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X-MS-Exchange-Organization-ModifySensitivityLabel: 00000000-0000-0000-0000-000000000000;defa4170-0d19-0005-0004-bc88714345d2 x-codetwo-clientsignature-inserted: true X-MS-Exchange-CrossTenant-MailboxType: HOSTED X-MS-Exchange-CrossTenant-UserPrincipalName: 2d5R3wjgfHpB1Niy2EoYi760vhzDoaYjTTy/SsDRBzE2AulgQRZB3q/rHUB+27A+hKa/ldSiz/QIOJvZWcQlbEKyhgSXTxhUPVEFvW4udq4= This is a multipart message in MIME format. ------=_NextPart_000_00A7_01DD24DA.A11807C0 Content-Type: text/plain; charset="utf-8" Content-Transfer-Encoding: 8bit Teie: 09.07.2026 nr 1.2-3/1757-1 Meie: 05.08.2026 nr JUR-3/3769-2 Tere! Edastame tagasiside pakendiseaduse ja sellega seonduvalt teiste seaduste muutmise seaduse eelnõule. Soovime tähelepanu juhtida sellele, et määrus (EL) 2025/40 sisaldab mitmeid erisusi teatud tootekategooriate, sealhulgas ravimite ja meditsiiniseadmete pakendite suhtes. Kuna seletuskiri annab ülevaate ELi pakendi- ja pakendijäätmete määrusest, soovitame selguse huvides käsitleda selles ka määruses ette nähtud erisusi. Näiteks on seletuskirja punktis 2.1 märgitud, et kõik pakendid peavad olema 2030. aastaks ringlussevõetavad majanduslikult teostataval viisil ning plastikpakendite puhul kehtestatakse siduvad ringlussevõetud materjali miinimumnõuded. Samas näevad määruse artikli 6 lõige 11 ja artikli 7 lõige 11 ette erandid teatavatele pakenditele, sealhulgas ravimite esmapakenditele, teatud ravimite välispakenditele ning meditsiiniseadme kontaktitundlikele pakenditele, mille suhtes nimetatud nõudeid ei kohaldata. Lisaks sisaldab määruse artikli 12 lõige 11 erisusi pakendi märgistamise nõuete osas. Seetõttu soovitame seletuskirjas nendele erisustele viidata. Lugupidamisega Helen Tõnise õigusnõunik Õigusosakond Ravimiamet 737 4140 www.ravimiamet.ee Selles e-kirjas sisalduv teave (kaasa arvatud manused) on mõeldud ametialaseks kasutamiseks ning seda võivad kasutada vaid e-kirja adressaadid. E-kirjas sisalduvat teavet ei tohi ilma saatja selgelt väljendatud loata edasi saata ega mis tahes viisil kolmandatele isikutele avaldada. Juhul, kui Te olete saanud käesoleva e-kirja eksituse tõttu, teavitage sellest koheselt saatjat ning kustutage e-kiri. This e-mail and any attachments transmitted may contain confidential and privileged information. If you are not the intended recipient, please notify the sender immediately by returning the e-mail and permanently deleting what you have received. 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Teie: 09.07.2026 nr 1.2-3/1757-1
Meie: 05.08.2026 nr JUR-3/3769-2


Tere!

Edastame tagasiside pakendiseaduse ja sellega seonduvalt teiste seaduste = muutmise seaduse eeln=C3=B5ule.

Soovime t=C3=A4helepanu juhtida sellele, et m=C3=A4=C3=A4rus (EL) = 2025/40 sisaldab mitmeid erisusi teatud tootekategooriate, sealhulgas = ravimite ja meditsiiniseadmete pakendite suhtes. Kuna seletuskiri annab = =C3=BClevaate ELi pakendi- ja pakendij=C3=A4=C3=A4tmete = m=C3=A4=C3=A4rusest, soovitame selguse huvides k=C3=A4sitleda selles ka m=C3=A4=C3=A4ruses ette n=C3=A4htud = erisusi. 

N=C3=A4iteks on seletuskirja punktis 2.1 m=C3=A4rgitud, et k=C3=B5ik = pakendid peavad olema 2030. aastaks ringlussev=C3=B5etavad = majanduslikult teostataval viisil ning plastikpakendite puhul = kehtestatakse siduvad ringlussev=C3=B5etud materjali = miinimumn=C3=B5uded. Samas n=C3=A4evad m=C3=A4=C3=A4ruse artikli 6 l=C3=B5ige 11 ja artikli 7 l=C3=B5ige 11 ette erandid teatavatele = pakenditele, sealhulgas ravimite esmapakenditele, teatud ravimite = v=C3=A4lispakenditele ning meditsiiniseadme kontaktitundlikele = pakenditele, mille suhtes nimetatud n=C3=B5udeid ei kohaldata. Lisaks = sisaldab m=C3=A4=C3=A4ruse artikli 12 l=C3=B5ige 11 erisusi pakendi = m=C3=A4rgistamise n=C3=B5uete osas. Seet=C3=B5ttu soovitame = seletuskirjas nendele erisustele viidata. 


Lugupidamisega 

Helen T=C3=B5nise

=C3=B5igusn=C3=B5unik

=C3=95igusosakond


Ravimiamet

737 4140

www.ravimiamet.ee


Selles e-kirjas sisalduv teave (kaasa arvatud manused) on = m=C3=B5eldud ametialaseks kasutamiseks ning seda v=C3=B5ivad kasutada = vaid e-kirja adressaadid. E-kirjas sisalduvat teavet ei tohi ilma saatja = selgelt v=C3=A4ljendatud loata edasi saata ega mis tahes viisil = kolmandatele isikutele avaldada. Juhul, kui Te olete saanud = k=C3=A4esoleva e-kirja eksituse t=C3=B5ttu, teavitage sellest koheselt = saatjat ning kustutage e-kiri. 
This e-mail and any attachments transmitted may = contain confidential and privileged information. If you are not the = intended recipient, please notify the sender immediately by = returning the e-mail and permanently deleting what you have = received. Any dissemination or use of this information by a third person without permission is = prohibited and may be illegal. 

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