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Docusign Envelope ID: 3C71576F-7CEF-477E-B536-96D270625B89 Date March 20, 2026 Page 01 | 2 Natalia Andrulonis-Oğul Boehringer Ingelheim | RCV GmbH & Co KG | Dr.-Boehringer-Gasse 5-11, 1121 Vienna M +43 (664) 808450346 T +43 (1) 80105-5763 natalia.andrulonis-ogul.ext@ Sotsiaalministeerium boehringer-ingelheim.com Suur-Ameerika 1, 10122 Tallinn Boehringer Ingelheim [email protected] RCV GmbH & Co KG Dr. Boehringer-Gasse 5-11 1121 Vienna, Austria Teema: Tagasiside määruse nr 55 § 7 muutmise eelnõule – veterinaarravimi müügiloa haldamise aastatasu Lugupeetud sotsiaalminister, Täname võimaluse eest anda tagasisidet veterinaarravimi müügiloa haldamise aastatasu korralduse plaanitava muudatusega seoses. Käesolevaga esitab Boehringer Ingelheim (edaspidi BI) oma seisukohad seoses veterinaarravimi müügiloa haldamise aastatasu arvestamise aluste muutmise kavatsusega, millega tehakse ettepanek täiendada tervise- ja tööministri 05.07.2022.a. määrust nr 55 „Ravimi müügiloa muutmise ning erialase hindamise tingimused ja tasu suurus“ (edaspidi määrus nr 55) § 7 uue lõikega 6. 1. Üldine seisukoht – muudatus on mõistlik ja põhjendatud BI toetab kavandatavat muudatust, millega kehtestatakse madalam aastatasu – 750 euro – määruse lisas nimetatud toimeainega toiduloomal kasutatava veterinaarravimi müügiloa eest. Eelnõus esitatu kohaselt on muudatuse eesmärk luua meede, millega võimaldatakse toiduloomadele ja -lindudele ette nähtud esmavajalike ja kriitilise tähtsusega veterinaarravimite vähendatud müügiloa haldamistasu, et soodustada kliiniliselt hädavajalike, samas tõhusate, kvaliteetsete ja ohutute ravimite turustamise alustamist ning kättesaadavuse püsimist Eestis. BI on seisukohal, et see muudatus on väga vajalik ja õige samm püstitatud eesmärgi saavutamiseks ning õiguskantsleri 16.12.2025 hinnangus kirjeldatud põhiseaduse vastase olukorra muutmiseks. Nii nagu ka muudatuse selgituses on märgitud, leiab ka BI, et plaanitava muudatusega kaasneb soodne mõju toiduloomadel kasutatavate ravimite valiku suurenemisele, ravimi kiiremale turule jõudmisele, mis omakorda parandab loomade ja inimeste tervisekaitset. Lisaks on madalam tasu paremini proportsioonis Ravimiameti tegelike kuludega vastavate müügilubade haldamisel. Life forward Docusign Envelope ID: 3C71576F-7CEF-477E-B536-96D270625B89 2. Vajalikud on täiendavad sammud aastatasude vähendamiseks ja põhiseaduspärasuse Date March 20, 2026 tagamiseks Page 002 | 2 BI nõustub õiguskantsleri hinnanguga praeguste kehtivate aastatasude osas, mida muudatus ei puuduta – 1395 euro suurune ühetaoline aastatasu on ebaproportsionaalselt suur arvestades Ravimiameti tegelike kuludega ega võimalda arvestada veterinaarravimite turu tegelikku olukorda. Nagu õiguskantsler on osutanud, võib tasud kulude katteallikana kehtestada, kuid veterinaarravimite müügilubade hoidjad ei pea Ravimiameti tegevust rahastama suuremas ulatuses kui see aastatasu eesmärke silmas pidades vajalik on. Lisaks õiguskantsleri poolt esile toodud summadele ja arvutustele märgime, et arvestades BI 50+ müügiluba, maksab BI aastas tasuna sellise summa, mis piltlikult väljendades katab 1 täistööajaga ametniku kogu tööaja terve aasta jooksul ja ka siis jääb sellest summast veel kõikideks muudeks tegevuskuludeks omajagu üle. BI hinnangul ei ole realistlik, et BI veterinaarravimite müügilubade hindamist mittevajavate muudatuste haldamine sellise proportsiooni Ravimiameti tegevusest moodustaks. Seega on ilmne, et praegune aastatasu ei ole proportsionaalne tegelike halduskuludega. Sotsiaalministeerium on märkinud, et kavandatava muudatuse, st toiduloomadele vajalike kriitiliste müügilubade tasu alandamise, eelduslikuks mõjuks on kliiniliselt hädavajalike, samas tõhusate, kvaliteetsete ja ohutute ravimite turustamise alustamise soodustamine ning kättesaadavuse püsimise tagamine Eestis. Seega möönab ministeerium ka ise, et just tasu alandamine on sobiv meede nimetatud eesmärgi täitmisel. Seetõttu tuleks ebaproportsionaalselt kõrgete tasude asemel, mis ravimite kättesaadavust Eestis mitte kuidagi ei soodusta, luua paindlikum süsteem. Nii nagu ka õiguskantsler on kirjeldanud, on võimalusi erinevaid: diferentseeritud tasu süsteem sõltuvalt käibe kategooriast, käibepõhine tasu, kindlaksmääratud summaga tasu koos võimalusega taotleda tasu vähendamist või sellest vabastamist. BI on valmis osalema edasistes aruteludes ning esitama vajadusel täiendavaid andmeid ja analüüse. Lugupidamisega Boehringer Ingelheim Natalia Andrulonis-Oğul Regional Regulatory Affairs Manager Life forward Docusign Envelope ID: 3C71576F-7CEF-477E-B536-96D270625B89 Date March 20, 2026 Page 01 | 2 Natalia Andrulonis-Oğul Boehringer Ingelheim | RCV GmbH & Co KG | Dr.