http://www.legislation.gov.uk/uksi/1994/3144/contents/made

The Medicines for Human Use (Marketing Authorisations Etc.) Regulations 1994

Manufacturing licences

King's Printer of Acts of Parliament

2019-11-27

MEDICINES

These Regulations implement for the United Kingdom, and in so far as they are concerned with medicinal products for human use, the Council Directives mentioned in regulation 1(2) in the definition of “relevant Community provisions”. They also contain provisions supplementing the provisions of Council Regulation (EEC) No. 2309/93. Both the Directives and the Regulation are concerned with the marketing of medicinal products.

The Medicines for Human Use (Marketing Authorisations Etc.) Regulations 1994

reg 1 defn(s)

The Medicines (Advisory Bodies) Regulations 2005

reg 9

Sch 2

para 1

Medicines for Human Use (Marketing Authorisations etc.) Regs

The Medicines for Human Use (Marketing Authorisations Etc.) Regulations 1994

reg 5

The Medicines (Advisory Bodies) Regulations 2005

reg 9

Sch 2

para 2

Medicines for Human Use (Marketing Authorisations etc.) Regs

The Medicines for Human Use (Marketing Authorisations Etc.) Regulations 1994

reg 9

The Medicines (Advisory Bodies) Regulations 2005

reg 9

Sch 2

para 3

Medicines for Human Use (Marketing Authorisations etc.) Regs

The Medicines for Human Use (Marketing Authorisations Etc.) Regulations 1994

Sch 2

The Medicines (Advisory Bodies) Regulations 2005

reg 9

Sch 2

para 4

Medicines for Human Use (Marketing Authorisations etc.) Regs

The Medicines for Human Use (Marketing Authorisations Etc.) Regulations 1994

reg 1 defn(s)

The Medicines (Sale or Supply) (Miscellaneous Amendments) Regulations 2005

reg 2(a)

Medicines for Human Use (Marketing Authorisations etc.) Regs

The Medicines for Human Use (Marketing Authorisations Etc.) Regulations 1994

reg 1 defn(s)

The Medicines (Sale or Supply) (Miscellaneous Amendments) Regulations 2005

reg 2(b)(i)

reg 2(b)(c)(i)

Medicines for Human Use (Marketing Authorisations etc.) Regs

The Medicines for Human Use (Marketing Authorisations Etc.) Regulations 1994

reg 1 defn(s)

The Medicines (Sale or Supply) (Miscellaneous Amendments) Regulations 2005

reg 2(b)(ii)

reg 2(b)(ii)(iii)

reg 2(b)(c)(ii)

(iii)

Medicines for Human Use (Marketing Authorisations etc.) Regs

The Medicines for Human Use (Marketing Authorisations Etc.) Regulations 1994

Sch 3

para 10A

The Medicines (Provision of False or Misleading Information and Miscellaneous Amendments) Regulations 2005

reg 3(a)

Medicines for Human Use (Marketing Authorisations etc.) Regs

The Medicines for Human Use (Marketing Authorisations Etc.) Regulations 1994

Sch 3

para 13A

The Medicines (Provision of False or Misleading Information and Miscellaneous Amendments) Regulations 2005

reg 3(b)

Medicines for Human Use (Marketing Authorisations etc.) Regs

The Medicines for Human Use (Marketing Authorisations Etc.) Regulations 1994

Sch 3

para 15

The Medicines (Provision of False or Misleading Information and Miscellaneous Amendments) Regulations 2005

reg 3(c)

Medicines for Human Use (Marketing Authorisations etc.) Regs

The Medicines for Human Use (Marketing Authorisations Etc.) Regulations 1994

Sch 3

para 17

The Medicines (Provision of False or Misleading Information and Miscellaneous Amendments) Regulations 2005

reg 3(d)

Medicines for Human Use (Marketing Authorisations etc.) Regs

The Medicines for Human Use (Marketing Authorisations Etc.) Regulations 1994

reg 1 defn(s)

The Blood Safety and Quality Regulations 2005

reg 25(3)

Medicines for Human Use (Marketing Authorisations etc.) Regs

The Medicines for Human Use (Marketing Authorisations Etc.) Regulations 1994

reg 1 defn(s)

The Medicines for Human Use (Marketing Authorisations Etc.) Amendment Regulations 2005

reg 2

Medicines for Human Use (Marketing Authorisations etc.) Regs

The Medicines for Human Use (Marketing Authorisations Etc.) Regulations 1994

Sch 1

paras 1

The Medicines for Human Use (Marketing Authorisations Etc.) Amendment Regulations 2005

reg 3

Medicines for Human Use (Marketing Authorisations etc.) Regs

The Medicines for Human Use (Marketing Authorisations Etc.) Regulations 1994

reg. 4(3)

The Medicines (Marketing Authorisations Etc.) Amendment Regulations 2005

reg. 2(6)(a)

reg. 1(a)

Medicines for Human Use (Marketing Authorisations etc.) Regs

The Medicines for Human Use (Marketing Authorisations Etc.) Regulations 1994

reg. 1(2)

The Medicines (Marketing Authorisations Etc.) Amendment Regulations 2005

reg. 2(2)(a)(i)

reg. 1(a)

Medicines for Human Use (Marketing Authorisations etc.) Regs

The Medicines for Human Use (Marketing Authorisations Etc.) Regulations 1994

reg. 1(2)

The Medicines (Marketing Authorisations Etc.) Amendment Regulations 2005

reg. 2(2)(a)(ii)

reg. 1(b)

Medicines for Human Use (Marketing Authorisations etc.) Regs

The Medicines for Human Use (Marketing Authorisations Etc.) Regulations 1994

reg. 1(2)

The Medicines (Marketing Authorisations Etc.) Amendment Regulations 2005

reg. 2(2)(a)(iii)

(aa)

reg. 1(a)

Medicines for Human Use (Marketing Authorisations etc.) Regs

The Medicines for Human Use (Marketing Authorisations Etc.) Regulations 1994

reg. 1(2)

The Medicines (Marketing Authorisations Etc.) Amendment Regulations 2005

reg. 2(2)(a)(iii)

(bb)

reg. 1(a)

Medicines for Human Use (Marketing Authorisations etc.) Regs

The Medicines for Human Use (Marketing Authorisations Etc.) Regulations 1994

reg. 1(2)

The Medicines (Marketing Authorisations Etc.) Amendment Regulations 2005

reg. 2(2)(a)(iv)

reg. 1(b)

Medicines for Human Use (Marketing Authorisations etc.) Regs

The Medicines for Human Use (Marketing Authorisations Etc.) Regulations 1994

reg. 1(2)

The Medicines (Marketing Authorisations Etc.) Amendment Regulations 2005

reg. 2(2)(a)(v)

reg. 1(a)

Medicines for Human Use (Marketing Authorisations etc.) Regs

The Medicines for Human Use (Marketing Authorisations Etc.) Regulations 1994

reg. 1(2)

The Medicines (Marketing Authorisations Etc.) Amendment Regulations 2005

reg. 2(2)(a)(vi)

(aa)

reg. 1(a)

Medicines for Human Use (Marketing Authorisations etc.) Regs

The Medicines for Human Use (Marketing Authorisations Etc.) Regulations 1994

reg. 1(2)

The Medicines (Marketing Authorisations Etc.) Amendment Regulations 2005

reg. 2(2)(a)(vi)

(bb)

reg. 1(a)

Medicines for Human Use (Marketing Authorisations etc.) Regs

The Medicines for Human Use (Marketing Authorisations Etc.) Regulations 1994

reg. 1(2)

