From:
(SANTE)
Sent:
vendredi 5 février 2021 16:12
To:
(SANTE)
Cc:
(SANTE)
Subject:
FW: NIP - Discussion with EFPIA
Attachments:
EFPIA issues for meeting with DG Sante (5 February
2021).docx
,
From Sante the participants were:
.
The industry representatives welcome the EU-UK TCA and happy to have the annex on medicines,
however they are disappointed to see that it does not include the batch testing. They also pointed out
that the COM BREXIT notice is helpful however there are stil technical issues as regards the
implementation of the Notice that is challenging.
The technical issues raised were related to:
The deletion of the UK batch release sites during 12-month phase-in period:
To this DG SANTE explained the COM BREXIT Notice and informed that MS are also further discussing
thiss aspects in the CMDh and there would be an update of the CMDh practical guidance. DG SANTE
inquired how many sites and products are concerned? Industry informed that they do not have the
information at hand, however they wil further inquire this.
Location of MAH for Marketing Authorisations which include Northern Ireland
within their scope: clarification needed on implementation by end of 2020 in order
to avoid delays in applications and subsequent supply of medicines.
DG Sante explained the framework rules and the explaiantions given in the previsous COM BREXIT
guidances or EMA or CMDh practical guidances on this issues. DG Sante inquired how many products or
sites are concerned? Industry could not reply to this question however they wil further inquire about
this and let us know. Industry underlined that they face challenges how to move the MAHs from GB.
Lack of MHRA access to EMA Common Repository and CESP: duplication of
effort/resources.
DG Sante explained the framework about the access given to the UK to the EU EMA Databases and the
COM Decision is implementing the NI Protocol and took note of the issue raised by the industry.
In addition, industry raised the fact that beyond BREXIT they have experienced that the requirements
for the import licenses requirements are not harmonized between MS.
DG Sante invited the industry to raise the issues with the MS or via the IWG stakeholders meetings. In
case these issues relate to the customs issues then these should be discussed with the MS customs
authorities or the DG Taxud.
As regards the application of the COM Brexit Notice, industry informed that the timeframe given until
the end of 2021 is helpful, however there are some outstanding issues as practical issues related to the
supply in the NI and QC testing. Industry is looking to find alternative supply routes to NI. Industry
inquired whether en extension could be possible, however from DG SANTE side we could not reply at
such a political question at our technical level.
In case you would like to add something else, just let me know.
Thank you, best wishes,
From:
@efpia.eu>
Sent: Tuesday, February 2, 2021 3:02 PM
To:
(SANTE) <
@ec.europa.eu>
Cc:
@efpia.eu>;
(SANTE) <
@ec.europa.eu>
Subject: Re: NIP - Discussion with EFPIA
Leopold Plaza Building
Rue du Trône 108
B-1050 Bruxelles
Dear
Thank you for your email.
will organise a meeting.
Kind regards,
From:
@efpia.eu>
Sent: Tuesday, January 19, 2021 8:34 AM
To:
(SANTE)
@ec.europa.eu>
Cc:
@efpia.eu>
Subject: NIP - Discussion with EFPIA
Leopold Plaza Building
Rue du Trône 108
B-1050 Bruxelles
Tel: +32 (0) 2 626.25.55 (Switchboard)