European Parliament
Press release - Carbon removals: MEPs adopt a new EU certification scheme
- Certification framework to boost high-quality carbon removals and counter greenwashing
- - Certification framework to boost high-quality carbon removals and counter greenwashing
- New rules will enable farmers to get paid to remove carbon
- Public EU registry to ensure transparency
The law will set up an EU certification framework for carbon removals to boost their uptake and help achieve EU climate neutrality by 2050. - Parliament on Wednesday adopted the provisional political agreement with EU countries on a new voluntary certification framework for carbon removals, with 441 votes in favour, 139 against and 41 abstentions.
- The legislation covers different types of carbon removals, namely permanent carbon storage through industrial technologies, carbon storage in long-lasting products and carbon farming.
- You can read more about the new rules in the press release after the deal with EU countries.
Press release - “Parliament 2024”: a more modern and efficient Parliament after the elections
The new internal rules will strengthen Parliament’s working methods, its institutional role, and its capacity to act.Committee on Constitutional Affairs Source : © European Union, 2024 - EP
The new internal rules will strengthen Parliament’s working methods, its institutional role, and its capacity to act.Committee on Constitutional Affairs Source : © European Union, 2024 - EP
Press release - Discharge: MEPs sign off EU budget for 2022
The European Parliament on Thursday granted discharge to the Commission, all decentralised agencies and the development funds.Committee on Budgetary Control Source : © European Union, 2024 - EP
The European Parliament on Thursday granted discharge to the Commission, all decentralised agencies and the development funds.Committee on Budgetary Control Source : © European Union, 2024 - EP
Press release - 2024 LUX European Audience Film Award: press conference with the winner
2024 LUX European Audience Film Award: press conference with the winner
- 2024 LUX European Audience Film Award: press conference with the winner
A press conference with a representative of the 2024 LUX Award winner will take place on Tuesday, after the announcement at the award ceremony. - When: 16 April at 19.15 CET
Where: Parliament’s Anna Politkovskaya press conference room in Brussels (SPAAK 0A50)
Participants: representative of the winning film, EP Vice-President Evelyn Regner (S&D, AT) and Honorary President of the LUX European Audience Film Award and Chair of the European Film Academy, Mike Downey
How: Accredited media representatives can attend the press conference physically. - Journalists who have never used Interactio before are asked to connect 30 minutes before the start of the press conference to perform a connection test.
- The award ceremony
The ceremony will start at 18.00 in the Hemicycle of the European Parliament in Brussels.
Press release - “The Teachers’ Lounge” wins the LUX Audience Award 2024
“The Teachers’ Lounge” wins the LUX Audience Award 2024
- “The Teachers’ Lounge” wins the LUX Audience Award 2024
“The Teachers’ Lounge” by German director Ilker Çatak won the 2024 LUX European Audience Film Award on Tuesday, in a ceremony in Parliament’s hemicycle in Brussels. - The film, produced in Germany, tells a story about Carla, a young high school teacher, distinguished from her colleagues by her idealism.
- When a series of unsolved thefts sour the atmosphere among the teaching staff, Carla decides to investigate.
- Press conference and related events
You can watch the press conference with the winner Evelyn Regner and Mike Downey after the ceremony on EbS and EP Live.
Press release - Geopolitical situation makes voting in European elections even more important
The European Parliament’s last Eurobarometer survey before the elections in June reveals awareness among citizens and concern for the current geopolitical context. Source : © European Union, 2024 - EP
The European Parliament’s last Eurobarometer survey before the elections in June reveals awareness among citizens and concern for the current geopolitical context. Source : © European Union, 2024 - EP
Press release - European Parliament Press Kit for the Special European Council of 17 and 18 April 2024
In this press kit, you will find a selection of the European Parliament’s press releases reflecting MEPs’ priorities for topics on the summit agenda. Source : © European Union, 2024 - EP
In this press kit, you will find a selection of the European Parliament’s press releases reflecting MEPs’ priorities for topics on the summit agenda. Source : © European Union, 2024 - EP
Press release - EP President Metsola at EUCO: The Single Market is Europe’s greatest economic driver
Doubling down on the Single Market ensures Europe’s long-term competitiveness, prosperity and leadership on the global stage, said President Metsola at the Special European Council. Source : © European Union, 2024 - EP
Doubling down on the Single Market ensures Europe’s long-term competitiveness, prosperity and leadership on the global stage, said President Metsola at the Special European Council. Source : © European Union, 2024 - EP
Draft revised Heads of Medicines Agency / European Medicines Agency guidance document on the identification of personal data and commercially confidential information within the structure of the marketing authorisation application dossier
See websites for contact details
- See websites for contact details
Heads of Medicines Agencies www.hma.eu
European Medicines Agency www.ema.europa.eu11
Table of contents
12
Abbreviations .............................................................................................. 3
13
Definitions ................................................................................................... 4
14
1.
