose control of execution of this order on the First Deputy Minister R. Salyutin.

4. This order becomes effective from the date of its official publication.

Minister

A. Musy

It is approved:

The chairman of Public service of Ukraine on questions

regulatory policy and development of entrepreneurship

 

 

M. Yu. Brodsky

Chairman of Public service special

communication and information security of Ukraine

 

V. P. Zverev

Approved by the Order of the Ministry of Health of Ukraine of May 8, 2014, No. 314

Procedure for maintaining the State register of medicines of Ukraine

I. General provisions

1. This Procedure establishes requirements for forming, maintaining, storage, protection of the State register of medicines of Ukraine (further the State register) and to its use.

2. The state register is kept in the form of the specialized electronic database containing data on the medicines, including the medical immunobiological supplies (further - medicines) registered (re-registered) by the Ministry of Health of Ukraine in accordance with the established procedure, permitted for production and application in Ukraine for the purpose of information support in the sphere of creation, production, quality control and realization of medicines.

The state register is kept in state language in electronic form and consists of reference, insurance, working and information funds.

3. In this Procedure terms are used in the following values:

the administrator of the State register - the state company "State Expert Centre of the Ministry of Health of Ukraine";

the holder of the State register - the Ministry of Health of Ukraine;

reference information on medicines of the State register information on medicines entered based on the relevant order of the Ministry of Health of Ukraine;

reference fund of the State register - information and telecommunication system which provides storage and accounting of reference information on medicines of the State register in control condition;

information fund of the State register - the information and telecommunication system which is specially created for provision to wide range of users of information from the State register which provides functioning of the separate database in which the copy of reference information on medicines is stored;

copy of reference information on medicines of the State register copy of information on medicines identical to the relevant reference information on medicines of the State register;

the user of the State register - any legal entity or physical person having access to information fund of the State register;

working fund of the State register - information and telecommunication system which provides maintaining the State register and is used for preparation and information processing about medicines in case of their entering into reference fund of the State register which provides information support of the holder of the State register and health care;

insurance fund of the State register - archive copies of reference fund of the State register which are stored on data carriers and are intended for recovery in authentic form of reference fund of the State register for the corresponding date in case of its total or partial loss.

4. Inclusion in the State register of information on medicine is performed based on the order of the Ministry of Health of Ukraine on state registration (re-registration, updating in the address, etc.).

5. The medicine exception of information and reference funds of the State register is performed in connection with expiration of its state registration or based on the order of the Ministry of Health of Ukraine on the termination (reducing) action of the registration certificate.

6. The administrator of the State register for the purpose of ensuring openness and general availability for acquaintance provides access to information fund of the State register on the official site of the State register (www.drlz.kiev.ua) and distribution of its data by mass media, if necessary performs the edition (reissuing) of the State register in printed form.

II. Procedure for forming and maintaining the state register

1. The holder of the State register develops the organizational and methodological principles of maintaining the State register, makes the decision on inclusion in the State register of information on medicine, is responsible for control condition of reference fund, performs actions for preserving insurance fund of the State register.

2. The administrator of the State register performs maintenance of program information support of the State register, is responsible for its functioning, preserving data and protection them from destruction and/or unauthorized access, provides receipt of information on medicines in reference fund of the State register and its preserving, exercises control of provision of information from the State register, creates and supports information fund of the State register, provides compliance provided to legal entities and physical persons from information fund of the State register, reference fund of the State register, performs servicing of users of the State register and will organize access control to it.

The administrator of the State register provides confidentiality and integrity of information processed in the State register according to requirements of the legislation in the sphere of information security.

3. The holder of the State register enters in the State register data on medicine by the publication of the order of the Ministry of Health of Ukraine on its state registration (re-registration) and/or modification of registration materials throughout action of the registration certificate.

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