This snapshot, taken on 05/01/2004, shows web content selected for preservation by The National Archives. External links, forms and search boxes may not work in archived websites.
UK Biotechnology Regulatory Atlas - Home Route Planner Route Planner Map A Map B Map C Map D Map E Map F Map G Map H Map I i-bio logo

Questions
Index

This page consists of a list of every question posed throughout the Biotechnology Atlas.
Click on a question to be taken through to the appropriate Checkpoint.
[Contents]
[Introduction]
[Abbreviations]
[Contact Points]
[Questions Index]
[Disclaimers]
[Purchase]
 
 
 
A | B | C1 | C2 | C3 | C4 | D | E | F1 | F2 | F3 | G1 | G2 | G3 | H | I1 | I2 | I3
  • A1
 What is at issue, and is the Government aware?

  
  • A2
 How are strategic issues in human genetics being tackled?

  
  • A3
 How are strategic agriculture and environment issues being tackled?

  
  • A4
 Is there a global strategy to improve biosafety?

  
  • A5
 Will biotechnology operators have to make amends for any environmental damage?

  
  • A6
 How are strategic issues in food safety being tackled?

  
  • A7
 How can I get involved in strategic debate and decision making?

  
  back to top
  • B1
 Why patent?

  
  • B2
 What are the principal laws that apply to biotechnology patents?

  
  • B3
 Which official bodies are responsible for the patenting process?

  
  • B4
 Is my invention patentable?

  
  • B5
 Are there any special requirements for patenting micro-organisms?

  
  • B6
 Are there different procedures for protecting novel plant varieties?

  
  • B7
 What about human material?

  
  • B8
 How can I avoid infringing existing patents?

  
  • B9
 How is international patent law and procedure organised?

  
  • B10
 What is changing in the world of patent law?
  
  back to top
  • C1.1  
 Which laws apply generally to technological operations?

  
  • C1.2
 Are there special requirements for work with oncogenes?

  
  • C1.3

Which regulations apply specifically to biological agents?

  
  • C1.4
 Which national advisory body covers biological agents?

  
  • C1.5
 How have the 2002 Regulations improved the control of biological agents?

  
  • C1.6
 What guidance is available to help me comply with COSHH?

  
  back to top
  • C2.1  
 Which laws apply?

  
  • C2.2
 Which bodies administer and enforce the law?

  
  • C2.3
 Are there alternatives to the use of animals?

  
  • C2.4
 How can I obtain a certificate of designation?

  
  • C2.5
 How can I obtain a project licence?

  
  • C2.6
 How can I obtain a personal licence?

  
  • C2.7
 What will be required of me during the work?

  
  • C2.8
 Are the laws and procedures likely to change?

  
  back to top
  • C3.1  
 Which laws apply?

  
  • C3.2
 What controls have been introduced to prevent overt misuse?

  
  • C3.3
 What is the scope of new controls affecting bona fide biotechnology activities?

  
  • C3.4
 What new duties have been imposed affecting those involved in bona fide biotechnology activities?

  
  • C3.5
 How are international measures against bioterrorism likely to develop?

  
  back to top
  • C4.1  
 What controls apply to the transport of biotechnology resources and products?

  
  • C4.2
 What controls apply to the import of biotechnology resources and products?

 
  • C4.3
 What controls apply to the export of biotechnology resources and products?

  
  back to top
  • D1
 What is meant here by 'genetic modification' and 'contained use'?

  
  • D2
 Which advisory and regulatory bodies ensure compliance with the law?

  
  • D3
 What are the main requirements of the current regulations?

  
  • D4
 How are the risks of contained use assessed and classified?

  
  • D5
 How should I notify the premises to be used?

  
  • D6
 How should I notify individual activities?

  
  • D7
 Is notified information made public?

  
  • D8
 What requirements must be met while the activity is being carried out?

  
  back to top
  • E1
 Which advisory and regulatory bodies cover releases of novel GMOs?

  
  • E2
 Which laws cover releases of GMOs?

  
  • E3
 Under what circumstances must I obtain consent to the release of GMOs?

  
  • E4
 Might other GM laws apply to my product as well?

  
  • E5
 What approach should I take to product development?

  
  • E6
 How do I go about obtaining consent?

  
  • E7
 What must the public be told about GMO releases?

  
  • E8
 What will be required of me during and after the release event?

  
  back to top
  • F1.1
 Which substances are regulated as medicines?

  
  • F1.2
 What are the principal laws?

  
  • F1.3
 Which regulatory and advisory bodies cover human medicines?

  
  • F1.4
 What procedures must I follow during product development?

  
  • F1.5
 How should I conduct clinical trials?

  
  • F1.6
 How can I obtain marketing authorisation?

  
  • F1.7
 What manufacturing procedures must I follow?