-Boehringer-Gasse 5-11, 1121 Vienna M +43 (664) 808450346 T +43 (1) 80105-5763 natalia.andrulonis-ogul.ext@ Ministry of Social Affairs boehringer-ingelheim.com Suur-Ameerika 1, 10122 Tallinn Boehringer Ingelheim [email protected] RCV GmbH & Co KG Dr. Boehringer-Gasse 5-11 1121 Vienna, Austria Subject: Feedback on the draft amendment to Regulation No. 55, Section 7 – annual fee for the administration of marketing authorisations for veterinary medicinal products Dear Minister of Social Affairs, Thank you for the opportunity to provide feedback on the planned amendment to the regulations governing the annual fee for the administration of veterinary medicinal product marketing authorisations. Boehringer Ingelheim (hereinafter BI) hereby submits its views on the proposed amendment to the basis for calculating the annual fee for the administration of veterinary medicinal product marketing authorisations, which proposes to supplemented Labour of 5 July 2022 No. 55 „Conditions for the amendment of a marketing authorisation for a medicinal product and for a specialist assessment, and the amount of the fee“ (hereinafter Regulation No. 55) with a new paragraph 6 in Section 7. 1. General position – the amendment is reasonable and justified BI supports the proposed amendment, which establishes a lower annual fee – 750 euros – for a marketing authorisation for a veterinary medicinal product containing the active substance listed in the Annex to the Regulation and intended for use in food-producing animals. According to the draft, the aim of the amendment is to introduce a measure allowing for a reduced marketing authorisation fee for essential and critical veterinary medicinal products intended for food-producing animals and poultry, in order to facilitate the launch of clinically essential, yet effective, high-quality and safe medicines in Estonia. BI is of the view that this amendment is a very necessary and appropriate step towards achieving the stated objective and rectifying the situation described in the Chancellor of Justice’s assessment of 16 December 2025 as being contrary to the Constitution. As noted in the explanatory memorandum to the amendment, BI also considers that the proposed Life forward Docusign Envelope ID: 3C71576F-7CEF-477E-B536-96D270625B89 amendment will have a positive impact on increasing the range of medicines available for Date March 20, 2026 food-producing animals and accelerating the time to market for medicines, which in turn will Page 002 | 2 improve the protection of animal and human health. Furthermore, a lower fee is more proportionate to the actual costs incurred by the State Agency of Medicines in administering the relevant marketing authorisations. 2. Further steps are needed to reduce annual fees and ensure constitutionality BI agrees with the Chancellor of Justice’s assessment regarding the current annual fees, which are not affected by the amendment – the flat-rate annual fee of 1,395 euros is disproportionately high given the State Agency of Medicines’ actual costs and does not allow for the actual situation in the veterinary medicines market to be taken into account. As the Chancellor of Justice has pointed out, fees may be imposed as a source of funding, but holders of marketing authorisations for veterinary medicinal products should not be required to finance the activities of the State Agency of Medicines to a greater extent than is necessary in view of the objectives of the annual fee. In addition to the figures and calculations highlighted by the Chancellor of Justice, we note that, taking into account the BI 50+ marketing authorisation, BI pays an annual fee amounting to, figuratively speaking, the full- time working hours of one