Transparency

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

Retrieved on:

星期四, 四月 18, 2024

Steps, Union, Patient, CTD, Syndrome, CCI, Local, Disclosure, Toxicity, Process validation, MAH, Clinical trial, IP, RMP, Pharmacovigilance, Cell, Legislation, Annex, Trial of the century, Escherichia coli, Safety, Pediatrics, INTRODUCTION, Documentation, Prevalence, Vital signs, Tablet, Design, Transparency, Conclusion, Pip, Analysis, European Parliament, INN, Record, Quality, Generic, Biology, CMO, Genotoxicity, Composition, CTIS, Uncontrolled, Health care, European Medicines Agency, Prejudice, Committee, Policy, HCP, Animal, Characterization, Cell bank, Fertility, IRB, CMOS, Risk management, Private law, European Pharmacopoeia, Telephone, Research, Good, Data Protection Directive, Ampere-hour, IEC, QP, Human, Personal data, Labelling, Bibliography, Figure, MAA, R4, Institutional review board, Elucidation, Marketing, M4, ChromeOS, Contract research organization, Mental, Impairment, Toxicokinetics, NCA, Independent, Metabolite, Drug, Risk, Metabolism, GMO, Organ, EMA, Common Technical Document, General Data Protection Regulation, Confidentiality, PPD, PI, Language, DRUG, Privacy, Result, Claimed, Medication, Comparison, Ethics, Drive, PD, Narrative, EEA, Developmental toxicity, Saccharomyces cerevisiae, Pharmacopoeia, PIP, MCB, HMA, Physical chemistry, Midol, Particle size, Council, GCP, European Economic Area, Draft, Fermentation, Overview, Justification, Control, Dicarboxylic acid, Pharmacology, WCB, Expert, Immunogenicity, Data, Study, Publication, European, ICH, Element, Analytical procedures (finance auditing), Name, Common, Guideline, Exceptional circumstances, ID, Liver, Chin Na, Toxicology, Protein primary structure, Immunosuppressive drug, Vaccine

Key Points:

See websites for contact details
Heads of Medicines Agencies www.hma.eu
European Medicines Agency www.ema.europa.eu
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Table of contents

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Abbreviations .............................................................................................. 3

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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
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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
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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).
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The applicant remains responsible for compliance with the relevant legislation in cases where such data

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is inadvertently included in the MAA dossier.
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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
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undermined should be foreseeable and not purely hypothetical.
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Information that is already in the public domain is not considered to be commercially confidential.
Information on the Quality and Manufacturing of medicines
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A general principle regarding quality and manufacturing information is that detailed information could

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be considered commercially confidential but general information should be disclosed.
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In general, and if not in the public domain, the names of manufacturers or suppliers of the active

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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

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not commercially confidential.
General information on the fermentation and purification process
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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

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not commercially confidential.
In general, the data included in clinical trial study reports is considered to be data that can be
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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

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333

339

(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) agreements

principal investigator

Study Reports
5.3.3.3

as 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
5.3.5.4

Other Clinical Study Reports

5.3.6

Reports of Post-Marketing
Experience

5.3.7

Direct identifiers such as name,
signature, contact details, etc.

Fuller, Smith & Turner PLC: Total Voting Rights and Treasury Shares

Retrieved on:

星期三, 四月 10, 2024

Transparency, Disclosure, FCA, Financial adviser

Key Points:

The following notification is made in accordance with the UK Financial Conduct Authority Disclosure and Transparency Rule 5.6.1.
As at 31 March 2024, the Company’s issued share capital consisted of 41,182,339 ‘A’ Ordinary Shares of 40 pence each, 89,052,625 ‘B’ Ordinary Shares of 4 pence each, and 13,366,013 ‘C’ Ordinary Shares of 40 pence each, each carrying one vote.
Of this total, 4,143,691 ‘A’ Ordinary Shares and 4,327,915 ‘B’ Ordinary Shares are held in treasury.
Therefore, the total number of listed voting rights in the Company for the purpose of Disclosure and Transparency Rule 5.6.1 (calculated in accordance with Disclosure and Transparency Rule 5.6.2) as at 31 March 2024 was 37,038,648.

Fuller, Smith & Turner PLC: Transaction in own securities - conclusion and extension of buyback programme

Retrieved on:

星期三, 四月 10, 2024

FSA, Transparency, Disclosure

Key Points:

The Company intends to hold the repurchased shares in Treasury.
Following the purchase of the said shares, Fuller’s listed issued share capital consists of 41,082,339 Ordinary Shares.
Of this total, 4,125,905 Ordinary Shares are held in treasury.
Therefore, the total number of listed voting rights in the Company for the purpose of Disclosure and Transparency Rule 5.6.1 (calculated in accordance with Disclosure and Transparency Rule 5.6.2) is 37,056,434.

