Statutes Of The Register Of Medicinal Products


Published: 2016-05-28

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Statutes of the Register of Medicinal Products

Passed 20.05.2016 Annex 36

This Regulation is established on the basis of subsection 79 (1) of the Medicinal Products Act

Chapter 1 General provisions 

§ 1.  Official name of the register

(1) The Register of Medicinal Products is a state register established on the basis of subsection 79 (1) of the Medicinal Products Act under the official name of Ravimiregister [Register of Medicinal Products](hereinafter register) and serves as a database forming a part of the state information system.
(2) The English name of the register is the Register of Medicinal Products.

§ 2.  Purpose of operation of the register

The purpose of operation of the register is to keep account of the medicinal products, which have been granted marketing authorisation and are distributed in Estonia as well as food for particular nutritional uses and food supplements for which the payment obligations will be assumed by the Estonian Health Insurance Fund, to identify the same via a unique code attributed to each packaging size in information systems and information exchange in health care, to process the related data and to give the public the relevant information.

§ 3.  Chief processor of the register

(1) The chief processor of the register is the State Agency of Medicines.
(2) The chief processor of the data to be entered in the register on the basis of section 8 is the Ministry of Social Affairs.

§ 4.  Protection of data entered in the register

(1) The chief processor shall use organisational and technical measures to ensure the integrity and authenticity of the data entered in the register, as well as the processing, protection, preservation and archiving of the data.
(2) The State Agency of Medicines shall ensure the operation of the register.
(3) The register shall have a security class of K2T1S1.
(4) The register shall have a medium security level (M).

§ 5.  Legal effect of the data entered in the register

The data entered in the register shall have legal effect to the extent provided by law.

Chapter 2 Method of operation of the register and data to be entered in the register 

§ 6.  Method of operation of the register

The register shall be operated as a computerised database.

§ 7.  Source documents for entry of data in the register by the State Agency of Medicines

(1) The source documents for entry of an authorised medicinal product in the register shall consist of the State Agency of Medicines' or the European Commission's decision on:
1) the issue or renewal of the marketing authorisation;
2) the change of circumstances forming the basis for the grant of marketing authorisation;
3) suspension or revocation of the marketing authorisation.
(2) The source document for entry of an unauthorised medicinal product in the register shall consist of the State Agency of Medicines' decision on the issue of a special authorisation.
(3) The source document for entry of a veterinary medicinal product not subject to the marketing authorisation requirement on the basis of clause 63 (2) 5) of the Medicinal Products Act in the register shall be the notification of the import of the medicinal product.
(4) Restrictions on the issue of a medical prescription for medicinal products stipulated in subsections 2 (7) and (13) and Annex 4 of the regulation of the minister responsible for the field, established on the basis of subsection 33 (7) of the Medicinal Products Act.
(5) The source document for entry of food for particular nutritional uses and food supplements to be compensated on the basis of subsection 41 (8) of the Health Insurance Act in the register shall consist of the Estonian Health Insurance Fund's notification of the compensation decision.

§ 8.  Source documents for entry of data in the register by the Ministry of Social Affairs

The source documents for entry of data in the register by the Ministry of Social Affairs shall consist of the following:
1) the regulation of the minister responsible for the field, established on the basis of subsection 43 (1) of the Health Insurance Act;
2) the regulation of the minister responsible for the field, established on the basis of subsection 42 (2) 1 of the Health Insurance Act;
3) a price agreement between the minister responsible for the field on the basis of subsection 42 (4) of the Health Insurance Act and the manufacturer of the medicinal product or the marketing authorisation holder or its representative.