official for an entire year, and even then, a considerable amount remains from this sum to cover all other operating costs. In BI’s view, it is unrealistic that the administration of changes to veterinary medicinal product marketing authorisations that do not require assessment should constitute such a proportion of the State Agency of Medicines’ activities. It is therefore clear that the current annual fee is not proportionate to the actual administrative costs. The Ministry of Social Affairs has noted that the intended effect of the proposed amendment, i.e. the reduction in fees for critical marketing authorisations required for food-producing animals, is to facilitate the launch of clinically essential, yet effective, high-quality and safe medicines, and to ensure their continued availability in Estonia. The Ministry therefore acknowledges itself that reducing the fee is the appropriate measure for achieving this objective. For this reason, instead of disproportionately high fees, which in no way promote the availability of medicines in Estonia, a more flexible system should be established. As the Chancellor of Justice has also described, there are various options: a differentiated fee system depending on the category of turnover, a turnover-based fee, or a fixed-sum fee with the possibility of applying for a reduction or exemption from the fee. BI is prepared to participate in further discussions and to provide additional data and analyses if necessary. Yours faithfully Boehringer Ingelheim Natalia Andrulonis-Oğul Regional Regulatory Affairs Manager Life forward Certificate Of Completion Envelope Id: 3C71576F-7CEF-477E-B536-96D270625B89 Status: Completed Subject: BI_Tagasiside_Määrus nr 55_20.03.2026 Source Envelope: Document Pages: 4 Signatures: 2 Envelope Originator: Certificate Pages: 3 Initials: 0 Natalia Andrulonis-Oğul AutoNav: Enabled Binger Straße 173 EnvelopeId Stamping: Enabled Ingelheim, Rheinland-Pfalz CT 55216 Time Zone: (UTC+01:00) Belgrade, Bratislava, Budapest, Ljubljana, Prague [email protected] m IP Address: 2001:4bb8:168:6 Record Tracking Status: Original Holder: Natalia Andrulonis-Oğul Location: DocuSign 3/20/2026 12:27:48 PM natalia.andrulonis-ogul.ext@boehringer-inge lheim.com Signer Events Signature Timestamp Natalia Andrulonis-Oğul Sent: 3/20/2026 12:28:38 PM [email protected] Viewed: 3/20/2026 12:28:44 PM Signed: 3/20/2026 12:29:59 PM om Regional Regulatory Affairs Manager Signature Adoption: Pre-selected Style Boehringer Ingelheim RCV GmbH & Co KG Using IP Address: Security Level: Email, Account Authentication 2001:4bb8:168:61c5:d93d:44a5:91f8:bd54 (None) Electronic Record and Signature Disclosure: Accepted: 9/2/2025 11:40:35 AM ID: dc553c42-ae93-4c97-9ca2-0198fb831867 In Person Signer Events Signature Timestamp Editor Delivery Events Status Timestamp Agent Delivery Events Status Timestamp Intermediary Delivery Events Status Timestamp Certified Delivery Events Status Timestamp Carbon Copy Events Status Timestamp Witness Events Signature Timestamp Notary Events Signature Timestamp Envelope Summary Events Status Timestamps Envelope Sent Hashed/Encrypted 3/20/2026 12:28:38 PM Certified Delivered Security Checked 3/20/2026 12:28:44 PM Signing Complete Security Checked 3/20/2026 12:29:59 PM Completed Security Checked 3/20/2026 12:29:59 PM Payment Events Status Timestamps Electronic Record and Signature Disclosure Electronic Record and Signature Disclosure created on: 8/25/2025 11:34:11 AM Parties agreed to: Natalia Andrulonis-Oğul Heads up Boehringer employees - Working Abroad Policy: If you are working abroad, on a business trip or TWA, please be aware that certain activities are not permitted, including the signing of contracts. 