The Medicines (Marketing Authorisations Etc.) Amendment Regulations 2005

reg. 2(2)(a)(vii)

reg. 1(a)

Medicines for Human Use (Marketing Authorisations etc.) Regs

The Medicines for Human Use (Marketing Authorisations Etc.) Regulations 1994

reg. 1(2)

The Medicines (Marketing Authorisations Etc.) Amendment Regulations 2005

reg. 2(2)(a)(viii)

reg. 1(a)

Medicines for Human Use (Marketing Authorisations etc.) Regs

The Medicines for Human Use (Marketing Authorisations Etc.) Regulations 1994

reg. 1(3)

The Medicines (Marketing Authorisations Etc.) Amendment Regulations 2005

reg. 2(2)(b)

reg. 1(a)

Medicines for Human Use (Marketing Authorisations etc.) Regs

The Medicines for Human Use (Marketing Authorisations Etc.) Regulations 1994

reg. 1(5A)

The Medicines (Marketing Authorisations Etc.) Amendment Regulations 2005

reg. 2(2)(c)

reg. 1(b)

Medicines for Human Use (Marketing Authorisations etc.) Regs

The Medicines for Human Use (Marketing Authorisations Etc.) Regulations 1994

reg. 3(1)

The Medicines (Marketing Authorisations Etc.) Amendment Regulations 2005

reg. 2(3)

reg. 1(a)

Medicines for Human Use (Marketing Authorisations etc.) Regs

The Medicines for Human Use (Marketing Authorisations Etc.) Regulations 1994

reg. 3A(1)

The Medicines (Marketing Authorisations Etc.) Amendment Regulations 2005

reg. 2(4)(a)

reg. 1(a)

Medicines for Human Use (Marketing Authorisations etc.) Regs

The Medicines for Human Use (Marketing Authorisations Etc.) Regulations 1994

reg. 3A(6)

The Medicines (Marketing Authorisations Etc.) Amendment Regulations 2005

reg. 2(4)(b)

reg. 1(a)

Medicines for Human Use (Marketing Authorisations etc.) Regs

The Medicines for Human Use (Marketing Authorisations Etc.) Regulations 1994

reg. 3A(8)

The Medicines (Marketing Authorisations Etc.) Amendment Regulations 2005

reg. 2(4)(c)

reg. 1(a)

Medicines for Human Use (Marketing Authorisations etc.) Regs

The Medicines for Human Use (Marketing Authorisations Etc.) Regulations 1994

reg. 3B

The Medicines (Marketing Authorisations Etc.) Amendment Regulations 2005

reg. 2(5)

reg. 1(a)

Medicines for Human Use (Marketing Authorisations etc.) Regs

The Medicines for Human Use (Marketing Authorisations Etc.) Regulations 1994

reg. 4(6)

The Medicines (Marketing Authorisations Etc.) Amendment Regulations 2005

reg. 2(6)(b)

reg. 1(a)

Medicines for Human Use (Marketing Authorisations etc.) Regs

The Medicines for Human Use (Marketing Authorisations Etc.) Regulations 1994

reg. 4(6A)

(6B)

The Medicines (Marketing Authorisations Etc.) Amendment Regulations 2005

reg. 2(6)(c)

reg. 1(a)

Medicines for Human Use (Marketing Authorisations etc.) Regs

The Medicines for Human Use (Marketing Authorisations Etc.) Regulations 1994

reg. 4(9)

The Medicines (Marketing Authorisations Etc.) Amendment Regulations 2005

reg. 2(6)(d)

reg. 1(a)

Medicines for Human Use (Marketing Authorisations etc.) Regs

The Medicines for Human Use (Marketing Authorisations Etc.) Regulations 1994

reg. 5(4)

The Medicines (Marketing Authorisations Etc.) Amendment Regulations 2005

reg. 2(7)(a)

reg. 1(a)

Medicines for Human Use (Marketing Authorisations etc.) Regs

The Medicines for Human Use (Marketing Authorisations Etc.) Regulations 1994

reg. 5(5)-(9)

The Medicines (Marketing Authorisations Etc.) Amendment Regulations 2005

reg. 2(7)(b)

reg. 1(a)

Medicines for Human Use (Marketing Authorisations etc.) Regs

The Medicines for Human Use (Marketing Authorisations Etc.) Regulations 1994

reg. 5A(1A)

The Medicines (Marketing Authorisations Etc.) Amendment Regulations 2005

reg. 2(8)

reg. 1(a)

Medicines for Human Use (Marketing Authorisations etc.) Regs

The Medicines for Human Use (Marketing Authorisations Etc.) Regulations 1994

reg. 6(5)

The Medicines (Marketing Authorisations Etc.) Amendment Regulations 2005

reg. 2(9)(a)

reg. 1(b)

Medicines for Human Use (Marketing Authorisations etc.) Regs

The Medicines for Human Use (Marketing Authorisations Etc.) Regulations 1994

reg. 6(7A)

The Medicines (Marketing Authorisations Etc.) Amendment Regulations 2005

reg. 2(9)(b)

reg. 1(a)

Medicines for Human Use (Marketing Authorisations etc.) Regs

The Medicines for Human Use (Marketing Authorisations Etc.) Regulations 1994

reg. 6A(1)

The Medicines (Marketing Authorisations Etc.) Amendment Regulations 2005

reg. 2(10)(a)

reg. 1(a)

Medicines for Human Use (Marketing Authorisations etc.) Regs

The Medicines for Human Use (Marketing Authorisations Etc.) Regulations 1994

reg. 6A(2)

The Medicines (Marketing Authorisations Etc.) Amendment Regulations 2005

reg. 2(10)(b)

reg. 1(a)

Medicines for Human Use (Marketing Authorisations etc.) Regs

The Medicines for Human Use (Marketing Authorisations Etc.) Regulations 1994

reg. 7(1)

The Medicines (Marketing Authorisations Etc.) Amendment Regulations 2005

reg. 2(11)(a)

reg. 1(b)

Medicines for Human Use (Marketing Authorisations etc.) Regs

The Medicines for Human Use (Marketing Authorisations Etc.) Regulations 1994

reg. 7(3A)

The Medicines (Marketing Authorisations Etc.) Amendment Regulations 2005

reg. 2(11)(b)

reg. 1(a)

Medicines for Human Use (Marketing Authorisations etc.) Regs

The Medicines for Human Use (Marketing Authorisations Etc.) Regulations 1994

reg. 7(7)

The Medicines (Marketing Authorisations Etc.) Amendment Regulations 2005

reg. 2(11)(c)

reg. 1(a)

Medicines for Human Use (Marketing Authorisations etc.) Regs

The Medicines for Human Use (Marketing Authorisations Etc.) Regulations 1994

reg. 9(15)

(16)

The Medicines (Marketing Authorisations Etc.) Amendment Regulations 2005

reg. 2(12)

reg. 1(a)

Medicines for Human Use (Marketing Authorisations etc.) Regs

The Medicines for Human Use (Marketing Authorisations Etc.) Regulations 1994

Sch. 1

para. 1

The Medicines (Marketing Authorisations Etc.) Amendment Regulations 2005

reg. 2(13)(a)

reg. 1(a)

Medicines for Human Use (Marketing Authorisations etc.) Regs

The Medicines for Human Use (Marketing Authorisations Etc.) Regulations 1994

Sch. 1

para. 2(e)

The Medicines (Marketing Authorisations Etc.) Amendment Regulations 2005

reg. 2(13)(b)

reg. 1(a)

