Composition

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Table of contents

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

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Definitions ................................................................................................... 4

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1.

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hiding) in such a manner that the recipient can no longer attribute the resulting information to a data

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subject and make it identifiable.

Contract Manufacturing Organisation (CMO): shall mean an arrangement under which a

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manufacturer provides upstream manufacturing services under contract on behalf of third-party

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pharmaceutical companies.

Protected Personal Data (PPD): shall mean any personal data which should be protected from

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disclosure.

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authorisation (MA) has been granted or refused or that the MAA has been withdrawn.

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national rules on transparency.

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legislation and case law on transparency and data protection.

This guidance document is intended to apply to information/documents on medicinal products for

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human use, for which the procedure has been finalised under the national, mutual recognition,

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decentralised and centralised procedures.

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parties shall be informed or consulted as needed depending on respective national and European legal

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frameworks.

In the following sections, the agreed principles on PD and CCI are presented, including guidance on

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whether such information can be disclosed.

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Any information identified as PD or CCI must be subject to a preliminary review by the EMA/NCA prior

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to the possible disclosure of the information/documents.

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The protection of PD is enshrined in EU legislation; it is a fundamental right of EU citizens.

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compliance with the applicable European/national legislation, PD should be anonymised in order to

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avoid the disclosure of the document undermining the privacy and integrity of any individual.

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removed from the information/documents in order to limit the risk of re-identification.

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defined role or responsibility and it is in the public interest to disclose this data.

Applicants are advised that non-essential information (e.g., personal address, personal phone number)

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should not be included in the MAA dossier.

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confidentiality of records that could identify subjects should be protected, respecting the privacy and

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confidentiality rules in accordance with the applicable regulatory requirement(s).

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.

EMA/NCA applies a risk-based approach to assess which personal data elements need to be removed

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from the information/documents in order to limit the risk of re-identification.

EMA/NCA applies a risk-based approach to assess which personal data elements need to be removed

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from the information/documents in order to limit the risk of re-identification.

Any proposal to consider information as commercially confidential should be properly justified by the

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owner of the information.

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undermined should be foreseeable and not purely hypothetical.

Information that is already in the public domain is not considered to be commercially confidential.

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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.

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.

A general description of the type of test methods used and the appropriateness of the specification is

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not commercially confidential.

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is not commercially confidential, although details including operating parameters and specific material

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requirements are commercially confidential.

A general description of the type of test methods used and the appropriateness of the specification is

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not commercially confidential.

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disclosed once PD has been anonymised.

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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(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.

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.