Provisions On Pricing Principles

Original Language Title: Noteikumi par zāļu cenu veidošanas principiem

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Read the untranslated law here: https://www.vestnesis.lv/ta/id/120074

Cabinet of Ministers Regulations No. 803 in Riga 2005 October 25 (Mon. No 61 24. §) rules on pricing principles Issued in accordance with article 5 of the law of Pharmacy (4) i. General questions 1. determine drug (excluding veterinary drug) pricing principles.
2. the rules shall not apply to the pricing of medicinal products, which shall be purchased in accordance with the law "on procurement for State or local government needs".
3. The amount of the medicinal drug price list shall be established in accordance with the laws and regulations of the outpatient treatments and medicines for the purchase of medical equipment for the compensation procedures.
II. the manufacturer of the medicinal product, medicine and pharmacy lieltirgotav 4. responsibilities of the pharmaceutical manufacturer or his authorized representative (hereinafter referred to as the pharmaceutical manufacturer), launched the distribution of medicinal products in the territory of Latvia, in writing and electronically deliver medicine State agency information on the manufacturer of the medicinal product concerned sales price (for each pharmaceutical form, depending on the quantity of the active substances of the medicinal products unit and number of units in a package) without the value added tax (hereinafter referred to as producer price) lats and euros according to the Bank of Latvia exchange rate on the date of the provision of information.
5. the manufacturer of the medicinal product for projected changes in prices of medicinal products the manufacturer shall inform the State Agency of medicines and the lieltirgotav, which distributes its manufactured products, no later than 30 days before the new producer price of medicinal products. Drug manufacturer 15dien after the State Agency of medicines of the written request, provide reasonable written information about the medicine price increase.
6. where the manufacturer of a medicinal product is not the holder of the registration certificate for medicinal products, the rules 4, 5 and 22 companies mentioned in the duties of the holder of the registration certificate of the medicinal product or its authorized representative (hereinafter referred to as the registration certificate holder). In this case, in addition to the drug manufacturer's price to be declared separately the costs that result due to the drug registration and preparation for distribution.
7. Medicine parallel distributor simultaneously with the announcement of the parallel distribution of medicinal products distributed to launch the territory of Latvia in writing and electronically deliver medicine State agency information on the sales price of the medicinal product in Latvia (for each pharmaceutical form depending on the quantity of the active substances of the medicinal products unit and number of units in a package) without the value added tax (hereinafter referred to as the parallel distributor price) lats and euros according to the Bank of Latvia exchange rate on the date of the provision of information.
8. the parallel importer of a medicinal product simultaneously with the application for the authorisation of parallel distribution of medicinal products imported in the Republic of Latvia in writing and electronically deliver medicine State agency information on the sales price of the medicinal product in Latvia (for each pharmaceutical form depending on the quantity of the active substances of the medicinal products unit and number of units in a package) without the value added tax (hereinafter referred to as the parallel importer price) lats and euros according to the Bank of Latvia exchange rate on the date of the provision of information.
9. Drug dealer for the planned parallel parallel distributor price changes and the parallel importer on the parallel importer's scheduled price changes of the State Agency of Medicines shall inform no later than 15 days before the date of application for the new price. Drug dealer and drug parallel parallel importer within seven days after the State Agency's written request, provide reasonable written information about the medicine price increase.
10. The price at which a medicine was sold to lieltirgotav medicinal products (hereinafter referred to as the lieltirgotav price), composed by multiplying the price by the manufacturer with the adjustment factor and adding the adjustment amount and value added tax value in dollars. Adjustment factor, and the amount of the adjustment shall be based on producer prices (annex 1). To determine the price of lieltirgotav, the following formula is used: LC = RC x k + X + VAT-price lieltirgotav LC;
RC-manufacturer price;
k-correction factor;
X-the adjustment amount in dollars;
VAT-value added tax.
11. This provision 6. in the case referred to in paragraph lieltirgotav of prices, calculated in accordance with the provisions of paragraph 10, the formula specified in the manufacturer's price plus the costs shown separately, formed in connection with the registration of the medicinal product and preparation for distribution.
12. in accordance with paragraph 10 of these rules to create the lieltirgotav price is the maximum price in the lieltirgotav regardless of the specific distribution of medicines involved in lieltirgotav.
13. The price at which pharmacy sell medicinal products (hereinafter referred to as the pharmacy price), composed by multiplying the price at which the pharmacy buying medicine from drug producers or drug lieltirgotav, excluding the value added tax (hereinafter referred to as the purchase price), with adjustments to the rate and the amount of the adjustment and adding value added tax value in dollars. Adjustment factor, and the amount of the adjustment shall be based on the purchase price (annex 2). To determine the price of a drugstore, uses the following formula: AC = x + Y + n IC VAT ACT – the drugstore price;
IC-the purchase price;
n – correction factor;
Y-the adjustment amount in dollars;
VAT-value added tax.
14. in accordance with paragraph 13 of these rules to create pharmacy price is the maximum price of pharmacies regardless of the process of distribution of medicinal products in pharmacies.
15. The Pharmacy price of medicinal products made up, price, consisting of raw and packaging material costs, plus the amount of the adjustment according to the dosage forms (annex 3) and value added tax value in dollars. To determine the price of medicines in pharmacies made, uses the following formula: AIZC = II + IM + Z + VAT AIZC-pharmacy medicines produced in price;
II – the cost of raw materials;
IMI – packaging material costs;
Z-the adjustment amount in dollars;
VAT-value added tax.
16. According to paragraph 15 of these rules in the pharmacy made the medicine price is the maximum price of medicines produced in pharmacies.
17. If a pharmacy purchase another pharmacy medicines, made as a premium not exceeding 10 percent of the price, which is built in accordance with the provisions of paragraph 15, excluding value added tax.
18. Drug producers, drug and pharmacy lieltirgotav ensures the availability of price calculations in national pharmaceutical inspection test.
III. duties of the supervisory body of the National Medicines Agency 19:19.1. establish and maintain a database that includes this provision referred to in paragraph 4, the information supplied by the manufacturer and the rules referred to in paragraph 6 of the registration certificate holder information provided on the manufacturer's price, as well as costs in connection with the registration of the medicinal product and preparation for distribution (hereinafter database);
19.2. these provisions be inserted in the database referred to in paragraph 7 of the medicine in parallel retailer information about parallel dealer price, and this provision is referred to in point 8 of the parallel importer of a medicinal product information on the parallel importer's price;
19.3. within seven days of receipt of the information updates the data in the database, the data that the herbal medicine manufacturer, the holder of the registration certificate, drug dealer or parallel parallel importer in accordance with these rules 5, 6 and 9;
19.4. constantly analyzes the data in the database, identifying the risks that threaten the stability of prices of medicines;
19.5. by this rule 19.4. the risks referred to in the request in writing of the identification data of the applicant reasonable information about the medicine price reasons;
12.2., within 15 days after 19.5. This provision of the information referred to in subparagraph receipt and inform it analyzes the Health Ministry for unjustified price increases of medicinal products;
19.7. preparing and providing the Health Ministry quarterly updates on price dynamics;
19.8. ensure database availability State Pharmaceutical inspection.
20. national pharmaceutical inspection controls the execution of these rules.
IV. Closing questions 21. Be declared unenforceable in the Cabinet of Ministers of 29 December 1998, Regulation No 501 "medicinal and pharmaceutical product pricing rules" (Latvian journal, 1999, no. 1).
22. the manufacturer of the medicinal product in these regulations referred to in paragraph 4, the information about the distribution of medicinal products in the territory of Latvia has been started up to this date of entry into force of the provisions, provides drug national agency by January 1, 2006, and a further two times in the year to the first half-year as well as the date when the producer price changes.
23. the parallel distributor of medicines that rule the information referred to in paragraph 7 of the parallel imported medicinal products distribution permission is received up to the date of entry into force of the provisions, provides drug national agency by January 1, 2006, as well as further if changes in parallel to a dealer price.
24. the parallel importer of a pharmaceutical that rule the information referred to in paragraph 8 of the parallel imported medicinal products distribution permission is received up to the date of entry into force of the provisions, provides drug national agency by January 1, 2006, as well as in the future, if the parallel importer change the price.
25. The entry into force of the provisions by 1 December 2005.
Prime Minister, Minister of finance Spurdziņš o. Health Minister g. Smith Editorial Note: the entry into force of the provisions by 1 December 2005.
 
