- Status
- In Force
- Penalty ceiling
- Regulated
Does it bind you?
Business-side roles with duties under this instrument.
Any Person5
Manufacturer2
Client1
Contractor1
Other Acts binding the same actors
If a role above is yours, these are the other instruments that most often bind it.
Any Person — also bound by 2684 other Acts
Human Medicines Regulations 2012
184 duties
Merchant Shipping Act 1995
144 duties
Insolvency (England and Wales) Rules 2016
104 duties
Communications Act 2003
92 duties
Road Traffic Act 1988
92 duties
Manufacturer — also bound by 551 other Acts
Measuring Instruments Regulations 2016
85 duties
Human Medicines Regulations 2012
75 duties
Client — also bound by 63 other Acts
Building Regulations 2010
12 duties
Contractor — also bound by 171 other Acts
What it requires
Regulations creating concrete business duties or carrying penalties, grouped as the instrument is structured. Titles link to the source text — blue means you’re leaving for legislation.gov.uk.
s.art004
Technical expertise
Regulated
- Provide written declaration of technical expertise to manufacturer/importerAny Person
s.art005
Availability of the primary repository
Regulated
- Guarantee 99.5% monthly uptime and back up primary repositoryAny Person
s.art008
Legal and financial independence
Regulated
- Issue written legal and financial independence declaration with data storage contractContractor
s.art010
Information security management
Regulated
- Ensure data storage contracts require information security standards declarationClient
s.art014
Communication with other parties
Regulated
- Data storage providers must cooperate with each other and authoritiesAny Person
s.art015
Audits
Regulated
- Include audit and access clauses in tobacco traceability data storage contractsAny Person
s.art017
Termination of contract
Regulated
- Set termination terms in storage contracts; end immediately on serious breachManufacturer
s.art018
Suspension of services
Regulated
- Include no-suspension-for-late-payment clause in storage contractManufacturer
s.art019
Data portability
Regulated
- Ensure data portability when switching primary repository providersAny Person
12 other provisions — procedural and definitional
s.art001
Subject matter
s.art002
Definitions
s.art003
Key responsibilities under the contract
s.art006
Access rights
s.art007
Sub-contracting
s.art009
Data protection and confidentiality
s.art011
Costs
s.art012
Participation in secondary repository system
s.art013
Duration
s.art016
Liability
s.art020
Applicable law and jurisdiction
s.art021
Entry into force
Duty extraction and severity labels are Guvnor’s analysis of the instrument, not the instrument itself. Always verify against the linked source text.