Paragraph 10

In regulation 15 (amendment of regulation 18 (wholesale dealing in medicinal products))—

(a)

in paragraph (2)(c), in the inserted sub-paragraph (c)—

(i)

after “medicinal product” insert “into Great Britain”;

(ii)

omit “for either purpose”;

(b)

after paragraph (2) insert—

“(2A)
After paragraph (2) insert—

“(2A)
Paragraph (1)(c) does not apply to imports into Great Britain from an EEA State of medicinal products that have been released for sale, supply or distribution in an EEA State or the United Kingdom before IP completion day.

(2B)
For the purposes of paragraph (2A) a medicinal product has been released for sale, supply or distribution where, after the stage of manufacturing has taken place, the product is the subject matter of a written or verbal agreement between two or more persons for the transfer of ownership, any other property right, or possession concerning the product, or where the product is the subject matter of an offer to a person to conclude such an agreement.”.”;

(c)

for paragraph (3) substitute—

“(3)
For paragraph (6) substitute—

“(6)
A wholesale dealer’s licence does not authorise the distribution of a medicinal product by way of wholesale dealing, or possession of a medicinal product for the purpose of such distribution, unless—

(a)
in the case of a product for sale or supply in Great Britain, a UKMA(GB) or UKMA(UK), certificate of registration or traditional herbal registration is in force in respect of the product, or

(b)
in the case of a product for sale or supply in Northern Ireland, a UKMA(NI) or UKMA(UK), EU marketing authorisation, Article 126a authorisation, certificate of registration or traditional herbal registration is in force in respect of the product,

but this is subject to the exceptions in regulation 43(6).”.”;

(d)

for paragraph (4) substitute—

“(4)
In paragraph (7) for “paragraph (6)” substitute “paragraph (6)(b)”.”.