Retained EU Law SI 2006/816 United Kingdom

Regulation (EC) No 816/2006 of the European Parliament and of the Council of 17 May 2006 on compulsory licensing of patents relating to the manufacture of pharmaceutical products for export to countries with public health problems

Status
In Force
Penalty ceiling
Regulated

Does it bind you?

Business-side roles with duties under this instrument.

Licence Holder1

Plus 2 duties on the regulator, Crown ministers and public bodies — folded into the section list below.

Other Acts binding the same actors

If a role above is yours, these are the other instruments that most often bind it.

Licence Holder — also bound by 225 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.art010 Compulsory licence conditions Regulated
  • Label products made under compulsory licence and post supply details onlineLicence Holder
s.art014 Action by customs authorities Regulated
Other duties (1) — Crown / regulator
  • Customs authorities must detain suspected illicit pharmaceutical imports and notify all partiesCrown / Minister / Government department
s.art016 Termination or review of the licence Regulated
Other duties (1) — Crown / regulator
  • Competent authority must review compulsory licence conditions on requestCrown / Minister / Government department
17 other provisions — procedural and definitional
s.art001 Scope
s.art002 Definitions
s.art003 Competent authority
s.art004 Eligible importing countries
s.art005 Extension to least-developed and developing countries which are not members of the WTO
s.art006 Application for a compulsory licence
s.art007 Rights of the rights-holder
s.art008 Verification
s.art009 Prior negotiation
s.art011 Refusal of the application
s.art012 Notification
s.art013 Prohibition of importation
s.art015 Personal luggage exception
s.art017 Appeals
s.art018 Safety and efficacy of medicinal products
s.art019 Review
s.art020 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.