Annex 1: Cabinet

25 October 2005-Regulation No 803 companies corresponding to the price adjustment factor and adjustment amounts no PO box
The producer price (LCY) correction factor for adjustment amount (in LCY) 1.
until 2.99 1.18 0.00 2.
3.00-9.99 1.15 0.09 3.
10.00 and more Health Minister 1.1 0.59 G. Buchanan, annex 2 of the Cabinet of Ministers of 25 October 2005, regulations no 803 purchase price for medicines appropriate weightings and adjustments to amounts no PO box
The purchase price (in dollars) the correction factor correction amount (in LCY) 1.
to 0.99 1.4 0.00 2.
1.00-1.99 1.35 0.05 3.
2.00-2.99 1.3 0.15 4.
3.00-5.00 5 1.25 0.30.
5.00 – 1.2 0.55 9.99 6.
10.00 – 19.99 1.15 1.05 7.
20.00 and more Health Minister 1.1 2.05 G. Buchanan, annex 3 of the Cabinet of Ministers of 25 October 2005, regulations no 803 pharmacy made the pricing of medicines applicable adjustments amounts no PO box
Pharmaceutical form the adjustment amount (in LCY) 1.
Eye drops 2 1.00.
Zinc Glue 2.00 3.
Nose drops to five ingredients more than five ingredients 1.00 1.50 4.
Homeopathy and homeopathic solutions grain with the dilution factor 200 dilution factor 1000 5.00 to 10.00 5.
Cosmetic lotions to five ingredients more than five ingredients 1.50/2.00 suspension or 6.
Cosmetic creams, masks 2.00 7.
Powder with one ingredient in one unit 8 0.05.
Compound powder does not deliver additional 1.50 – the metered dose for every 10 units 0.50 9.
Candles and beads 10 units for every additional 3.00 next 10 units 10 1.00.
Solution of the potion, infusions, up to three ingredients more than four ingredients 1.00 1.50 11.
The flower up to three ingredients 1.20 four or five ingredients more than five ingredients 1.50 2.00 total weight 1 kg or more-in addition to 1.00 12.
Subsidiary colouring and smelling medicine – in addition to 1.00 13.
Medicinal products used in the manufacture of homeopathic triturācij, – in addition to 1.00 Health Minister g. Smith