From:
(TRADE)
Sent:
jeudi 1 octobre 2020 12:07
To:
(EMA); VGTO (
;
@efpia.eu';
@novonordisk.com';
@danskerhverv.dk';
@efpia.eu';
@efpia.eu';
@efpia.eu';
'
@efpia.eu';
(SANTE);
(TRADE);
(TRADE);
(TRADE);
(TRADE);
(TRADE);
(SANTE)
Cc:
EEAS-TOKYO);
(EEAS-TOKYO)
Subject:
Meeting 28-09-2020 between European Commission, Danish
Chamber of Commerce and Novo Nordisk
Attachments:
Meeting with the EU Commission 28092020
VGTO_STPE_Bremerskov.pptx
Dear participants,
Once again, I would like to thank you for attending the meeting on Monday. We hope that the
discussion allowed to shed some light on the issue amongst all present participants.
I take this opportunity to summarize the discussion and outline the next steps. I also attach the
presentation kindly shared by
Summary of the discussion:
- EFPIA, the Danish Chamber of Commerce and Novo Nordisk raised concerns about repeated
unnecessary and duplicate paper based and possibly on-site inspections by the Japanese competent
health authorities (MHLW/PMDA), notably in Denmark but possibly also in other MS.
- In order to ensure fol ow up and also with the view to identify practices that would qualify as violations
of the MRA, the Commission reiterated its request to industry to share concrete examples of duplication
of approval procedures and excessive demands.
- Based on the description of the situation by the participants of the meeting, there seems to be
different assessment/inspection practices between the regulators of the two parties. This could explain
the claim by the industry of an absence of reciprocity and the important request of additional
documents during a Japanese paper-based inspection in comparison with Danish inspection.
- Industry has provided the attached presentation to be shared with the Japanese authorities (PMDA,
etc.) through the kind assistance of Kishioka-san, liaison officer at EMA who will liaise with
MHLW/PMDA and wil discuss the matter based on concrete examples.
explained during
the meeting that the text of the MRA was clearly restricted to on-site inspections (Article 2 d of the
sectoral annex). As for the objective of the paper based inspection, he explained that even when a GMP
certificate by MRA partner exists, it may link to a po
includes the assessment of the control of a specific product in addition to other aspects such as
equipment, utilities and facilities, and system.
-MHLW/PMDA wil look into the elements provided in the attached presentation and pget back to the
Commission with additional comments. Based on the information provided above by MHLW/PMDA and
additional information on the concrete examples the industry has been asked to provide, the
Commission wil then determine the best way of procee
concerns.
Best regards,
European Commission
DG Trade - Unit C1 - Far East Asia
Rue de la Loi, 170 - 1000 Brussels/Belgium
+32