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The Medicines for Human Use (Manufacturing, Wholesale Dealing and Miscellaneous Amendments) Regulations 2005
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- UK Statutory Instruments
- 2005 No. 2789
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Changes and effects yet to be applied to :
- Sch. 2 para. 7(8) words revoked by S.I. 2010/1882 reg. 10(b)(i)
- Sch. 4 para. 3(8) words revoked by S.I. 2010/1882 reg. 10(b)(ii)
- Regulations revoked by S.I. 2012/1916 Sch. 35
- reg. 1(2) words substituted by S.I. 2010/1882 reg. 10(a)
- reg. 8(3) substituted by S.I. 2009/1164 reg. 4
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
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