Request for information

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Eveli Holst

Saatja: Eveli Holst Saatmisaeg: kolmapäev, 4. veebruar 2026 16:55 Adressaat: BAUTZ Ketty Koopia: Signe Leito Teema: Vs: Request of information - Aripiprazole Generics Programme-

Hello Yes, we still have samples left. The scans are made for the outer packages of the following four samples:

Aripiprazole Zentiva – IT _ Sample J Aripiprazole Sandoz – SE _ sample G Aripiprazole Sandoz – EL _ sample I Aripiprazole Mylan pharma – HR _ Sample E The scans are uploaded to ACT as you requested. Please follow up. If you have any more questions or request, we are pleased to help you if we can.

On behalf of Signe Leito. With best regards,

Eveli Holst State Agency of Medicines Laboratory laboratory specialist Phone 737 4140 [email protected] 1 Nooruse Str 50411 Tartu 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.

Saatja: BAUTZ Ketty <[email protected]> Saatmisaeg: esmaspäev, 2. veebruar 2026 16:21

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Adressaat: Ravimiamet <[email protected]>; Signe Leito <[email protected]> Teema: Request of information - Aripiprazole Generics Programme-

Dear Colleagues, I hope you are doing well! I’m coming back to you following a request from EMA regarding the label check questionnaires that have been filled in by the samplers for Aripiprazole. I know it’s a long time now that you received the samples, but I wanted to know if you would still have samples left to get scans of the outer packages. If yes, we would like to receive pictures of the following samples: Aripiprazole Zentiva – IT _ Sample J Aripiprazole Sandoz – SE _ sample G Aripiprazole Sandoz – EL _ sample I Aripiprazole Mylan pharma – HR _ Sample E These can be uploaded here: https://act.edqm.eu/s/SRkjRyfw5pxWDwf Many thanks in advance! Ketty De : BAUTZ Ketty Envoyé : mercredi 27 juillet 2022 12:00 À : [email protected] Objet : FW: Aripiprazole Generics Programme- Shipment and current status Dear Colleagues, In the absence of Signe, please find below the email that was addressed to her. Please note that the shipment of samples was moved from the 02/08/22 to the 09/08/22 – hope someone will be in the office to take care of the parcel. Kind regards; Ketty

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

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From: BAUTZ Ketty Sent: mercredi 27 juillet 2022 11:51 To: 'Signe Leito' <[email protected]> Subject: Aripiprazole Generics Programme- Shipment and current status Dear Signe, I hope you are doing well. I come back to you regarding the sampling status of the Aripirprazole generics programme. The following reference substances – that were requested for the feasibility study – are still not yet available:

NAME

Impurity-1: 7-hydroxy-3, 4-dihydroquinolin-2(1H)-one

Impurity-2: 1-(2, 3-dichlorophenyl) Piperazine Hydrochloride

Impurity-3: 7-[4-(4-(2, 3-dichlorophenyl)-1-oxy-piperazin-1-yl)butoxy]-3, 4-dihydro-2-(1H)-quinolinone(N oxide impurity)

Aripiprazole Working standard

Placebo

Aripiprazole Zentiva, 5 mg, Tablet

Despite several reminders/emails sent to the MAH, nothing was received until now. The same for the ARIPIPRAZOLE ACCORD, 15 mg, Tablet sample – CTS from Accord – despite several requests, the samples still haven’t been received. The MAH says it’s ongoing, but this is the status that is given since months… I would suggest to start the analysis without these samples, if this is feasible for you (especially regarding the missing substances from Zentiva).

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I would like to send you the samples as of next week, if this is fine for you. We can start the clock later on – but at least samples would be in your premises. Hope this is fine for you. In order to prepare the RDS, I would need the testing protocol. For information, this is the list of samples that are going to be sent to you:

EDQM N°1 DATE OF ARRIVAL

EDQM NUMBER

NAME

SFE415040 14/03/2022 DBO415171 Abilify, 15 mg, Tablet - CTS A

SFE415337 24/03/2022 DBO415401 Abilify, 5 mg, Tablet - Sample A

SFE415250 18/03/2022 DBO415264 Abilify, 15 mg, Tablet - Sample B

SFE415373 30/03/2022 DBO415448 Abilify, 30 mg, Tablet - Sample C

SFE415327 25/03/2022 DBO415396 ARIPIPRAZOLE MYLAN PHARMA, 15 mg, Tablet - CTS B

SFE415263 22/03/2022 DBO415402 ARIPIPRAZOLE MYLAN PHARMA, 5 mg, Tablet - Sample D

SFE415619 13/04/2022 DBO415706 ARIPIPRAZOLE MYLAN PHARMA, 15 mg, Tablet - Sample E

SFE415017 10/03/2022 DBO415098 ARIPIPRAZOLE MYLAN PHARMA, 30 mg, Tablet - Sample F

SFE415522 08/04/2022 DBO415637 ARIPIPRAZOLE SANDOZ, 15 mg, Tablet - CTS C

SFE416373 10/06/2022 DBO416530 ARIPIPRAZOLE SANDOZ, 5 mg, Tablet - Sample G

N/A N/A N/A ARIPIPRAZOLE SANDOZ, 15 mg, Tablet - Sample H

SFE416091 23/05/2022 DBO416155 ARIPIPRAZOLE SANDOZ, 30 mg, Tablet - Sample I

SFE415470 06/04/2022 DBO415555 ARIPIPRAZOLE ZENTIVA, 15 mg, Tablet - CTS D

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SFE415177 18/03/2022 DBO415253 ARIPIPRAZOLE ZENTIVA, 5 mg, Tablet - Sample J

SFE415486 07/04/2022 DBO415639 ARIPIPRAZOLE ZENTIVA, 15 mg, Tablet - Sample K

ARIPIPRAZOLE ACCORD, 15 mg, Tablet - CTS E

SFE416396 13/06/2022 DBO416531 ARIPIPRAZOLE ACCORD, 5 mg, Tablet - Sample M

ARIPIPRAZOLE ACCORD, 15 mg, Tablet - Sample N

SFE414900 04/03/2022 DBO415097 ARIPIPRAZOLE ACCORD, 30 mg, Tablet - Sample O

Kind regards, Ketty

From: Signe Leito <[email protected]> Sent: mercredi 18 mai 2022 16:06 To: EDQM Dispatch <[email protected]> Cc: BAUTZ Ketty <[email protected]> Subject: Shipment # 0080508780 received Dear Dispatch Unit, This is to inform you, that we received the parcel today. Please find attached the Acknowledgment of Receipt and the report of the temperature recorder Libero CB. With best regrads, Signe Leito Leading Specialist of Quality Control Laboratory State Agency of Medicines [email protected] 1 Nooruse Street 50411 Tartu Estonia Phone: +372 737 4140 www.ravimiamet.ee

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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 ekirja eksituse tõttu, teavitage sellest kohe 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.

Saatja: EDQM Dispatch <[email protected]> Saatmisaeg: esmaspäev, 16. mai 2022 17:14 Adressaat: Signe Leito <[email protected]>; [email protected]; [email protected] Teema: ECH: Prior to Dispatch Notif # 0080508780

Dear Sir/Madame, Please note we are going to send the samples related to the request of Ketty BAUTZ about Aripiprazole Generics programme. You will find enclosed all the details of the parcel and the Acknowledgment of Receipt that will have to be completed at receipt of the parcel. A hard copy will also be attached to the parcel. As soon as the parcel will be sent, you will receive a dispatch notification with the tracking number or AWB to follow the parcel. P.S.: Please let us know asap if your premises are closed in the next few days so we will reschedule the shipment. Kind regards, Dispatching Section Council of Europe, European Directorate for the Quality of Medicines & HealthCare (EDQM) 7, allée Kastner CS 30026 F- 67081 Strasbourg (FRANCE) Tel. : +33 (0)3 88 41 30 30 Fax : +33 (0)3 88 41 27 71 www.edqm.eu and www.edqm.eu/hd (helpdesk)

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