Paragraph 6 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)
Any holder of a marketing authorization who fails promptly to—
update information concerning the product or any connected matter as required by Article 4 of the 1965 Directive or Article 6 of Council Regulation (EEC) No. 2309/93; or
take any steps reasonably necessary to take account of technical and scientific progress for the purposes of making any changes or amendments as required by Article 9a of the 1965 Directive or Article 15.1 of Council Regulation (EEC) No. 2309/93; or
introduce any changes or make any amendments that may be required in accordance with those Articles; or
provide information to the EMEA, the Commission or the licensing authority as required by Article 15.2 of Council Regulation (EEC) No. 2309/93; or
submit any application to the licensing authority or the Community to make any changes or variation as required by Article 9a of the 1965 Directive or Article 15.3 of Council Regulation (EEC) No. 2309/93,
shall be guilty of an offence.