- Latest available (Revised)
- Original (As made)
The Medicines for Human Use (Marketing Authorisations Etc.) Regulations 1994
You are here:
- UK Statutory Instruments
- 1994 No. 3144
- SCHEDULE 3
- Paragraph 10
What Version
More Resources
Status:
This is the original version (as it was originally made). This item of legislation is currently only available in its original format.
Offences
10. Any person who, while employed or engaged as an appropriately qualified person responsible for pharmacovigilance for the purposes of Chapter 3 of Title II of Council Regulation (EEC) No. 2309/93, or Chapter Va of Council Directive 75/319/EEC fails to—
(a)establish or maintain a system for collecting and collating information about suspected adverse reactions;
(b)prepare for the licensing authority a report on any such reactions; or
(c)ensure that a request from the licensing authority for the provision of additional information necessary for the evaluation of the benefits and risks afforded by a relevant medicinal product is answered fully and promptly,
as required by any provision of any such Chapter, shall be guilty of an offence.
Options/Help
Print Options
PrintThe Whole Instrument
PrintThe Whole Schedule
PrintThis Section only
Legislation is available in different versions:
Latest Available (revised):The latest available updated version of the legislation incorporating changes made by subsequent legislation and applied by our editorial team. Changes we have not yet applied to the text, can be found in the ‘Changes to Legislation’ area.
Original (As Enacted or Made): The original version of the legislation as it stood when it was enacted or made. No changes have been applied to the text.
Opening Options
Different options to open legislation in order to view more content on screen at once
More Resources
Access essential accompanying documents and information for this legislation item from this tab. Dependent on the legislation item being viewed this may include:
- the original print PDF of the as enacted version that was used for the print copy
- lists of changes made by and/or affecting this legislation item
- confers power and blanket amendment details
- all formats of all associated documents
- correction slips
- links to related legislation and further information resources
All content is available under the Open Government Licence v3.0 except where otherwise stated. This site additionally contains content derived from EUR-Lex, reused under the terms of the Commission Decision 2011/833/EU on the reuse of documents from the EU institutions. For more information see the EUR-Lex public statement on re-use.