Medicines for Human Use (Marketing Authorisations etc.) Regs

The Medicines for Human Use (Marketing Authorisations Etc.) Regulations 1994

Sch. 1

para. 5A

The Medicines (Marketing Authorisations Etc.) Amendment Regulations 2005

reg. 2(13)(c)

reg. 1(a)

Medicines for Human Use (Marketing Authorisations etc.) Regs

The Medicines for Human Use (Marketing Authorisations Etc.) Regulations 1994

Sch. 3

para. 1A(1)

The Medicines (Marketing Authorisations Etc.) Amendment Regulations 2005

reg. 2(14)(a)(i)

reg. 1(a)

Medicines for Human Use (Marketing Authorisations etc.) Regs

The Medicines for Human Use (Marketing Authorisations Etc.) Regulations 1994

Sch. 3

para. 1A(1)(a)

The Medicines (Marketing Authorisations Etc.) Amendment Regulations 2005

reg. 2(14)(a)(ii)

reg. 1(a)

Medicines for Human Use (Marketing Authorisations etc.) Regs

The Medicines for Human Use (Marketing Authorisations Etc.) Regulations 1994

Sch. 3

para. 1A(1)(b)

The Medicines (Marketing Authorisations Etc.) Amendment Regulations 2005

reg. 2(14)(a)(iii)

reg. 1(a)

Medicines for Human Use (Marketing Authorisations etc.) Regs

The Medicines for Human Use (Marketing Authorisations Etc.) Regulations 1994

Sch. 3

para. 1A(2)

The Medicines (Marketing Authorisations Etc.) Amendment Regulations 2005

reg. 2(14)(a)(iv)

reg. 1(a)

Medicines for Human Use (Marketing Authorisations etc.) Regs

The Medicines for Human Use (Marketing Authorisations Etc.) Regulations 1994

Sch. 3

para. 1AA

The Medicines (Marketing Authorisations Etc.) Amendment Regulations 2005

reg. 2(14)(b)

reg. 1(a)

Medicines for Human Use (Marketing Authorisations etc.) Regs

The Medicines for Human Use (Marketing Authorisations Etc.) Regulations 1994

Sch. 3

para. 2

The Medicines (Marketing Authorisations Etc.) Amendment Regulations 2005

reg. 2(14)(c)

reg. 1(a)

Medicines for Human Use (Marketing Authorisations etc.) Regs

The Medicines for Human Use (Marketing Authorisations Etc.) Regulations 1994

Sch. 3

para. 2A

The Medicines (Marketing Authorisations Etc.) Amendment Regulations 2005

reg. 2(14)(d)

reg. 1(a)

Medicines for Human Use (Marketing Authorisations etc.) Regs

The Medicines for Human Use (Marketing Authorisations Etc.) Regulations 1994

Sch. 3

para. 4

The Medicines (Marketing Authorisations Etc.) Amendment Regulations 2005

reg. 2(14)(e)

reg. 1(b)

Medicines for Human Use (Marketing Authorisations etc.) Regs

The Medicines for Human Use (Marketing Authorisations Etc.) Regulations 1994

Sch. 3

para. 7

The Medicines (Marketing Authorisations Etc.) Amendment Regulations 2005

reg. 2(14)(e)

reg. 1(b)

Medicines for Human Use (Marketing Authorisations etc.) Regs

The Medicines for Human Use (Marketing Authorisations Etc.) Regulations 1994

Sch. 3

para. 8

The Medicines (Marketing Authorisations Etc.) Amendment Regulations 2005

reg. 2(14)(e)

reg. 1(b)

Medicines for Human Use (Marketing Authorisations etc.) Regs

The Medicines for Human Use (Marketing Authorisations Etc.) Regulations 1994

Sch. 3

para. 9

The Medicines (Marketing Authorisations Etc.) Amendment Regulations 2005

reg. 2(14)(e)

reg. 1(b)

Medicines for Human Use (Marketing Authorisations etc.) Regs

The Medicines for Human Use (Marketing Authorisations Etc.) Regulations 1994

Sch. 3

para. 10

The Medicines (Marketing Authorisations Etc.) Amendment Regulations 2005

reg. 2(14)(e)

reg. 1(b)

Medicines for Human Use (Marketing Authorisations etc.) Regs

The Medicines for Human Use (Marketing Authorisations Etc.) Regulations 1994

Sch. 3

para. 6(b)

The Medicines (Marketing Authorisations Etc.) Amendment Regulations 2005

reg. 2(14)(f)(i)

reg. 1(b)

Medicines for Human Use (Marketing Authorisations etc.) Regs

The Medicines for Human Use (Marketing Authorisations Etc.) Regulations 1994

Sch. 3

para. 6(cc)

The Medicines (Marketing Authorisations Etc.) Amendment Regulations 2005

reg. 2(14)(f)(ii)

reg. 1(a)

Medicines for Human Use (Marketing Authorisations etc.) Regs

The Medicines for Human Use (Marketing Authorisations Etc.) Regulations 1994

Sch. 3

para. 6(d)

The Medicines (Marketing Authorisations Etc.) Amendment Regulations 2005

reg. 2(14)(f)(iii)

reg. 1(b)

Medicines for Human Use (Marketing Authorisations etc.) Regs

The Medicines for Human Use (Marketing Authorisations Etc.) Regulations 1994

Sch. 3

para. 6(dd)

The Medicines (Marketing Authorisations Etc.) Amendment Regulations 2005

reg. 2(14)(f)(iv)

reg. 1(b)

Medicines for Human Use (Marketing Authorisations etc.) Regs

The Medicines for Human Use (Marketing Authorisations Etc.) Regulations 1994

Sch. 3

para. 6(e)

The Medicines (Marketing Authorisations Etc.) Amendment Regulations 2005

reg. 2(14)(f)(v)

reg. 1(b)

Medicines for Human Use (Marketing Authorisations etc.) Regs

The Medicines for Human Use (Marketing Authorisations Etc.) Regulations 1994

Sch. 3

para. 6A

The Medicines (Marketing Authorisations Etc.) Amendment Regulations 2005

reg. 2(14)(g)

reg. 1(a)

Medicines for Human Use (Marketing Authorisations etc.) Regs

The Medicines for Human Use (Marketing Authorisations Etc.) Regulations 1994

Sch. 3 para. 6B–6F

The Medicines (Marketing Authorisations Etc.) Amendment Regulations 2005

reg. 2(14)(h)

reg. 1(a)

Medicines for Human Use (Marketing Authorisations etc.) Regs

The Medicines for Human Use (Marketing Authorisations Etc.) Regulations 1994

Sch. 3

para. 17

The Medicines (Marketing Authorisations Etc.) Amendment Regulations 2005

reg. 2(14)(i)

reg. 1(a)

Medicines for Human Use (Marketing Authorisations etc.) Regs

The Medicines for Human Use (Marketing Authorisations Etc.) Regulations 1994

Sch. 3

para. 18

The Medicines (Marketing Authorisations Etc.) Amendment Regulations 2005

reg. 2(14)(j)

reg. 1(a)

Medicines for Human Use (Marketing Authorisations etc.) Regs

The Medicines for Human Use (Marketing Authorisations Etc.) Regulations 1994

Sch. 6

para. 4B

The Medicines (Marketing Authorisations Etc.) Amendment Regulations 2005

reg. 2(15)

reg. 1(a)

Medicines for Human Use (Marketing Authorisations etc.) Regs

The Medicines for Human Use (Marketing Authorisations Etc.) Regulations 1994

Sch. 2

para. 2(a)

The Medicines (Advisory Bodies) (No. 2) Regulations 2005

Sch. 2

para. 1(2)

reg. 1(2)(a)