Fuller, Smith & Turner PLC: Transaction in own shares

Retrieved on:

星期三, 四月 10, 2024

Transparency, Disclosure, FCA, Security (finance)

Key Points:

The Company intends to hold the repurchased shares in Treasury.
Following the purchase of the said shares, Fuller’s listed issued share capital consists of 41,182,339 ‘A’ ordinary shares of 40p each.
Of this total, 4,183,836 A’ ordinary shares are held in treasury.
Therefore, the total number of listed voting rights in the Company for the purpose of Disclosure and Transparency Rule 5.6.1 (calculated in accordance with Disclosure and Transparency Rule 5.6.2) is 36,998,503.

Fuller, Smith & Turner PLC: Transaction in own shares

Retrieved on:

星期三, 四月 10, 2024

Transparency, Disclosure, FCA, Security (finance)

Key Points:

The Company intends to hold the repurchased shares in Treasury.
Following the purchase of the said shares, Fuller’s listed issued share capital consists of 41,182,339 ‘A’ ordinary shares of 40p each.
Of this total, 4,064,417 A’ ordinary shares are held in treasury.
Therefore, the total number of listed voting rights in the Company for the purpose of Disclosure and Transparency Rule 5.6.1 (calculated in accordance with Disclosure and Transparency Rule 5.6.2) is 37,117,922.

Fuller, Smith & Turner PLC: Transaction in own shares

Retrieved on:

星期三, 四月 10, 2024

Transparency, Disclosure, FCA, Security (finance)

Key Points:

The Company intends to hold the repurchased shares in Treasury.
Following the purchase of the said shares, Fuller’s listed issued share capital consists of 41,182,339 ‘A’ ordinary shares of 40p each.
Of this total, 4,095,192 A’ ordinary shares are held in treasury.
Therefore, the total number of listed voting rights in the Company for the purpose of Disclosure and Transparency Rule 5.6.1 (calculated in accordance with Disclosure and Transparency Rule 5.6.2) is 37,087,147.

Fuller, Smith & Turner PLC: Transaction in own shares

Retrieved on:

星期三, 四月 10, 2024

Transparency, Disclosure, FCA, Security (finance)

Key Points:

The Company intends to hold the repurchased shares in Treasury.
Following the purchase of the said shares, Fuller’s listed issued share capital consists of 41,182,339 ‘A’ ordinary shares of 40p each.
Of this total, 4,065,192 A’ ordinary shares are held in treasury.
Therefore, the total number of listed voting rights in the Company for the purpose of Disclosure and Transparency Rule 5.6.1 (calculated in accordance with Disclosure and Transparency Rule 5.6.2) is 37,117,147.

Fuller, Smith & Turner PLC: Transaction in own shares

Retrieved on:

星期三, 四月 10, 2024

Transparency, Disclosure, FCA, Security (finance)

Key Points:

The Company intends to hold the repurchased shares in Treasury.
Following the purchase of the said shares, Fuller’s listed issued share capital consists of 41,182,339 ‘A’ ordinary shares of 40p each.
Of this total, 4,141,163 A’ ordinary shares are held in treasury.
Therefore, the total number of listed voting rights in the Company for the purpose of Disclosure and Transparency Rule 5.6.1 (calculated in accordance with Disclosure and Transparency Rule 5.6.2) is 37,041,176.

Fuller, Smith & Turner PLC: Transaction in own shares

Retrieved on:

星期三, 四月 10, 2024

Transparency, Disclosure, FCA, Security (finance)

Key Points:

The Company intends to hold the repurchased shares in Treasury.
Following the purchase of the said shares, Fuller’s listed issued share capital consists of 41,182,339 ‘A’ ordinary shares of 40p each.
Of this total, 4,163,836 A’ ordinary shares are held in treasury.
Therefore, the total number of listed voting rights in the Company for the purpose of Disclosure and Transparency Rule 5.6.1 (calculated in accordance with Disclosure and Transparency Rule 5.6.2) is 37,018,503.

Fuller, Smith & Turner PLC: Transaction in own shares

Retrieved on:

星期三, 四月 10, 2024

Transparency, Disclosure, FCA, Security (finance)

Key Points:

The Company intends to hold the repurchased shares in Treasury.
Following the purchase of the said shares, Fuller’s listed issued share capital consists of 41,182,339 ‘A’ ordinary shares of 40p each.
Of this total, 4,110,192 A’ ordinary shares are held in treasury.
Therefore, the total number of listed voting rights in the Company for the purpose of Disclosure and Transparency Rule 5.6.1 (calculated in accordance with Disclosure and Transparency Rule 5.6.2) is 37,072,147.