Paragraph 12 Offences

Changes not yet applied. Later legislation changes this provision in ways not yet written into the text below:

Sch 3, para 10A added by Medicines (Provision of False or Misleading Information and Miscellaneous Amendments) 2005 reg 3(a)
Sch 3, para 13A added by Medicines (Provision of False or Misleading Information and Miscellaneous Amendments) 2005 reg 3(b)
Sch 3, para 15 am by Medicines (Provision of False or Misleading Information and Miscellaneous Amendments) 2005 reg 3(c)
Sch 3, para 17 added by Medicines (Provision of False or Misleading Information and Miscellaneous Amendments) 2005 reg 3(d)
Sch. 3 para. 6(d) words substituted by Medicines (Marketing Authorisations Etc.) 2005 reg. 2(14)(f)(iii)
Sch. 3 para. 6(dd) inserted by Medicines (Marketing Authorisations Etc.) 2005 reg. 2(14)(f)(iv)
sch 3 am by Medicines for Human Use (National Rules for Homoeopathic Products) 2006 reg 5
Sch.3, para.11 amended by Medicines for Human Use (Marketing Authorisation Etc.) 1998 reg.5(1)
Sch.3, para.12 amended by Medicines for Human Use (Marketing Authorisation Etc.) 1998 reg.5(2)
Sch. 3 para. 3A word substituted by Medicines (Products for Human Use) (Amendments to Fees for Variations) 2009 reg. 9(4)
Sch. 3 para. 13C applied (with modifications) by Medicines for Human Use (Advanced Therapy Medicinal Products and Miscellaneous Amendments) 2010 reg. 5
Sch. 3 para. 14 applied (with modifications) by Medicines for Human Use (Advanced Therapy Medicinal Products and Miscellaneous Amendments) 2010 reg. 5
Sch. 3 para. 17 applied (with modifications) by Medicines for Human Use (Advanced Therapy Medicinal Products and Miscellaneous Amendments) 2010 reg. 5
Sch. 3 para. 10B inserted by Medicines for Human Use (Advanced Therapy Medicinal Products and Miscellaneous Amendments) 2010 Sch. 5 para. 3(2)
Sch. 3 para. 11 words inserted by Medicines for Human Use (Advanced Therapy Medicinal Products and Miscellaneous Amendments) 2010 Sch. 5 para. 3(3)
Sch. 3 para. 12 words inserted by Medicines for Human Use (Advanced Therapy Medicinal Products and Miscellaneous Amendments) 2010 Sch. 5 para. 3(3)
Sch. 3 para. 13C inserted by Medicines for Human Use (Advanced Therapy Medicinal Products and Miscellaneous Amendments) 2010 Sch. 5 para. 3(4)
Sch. 3 para. 15 words substituted by Medicines for Human Use (Advanced Therapy Medicinal Products and Miscellaneous Amendments) 2010 Sch. 5 para. 3(5)
Sch 3, para 3A added by Medicines for Human Use (Fees and Miscellaneous Amendments) 2003 reg 7(1), (4)(a)
Sch 3, para 6 am by Medicines for Human Use (Fees and Miscellaneous Amendments) 2003 reg 7(1), (4)(b)
Sch. 3 para. 6(cc) inserted by Medicines (Marketing Authorisations and Miscellaneous Amendments) 2004 reg. 3(4)(a)
Sch. 3 para. 6A inserted by Medicines (Marketing Authorisations and Miscellaneous Amendments) 2004 reg. 3(4)(b)
Sch. 3 para. 1A(1) Sch. 3 para. 1A renumbered as Sch. 3 para. 1A(1) by Medicines (Marketing Authorisations Etc.) 2005 reg. 2(14)(a)(i)
Sch. 3 para. 1A(1)(a) words inserted by Medicines (Marketing Authorisations Etc.) 2005 reg. 2(14)(a)(ii)
Sch. 3 para. 1A(1)(b) words inserted by Medicines (Marketing Authorisations Etc.) 2005 reg. 2(14)(a)(iii)
Sch. 3 para. 1A(2) inserted by Medicines (Marketing Authorisations Etc.) 2005 reg. 2(14)(a)(iv)
