Telephone

11

Table of contents

12

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

13

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

14

1.

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.

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.

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

95

disclosure.

102

authorisation (MA) has been granted or refused or that the MAA has been withdrawn.

106

national rules on transparency.

107

legislation and case law on transparency and data protection.

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.

124

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

125

frameworks.

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

141

whether such information can be disclosed.

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.

145

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

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.

152

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

164

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)

169

should not be included in the MAA dossier.

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).

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

186

is inadvertently included in the MAA dossier.

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.

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.

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

206

owner of the information.

209

undermined should be foreseeable and not purely hypothetical.

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

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.

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.

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

249

not commercially confidential.

259

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

260

requirements are commercially confidential.

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

274

not commercially confidential.

283

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

332
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.

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.