  
  • F1.8
 What controls are there on supply and product monitoring?

  
  back to top
  • F2.1
 Which advisory and regulatory bodies cover veterinary medicines?

  
  • F2.2
 What are the principal laws?

  
  • F2.3
 What procedures must I follow when developing veterinary biotechnology products?

  
  • F2.4
 How can I obtain a marketing authorisation for a veterinary biotechnology product?

  
  • F2.5
 What rules must I follow when manufacturing a veterinary biotechnology product?

  
  • F2.6
 What controls apply during the use of veterinary biotechnology products?

  
  • F2.7
 Are there likely to be changes in the law affecting veterinary biotechnology products?

  
  back to top
  • F3.1
 Which regulatory and advisory bodies cover medical devices and in vitro diagnostics?

  
  • F3.2
 Which items are legally classed as medical devices?

  
  • F3.3
 What must be done before a medical device may be placed on the market?

  
  • F3.4
 Which items are legally classed as in vitro diagnostic devices?

  
  • F3.5
 What must be done before an in vitro diagnostic device may be placed on the market?

  
  • F3.6
 Are there further regulatory developments in prospect?

  
  back to top
  • G1.1
 How is stem cell research regulated?

  
  • G1.2
 Is human cloning permitted?

  
  • G1.3
 What is gene therapy?

  
  • G1.4
 Which advisory and regulatory bodies cover gene therapy?

  
  • G1.5
 Must gene therapy be authorised?

  
  • G1.6
 What is xenotransplantation?

  
  • G1.7
 Which advisory body specialises in xenotransplantation?

  
  • G1.8
 Must xenotransplantation be authorised?

  
  back to top
  • G2.1
 What is stem cell research?

  
  • G2.2
 How is stem cell research regulated?

  
  • G2.3
 What are the policy trends in stem cell research?

  
  • G2.4
 What is gene therapy?

  
  • G2.5
 Which advisory and regulatory bodies cover gene therapy?

  
  • G2.6
 Must gene therapy be authorised?

  
  • G2.7
 Is human cloning permitted?

  
  • G2.8
 What is xenotransplantation?

  
  • G2.9
 Which advisory body specialises in xenotransplantation?

  
  • G2.10
 Must xenotransplantation be authorised?

  
  back to top
  • G3.1
 What are the principal laws determining rights of access to personal information?

  
  • G3.2
 How may genetic tests and their results be used for health care and personal profiling?

  
  • G3.3
 How are the risks and benefits of prenatal genetic testing regulated?

  
  • G3.4
 How may genetic tests and their results be used in forensics?

  
  • G3.5
 How may genetic tests and their results be used to establish family relationships?

  
  • G3.6
 May genetic tests and results be applied for utilitarian ends, such as by insurers or employers?

  
  back to top
  • H1
 How does regulation affect environmental biotechnology?

  
  • H2
 How can biologicals be used to assess the state of the environment?

  
  • H3
 How can biotechnology be used to replace hazardous chemicals?

  
  • H4
 How can bioremediation be carried out?

  
  • H5
 Does the law influence the feasibility of bioremediation activities?

  
  • H6
 Which laws cover releases of non-native organisms?

  
  • H7
 How are health risks to native organisms controlled?

  
  back to top
  • I1.1
 Who is responsible for regulating plant propagation materials?

  
  • I1.2
 Which laws control the marketing of seed from novel agricultural crops?

  
  • I1.3
 How can I obtain authorisation to market novel seeds?

  
  • I1.4
 How must GM seeds be identified to the supply chain?

  
  • I1.5
 Is the law on GM seeds likely to change?

  
  • I1.6
 What are the laws covering genetically modified trees?

  
  back to top
  • I2.1
 Which advisory and regulatory bodies cover animal feed?

  
  • I2.2
 What are the principal regulations?

  
  • I2.3
 How are enzyme and cell technologies regulated in relation to animal feed?

  
  • I2.4
 How is the inclusion of GM products in animal feed regulated?

  
  • I2.5
 What claims may be made on GM feed product labels?

  
  • I2.6
 Is the law on GM animal feed likely to change?

  
  back to top
  • I3.1
 Where can I find out about the law on novel food ingredients, additives and processing aids?

  
  • I3.2
 What are the principal laws covering novel foods?

  
  • I3.3
 Which regulatory and advisory bodies cover novel foods?

  
  • I3.4
 How should I assess the safety of novel foods before applying for marketing authorisation?

  
  • I3.5
 How can I obtain authorisation to market a novel food?

  
  • I3.6
 Is there a simplified procedure for more straightforward cases?

  
  • I3.7
 How must novel foods be labelled?

  
  • I3.8
 What is the regulatory position on post-market monitoring of novel foods?  
     
   
dti logoLGC logo
   Textlinks - for fast site navigation back to top
[Route Planner] [A] [B] [C] [D] [E] [F] [G] [H] [I]