Sch. 3 para. 1AA inserted by Medicines (Marketing Authorisations Etc.) 2005 reg. 2(14)(b)
Sch. 3 para. 2 words inserted by Medicines (Marketing Authorisations Etc.) 2005 reg. 2(14)(c)
Sch. 3 para. 2A inserted by Medicines (Marketing Authorisations Etc.) 2005 reg. 2(14)(d)
Sch. 3 para. 4 words substituted by Medicines (Marketing Authorisations Etc.) 2005 reg. 2(14)(e)
Sch. 3 para. 7 words substituted by Medicines (Marketing Authorisations Etc.) 2005 reg. 2(14)(e)
Sch. 3 para. 8 words substituted by Medicines (Marketing Authorisations Etc.) 2005 reg. 2(14)(e)
Sch. 3 para. 9 words substituted by Medicines (Marketing Authorisations Etc.) 2005 reg. 2(14)(e)
Sch. 3 para. 10 words substituted by Medicines (Marketing Authorisations Etc.) 2005 reg. 2(14)(e)
Sch. 3 para. 6(b) words substituted by Medicines (Marketing Authorisations Etc.) 2005 reg. 2(14)(f)(i)
Sch. 3 para. 6(cc) words inserted by Medicines (Marketing Authorisations Etc.) 2005 reg. 2(14)(f)(ii)
Sch. 3 para. 6(e) words substituted by Medicines (Marketing Authorisations Etc.) 2005 reg. 2(14)(f)(v)
Sch. 3 para. 6A words inserted by Medicines (Marketing Authorisations Etc.) 2005 reg. 2(14)(g)
Sch. 3 para. 6B–6F inserted by Medicines (Marketing Authorisations Etc.) 2005 reg. 2(14)(h)
Sch. 3 para. 17 words inserted by Medicines (Marketing Authorisations Etc.) 2005 reg. 2(14)(i)
Sch. 3 para. 18 19 inserted by Medicines (Marketing Authorisations Etc.) 2005 reg. 2(14)(j)
Sch. 3 para. 6(a) words substituted by Medicines (Codification Amendments Etc.) 2002 reg. 8(h)(i)
Sch. 3 para. 6(b) words substituted by Medicines (Codification Amendments Etc.) 2002 reg. 8(h)(ii)
Sch. 3 para. 6(e) words substituted by Medicines (Codification Amendments Etc.) 2002 reg. 8(h)(ii)
Sch. 3 para. 6(c) words substituted by Medicines (Codification Amendments Etc.) 2002 reg. 8(h)(iii)
Sch. 3 para. 7 words substituted by Medicines (Codification Amendments Etc.) 2002 reg. 8(h)(iv)
Sch. 3 para. 8 words substituted by Medicines (Codification Amendments Etc.) 2002 reg. 8(h)(iv)
Sch. 3 para. 9 words substituted by Medicines (Codification Amendments Etc.) 2002 reg. 8(h)(iv)
Sch. 3 para. 10 words substituted by Medicines (Codification Amendments Etc.) 2002 reg. 8(h)(iv)
Sch. 3 para. 10(d) and words substituted for words in Sch. 3 para. 10(c) by Medicines (Codification Amendments Etc.) 2002 reg. 8(h)(v)
Sch. 3 para. 11 words substituted by Medicines (Codification Amendments Etc.) 2002 reg. 8(h)(vi)
Sch. 3 para. 12 words substituted by Medicines (Codification Amendments Etc.) 2002 reg. 8(h)(vi)

Where, in relation to a relevant medicinal product—

(a)

the labelling of the product, or any package leaflet accompanying the product, does not comply with; or

(b)

the product is not accompanied by a package leaflet required to be provided by virtue of,

the applicable requirements of Council Directive 92/27/EEC or Schedule 5, any person, other than the holder of the marketing authorization for that product, who in the course of a business carried on by him, sells or supplies or procures the sale or supply of that product knowing, or having reasonable cause to believe, that the labelling does not so comply or, as the case may be, that the product is not so accompanied, shall be guilty of an offence.