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§ 43. List of medicinal products

(1)        The list of medicinal products shall be established by a regulation of the Minister of Social Affairs.

(2)        The following criteria shall be taken into account upon establishment of the list of medicinal products:

1)         the need of an insured person to obtain a medicinal product as a result of the provision of a health service;

2)         the proven medical efficacy of a medicinal product and the need of an insured person to obtain other medicinal products in the course of his or her treatment;

3)         the economic justification of the use of a medicinal product;

4)         the existence of alternative medicinal products or means of treatment;

5)         conformity with the financial resources of health insurance and with the principle provided for in subsection 25 (3) of this Act.

(3)        The procedure for drawing up and amending the list of medicinal products, the detailed contents of the criteria provided for in subsection (2) of this section and the persons to assess compliance with the criteria shall be established by a regulation of the Minister of Social Affairs.

(4)        Only medicinal products which have been issued valid marketing authorisations in Estonia may be entered in the list of medicinal products.

(28.06.2004 entered into force 01.08.2004 - RT I 2004, 56, 400)

(5)        The following information shall be entered in the list of medicinal products:

1)         the active ingredients and the Anatomical Therapeutic Chemical codes (ATC codes) of the medicinal products;

2)         pharmaceutical preparations;

3)         the manufacturers of the medicinal products;

4)         diseases in the case of which medicinal products containing an active ingredient intended for the treatment or alleviation of the disease are sold at a discount of 100 per cent;

5)         diseases in the case of which medicinal products containing an active ingredient intended for the treatment or alleviation of the disease are sold at a discount of 75 per cent;

(28.06.2004 entered into force 01.08.2004 - RT I 2004, 56, 400)

6)         the discount rates for the pharmaceutical forms, strengths and packages of medicinal products.

(6)        A medicinal product may be entered in the list of medicinal products with a condition the objective of which is to:

1)         ensure that the entry in the list of medicinal products enters into force after a price agreement is entered into or a reference price is established;

2)         ensure that the medicinal product is deleted from the list of medicinal products upon termination of the price agreement;

3)         establish a lower discount rate for a certain pharmaceutical form, strength or package of the same medicinal product;

4)         restrict a right to issue prescriptions for medicinal products, imposed in the interests of the health of insured persons or in order to ensure that the issue of prescriptions for medicinal products is justified;

5)         ensure the efficient and purposeful use of health insurance funds.