Search Legislation

Advanced Search

The Medicines for Human Use (Manufacturing, Wholesale Dealing and Miscellaneous Amendments) Regulations 2005

Status:

This is the original version (as it was originally made).

This section has no associated Explanatory Memorandum

5.—(1) The licence holder shall arrange for all persons engaged in the production of BCG vaccine to be examined clinically by a doctor and where appropriate, radiologically and bacteriologically, at least every twelve months and whenever such a person shows signs of ill health.

(2) The licence holder shall ensure (as far as paragraph (c) below is concerned, in so far as is reasonably practicable), that persons falling within the following descriptions shall not engage in the production of BCG vaccine, that is to say—

(a)persons examined as aforesaid who are found to be suffering from active or potentially active tuberculosis lesions,

(b)persons who show a negative reaction when tested with tuberculin, or

(c)persons who are in close contact with a person who is suffering from any active form of tuberculosis.

(3) If on examination in accordance with subparagraph (1), a person engaged in the production of BCG vaccine is found to be suffering from active or potentially active tuberculosis lesions, then, after that person has been removed from the separate premises or separate parts of premises referred to in paragraph (1), the licence holder shall—

(a)make arrangements for those separate premises or separate parts of premises and all equipment used in the production of BCG vaccine to be treated in such a manner as to remove the risk of contamination of the vaccine; and

(b)cease to use any unsealed cultures of BCG and all current preparations of BCG vaccine which may have become contaminated with other Mycobacterium tuberculosis organisms.

Back to top

Options/Help

Print Options

Close

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.

Close

Opening Options

Different options to open legislation in order to view more content on screen at once

Close

Explanatory Memorandum

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.

Close

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
Close

More Resources

Use this menu to access essential accompanying documents and information for this legislation item. Dependent on the legislation item being viewed this may include:

  • the original print PDF of the as made version that was used for the print copy
  • correction slips

Click 'View More' or select 'More Resources' tab for additional information including:

  • lists of changes made by and/or affecting this legislation item
  • confers power and blanket amendment details
  • all formats of all associated documents
  • links to related legislation and further information resources