Paragraph 6

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)

Any person who sells or supplies a relevant medicinal product in accordance with any of paragraphs 1 to 4 shall maintain, and keep for a period of at least 5 years, a record showing—

(a)

the source from which that person obtained that product;

(b)

the person to whom and the date on which the sale or supply was made;

(c)

the quantity of each sale or supply;

(d)

the batch number of the batch of that product from which the sale or supply was made; and

(e)

details of any suspected adverse reaction to the product so sold or supplied of which he is aware.