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

Made: 10th October 2005

Laid before Parliament: 10th October 2005

Coming into force: 30th October 2005

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Citation, commencement and interpretation

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Requirement that manufacturer's licence holders comply with certain obligations in relation to the manufacture and assembly of relevant medicinal products

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Requirement that manufacturer's licence holders comply with certain obligations in relation to the import from a third country of relevant medicinal products

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Requirements as to qualified persons

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Offence relating to the sale and supply of starting materials for use in the manufacture of relevant medicinal products

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Standard provisions for manufacturer's licences

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Additional standard provisions for manufacturers licences which relate to vaccines, toxins and sera

7

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Requirement that holders of wholesale dealer's licences comply with certain obligations

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Requirement that wholesale dealers deal only with specified persons

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Requirement as to responsible persons

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Standard provisions for wholesale dealer's licences

11

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Application of these Regulations to manufacturer's and wholesale dealer's licences

12

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Consequential and other amendments to enactments

13

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Revocations

14

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Transitional provisions

15

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SCHEDULE 1 — STANDARD PROVISIONS WHICH MAY BE INCORPORATED IN A MANUFACTURER'S LICENCE RELATING TO THE MANUFACTURE AND ASSEMBLY OF RELEVANT MEDICINAL PRODUCTS

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6

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7

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8

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9

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10

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11

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12

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13

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SCHEDULE 2 — STANDARD PROVISIONS WHICH MAY BE INCORPORATED IN A MANUFACTURER'S LICENCE RELATING TO THE IMPORT OF RELEVANT MEDICINAL PRODUCTS FROM A THIRD COUNTRY

1

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2

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3

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5

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6

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7

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8

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SCHEDULE 3 — STANDARD PROVISIONS WHICH MAY BE INCORPORATED IN A MANUFACTURER'S LICENCE WHICH RELATES TO VACCINES, TOXINS OR SERA

PART 1 — STANDARD PROVISIONS WHICH MAY BE INCORPORATED IN A MANUFACTURER'S LICENCE WHICH RELATES TO VACCINES

1

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3

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5

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6

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7

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8

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PART 2 — STANDARD PROVISIONS WHICH MAY BE INCORPORATED IN A MANUFACTURER'S LICENCE WHICH RELATES TO SMALLPOX VACCINES

1

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2

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3

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PART 3 — STANDARD PROVISIONS WHICH MAY BE INCORPORATED IN A MANUFACTURER'S LICENCE WHICH RELATES TO BCG VACCINES

1

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2

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3

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4

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5

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6

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PART 4 — STANDARD PROVISIONS WHICH MAY BE INCORPORATED IN A MANUFACTURER'S LICENCE WHICH RELATES TO TOXINS

1

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2

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3

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PART 5 — STANDARD PROVISIONS WHICH MAY BE INCORPORATED IN A MANUFACTURER'S LICENCE WHICH RELATES TO SERA

1

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2

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3

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4

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5

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6

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8

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SCHEDULE 4 — STANDARD PROVISIONS WHICH MAY BE INCORPORATED IN A WHOLESALE DEALER'S LICENCE

1

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2

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3

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4

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SCHEDULE 5 — CONSEQUENTIAL AND OTHER AMENDMENTS OF ENACTMENTS

PART 1 — AMENDMENTS TO THE ACT

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3

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4

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5

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6

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7

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8

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9

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10

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PART 2 — AMENDMENTS TO ORDERS AND REGULATIONS

Amendments to the Standard Provisions Regulations

1

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Amendments to the Applications Regulations

2

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Amendments to the Medicines (Renewal Applications for Licences and Certificates) Regulations 1974

3

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Amendments to the Medicines (Retail Sale or Supply of Herbal Remedies) Order 1977

4

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SCHEDULE 6 — TRANSITIONAL PROVISIONS

Wholesale dealer's licences granted before 30th October 2005 relating to the import of medicinal products from third countries

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Applications for wholesale dealer's licences made before 30th October 2005

2

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Manufacturer's and wholesale dealer's licences granted before 30th October 2005

3

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Signed

Signed by authority of the Secretary of State for Health

Warner — Minister of State, — Department of Health — 5th October 2005

Sealed with the Official Seal of the Department of Health, Social Services and Public Safety

A.McCormick — Permanent Secretary, — Department of Health, Social Services and Public Safety — 10th October 2005

Sealed with the OfficialSealof the Department of Agriculture and Rural Development

Pat Toal — Permanent Secretary, — Department of Agriculture and Rural Development — 7th October 2005

Explanatory note

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Footnotes

[^f00001]: S.I. 1972/181.

