F1PART 12ASale of medicines to the public at a distance
Person who may sell medicinal products by information society services256B
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 of persons selling medicinal products at a distance that is published on the relevant website of the member State.
3
Condition B is that the product to be sold by information society services is covered by 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.
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 in the member State in which that person is established.
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 the competent authority in a member State in which the person is established.
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
the notification from that person is suspended by the competent authority of a member State; or
c
the competent authority of a member State has been notified under regulation 256E(b) to remove that person from the list.
Pt. 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