The Medicines for Human Use (Marketing Authorisations Etc.) Regulations 1994

Sch. 2

para. 14(8)(a)

The Medicines (Advisory Bodies) (No. 2) Regulations 2005

Sch. 2

para. 1(3)

reg. 1(2)(a)

The Medicines for Human Use (Marketing Authorisations Etc.) Regulations 1994

reg 1 defn(s)

The Medicines for Human Use (Kava-kava) (Prohibition) Order 2002

art 3(d)(ii)

Medicines for Human Use (Marketing Authorisations etc.) Regs

The Medicines for Human Use (Marketing Authorisations Etc.) Regulations 1994

reg 5

The Medicines for Human Use and Medical Devices (Fees and Miscellaneous Amendments) Regulations 2002

reg 3(1)

(2)

Medicines for Human Use (Marketing Authorisations etc.) Regs

The Medicines for Human Use (Marketing Authorisations Etc.) Regulations 1994

reg 5A

The Medicines for Human Use and Medical Devices (Fees and Miscellaneous Amendments) Regulations 2002

reg 3(1)

(3)

Medicines for Human Use (Marketing Authorisations etc.) Regs

The Medicines for Human Use (Marketing Authorisations Etc.) Regulations 1994

reg 6

The Medicines for Human Use and Medical Devices (Fees and Miscellaneous Amendments) Regulations 2002

reg 3(1)

(4)

Medicines for Human Use (Marketing Authorisations etc.) Regs

The Medicines for Human Use (Marketing Authorisations Etc.) Regulations 1994

reg 8

The Medicines for Human Use and Medical Devices (Fees and Miscellaneous Amendments) Regulations 2002

reg 3(1)

(5)

Medicines for Human Use (Marketing Authorisations etc.) Regs

The Medicines for Human Use (Marketing Authorisations Etc.) Regulations 1994

Sch 5

para 6

The Medicines for Human Use and Medical Devices (Fees and Miscellaneous Amendments) Regulations 2002

reg 3(1)

(6)

Medicines for Human Use (Marketing Authorisations etc.) Regs

The Medicines for Human Use (Marketing Authorisations Etc.) Regulations 1994

reg. 1(2)

The Medicines (Codification Amendments Etc.) Regulations 2002

reg. 8(a)(i)

reg. 1(1)

Medicines for Human Use (Marketing Authorisations etc.) Regs

The Medicines for Human Use (Marketing Authorisations Etc.) Regulations 1994

reg. 1(2)

The Medicines (Codification Amendments Etc.) Regulations 2002

reg. 8(a)(ii)

reg. 1(1)

Medicines for Human Use (Marketing Authorisations etc.) Regs

The Medicines for Human Use (Marketing Authorisations Etc.) Regulations 1994

reg. 1(2)

The Medicines (Codification Amendments Etc.) Regulations 2002

reg. 8(a)(iii)

reg. 1(1)

Medicines for Human Use (Marketing Authorisations etc.) Regs

The Medicines for Human Use (Marketing Authorisations Etc.) Regulations 1994

reg. 4(6)

The Medicines (Codification Amendments Etc.) Regulations 2002

reg. 8(b)

reg. 1(1)

Medicines for Human Use (Marketing Authorisations etc.) Regs

The Medicines for Human Use (Marketing Authorisations Etc.) Regulations 1994

reg. 5(4)

The Medicines (Codification Amendments Etc.) Regulations 2002

reg. 8(d)

reg. 1(1)

Medicines for Human Use (Marketing Authorisations etc.) Regs

The Medicines for Human Use (Marketing Authorisations Etc.) Regulations 1994

reg. 8(2)

The Medicines (Codification Amendments Etc.) Regulations 2002

reg. 8(e)

reg. 1(1)

Medicines for Human Use (Marketing Authorisations etc.) Regs

The Medicines for Human Use (Marketing Authorisations Etc.) Regulations 1994

Sch. 1

para. 2(e)

The Medicines (Codification Amendments Etc.) Regulations 2002

reg. 8(f)

reg. 1(1)

Medicines for Human Use (Marketing Authorisations etc.) Regs

The Medicines for Human Use (Marketing Authorisations Etc.) Regulations 1994

Sch. 2

para. 3

The Medicines (Codification Amendments Etc.) Regulations 2002

reg. 8(g)(i)

reg. 1(1)

Medicines for Human Use (Marketing Authorisations etc.) Regs

The Medicines for Human Use (Marketing Authorisations Etc.) Regulations 1994

Sch. 2

para. 4(a)

The Medicines (Codification Amendments Etc.) Regulations 2002

reg. 8(g)(ii)

reg. 1(1)

Medicines for Human Use (Marketing Authorisations etc.) Regs

The Medicines for Human Use (Marketing Authorisations Etc.) Regulations 1994

Sch. 2

para. 4(b)

The Medicines (Codification Amendments Etc.) Regulations 2002

reg. 8(g)(iii)

reg. 1(1)

Medicines for Human Use (Marketing Authorisations etc.) Regs

The Medicines for Human Use (Marketing Authorisations Etc.) Regulations 1994

Sch. 3

para. 6(a)

The Medicines (Codification Amendments Etc.) Regulations 2002

reg. 8(h)(i)

reg. 1(1)

Medicines for Human Use (Marketing Authorisations etc.) Regs

The Medicines for Human Use (Marketing Authorisations Etc.) Regulations 1994

Sch. 3

para. 6(b)

The Medicines (Codification Amendments Etc.) Regulations 2002

reg. 8(h)(ii)

reg. 1(1)

Medicines for Human Use (Marketing Authorisations etc.) Regs

The Medicines for Human Use (Marketing Authorisations Etc.) Regulations 1994

Sch. 3

para. 6(e)

The Medicines (Codification Amendments Etc.) Regulations 2002

reg. 8(h)(ii)

reg. 1(1)

Medicines for Human Use (Marketing Authorisations etc.) Regs

The Medicines for Human Use (Marketing Authorisations Etc.) Regulations 1994

Sch. 3

para. 6(c)

The Medicines (Codification Amendments Etc.) Regulations 2002

reg. 8(h)(iii)

reg. 1(1)

Medicines for Human Use (Marketing Authorisations etc.) Regs

The Medicines for Human Use (Marketing Authorisations Etc.) Regulations 1994

Sch. 3

para. 7

The Medicines (Codification Amendments Etc.) Regulations 2002

reg. 8(h)(iv)

reg. 1(1)

Medicines for Human Use (Marketing Authorisations etc.) Regs

The Medicines for Human Use (Marketing Authorisations Etc.) Regulations 1994

Sch. 3

para. 8

The Medicines (Codification Amendments Etc.) Regulations 2002

reg. 8(h)(iv)

reg. 1(1)

Medicines for Human Use (Marketing Authorisations etc.) Regs

The Medicines for Human Use (Marketing Authorisations Etc.) Regulations 1994

Sch. 3

para. 9

The Medicines (Codification Amendments Etc.) Regulations 2002

reg. 8(h)(iv)

reg. 1(1)

Medicines for Human Use (Marketing Authorisations etc.) Regs

The Medicines for Human Use (Marketing Authorisations Etc.) Regulations 1994

Sch. 3

para. 10

The Medicines (Codification Amendments Etc.) Regulations 2002

reg. 8(h)(iv)

reg. 1(1)

Medicines for Human Use (Marketing Authorisations etc.) Regs

The Medicines for Human Use (Marketing Authorisations Etc.) Regulations 1994

Sch. 3 para. 10(d) and words

The Medicines (Codification Amendments Etc.) Regulations 2002

reg. 8(h)(v)

reg. 1(1)

Medicines for Human Use (Marketing Authorisations etc.) Regs

The Medicines for Human Use (Marketing Authorisations Etc.) Regulations 1994

Sch. 3

para. 11

The Medicines (Codification Amendments Etc.) Regulations 2002

reg. 8(h)(vi)

reg. 1(1)

Medicines for Human Use (Marketing Authorisations etc.) Regs

The Medicines for Human Use (Marketing Authorisations Etc.) Regulations 1994

Sch. 3

para. 12

The Medicines (Codification Amendments Etc.) Regulations 2002

reg. 8(h)(vi)

reg. 1(1)

Medicines for Human Use (Marketing Authorisations etc.) Regs

The Medicines for Human Use (Marketing Authorisations Etc.) Regulations 1994

Sch. 5

para. 2

The Medicines (Codification Amendments Etc.) Regulations 2002

reg. 8(i)(i)

reg. 1(1)

Medicines for Human Use (Marketing Authorisations etc.) Regs

The Medicines for Human Use (Marketing Authorisations Etc.) Regulations 1994

Sch. 5

para. 2

The Medicines (Codification Amendments Etc.) Regulations 2002

reg. 8(i)(ii)

reg. 1(1)

Medicines for Human Use (Marketing Authorisations etc.) Regs

The Medicines for Human Use (Marketing Authorisations Etc.) Regulations 1994

Sch. 1

para. 3(1)(a)

The General Medical Services Transitional and Consequential Provisions (Wales) (No. 2) Order 2004

Sch. 1

para. 12

art. 1(1)

Medicines for Human Use (Marketing Authorisations etc.) Regs

The Medicines for Human Use (Marketing Authorisations Etc.) Regulations 1994

Sch. 1

para. 3(1)(a)

The General Medical Services and Personal Medical Services Transitional and Consequential Provisions Order 2004

Sch. 1

para. 12

art. 1(1)

Medicines for Human Use (Marketing Authorisations etc.) Regs

The Medicines for Human Use (Marketing Authorisations Etc.) Regulations 1994

reg. 1(2)

The Medicines for Human Use (Clinical Trials) Regulations 2004

Sch. 10 Pt. 2

para. 12(a)(i)

reg. 1

The Medicines for Human Use (Marketing Authorisations Etc.) Regulations 1994

reg. 1(5)

The Medicines for Human Use (Clinical Trials) Regulations 2004

Sch. 10 Pt. 2

para. 12(a)(ii)

reg. 1

The Medicines for Human Use (Marketing Authorisations Etc.) Regulations 1994

Sch. 1

para. 2(e)

The Medicines for Human Use (Clinical Trials) Regulations 2004

Sch. 10 Pt. 2

para. 12(b)

reg. 1

The Medicines for Human Use (Marketing Authorisations Etc.) Regulations 1994

reg. 1(2)

The Medicines (Marketing Authorisations and Miscellaneous Amendments) Regulations 2004

reg. 3(2)(a)(i)

reg. 1

The Medicines for Human Use (Marketing Authorisations Etc.) Regulations 1994

reg. 1(2)

The Medicines (Marketing Authorisations and Miscellaneous Amendments) Regulations 2004

reg. 3(2)(a)(ii)

reg. 1

The Medicines for Human Use (Marketing Authorisations Etc.) Regulations 1994

reg. 1(2)

The Medicines (Marketing Authorisations and Miscellaneous Amendments) Regulations 2004

reg. 3(2)(a)(iii)

reg. 1

The Medicines for Human Use (Marketing Authorisations Etc.) Regulations 1994

reg. 1(2)

The Medicines (Marketing Authorisations and Miscellaneous Amendments) Regulations 2004

reg. 3(2)(a)(iv)

reg. 1

The Medicines for Human Use (Marketing Authorisations Etc.) Regulations 1994

reg. 1(2)

The Medicines (Marketing Authorisations and Miscellaneous Amendments) Regulations 2004

reg. 3(2)(a)(v)

(aa)

reg. 1

The Medicines for Human Use (Marketing Authorisations Etc.) Regulations 1994

reg. 1(2)

The Medicines (Marketing Authorisations and Miscellaneous Amendments) Regulations 2004

reg. 3(2)(a)(v)

(bb)

reg. 1

The Medicines for Human Use (Marketing Authorisations Etc.) Regulations 1994

reg. 1(5A)

The Medicines (Marketing Authorisations and Miscellaneous Amendments) Regulations 2004

reg. 3(2)(b)

reg. 1

The Medicines for Human Use (Marketing Authorisations Etc.) Regulations 1994

Sch. 2

para. 3

The Medicines (Marketing Authorisations and Miscellaneous Amendments) Regulations 2004

reg. 3(3)

reg. 1

The Medicines for Human Use (Marketing Authorisations Etc.) Regulations 1994

Sch. 3

para. 6(cc)

The Medicines (Marketing Authorisations and Miscellaneous Amendments) Regulations 2004

reg. 3(4)(a)

reg. 1

The Medicines for Human Use (Marketing Authorisations Etc.) Regulations 1994

Sch. 3

para. 6A

The Medicines (Marketing Authorisations and Miscellaneous Amendments) Regulations 2004

reg. 3(4)(b)

reg. 1

The Medicines for Human Use (Marketing Authorisations Etc.) Regulations 1994

Sch. 6

para. 4A

The Medicines (Marketing Authorisations and Miscellaneous Amendments) Regulations 2004

reg. 3(5)

reg. 1

The Medicines for Human Use (Marketing Authorisations Etc.) Regulations 1994

reg. 9(14)

The Food Safety Act 1990 (Amendment) Regulations 2004

reg. 7

reg. 1(1)

The Medicines for Human Use (Marketing Authorisations Etc.) Regulations 1994

reg. 1(2)

The Pharmacy Order 2010

Sch. 4

para. 26

Sch. 5

art. 1(5)

art. 2(1)

Sch.

Medicines for Human Use (Marketing Authorisations etc.) Regs

The Medicines for Human Use (Marketing Authorisations Etc.) Regulations 1994

Sch. 3

para. 13C

The Medicines for Human Use (Advanced Therapy Medicinal Products and Miscellaneous Amendments) Regulations 2010

reg. 5

reg. 1(1)

The Medicines for Human Use (Marketing Authorisations Etc.) Regulations 1994

Sch. 3

para. 14

The Medicines for Human Use (Advanced Therapy Medicinal Products and Miscellaneous Amendments) Regulations 2010

reg. 5

reg. 1(1)

The Medicines for Human Use (Marketing Authorisations Etc.) Regulations 1994

Sch. 3

para. 17

The Medicines for Human Use (Advanced Therapy Medicinal Products and Miscellaneous Amendments) Regulations 2010

reg. 5

reg. 1(1)

The Medicines for Human Use (Marketing Authorisations Etc.) Regulations 1994

reg. 1(2)

The Medicines for Human Use (Advanced Therapy Medicinal Products and Miscellaneous Amendments) Regulations 2010

Sch. 5

para. 1(a)

reg. 1(1)

The Medicines for Human Use (Marketing Authorisations Etc.) Regulations 1994

reg. 1(2)

The Medicines for Human Use (Advanced Therapy Medicinal Products and Miscellaneous Amendments) Regulations 2010

Sch. 5

para. 1(c)

reg. 1(1)

The Medicines for Human Use (Marketing Authorisations Etc.) Regulations 1994

reg. 1(2)

The Medicines for Human Use (Advanced Therapy Medicinal Products and Miscellaneous Amendments) Regulations 2010

Sch. 5

para. 1(d)(ii)

reg. 1(1)

The Medicines for Human Use (Marketing Authorisations Etc.) Regulations 1994

reg. 1(2)

The Medicines for Human Use (Advanced Therapy Medicinal Products and Miscellaneous Amendments) Regulations 2010

Sch. 5

para. 1(b)

reg. 1(1)

The Medicines for Human Use (Marketing Authorisations Etc.) Regulations 1994

reg. 1(2)

The Medicines for Human Use (Advanced Therapy Medicinal Products and Miscellaneous Amendments) Regulations 2010

Sch. 5

para. 1(d)(i)

reg. 1(1)

The Medicines for Human Use (Marketing Authorisations Etc.) Regulations 1994

Sch. 1

para. 2(b)

The Medicines for Human Use (Advanced Therapy Medicinal Products and Miscellaneous Amendments) Regulations 2010

Sch. 5

para. 2

reg. 1(1)

The Medicines for Human Use (Marketing Authorisations Etc.) Regulations 1994

Sch. 3

para. 10B

The Medicines for Human Use (Advanced Therapy Medicinal Products and Miscellaneous Amendments) Regulations 2010

Sch. 5

para. 3(2)

reg. 1(1)

The Medicines for Human Use (Marketing Authorisations Etc.) Regulations 1994

Sch. 3

para. 11

The Medicines for Human Use (Advanced Therapy Medicinal Products and Miscellaneous Amendments) Regulations 2010

Sch. 5

para. 3(3)

reg. 1(1)

The Medicines for Human Use (Marketing Authorisations Etc.) Regulations 1994

Sch. 3

para. 12

The Medicines for Human Use (Advanced Therapy Medicinal Products and Miscellaneous Amendments) Regulations 2010

Sch. 5

para. 3(3)

reg. 1(1)

The Medicines for Human Use (Marketing Authorisations Etc.) Regulations 1994

Sch. 3

para. 13C

The Medicines for Human Use (Advanced Therapy Medicinal Products and Miscellaneous Amendments) Regulations 2010

Sch. 5

para. 3(4)

reg. 1(1)

The Medicines for Human Use (Marketing Authorisations Etc.) Regulations 1994

Sch. 3

para. 15

The Medicines for Human Use (Advanced Therapy Medicinal Products and Miscellaneous Amendments) Regulations 2010

Sch. 5

para. 3(5)

reg. 1(1)

The Medicines for Human Use (Marketing Authorisations Etc.) Regulations 1994

Sch. 6

para. 6

The Medicines for Human Use (Advanced Therapy Medicinal Products and Miscellaneous Amendments) Regulations 2010

Sch. 5

para. 4

reg. 1(1)

The Medicines for Human Use (Marketing Authorisations Etc.) Regulations 1994

Sch 5

para 5

The Medicines for Human Use (Marketing Authorisations Etc.) Amendment Regulations 2003

reg 2

Medicines for Human Use (Marketing Authorisations etc.) Regs

The Medicines for Human Use (Marketing Authorisations Etc.) Regulations 1994

Sch 5A

para 3

The Medicines for Human Use (Marketing Authorisations Etc.) Amendment Regulations 2003

reg 3

Medicines for Human Use (Marketing Authorisations etc.) Regs

The Medicines for Human Use (Marketing Authorisations Etc.) Regulations 1994

Sch 7

para 2

The Medicines (Child Safety) Regulations 2003

reg 7(e)

Medicines for Human Use (Marketing Authorisations etc.) Regs

The Medicines for Human Use (Marketing Authorisations Etc.) Regulations 1994

reg 1 defn(s)

The Medicines for Human Use (Fees and Miscellaneous Amendments) Regulations 2003

reg 7(1)

reg 7(2)(a)(i)

Medicines for Human Use (Marketing Authorisations etc.) Regs

The Medicines for Human Use (Marketing Authorisations Etc.) Regulations 1994

reg 1 defn(s)

The Medicines for Human Use (Fees and Miscellaneous Amendments) Regulations 2003

reg 7(1)

reg 7(2)(a)(ii)

(aa)

Medicines for Human Use (Marketing Authorisations etc.) Regs

The Medicines for Human Use (Marketing Authorisations Etc.) Regulations 1994

reg 1 defn(s)

The Medicines for Human Use (Fees and Miscellaneous Amendments) Regulations 2003

reg 7(1)

reg 7(2)(a)(ii)

(bb)

Medicines for Human Use (Marketing Authorisations etc.) Regs

The Medicines for Human Use (Marketing Authorisations Etc.) Regulations 1994

reg 1

The Medicines for Human Use (Fees and Miscellaneous Amendments) Regulations 2003

reg 7(1)

reg 7(2)(b)

Medicines for Human Use (Marketing Authorisations etc.) Regs

The Medicines for Human Use (Marketing Authorisations Etc.) Regulations 1994

reg 6A

The Medicines for Human Use (Fees and Miscellaneous Amendments) Regulations 2003

reg 7(3)

Medicines for Human Use (Marketing Authorisations etc.) Regs

The Medicines for Human Use (Marketing Authorisations Etc.) Regulations 1994

Sch 3

para 3A

The Medicines for Human Use (Fees and Miscellaneous Amendments) Regulations 2003

reg 7(1)

reg 7(4)(a)

Medicines for Human Use (Marketing Authorisations etc.) Regs

The Medicines for Human Use (Marketing Authorisations Etc.) Regulations 1994

Sch 3

para 6

The Medicines for Human Use (Fees and Miscellaneous Amendments) Regulations 2003

reg 7(1)

reg 7(4)(b)

Medicines for Human Use (Marketing Authorisations etc.) Regs

The Medicines for Human Use (Marketing Authorisations Etc.) Regulations 1994

reg.11

The Medicines for Human Use (Marketing Authorisation Etc.) Amendment Regulations 1998

reg.2

The Medicines for Human Use (Marketing Authorisations Etc.) Regulations 1994

Sch.3

para.11

The Medicines for Human Use (Marketing Authorisation Etc.) Amendment Regulations 1998

reg.5(1)

The Medicines for Human Use (Marketing Authorisations Etc.) Regulations 1994

Sch.3

para.12

The Medicines for Human Use (Marketing Authorisation Etc.) Amendment Regulations 1998

reg.5(2)

The Medicines for Human Use (Marketing Authorisations Etc.) Regulations 1994

Sch.5

para.5(1)(f)

(g)

The Medicines for Human Use (Marketing Authorisation Etc.) Amendment Regulations 1998

reg.3(1)

The Medicines for Human Use (Marketing Authorisations Etc.) Regulations 1994

Sch.5

para.5(2)(b)

The Medicines for Human Use (Marketing Authorisation Etc.) Amendment Regulations 1998

reg.3(2)

The Medicines for Human Use (Marketing Authorisations Etc.) Regulations 1994

Sch.5A

The Medicines for Human Use (Marketing Authorisation Etc.) Amendment Regulations 1998

reg.4

The Medicines for Human Use (Marketing Authorisations Etc.) Regulations 1994

sch 2

The Medicines for Human Use (Marketing Authorisations Etc.) Amendment Regulations 2009

reg 2

Medicines for Human Use (Marketing Authorisations etc.) Regs

The Medicines for Human Use (Marketing Authorisations Etc.) Regulations 1994

sch 1

The Medicines for Human Use (Miscellaneous Amendments) (No.2) Regulations 2009

reg 2

Medicines for Human Use (Marketing Authorisations etc.) Regs

The Medicines for Human Use (Marketing Authorisations Etc.) Regulations 1994

reg. 1(2)

The Medicines (Products for Human Use) (Amendments to Fees for Variations) Regulations 2009

reg. 9(2)(a)

reg. 10(1)

reg. 1(1)

