Paragraph 7

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

Sch 1, paras 1, 2 am by Medicines for Human Use (Marketing Authorisations Etc.) 2005 reg 3
Sch. 1 para. 3(1)(a) words substituted by General Medical Services and Personal Medical Services Transitional and Consequential Provisions 2004 Sch. 1 para. 12
Sch. 1 para. 3(1)(a) words substituted by General Dental Services, Personal Dental Services and Abolition of the Dental Practice Board Transitional and Consequential Provisions 2006 Sch. 1 para. 4
sch 1 am by Medicines for Human Use 2009 reg 2
Sch. 1 para. 2(b) words revoked by Medicines for Human Use (Advanced Therapy Medicinal Products and Miscellaneous Amendments) 2010 Sch. 5 para. 2
Sch. 1 para. 2(e) substituted by Medicines for Human Use (Clinical Trials) 2004 Sch. 10 Pt. 2 para. 12(b)
Sch. 1 para. 1 words inserted by Medicines (Marketing Authorisations Etc.) 2005 reg. 2(13)(a)
Sch. 1 para. 2(e) substituted by Medicines (Marketing Authorisations Etc.) 2005 reg. 2(13)(b)
Sch. 1 para. 5A inserted by Medicines (Marketing Authorisations Etc.) 2005 reg. 2(13)(c)
Sch. 1 para. 3(1)(a) words substituted by General Medical Services Transitional and Consequential Provisions 2004 Sch. 1 para. 12
Sch. 1 para. 2(e) words substituted by Medicines (Codification Amendments Etc.) 2002 reg. 8(f)

A person required to maintain the records mentioned in paragraph 6 shall—

(a)

notify the licensing authority of any suspected adverse reaction such as is mentioned in head (e) of that paragraph which is a serious adverse reaction; and

(b)

make available for inspection at all reasonable times by the licensing authority the records mentioned in that paragraph.