- redaction, masking,
68
hiding) in such a manner that the recipient can no longer attribute the resulting information to a data
69
subject and make it identifiable.
- 81
Contract Manufacturing Organisation (CMO): shall mean an arrangement under which a
82
manufacturer provides upstream manufacturing services under contract on behalf of third-party
83
pharmaceutical companies.
- 94
Protected Personal Data (PPD): shall mean any personal data which should be protected from
95
disclosure.
- ?Finalised? shall mean that the marketing
102
authorisation (MA) has been granted or refused or that the MAA has been withdrawn.
- The application of the general principles laid down in this guidance is without prejudice to
106
national rules on transparency.
- The guidance should be read in conjunction with the relevant applicable
107
legislation and case law on transparency and data protection.
- 117
This guidance document is intended to apply to information/documents on medicinal products for
118
human use, for which the procedure has been finalised under the national, mutual recognition,
119
decentralised and centralised procedures.
- Third
124
parties shall be informed or consulted as needed depending on respective national and European legal
125
frameworks.
- 140
In the following sections, the agreed principles on PD and CCI are presented, including guidance on
141
whether such information can be disclosed.
- EMA/131365/2024
Page 5/50
142
Any information identified as PD or CCI must be subject to a preliminary review by the EMA/NCA prior
143
to the possible disclosure of the information/documents.
- Principles on the protection of personal data (PD)
145
The protection of PD is enshrined in EU legislation; it is a fundamental right of EU citizens.
- In
146
compliance with the applicable European/national legislation, PD should be anonymised in order to
147
avoid the disclosure of the document undermining the privacy and integrity of any individual.
- EMA/NCA applies a risk-based approach to assess which PD elements are to be
152
removed from the information/documents in order to limit the risk of re-identification.
- are included in the MAA dossier because they have a legally
164
defined role or responsibility and it is in the public interest to disclose this data.
- 168
Applicants are advised that non-essential information (e.g., personal address, personal phone number)
169
should not be included in the MAA dossier.
- The
183
confidentiality of records that could identify subjects should be protected, respecting the privacy and
184
confidentiality rules in accordance with the applicable regulatory requirement(s).
- 185
The applicant remains responsible for compliance with the relevant legislation in cases where such data
186
is inadvertently included in the MAA dossier.
- 188
EMA/NCA applies a risk-based approach to assess which personal data elements need to be removed
189
from the information/documents in order to limit the risk of re-identification.
- 194
EMA/NCA applies a risk-based approach to assess which personal data elements need to be removed
195
from the information/documents in order to limit the risk of re-identification.
- 205
Any proposal to consider information as commercially confidential should be properly justified by the
206
owner of the information.
- In this respect, any reference(s) to the risk of that interest being
209
undermined should be foreseeable and not purely hypothetical.
- 210
Information that is already in the public domain is not considered to be commercially confidential.
- Information on the Quality and Manufacturing of medicines
226
A general principle regarding quality and manufacturing information is that detailed information could
227
be considered commercially confidential but general information should be disclosed.
- 234
In general, and if not in the public domain, the names of manufacturers or suppliers of the active
235
substance or the excipients are considered commercially confidential.
- 248
A general description of the type of test methods used and the appropriateness of the specification is
249
not commercially confidential.
- General information on the fermentation and purification process
259
is not commercially confidential, although details including operating parameters and specific material
260
requirements are commercially confidential.
- 273
A general description of the type of test methods used and the appropriateness of the specification is
274
not commercially confidential.
- In general, the data included in clinical trial study reports is considered to be data that can be
283
disclosed once PD has been anonymised.
- 338
In each module, a non-exhaustive list of information that may be considered protected personal data (PPD) or commercially confidential information
332
333339
(CCI) is included.
- ?
Direct contact details such as telephone
Therefore, please refer to the appropriate sub-
number, fax number, email, postal address,
modules hereafter for guidance.
- ?
Information that may reveal strategic
(contractual) agreements?
Any quality information on the clinical batches
principal investigator
that might be included here (such as e.g.
- ?
Information that may reveal strategic
(contractual) agreementsprincipal investigator
Study Reports
5.3.3.3as the evaluation of new formulation, innovative
number, fax number, email, postal
Paediatric Development Plan (PIP), etc.
- This may include taking into
More Than One Study
5.3.5.4Other Clinical Study Reports
5.3.6
Reports of Post-Marketing
Experience5.3.7
Direct identifiers such as name,
signature, contact details, etc.