[F1PART 12AU.K.Sale of medicines to the public at a distance

Textual Amendments

F1Pt. 12A inserted (coming into force in accordance with reg. 1(2) of the amending S.I.) by The Human Medicines (Amendment) Regulations 2013 (S.I. 2013/1855), regs. 1(2), 28

Person who may sell medicinal products by information society servicesU.K.

256B.—[F2(A1) This regulation applies to a person who is an established service provider (as defined in regulation 2(1) of the Electronic Commerce (EC Directive) Regulations 2002) in Northern Ireland.]

(1) A person may not sell a medicinal product at a distance to the public by means of information society services unless that person satisfies the following conditions.

(2) Condition A is that the person is included on the list F3....

[F4(3) Condition B is that the product to be sold by information society services is covered by a UK marketing authorisation or an authorisation granted—

(a)under Regulation (EC) No 726/2004; or

(b)by a competent authority of the member State in which that product is destined to be sold.

(3A) Condition B does not apply to—

(a)a special medicinal product;

(b)a medicinal product where the product is the result of a process of manufacture to which regulation 17(1) does not apply by virtue of any provision of section 10 of the Medicines Act 1968; or

(c)a medicinal product where—

(i)the product is a result of a process of assembly of a medicinal product that is an authorised medicinal product within the meaning of regulation 3(15);

(ii)regulation 17(1) does not apply to the process of assembly by virtue of any provision of section 10 of the Medicines Act 1968;

(iii)the process of assembly results in a change in the presentation of the authorised medicinal product; and

(iv)by reason of the change in paragraph (iii) the product does not comply with condition B.]

(4) Condition C is that the person selling the medicinal product is authorised or entitled to sell to the public, including by information society services, medicinal products of that type or classification F5....

(5) Condition D is that where the sale is to a member of the public in the United Kingdom, it is in accordance with regulations 214 (sale or supply of prescription only medicines), 220 (sale or supply of medicinal products not subject to general sale) and 221 (sale or supply of medicinal products subject to general sale).

(6) Condition E is that the person selling the medicinal product has given a valid notification to [F6the licensing authority].

(7) Condition F is that the person selling medicinal products at a distance complies with the relevant provisions of the Electronic Commerce (EC Directive) Regulations 2002.

(8) A person has not given a valid notification for the purposes of paragraph (6) if—

(a)that person is not included on the list;

(b)[F7that person’s entry on the list] is suspended by [F8the licensing authority]; or

(c)[F9the licensing authority] has been notified under regulation 256E(b) to remove that person from the list.]

Textual Amendments

F4Reg. 256B(3)(3A) substituted for reg. 256B(3) (31.12.2020) by S.I. 2019/775, reg. 197(3)(c) (as substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 151)

F7Words in reg. 256B(8)(b) substituted (E.W.S.) (1.4.2016) by The Human Medicines (Amendment) Regulations 2016 (S.I. 2016/186), regs. 1, 14 and words in reg. 256B(8)(b) substituted (N.I.) (1.4.2016) by The Human Medicines (Amendment) Regulations 2016 (S.R. 2016/407), regs. 1, 14