[^f00002]: 1972 c. 68.

[^f00003]: 1968 c. 67; the expression “the Ministers”, which is relevant to the powers being exercised in the making of these Regulations, is defined in section 1 of that Act as amended by article 2(2) of, and Schedule 1 to, S.I. 1969/388, by articles 2(1) and 5 of, and the Schedule to, S.I. 1999/3142, and by article 5(1) of, and paragraph 15 of Schedule 1 to, S.I. 2002/794.

[^f00004]: In the case of the Secretary of State, by virtue of article 2(2) of, and Schedule 1 to, S.I. 1969/388, article 2(1) of, and paragraph 1 of the Schedule to, S.I. 1999/3142, and article 3(1)(c) and (7) of, and paragraph 15 of Schedule 1 to, S.I. 2002/794; in the case of the Northern Ireland Departments, the powers vested in the Ministers in charge of those Departments by virtue of section 95(5) of, and paragraph 10 of Schedule 12 to, the Northern Ireland Act 1998 (c. 47) may now be exercised by the Departments by virtue of section 1(8) of, and paragraph 4(1)(b) of the Schedule to, the Northern Ireland Act 2000 (c. 1); the Departments were renamed by virtue of article 3(4) and (6) of S.I. 1999/283 (N.I.1).

[^f00005]: 1968 c. 67.

[^f00006]: S.I. 1994/ 3144 as amended by S.I. 1998/3105, 200/292, 2001/795, 2002/236, 2002/542, 2003/2321, 2004/3224 and 2005/768.

[^f00007]: S.I. 1971/974 as amended by S.I.1977/1052, 1978/1140, 1983/1725, 1993/832 and 2002/236.

[^f00008]: S.I. 1971/972, as amended by S.I. 1974/1523, 1977/675, 1983/1730, 1992/2846, 1999/4, 2002/236, 2003/2321, 2004/1031 and 2005/1710.

[^f00009]: OJ No. L262, 14.10.2003, p.22.

[^f00010]: OJ No. L311, 28.11.2001, p67

[^f00011]: OJ No. L33, 8.2.2003, p30.

[^f00012]: OJ No L159, 27.6.2003, p 46.

[^f00013]: OJ No L 136, 30.4. 2004, p.85.

[^f00014]: OJ No. L136, 30.4.2004, p.85.

[^f00015]: OJ No. C63 1.3.1994.

[^f00016]: OJ No. L214, 24.8.1993, p.1.

[^f00017]: OJ No L136, 30.4.2004, p.1.

[^f00018]: S.I. 2005/2750.

[^f00019]: S.I. 1994/105; as amended by S.I. 1994/899, 1995/541, 1996/482, 1998/574, 1999/566, 2001/795, 2002/236 and 542, 2003/625 and 2321, and 2004/666.

[^f00020]: OJ No. L 262 14.10.2003, p 22.

[^f00021]: Subsection 8(2D) is inserted by paragraph 1 of Schedule 5 to these Regulations, and will come into force on 30th October 2005.

[^f00022]: Subsection 8(3E) is inserted by paragraph 1 of Schedule 5 to these Regulations, and will come into force on 30th October 2005.

[^f00023]: S.I. 1974/832 revoked in relation to veterinary drugs by S.I. 1993/1227 and in relation to clinical trials certificates by S.I. 2004/1031.

[^f00024]: Section 8 was amended by S.I. 1977/1050, 1992/604/ 1993/834, 2002/236 and 2004/1031.

[^f00025]: Section 14 was amended by S.I. 1993/834 and 2002/236.

[^f00026]: Section 20 was amended by S.I. 1977/1050 and 2005/1094.

[^f00027]: Section 24 was amended by S.I. 1977/1050, 1994/276, 2002/236 and 2005/1094.