Subject: Vs: Compassionate use programs
From: "Ellen Lurje" <[email-masked]>
To: <[email-masked]>
Date: Sat, 18 May 2024 08:34:04 +0300

Dear Beatrice,

Thank you for contacting us!

Yes, we have a paragraph in our legislation:

§ 21.  Authorisation for distribution of unauthorised medicinal product

 (7) In the absence of authorised medicinal products with equivalent effect 
or where such products are not distributed according to treatment needs, the 
State Agency of Medicines may, in addition to the provisions of subsection 1 
of this section, grant an authorisation for distribution of:

 4) medicinal products offered free of charge by the manufacturer of 
medicinal products provided that the doctor providing treatment to the 
patient has confirmed that the medicinal product is necessary for 
life-saving purposes and there are no other options for the treatment of a 
chronic or life-threatening illness and also provided that the illness is 
deemed life-threatening and all other treatment methods for which the 
payment obligation is assumed by the Estonian Health Insurance Fund and that 
are medically suitable and financially accessible to the person have been 
exhausted, and it is likely that the benefits of the medicinal product 
outweigh possible risks.

https://www.riigiteataja.ee/en/eli/ee/Riigikogu/act/519012024002/consolide

To use a medicinal product via CUP, the program has to match the criteria 
stated for CUP, however it is named by the company (expanded access, early 
access, etc).

In European legislation named patient prescription usually refers to using 
unauthorised medicines but not under CUP circumstances (for example when 
there are shortages or an authorised medicine is not distributes in a 
particular country etc) (Article 5 of Directive 2001/83/EC1).

I hope this answered your questions, if not, let me know!

Kind regards,

Ellen Lurje
Specialist

Bureau of Clinical Assessment

Department Marketing Authorisations

State Agency of Medicines
 <mailto:[email-masked]> [email-masked]

1 Nooruse Street
50411 Tartu
Estonia
Phone: +372 737 4140

 <http://www.ravimiamet.ee/> 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 recieved. Any dissemination or use of this 
information by a third person without permission is prohibited and may be 
illegal.

From: BEATRICE - ELENA LASCU <[email-masked] 
<mailto:[email-masked]> >
Sent: neljapäev, 16. mai 2024 15:59
To: BEATRICE - ELENA LASCU <[email-masked] 
<mailto:[email-masked]> >
Subject: Compassionate use programs

Tähelepanu! Tegemist on väljastpoolt asutust saabunud kirjaga. Tundmatu 
saatja korral palume linke ja faile mitte avada.

Dear Sir/ Madam,

could you help me with an explanation of how Article 83 of Regulation (EC) 
No 726/2004 applies in your country? Could you help me with a legislative 
article?

In addition, is there a distinction made between CUP (compassionate use 
program), NPP (name patient prescription), or EAP (expanded access program)?

Thank you in advance for your help!

Beatrice Lascu, RPh