§ 9.  Data to be entered in the register

(1) Data on medicinal products and other products shall be entered in the register per packaging size on the basis of the following subdivision:
1) authorised medicinal product;
2) unauthorised medicinal product;
3) veterinary medicinal product not subject to the marketing authorisation requirement;
4) food for particular nutritional uses or food supplement for which the payment obligations will be assumed by the Estonian Health Insurance Fund.
(2) The following data shall be entered in the register with regard to medicinal products and other products specified in subsection (1):
1) product type in accordance with the subdivisions provided in subsection (1);
2) packaging code.
(3) The following data shall be entered in the register with regard to a medicinal product:
1) classification of the medicinal product into human medicinal products or veterinary medicinal products;
2) name of the medicinal product;
3) active substance and the relevant ATC code or, in the case of a veterinary medicinal product, the ATCvet code;
4) pharmaceutical form;
5) content of active substance per single dose, unit of volume or unit of mass of the medicinal product (strength of the medicinal product);
6) quantity in the packaging;
7) route of administration;
8) classification of the medicinal product into medicinal products not subject to medical prescription or medicinal products subject to medical prescription, including classification into the sub-category of medicinal products subject to restricted use;
9) classification of the active substance into narcotic drugs or psychotropic substances;
10) notation concerning a medicinal product which is not allowed to be dispensed by a pharmacy on the basis of a medical prescription;
11) notation concerning a medicinal product for the dispensing of which quantity restrictions have been established, along with the specification of the quantity restriction;
12) notation concerning a medicinal product which is not allowed to be dispensed on the basis of a repeat prescription.
(4) The following data shall be entered in the register with regard to the packaging of a medicinal product:
1) additional information on the packaging (where necessary);
2) in case of authorised medicinal products, the last date of import (on the basis of the notification or import authorisation).
(5) In addition to the data referred to in subsection (3), the following data shall be entered in the register with regard to an authorised medicinal product:
1) name of the marketing authorisation holder;
2) marketing authorisation number;
3) commencement of the term of validity of the marketing authorisation (day, month, year);
4) end of the term of validity of the marketing authorisation (day, month, year) or a notation indicating that the term is unspecified;
5) therapeutic indication;
6) summary of product characteristics (SPC);
7) package leaflet (PIL);
8) package labelling;
9) public assessment report, including a summary of the risk management plan;
10) restrictions on the marketing authorisation;
11) conditions of the marketing authorisation and the term of fulfilment of the conditions;
12) type of processing of the marketing authorisation;
13) notation regarding the licence for parallel import;
14) notation, if the medicinal product is subjected to additional supervision;
15) data on the discount rate;
16) restrictions on the discount rate, including diagnosis in accordance with the RHK-10 classification, age, medical indication;
17) restrictions on the issue of medical prescriptions at a discount, including the right to issue a medical prescription or the first medical prescription and the doctor's speciality in accordance with the FET classification;
18) limit price and information on medicinal products which have a retail price lower than or equal to the limit price and which are subject to a price agreement;
19) price agreement;
(6) In addition to the data referred to in subsection (3), the following data shall be entered in the register with regard to an unauthorised medicinal product and veterinary medicinal product not subject to the marketing authorisation requirement:
1) the manufacturer of the medicinal product;
2) information on whether or not the medicinal product is marketed on the basis of an application of a professional organisation of doctors;
3) where the medicinal product is marketed on the basis of an application of a professional organisation of doctors, information on the medicinal product.
(7) Where a veterinary medicinal product in involved, the animal species for whom the medicinal product is intended shall be entered in the register in addition to the data specified in subsection (3).
(8) Where a veterinary medicinal product not subject to the marketing authorisation requirement is involved, the data specified in clauses (3) 8)-12) shall not be entered in the register.
(9) The following data shall be entered in the register with regard to food for particular nutritional uses and food supplements for which the payment obligations will be assumed by the Estonian Health Insurance Fund:
1) name of the food for particular nutritional uses and food supplement;
2) composition;
3) pharmaceutical form (powder, solution, etc.);
4) quantity in the packaging;
5) manufacturer;
6) data on the discount rate;
7) restrictions on the discount rate, including diagnosis in accordance with the RHK-10 classification, age, medical indication;
8) restrictions on the issue of medical prescriptions at a discount, including the right to issue a medical prescription or the first medical prescription and the doctor's speciality in accordance with the FET classification;
9) limit price and information on food for particular nutritional uses or food supplements which have a retail price lower than or equal to the limit price and which are subject to a price agreement;
10) price agreement;
11) package leaflet.
(10) The following data shall be entered in the register with regard to staff members of the chief processor of the register, charged with the task of entering data in the register:
1) first name and surname;
2) authority;
3) position;
4) e-mail address.

