- Latest available (Revised)
- Original (As made)
This is the original version (as it was originally made).
2.Requirement that manufacturer’s licence holders comply with certain obligations in relation to the manufacture and assembly of relevant medicinal products
3.Requirement that manufacturer’s licence holders comply with certain obligations in relation to the import from a third country of relevant medicinal products
5.Offence relating to the sale and supply of starting materials for use in the manufacture of relevant medicinal products
7.Additional standard provisions for manufacturers licences which relate to vaccines, toxins and sera
8.Requirement that holders of wholesale dealer’s licences comply with certain obligations
9.Requirement that wholesale dealers deal only with specified persons
12.Application of these Regulations to manufacturer’s and wholesale dealer’s licences
1.The manufacturer’s licence holder shall place the quality control system...
2.The manufacturer’s licence holder may use a contract laboratory pursuant...
3.The manufacturer’s licence holder shall provide such information as may...
4.The manufacturer’s licence holder shall inform the licensing authority of...
5.The manufacturer’s licence holder shall— (a) keep readily available for...
6.The manufacturer’s licence holder shall keep readily available for examination...
7.Where the manufacturer’s licence holder has been informed by the...
8.The manufacturer’s licence holder shall ensure that any tests for...
9.Where the manufacturer’s licence relates to the assembly of any...
10.Where— (a) the manufacturer’s licence relates to the assembly of...
11.The licence holder shall keep readily available for examination by...
13.The licence holder shall take all reasonable precautions and exercise...
1.The manufacturer’s licence holder shall place the quality control system...
2.The manufacturer’s licence holder may use a contract laboratory pursuant...
3.The manufacturer’s licence holder shall provide such information as may...
4.The manufacturer’s licence holder shall— (a) keep readily available for...
5.Where the manufacturer’s licence holder has been informed by the...
6.The manufacturer’s licence holder shall ensure that any tests for...
7.(1) Where and insofar as the licence relates to relevant...
8.The licence holder shall take all reasonable precautions and exercise...
1.(1) The licence holder shall provide separate premises or separate...
2.The licence holder shall ensure that any procedure which, in...
5.The licence holder shall ensure— (a) that animals used in...
6.The licence holder shall provide a separate room in the...
7.Without prejudice to any other requirements to keep records, where...
8.Nothing in this Schedule shall operate so as to restrict...
2.The licence holder shall ensure that an adequate system of...
4.The licence holder shall notify the licensing authority if any...
5.The licence holder shall notify the licensing authority if any...
6.The licence holder shall ensure that laboratories in which any...
7.The licence holder shall provide such number of sterilizers as...
8.Without prejudice to any other requirements to keep records, the...
STANDARD PROVISIONS WHICH MAY BE INCORPORATED IN A WHOLESALE DEALER'S LICENCE
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.
Explanatory Memorandum sets out a brief statement of the purpose of a Statutory Instrument and provides information about its policy objective and policy implications. They aim to make the Statutory Instrument accessible to readers who are not legally qualified and accompany any Statutory Instrument or Draft Statutory Instrument laid before Parliament from June 2004 onwards.
Access essential accompanying documents and information for this legislation item from this tab. Dependent on the legislation item being viewed this may include:
Use this menu to access essential accompanying documents and information for this legislation item. Dependent on the legislation item being viewed this may include:
Click 'View More' or select 'More Resources' tab for additional information including: