http://www.legislation.gov.uk/uksi/1994/3144/schedule/7/paragraph/20/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
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 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(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. 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(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. 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(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(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. 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. 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. 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(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. 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
19
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 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
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
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. 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
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. 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
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. 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. 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 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
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.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.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. 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
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
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
Regulations
The Human Medicines Regulations 2012
Sch. 35
Sch. 32
reg. 1(2)
The Medicines for Human Use (Marketing Authorisations Etc.) Regulations 1994
Instrument
Scotland Act 1998
s.30
Sch.5 Pt.II
s.J4(a)
SCHEDULE 7CONSEQUENTIAL AMENDMENTS TO REGULATIONS
20
In the Medicines (Advertising) Regulations 199451—
a
in paragraph (1) of regulation 2, after the definition of “essential information” there shall be inserted the following definition—
“marketing authorization” means a marketing authorization granted by the European Commission under Council Regulation (EEC) No. 2309/93 or by the licensing authority under the Medicines for Human Use (Marketing Authorizations Etc.) Regulations 1994 and includes a product licence granted by the licensing authority under Part II of the Act;
b
in paragraph (1) of regulation 3, for the words “product licence” there shall be substituted the words “marketing authorization”; and
c
in regulation 4 for the words “product licence” there shall be substituted the words “marketing authorization”;
d
in sub-paragraph (l) of paragraph (1) of regulation 9, for the words “product licence” there shall be substituted the words “marketing authorization”;
e
in regulation 12, for the words “product licence” there shall be substituted the words “marketing authorization”; and
f
in Schedule 2—
i
in paragraph 1, for the word “licence” there shall be substituted the word “authorization”;
ii
in paragraph 2, for the words “product licence” there shall be substituted the words “marketing authorization”; and
iii
in paragraph 5, for the word “licence” there shall be substituted the word “authorization”; and