ORDER OF THE MINISTRY OF HEALTH OF UKRAINE

of August 18, 2014 No. 574

About approval of the Regulations on the register of wholesale selling prices on medicines and products of medical appointment, procedure for introduction in it for changes and forms of the declaration of change of wholesale selling price on medicine and product of medical appointment

According to the subitem of 1 Item 5, 6, to Item 14 of the Procedure for declaring of change of wholesale selling prices on medicines and products of the medical appointment approved by the resolution of the Cabinet of Ministers of Ukraine of July 2, 2014 No. 240, I order to the subitem of 1 Item:

1. Approve:

1) Regulations on the register of wholesale selling prices on medicines and products of medical appointment, procedure for introduction in it for changes which is applied;

2) form of the declaration of change of wholesale selling price on medicine which is applied;

3) form of the declaration of change of wholesale selling price on product of medical appointment which is applied.

2. (L. Konoshevich) to provide to management of pharmaceutical activities in accordance with the established procedure provision of this order on state registration in the Ministry of Justice of Ukraine.

3. Declare invalid the order of the Ministry of Health of Ukraine of September 7, 2012 No. 705 "About approval of the Regulations on the register of wholesale selling prices on medicines and products of medical appointment, procedure for introduction in it for changes and forms of statements about declaring of change of wholesale selling price on medicine or product of medical appointment", registered in the Ministry of Justice of Ukraine on September 24, 2012 at No. 1638/21950.

4. To impose control of execution of this order on the deputy minister N. Lisnevskaya.

5. This order becomes effective from the date of official publication.

Approved by the Order of the Ministry of Health of Ukraine of August 18, 2014 No. 574

Regulations on the register of wholesale selling prices on medicines and products of medical appointment, procedure for introduction of changes in it

1. This Provision determines procedure, form of maintaining and modification of the register of wholesale selling prices on medicines and products of medical appointment (further - the Register of the prices).

2. The register of the prices contains data about declared by the owner of the registration certificate on medicine or certificates on state registration of product of medical appointment, or person who constitutes the declaration of conformity, or authorized by them-faced change of wholesale selling price on medicine or product of medical appointment.

3. Data on the changes of wholesale selling price declared to declaring on medicine or product of medical appointment are entered in the Register of the prices based on the order of the Ministry of Health of Ukraine on declaring of change of wholesale selling price for medicines or products of medical appointment.

4. The register of the prices consists from:

1) the register of wholesale selling prices on medicines which is kept in the form given in appendix 1 to this Provision;

2) the register of wholesale selling prices on products of medical appointment which is kept in the form given in appendix 2 to this Provision.

5. The register of the prices creates and conducts in electronic form the Ministry of Health of Ukraine.

6. Data relatively are entered in the register of wholesale selling prices on medicines:

international unlicensed or commonly accepted name of medicine. If medicine contains several active agents, the data on active agents of medicine containing in the registration certificate of this medicine are specified;

trade name of medicine;

release forms;

dosages. If medicine contains several active agents, the information about quantitative composition of each active agent of medicine specified in the registration certificate of this medicine is specified;

quantities of units of medicine in consumer packaging;

names of the producer, country;

pharmakoterapevtichesky group which includes active ingredient (substances) of medicine (ATH code);

numbers of the registration certificate on medicine;

expiry dates of the registration certificate on medicine;

the registration certificate declared to declaring by the owner on medicine or person of change of wholesale selling price authorized by it on medicine of national and/or foreign production in hryvnias;

the official rate and type of foreign currency established by the National Bank of Ukraine for date of submission of the declaration of change of wholesale selling price on medicine;

dates and numbers of the order of the Ministry of Health of Ukraine on declaring of change of wholesale selling price on medicine.

7. Data are entered in the register of wholesale selling prices on products of medical appointment:

name of product of medical appointment, type, type, brand and so forth;

quantity of units of product of medical appointment in packaging (pieces, researches, etc.);

scope of product of medical appointment;

class of safety of product of medical appointment depending on potential risk of application;

number according to the catalog;

name of the manufacturing country, location of production or name of the producer, country;

certificate number about state registration of product of medical appointment or the declaration of conformity;

expiry date of the certificate on state registration of product of medical appointment or declaration of conformity;

declared to declaring by the owner of the certificate on state registration of product of medical appointment, or person who constitutes the declaration of conformity, or person authorized by them change of wholesale selling price on product of medical purpose of national and/or foreign production in hryvnias;

the official rate and type of foreign currency established by the National Bank of Ukraine for date of submission of the declaration of change of wholesale selling price on product of medical appointment;

date and number of the order of the Ministry of Health of Ukraine on declaring of change of wholesale selling price on product of medical appointment.

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