Medicines for Human Use (Marketing Authorisations etc.) Regs

The Medicines for Human Use (Marketing Authorisations Etc.) Regulations 1994

Sch. 2

para. 1

The Medicines (Products for Human Use) (Amendments to Fees for Variations) Regulations 2009

reg. 9(3)

reg. 10(1)

reg. 1(1)

Medicines for Human Use (Marketing Authorisations etc.) Regs

The Medicines for Human Use (Marketing Authorisations Etc.) Regulations 1994

Sch. 3

para. 3A

The Medicines (Products for Human Use) (Amendments to Fees for Variations) Regulations 2009

reg. 9(4)

reg. 10(1)

reg. 1(1)

Medicines for Human Use (Marketing Authorisations etc.) Regs

The Medicines for Human Use (Marketing Authorisations Etc.) Regulations 1994

Sch. 5

para. 9

The Medicines for Human Use (Miscellaneous Amendments) Regulations 2009

reg. 2

reg. 1

The Medicines for Human Use (Marketing Authorisations Etc.) Regulations 1994

reg 1 defn(s)

The Medicines for Human Use and Medical Devices (Fees and Miscellaneous Amendments) Regulations 2001

reg 2(1)(a)

(b)

Medicines for Human Use (Marketing Authorisations etc.) Regs

The Medicines for Human Use (Marketing Authorisations Etc.) Regulations 1994

reg 1 defn(s)

The Medicines for Human Use and Medical Devices (Fees and Miscellaneous Amendments) Regulations 2001

reg 2(1)(c)

Medicines for Human Use (Marketing Authorisations etc.) Regs

The Medicines for Human Use (Marketing Authorisations Etc.) Regulations 1994

reg 1 defn(s)

The Medicines for Human Use and Medical Devices (Fees and Miscellaneous Amendments) Regulations 2001

reg 2(1)(d)

Medicines for Human Use (Marketing Authorisations etc.) Regs

The Medicines for Human Use (Marketing Authorisations Etc.) Regulations 1994

reg 4

The Medicines for Human Use and Medical Devices (Fees and Miscellaneous Amendments) Regulations 2001

reg 2(2)

Medicines for Human Use (Marketing Authorisations etc.) Regs

The Medicines for Human Use (Marketing Authorisations Etc.) Regulations 1994

reg 5

The Medicines for Human Use and Medical Devices (Fees and Miscellaneous Amendments) Regulations 2001

reg 2(3)

Medicines for Human Use (Marketing Authorisations etc.) Regs

The Medicines for Human Use (Marketing Authorisations Etc.) Regulations 1994

reg 1

The Medicines for Human Use (National Rules for Homoeopathic Products) Regulations 2006

reg 2

Medicines for Human Use (Marketing Authorisations etc.) Regs

The Medicines for Human Use (Marketing Authorisations Etc.) Regulations 1994

reg 4

The Medicines for Human Use (National Rules for Homoeopathic Products) Regulations 2006

reg 3

Medicines for Human Use (Marketing Authorisations etc.) Regs

The Medicines for Human Use (Marketing Authorisations Etc.) Regulations 1994

sch 1A

The Medicines for Human Use (National Rules for Homoeopathic Products) Regulations 2006

reg 4

Medicines for Human Use (Marketing Authorisations etc.) Regs

The Medicines for Human Use (Marketing Authorisations Etc.) Regulations 1994

sch 3

The Medicines for Human Use (National Rules for Homoeopathic Products) Regulations 2006

reg 5

Medicines for Human Use (Marketing Authorisations etc.) Regs

The Medicines for Human Use (Marketing Authorisations Etc.) Regulations 1994

reg 1

The Medicines (Sale or Supply) (Miscellaneous Amendments) Regulations 2006

reg 3

Medicines for Human Use (Marketing Authorisations etc.) Regs

The Medicines for Human Use (Marketing Authorisations Etc.) Regulations 1994

Sch. 1

para. 3(1)(a)

The General Dental Services, Personal Dental Services and Abolition of the Dental Practice Board Transitional and Consequential Provisions Order 2006

Sch. 1

para. 4

art. 1(1)

The Medicines for Human Use (Marketing Authorisations Etc.) Regulations 1994

reg.1 defn(s).

The Medicines for Human Use (Marketing Authorisations Etc.) Amendment Regulations 2000

reg 2

Medicines for Human Use (Marketing Authorisations etc.) Regs

The Medicines for Human Use (Marketing Authorisations Etc.) Regulations 1994

reg.3A

The Medicines for Human Use (Marketing Authorisations Etc.) Amendment Regulations 2000

reg.3

Medicines for Human Use (Marketing Authorisations etc.) Regs

The Medicines for Human Use (Marketing Authorisations Etc.) Regulations 1994

Sch.3. para.1 A

The Medicines for Human Use (Marketing Authorisations Etc.) Amendment Regulations 2000

reg 4(1)

Medicines for Human Use (Marketing Authorisations etc.) Regs

The Medicines for Human Use (Marketing Authorisations Etc.) Regulations 1994

Sch.3. para.6

The Medicines for Human Use (Marketing Authorisations Etc.) Amendment Regulations 2000

reg 4(2)

Medicines for Human Use (Marketing Authorisations etc.) Regs

The Medicines for Human Use (Marketing Authorisations Etc.) Regulations 1994

Sch.5

para 5

The Medicines for Human Use (Marketing Authorisations Etc.) Amendment Regulations 2000

reg 5

Medicines for Human Use (Marketing Authorisations etc.) Regs

The Medicines for Human Use (Marketing Authorisations Etc.) Regulations 1994

reg. 1(2)

The Health and Social Care Act 2012 (Consequential Provision—Social Workers) Order 2012

Sch.

para. 11(a)

art. 1(2)

Medicines for Human Use (Marketing Authorisations etc.) Regs

The Medicines for Human Use (Marketing Authorisations Etc.) Regulations 1994

reg. 1(2)

The Health and Social Care Act 2012 (Consequential Provision—Social Workers) Order 2012

Sch.

para. 11(b)

art. 1(2)

Medicines for Human Use (Marketing Authorisations etc.) Regs

The Medicines for Human Use (Marketing Authorisations Etc.) Regulations 1994

Regulations

The Human Medicines Regulations 2012

Sch. 35

Sch. 32

reg. 1(2)

The Medicines for Human Use (Marketing Authorisations Etc.) Regulations 1994

Sch. 7

para. 12

The Natural Mineral Water, Spring Water and Bottled Drinking Water Regulations 1999

Sch. 4

reg. 1

Medicines for Human Use (Marketing Authorisations etc.) Regs

The Medicines for Human Use (Marketing Authorisations Etc.) Regulations 1994

Sch. 7

para. 19

The Natural Mineral Water, Spring Water and Bottled Drinking Water Regulations 1999

Sch. 4

reg. 1

Medicines for Human Use (Marketing Authorisations etc.) Regs

The Medicines for Human Use (Marketing Authorisations Etc.) Regulations 1994

Sch.7

para.22

The Medicines (Restrictions on the Administration of Veterinary Medicinal Products) Amendment Regulations 1997

reg.4

The Medicines for Human Use (Marketing Authorisations Etc.) Regulations 1994

reg.1 defn(s).