Chapter 3 Entry of data in the register, access to and issue of register data 

§ 10.  Data submitters

The State Agency of Medicines and the Ministry of Social Affairs shall submit information to the register.

§ 11.  Procedure for and terms of entry of data in the register

(1) The data on an authorised medicinal product shall be entered in the register within 24 hours of the entry into force of the decision regarding the issue or renewal of the marketing authorisation, change of circumstances forming the basis for the grant of the marketing authorisation, suspension or revocation of the marketing authorisation.
(2) Any amendments in the text of the summary of product characteristics, the package leaflet or package labelling shall be entered in the register within 24 hours of the introduction of the corresponding amendment.
(3) Data on a medicinal product which has been granted marketing authorisation by the European Commission shall be entered in the register within one month after issue of the marketing authorisation, amendment of the conditions of the marketing authorisation, suspension of the marketing authorisation or revocation of the marketing authorisation.
(4) Where the entry is based on the State Agency of Medicine's import authorisation, the data on the medicinal product shall be entered in the register within 24 hours of the issue of the import authorisation.
(5) Data on the import of a veterinary medicinal product not subject to the marketing authorisation requirement shall be entered in the register within 24 hours of the approval of the relevant notification.
(6) Data on other products shall be entered in the register within 24 hours of the approval of the relevant notification.
(7) Data on discounts associated with medicinal products and other products shall be entered in the register by the day of entry into force of the corresponding data.

§ 12.  Procedure for correcting and notifying of inaccurate data

(1) Upon discovering errors and inaccuracies in the register data, the chief processor of the register is obliged to immediately correct such errors. In case of substantial hindrances, the errors shall be corrected within five working days at the latest.
(2) Information on correction of register data shall be published on the State Agency of Medicine's website.

§ 13.  Access to register data

(1) The register data shall be public, except for data on prices established with a price arrangement of proprietary medicinal products. The valid data shall be made available on the register's website and via the X-road interface.
(2) Access-restricted data shall only be made available via the X-road interface.
(3) Register data shall be published within 24 hours after entry in the register.

§ 14.  Issue of register data

The register data shall be issued by the chief processor, based on the respective competence.

Chapter 4 Supervision of the operation of the register, financing of the operation of the register, retention of data and liquidation of the register 

§ 15.  Supervision of the operation of the register

Supervision of the operation of the register shall be carried out by the chief processors of the register and the data protection supervision authority, based on their respective competence.

§ 16.  Financing of the operation of the register

The operation of the register shall be financed from the state budget via the Ministry of Social Affairs.

§ 17.  Retention of data

(1) The entry of data in the register and change of register data shall be logged.
(2) The retention, archiving and destruction of data shall be governed by the Archives Act and legal acts established on its basis thereof, as well as the procedure established by the chief processor.
(3) The data in the register and the source documents of the register shall be retained.
(4) The registrar shall retain the data entered in the register until liquidation of the register.
(5) The retention period of the source documents shall be established by the chief processor of the register.

§ 18.  Liquidation of the register

The liquidation of the register shall be decided by the minister responsible for the field. The liquidation of the register shall be governed by the Archives Act and the legal act established on the basis of clause 439 (1) 6) of the Public Information Act.

§ 19.  Implementing provisions

(1) The issue of data on medical devices entered in the Code Centre before 1 January 2016, for which the payment obligations will be assumed by the Estonian Health Insurance Fund, shall be ensured for the Prescriptions Centre until 1 January 2017.
(2) Clauses 9 (6) 3) and 9 (9) 11) shall enter into force on 1 April 2017.

Jevgeni Ossinovski
Minister of Health and Labour
Marika Priske
Secretary General

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