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Pharmaceutical Wholesalers

Volume 447: debated on Monday 5 June 2006

To ask the Secretary of State for Health (1) if she will take steps to amend the Medicines Act 1969 to require the Medical and Healthcare Products Regulatory Agency to inspect the warehouses and operations of companies which self-distribute medicines and drugs; (73160)

(2) if she will require the Medicines and Healthcare Products Regulatory Agency to extend its inspection role to cover companies which self-distribute medicines and drugs and which are not covered by the requirement of the Medicines Act 1968.

The Medicines Act 1968, as amended, and orders and regulations under that Act, regulate the distribution of medicinal products in the United Kingdom. These provisions transpose into the United Kingdom's law the relevant requirements of Directive 2001/83/EC relating to medicinal products for human use.

Companies wishing to wholesale distribute medicines for human use are required, under the Act and related regulations, to be licensed and inspected by the Medicines and Healthcare products Regulatory Agency (MHRA) unless an exemption applies.

The term self-distribute, in relation to medicines for human use, is not a term used or defined in Directive 2001/83/EC or the United Kingdom medicines legislation, or in official guidance published by the MHRA.

The supply of medicines from a company's central distribution warehouse to its own retail outlets is not considered to be wholesale distribution as the supply is within the same legal entity.

The Royal Pharmaceutical Society of Great Britain is therefore responsible for the inspection of retail pharmacy businesses in England and Wales at which medicinal products are sold by retail or supplied in circumstances corresponding to retail.

To ask the Secretary of State for Health (1) how many and what percentage of pharmaceutical wholesaler dealer licence holders have been inspected by the Medicines and Healthcare products Regulatory Agency within the target period of three years; (73164)

(2) how many inspectors the Medicines and Healthcare products Regulatory Agency has available to inspect pharmaceutical wholesaler licence holders; and how many inspections each inspector has carried out in each of the last three years.

The Medicines and Healthcare products Regulatory Agency (MHRA), the Government body responsible for the safety and licensing of medicines in the United Kingdom, employs six full-time good distribution practice inspectors. These inspectors inspect the facilities of licensed wholesale dealers of medicines to confirm compliance with the European Commission’s guideline on good distribution practice and UK medicines regulations.

The current level of resource enables a regular and repeated inspection programme (at specified frequencies) of all (100 per cent.) of the facilities from where licensed wholesale distributors of medicinal products conduct their wholesale business to be maintained.

Details for the last three years of the numbers of inspections performed by good distribution practice inspectors is shown in the table:

Number of inspections

Inspector

2003-04

2004-05

2005-06

1

36

82

73

2

63

85

80

3

65

85

82

4

61

83

87

5

61

79

81

6

1

1

2

Total

302

414

403

1 Not in post 2 Training

For the year 2003-04 an additional GDP inspector was employed. This inspector performed 16 site inspections which are included in the totals for that year.