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By checking the 'I Agree' box, I confirm that: I can access and read this CONSENT TO PROCEED WITH ELECTRONIC SIGNATURES document; and I can print on paper the disclosure or save or send the disclosure to a place where I can print it, for future reference and access; and Until or unless I have notified my respective Company contact as described above, I consent to receive through electronic means all contractual documents, notices and other documents that are required to be provided or made available to me by the Company during the course of the business relationship with you. Saatja: [email protected] Saaja: "Mari Amos - SOM" <[email protected]> Teema: RE: Veterinaarravimi müügiloa haldamise aastatasu arvestamise aluste muudatus Kuupäev: 2026-03-20 11:45 Tähelepanu! Tegemist on välisvõrgust saabunud kirjaga. Tundmatu saatja korral palume linke ja faile mitte avada. Dear Mari Amos, Thank you for shared information. Please see attached our response to propose amendment. Kind regards Natalia Andrulonis-Ogul AH Reg. Affairs / Pharmaco_Countries Boehringer Ingelheim RCV GmbH & Co KG Dr.-Boehringer-Gasse 5-11 | 1121 Vienna, Austria T <tel:+43%20(1)%2080105-5763> +43 (1) 80105-5763 M <tel:+43%20(664)%20808450346> +43 (664) 808450346 E <mailto:[email protected]> [email protected] <https://www.boehringer-ingelheim.com/at/de> Boehringer Ingelheim RCV GmbH & Co KG, Firmenbuch-Nr.: FN 312077m, Handelsgericht Wien, Firmensitz: Wien, Rechtsform: Kommanditgesellschaft Komplementär: Boehringer Ingelheim RCV GmbH, Firmenbuch-Nr.: FN 310535w, Handelsgericht Wien, Firmensitz: Wien, Rechtsform: Gesellschaft mit beschränkter Haftung Diese E-Mail ist vertraulich zu behandeln. Sie kann besonderem rechtlichen Schutz unterliegen. Wenn Sie nicht der richtige Adressat sind, senden Sie bitte diese E-Mail an den Absender zurück, löschen die eingegangene E-Mail und geben den Inhalt der E-Mail nicht weiter. 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From: Mari Amos - SOM <[email protected]> Sent: Tuesday, 10 March 2026 18:49 To: [email protected]; [email protected]; [email protected]; [email protected]; [email protected]; [email protected]; [email protected]; [email protected]; [email protected]; [email protected]; [email protected]; zxVIE Andrulonis-Ogul,Natalia (AH RA_PV_CO) EXTERNAL <[email protected]>; [email protected]; [email protected]; [email protected]; [email protected]; [email protected]; [email protected]; [email protected]; [email protected]; [email protected]; [email protected]; [email protected]; [email protected]; [email protected]; [email protected]; [email protected]; [email protected]; [email protected]; [email protected]; [email protected]; [email protected]; [email protected]; [email protected]; [email protected]; [email protected]; [email protected]; [email protected]; [email protected]; [email protected]; [email protected]; [email protected]; [email protected]; [email protected]; [email protected]; [email protected]; [email protected]; [email protected]; [email protected]; [email protected]; [email protected]; [email protected]; [email protected]; [email protected]; [email protected]; [email protected]; Stack, Marie (G) <[email protected]>; [email protected]; [email protected]; [email protected]; [email protected]; [email protected]; [email protected]; [email protected]; [email protected] Cc: Andrus Varki <[email protected]> Subject: Veterinaarravimi müügiloa haldamise aastatasu arvestamise aluste muudatus Nieczęsto otrzymujesz wiadomości e-mail z adresu [email protected] <mailto:[email protected]> . <https://aka.ms/LearnAboutSenderIdentification> Dowiedz się, dlaczego jest to ważne CAUTION: Do not click links, scan QR codes, or open attachments unless you trust the sender; this email is from an external sender (outside Boehringer Ingelheim). Head veterinaarravimite müügiloa hoidjad ja eksperdid, Pöördun teie poole seoses plaanitava muudatusega veterinaarravimi müügiloa haldamise aastatasu korralduses. Muudatuse eesmärk on viia müügiloa haldamise aastatasu määramine kooskõlla õiguskantsleri ettepanekuga. Käesoleva kirja lisast leiate muudatust selgitava dokumendi ning Eesti jaoks esmavajalike toimeainete nimekirja. Ootame teie tagasisidet plaanitud muudatuse osas hiljemalt 22.märtsiks 2026. Soovi korral on muudatusi võimalik arutada ka veebikoosolekul, mis leiab aset 24.märtsil kell 11. Koosolekuga saab liituda selle lingi kaudu: <https://teams.microsoft.com/meet/31279751150133?p=9iYRJcedj4ka5ciztV> https://teams.microsoft.com/meet/31279751150133?p=9iYRJcedj4ka5ciztV Mari Amos nõunik [email protected] <mailto:[email protected]> Sotsiaalministeerium Suur-Ameerika 1 10122 Tallinn <https://www.sm.ee/> www.sm.ee