Instructions for Submitting Application and Documentation for Setting/Alignment of Maximum Price of a Medicine

Oct 28, 2026

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Guidance for marketing authorization holders and wholesale authorization holders on submitting documentation to set or align the maximum price of a medicinal product. Requires a cover letter with application purpose, applicant and medicine details (ATC, INN, brand, form, strength, packaging), and the medicine’s marketing authorization status supported by relevant CInMED decisions or import authorizations, plus expert opinion. Includes completion rules for the application form using reference-country price columns, conversions to euros via specified exchange rates, and requirements when comparable prices cannot be determined or for blood/plasma-derived medicines, submitted separately per pharmaceutical form, strength and packaging to CInMED registry.

LanguageEnglish

CategoryHealthcare

FormatPDF

Pages2

Reading Time5 min

AccessFree to download

Cover letter for setting/alignment of maximum price

Application purpose and required information

Application form for setting maximum price

Price sources, conversion to euros, and reference country rules

Special cases and submission requirements

For the purpose of setting/allignment of maximum price of a medicinal product, marketing authorisation holders and wholesale authorisation holders shall submit the following documentation: 1. Cover letter of the application for setting/alignment of maximum price (on the letterhead of the applicant): 􀁸 Subject: -Application for setting maximum price of a medicine – medicines for which the maximum price is to be determined for the first time, or - Application for alignment of maximum price of a medicine – medicines for which the maximum price has already been set 􀁸 In case that a medicine already has the maximum price set, and the application for alignment of maximum price is being submitted, it is necessary to provide the number of previously issued Decision issued by CInMED 􀁸 Data on the applicant (name and headquarters of a legal entity) 􀁸 Data on the medicine (ATC, INN, brand name, pharmaceutical form, strength, packaging) 􀁸 Information on the status of the medicine with regards to the procedure of issuance of marketing authorisation -If the medicine has been granted marketing authorisation, it is necessary to provide the date and number of the CInMED Decision on placing the medicine on the market - If the medicine has not been granted marketing authorisation, it is necessary to provide the information on its last import authorisation issued in accordance with the Article 29 of the Law on Medicines (number and date of CInMED Import Authorisation) . If a marketing authorisation procedure has been initiated for a medicine in question at CInMED, please provide the procedure number and date. In addition to the requirements on this basis, it is necessary to submit a statement from the manufacturer of the medicine, or the marketing authorization holder in the EU on the typeof medicine (whether the medicine has been authorized in the EU and/or the country of origin as an original, generic or biologically similar medicine) . If possible, please submit a statement on the status of the medicine by one of the competent authorities of the countries where the medicine obtained the marketing authorization. 􀁸 Expert opinion on the status of the medicine (original/generic/biologically similar medicine) 􀁸 Date and signature of a responsible person of the applicant. 2. Application form for setting maximum price of a medicine 1 When completing the application form please use the following information sources: Republic of Serbia: Website of the Republic Fund of Health Insurance: [www.rfzo.rs Va](www.rfzo.rs Va)žeća lista lekova (Lists A, A1, B, C and D) Please use the price from the column "I" -Wholesale price of the medicine for the packaging, converted into euros, using the middle exchange rate of the National Bank of Serbia on the day of price calculation (provide the date of price calculation) . Czech Republic: Website of the State Institute for Drug Control-SUKL: 1 Application forms are available on CInMED web portal: Legislation/Application form-medicines/Setting maximum prices of medicine/Application forms. [www.sukl.eu](www.sukl.eu) – List of reimbursed medicinal products Please use the final retail price from the column "CH" named MFC, multiplied by the correction factor 0.86 to get the wholesale price, converted into euros with the exchange rate published by the Central Bank of Montenegro for the Czech koruna (CZK) on the day of price calculation (provide the date of price calculation) . Romania: Website of the Ministry of Health of Romania: [www.ms.ro](www.ms.ro -Catalogul Public national)[ -Catalogul Public national](www.ms.ro -Catalogul Public national) al preturilor maximale ale medicamentelor de uz uman Please use the price from the column “N”-Preț ridicata maximal fără TVA (lei), converted into euros with the exchange rate published by the Central Bank of Montenegro for the Romanian leu (RON) on the day of price calculation (provide the date of price calculation) . The prices va

FAQs

Who must submit the application and documentation for setting or aligning a medicine’s maximum price?

Marketing authorisation holders and wholesale authorisation holders submit the required documentation to CInMED.

What must the cover letter include when applying to set or align the maximum price?

The cover letter must state the application subject (setting vs alignment), provide applicant data, medicine details (ATC, INN, brand, form, strength, packaging), and include the medicine’s marketing authorization status supported by CInMED decision details or import authorisation information, plus expert opinion and the responsible person’s date and signature.

How should prices from reference countries be used to complete the application form?

Use the specified price columns from the reference-country publications, convert to euros using the middle exchange rate (with the required price-calculation date), and apply the stated calculation rules. If comparable prices cannot be determined, provide evidence of authorization status and comparable prices in EU member states.

Oct 28, 2026

Upload by Hazel