Paragraph 11

A reference to the expiry date printed on the packaging of the product with—

(a)

a warning against using the product after that date;

(b)

if appropriate, details of special storage precautions to be taken;

(c)

if necessary, a warning concerning visible signs of deterioration;

(d)

the full qualitative composition (in active substances and excipients), and the quantitative composition in active substances, using common names, of each presentation of the medicinal product;

(e)

for each presentation of the product, the pharmaceutical form and content in weight, volume or units of dosage;

(f)

the name and address of the holder of the F1UK marketing authorisation F2..., Article 126a authorisation or traditional herbal registration relating to the product and, if applicable, the name of the holder's appointed representative; and

(g)

the name and address of the manufacturer of the product.

Annotations

Textual amendments

F1: Words in Sch. 27 para. 11(f) substituted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, reg. 204(3) (as amended by S.I. 2020/1488, reg. 1, Sch. 2 para. 158(b)); 2020 c. 1, Sch. 5 para. 1(1)
F2: Words in Sch. 27 para. 11(f) omitted (1.1.2025) by virtue of The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 143(b)