лекови.мкReference price intelligence

Pricing methodology for medicines

Mapped to the Methodology on the manner of forming the prices of medicines (Government of the Republic of North Macedonia, No. 45-4259/1 of 4 July 2019, consolidated text), adopted under Article 108(10) of the Law on Medicines and Medical Devices.

Reference countries and data sources (Art. 4)

The reference countries are Slovenia, Bulgaria, Croatia, Serbia and Greece. The comparison uses the latest official wholesale price data published by the competent authorities of those countries. If a comparison price cannot be established in any, or in only one, of the five countries, all EU member states serve as reference countries; if the medicine is not authorized in any EU member state, the price in the manufacturer's country applies.

Price basis and the "same medicine" (Art. 5–8)

Comparison is made at the wholesale price level, excluding VAT. The same medicine means the same INN, pharmaceutical form, strength and pack (Art. 6); the comparison price is established separately for each form, strength and pack (Art. 8). Where the same form is absent, related forms may be compared (e.g. tablet – coated tablet – capsule; suspension – syrup – solution), except that prolonged or modified release forms cannot be equated with non-modified forms. Where pack sizes differ, the closest pack is used and the comparison price is calculated per unit and scaled to the pack in question (Art. 7).

Country comparison price — generics (Art. 9)

Comparison price per country = average of all wholesale prices in that country with the same INN, form, strength and pack, from different manufacturers

Maximum wholesale price (Art. 11)

Maximum wholesale price in RNM = ( C₁ + C₂ ) / 2
where C₁ and C₂ are the two lowest country comparison prices

If a comparison price exists in only one reference country, the average is taken of that price and the lowest price across all EU member states (Art. 11(3)). Where no comparison price exists at all, the maximum wholesale price derives from the import price plus customs, import costs and wholesale margin, capped at 25% (import price up to EUR 10), 20% (over EUR 10.01) or 15% (over EUR 100.01) of the import price (Art. 11(5)).

Originator medicines (Art. 17)

Maximum wholesale price of the originator = average of the two lowest wholesale prices of the originator's own product (same manufacturer) in the reference countries

Biosimilars are priced at no more than 85% of the maximum wholesale price of the corresponding biological medicine; parallel imports at no more than 85% of the formed price of the same or similar authorized medicine (Art. 15, 15-a).

Currency conversion (Art. 10)

Comparison prices in foreign currency are converted to denars at the National Bank of RNM middle exchange rate applicable on the last 1 March preceding the calculation date.

Annual revision (Art. 12)

The Ministry of Health determines the maximum wholesale price once per year on 15 March and publishes it at lekovi.zdravstvo.gov.mk. The MAH is notified of the proposed calculation in advance and may submit objections; a request for price formation must follow within seven days of the determination, failing which the previously formed price ceases to be valid. The newly determined maximum price cannot exceed the existing maximum price (Art. 12(6)).

Retail margins (Art. 14)

  • Wholesale price up to EUR 5.00 — retail margin 28%
  • EUR 5.01 to 20.00 — margin 25%
  • EUR 20.01 to 100.00 — margin 20%
  • Above EUR 100.01 — fixed margin of MKD 1,200

How this tool applies the methodology

The calculation panel in the search view computes, from the currently filtered results: the country comparison price per Art. 9 (generic mode: average of all matching prices per country) or per Art. 17 (originator mode: the originator product's price per country); the maximum wholesale price per Art. 11 as the average of the two lowest country values; and an indicative retail price excluding VAT per the Art. 14 margin bands.

Analyst responsibility: the computed figures are valid only when the result set is filtered to a single INN, pharmaceutical form, strength and comparable pack (Art. 6, 8) — and, in originator mode, to the originator's brand. Per-unit scaling for non-identical packs (Art. 7) and the Art. 10 exchange rate cut-off must be applied by the analyst. Derived figures are analytical indications, not administrative decisions.