The Medicines (Aristolochia) (Emergency Prohibition) Order 1999

art.2(4)

The Medicines for Human Use (Marketing Authorisations Etc.) Regulations 1994

reg. 1

The Pharmacists and Pharmacy Technicians Order 2007

Sch. 1

para. 17

Medicines for Human Use (Marketing Authorisations etc.) Regs

The Medicines for Human Use (Marketing Authorisations Etc.) Regulations 1994

Sch.7

paras.12

The Natural Mineral Water, Spring Water and Bottled Drinking Water Regulations 1999

reg.21

Sch.4

The Medicines for Human Use (Marketing Authorisations Etc.) Regulations 1994

Instrument

Scotland Act 1998

s.30

Sch.5 Pt.II

s.J4(a)

The Medicines for Human Use (Marketing Authorisations Etc.) Regulations 1994

Sch.7

para.22

The Medicines (Restrictions on the Administration of Veterinary Medicinal Products) Amendment Regulations 1997

reg.4

The Medicines for Human Use (Marketing Authorisations Etc.) Regulations 1994

Sch. 7

para. 11

The Food Labelling Regulations 1996

Sch. 9

reg. 1

The Medicines for Human Use (Marketing Authorisations Etc.) Regulations 1994

1Citation, commencement and interpretation

2Responsibility for Member States' functions under the Regulations and Directives

3Marketing authorizations for relevant medicinal products

4Applications for the grant, renewal or variation of a United Kingdom marketing authorization

5Consideration, and grant or refusal, of an application for, or for renewal or variation of, a United Kingdom marketing authorization.

6Revocation, suspension or variation of a United Kingdom marketing authorization or the suspension of the use or marketing of medicinal products.

7Obligations of holders of marketing authorizations, and offences by holders of marketing authorizations and other persons

8Control of retail sale of supply of relevant medicinal products

9Consequential and other amendments of the Act and the Medicines Act 1971

10Application of enforcement provisions of the Act

11Other Schedules to have effect

SCHEDULE 1EXEMPTIONS AND EXCEPTIONS FROM THE PROVISIONS OF REGULATION 3

1Regulation 3(1) shall not apply to a relevant medicinal product...

2The conditions mentioned in paragraph 1 are that—

3(1) Subject to the following sub-paragraphs, regulation 3(1) shall not...

4(1) Regulation 3(1) shall not apply to the placing on...

5(1) Regulations 3(1) shall not apply to a radiopharmaceutical for...

6Any person who sells or supplies a relevant medicinal product...

7A person required to maintain the records mentioned in paragraph...

SCHEDULE 2PROCEDURAL PROVISIONS RELATING TO THE GRANT, REVOCATION AND SUSPENSION OF UNITED KINGDOM MARKETING AUTHORIZATIONS

1Interpretation

2Scope and application of the procedural provisions

3This Schedule shall cease to apply if at any time...

4This Schedule does not apply— (a) if the licensing authority...

5Requirement to consult the appropriate committee or the Medicines Commission

6Provisional opinion against authorization

7Licensing Authority’s decision

8Confirmation or alteration of the decision after taking into account the advice of the Medicines Commission

9Person appointed to hear representations

10Any notification given under paragraph 9— (a) in a case...

11Right to be heard by a person appointed or to make further representations

12(1) Where the applicant or holder gives notice under paragraph...

13Cases where suspension is to have immediate effect

14If after suspending an authorization with immediate effect by virtue...

SCHEDULE 3OFFENCES, PENALTIES ETC.

1Offences

2Any person who, in the course of a business carried...

3Without prejudice to any other sanction which may be available...

4Where the use, supply or marketing of a relevant medicinal...

5Any person who is or, immediately before its revocation or...

6Any holder of a marketing authorization who fails promptly to—...

7Any person responsible for placing on the market a relevant...

8Any person responsible for placing a relevant medicinal product on...

9Any person responsible for placing a relevant medicinal product on...

10Any person who, while employed or engaged as an appropriately...

11Any holder of a marketing authorization who sells or supplies...

12Where, in relation to a relevant medicinal product—

13Any person who fails to keep any record required under...

14Penalties

15Miscellaneous

16Where the holder of a marketing authorization is charged with...

SCHEDULE 4MODIFICATIONS OF ENFORCEMENT PROVISIONS OF THE ACT

1In section 107 of the Act (validity of decisions and...

2In section 108 of the Act (enforcement in England and...

3In section 109 of the Act (enforcement in Scotland), in...

4In section 110 of the Act (enforcement in Northern Ireland),...

5In section 111 of the Act (rights of entry)—

6In section 112 of the Act (power to inspect, take...

7In section 118 of the Act (restrictions on disclosure of...

8In section 119 of the Act (protection for officers of...

9In section 121 of the Act (contravention due to default...

10In section 122 of the Act (warranty as a defence)—...

11In section 124 of the Act (offences by bodies corporate),...

12In section 125 of the Act (prosecutions)—

13In section 127 of the Act (service of documents), the...

14In Schedule 3 to the Act (sampling), in paragraph 1(1),...

SCHEDULE 5LABELS

1Interpretation

2Introductory

3Dispensed relevant medicinal products

4Delivery and storage

5Relevant medicinal products on a general sale list

6Relevant medicinal products not on a general sale list

7Prescription only relevant medicinal products

8Exemptions

SCHEDULE 6TRANSITIONAL PROVISIONS

1If on 1st January 1995 there is in force in...

2Accordingly any right conferred or obligation imposed by these Regulations...

3(1) Subject to sub-paragraph (2), any application for a product...

4The provisions of the Medicines (Labelling) Regulations 1976 and of...

5Until 31st March 1995 the Medicines (Products for Human Use—Fees)...

SCHEDULE 7CONSEQUENTIAL AMENDMENTS TO REGULATIONS

1In the Medicines (Exemption from Licences) (Wholesale Dealing in Confectionery)...

2In the Medicines (Child Safety) Regulations 1975 in sub-paragraph (d)...

3In the Medicines (Labelling) Regulations 1976— (a) for the heading...

4In the Medicines (Manufacturer’s Undertakings for Imported Products) Regulations 1977...

5In the Medicines (Leaflets) Regulations 1977 (a) for the heading...

6In the medicines (Fluted Bottles) Regulations 1978, in paragraph (g)...

7In the Importation of Animal Products and Poultry Products Order...

8In the Medicines (Sale or Supply) (Miscellaneous Provisions) Regulations 1980,...

9In the Medicines (Pharmacy and General Sale) Exemption Order 1980—...

10In the Health and Safety (Dangerous Pathogens) Regulations 1981, in...

11In the Food Labelling Regulations 1984, in Column 2 of...

12In the Natural Mineral Waters Regulations 1985, in sub-paragraph (c)...

13In the Merchant Shipping (Medical Stores) Regulations 1986, in sub-paragraph...

14In the Trade Descriptions (Places of Production) (Marking) Order 1988,...

15In the Medicines (Exemption from Licences) (Wholesale Dealing) Order 1990—...

16In the Children’s Homes Regulations 1991, in paragraph (1) of...

17In the Medicines (Applications for Grant of Product Licences-Products for...

18In the Specified Animal Pathogens Order 1993, in sub-paragraph (a)...

19In the Drinking Water in Containers Regulations 1994, in paragraph...

20In the Medicines (Advertising) Regulations 1994— (a) in paragraph (1)...

21In the General Product Safety Regulations 1994, in regulation 11(c)(ii)(aa),...

22In the Medicines (Restrictions on the Administration of Veterinary Medicinal...

1994 No. 3144

MEDICINES

The Medicines for Human Use (Marketing Authorisations Etc.) Regulations 1994

Made8th December 1994

Laid before Parliament9th December 1994

Coming into force1st January 1995

The Secretary of State, in exercise of the powers conferred by section 2(2) of the European Communities Act 19721, being designated for the purpose of that section in relation to medicinal products2, hereby makes the following Regulations: